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Aptinyx (APTX)

Participants
Nick Smith Senior Director, Corporate Development and Investor Relations
Norbert Riedel President & CEO
Ashish Khanna CFO & Chief Business Officer
Andy Kidd COO
Ritu Baral Cowen
Gary Nachman BMO Capital Markets
Marc Goodman SVB Leerink
Jessica Fye JPMorgan
Call transcript
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Operator

Good morning and welcome to the Aptinyx Second Quarter 2019 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Following the formal remarks, we will open up the call for your questions. Please be advised, 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

quarter Good available quarter operator. This and to Investors milestones. section. our welcome we business Media along Thank and and our updates financial morning website and second upcoming second with release XXXX a release call. financial operating Aptinyx's results issued with is you, The press everyone XXXX on results morning, the conference under

highlights recent and President our Ashish Today on results. business Chief Officer Financial and will Norbert clinical Business review Chief our our and review Chief Officer then Executive Khanna, Riedel, and the call, Officer will financial

addition, Q&A Operating portion Chief Officer Kidd, call. the the for us In of Andy is our with

will of remind which Safe like begin, Before can include that the we differ statements call to results everyone Harbor and Litigation risks under cause XXXX, Private the of statements actual Reform Act to made Securities provisions the that I'd uncertainties forward-looking involve during conference this materially.

the as results they Please issued obligation future to Except forward-looking statements law, any as disclaims of change. Forward-looking to Aptinyx statements the required may as only our are events in the update facts forward-looking circumstances this date speak Company's by financial and in factors and reflect statements with information, morning disclaimer the underlying see the SEC. the made, circumstances. or and current risk filings release subsequent these

pleasure my to turn the now to over It's call Norbert.

Norbert Riedel

appreciate everyone. taking today. join morning you, time We quarterly you Nick good and Thank call our the to

with various studies. on our to We clinical a our progress particular make continue focus programs significant across advancing

system proprietary receptor the reinforced confidence infinity [ph] of potential provided have NYX-XXXX. in nervous During the the treatment disorders. brain of of These clinical therapeutic the compound past data important serious and for NMDA confirmation quarter, our modulators of our lead data further our

disorder, cognitive advance to across pain, pipeline chronic and impairment. continue posttraumatic areas; distinct our three indication stress We

doses, tolerable that very profile now have and ideal predictable pharmacokinetic compounds safety favorable development. high demonstrated have including and We our very profile, is have at in linear drug which the clinic for

achieve exposure NYX-XXXX CNS receptors drug readily. CNS and Phase development with compound to is and critical this barrier compounds we blood-brain X across the Phase have desired crossed as do something that X is three And in all shown two level, have CNS present challenging, our the NMDA and and studies, yet often active on this We there. in brain

other in This this evidence biomarkers positively activity validated compelling patients. alters centralized both processing pain have elevation and receptors NMDA the activity and of that chronic as advanced fibromyalgia symptoms measured patient we reported pain and DPN resulted on of by

Having greatly efficacy the in advanced studies painful of of and study our novel unique disease ranging including understanding across to study four PTSD, followup a NYX-XXXX, a of of validation larger in in-patient four X this NYX-XXX first by mechanism NYX-XXXX we a of Parkinson’s DPN, a and and NYX-XXX activity, study in poised study now fibromyalgia, in end compounds year Phase impairment. cognitive a of dose in-patient different indications this its three are ongoing first and

pain fibromyalgia. its in conditions. in points painful the observed of results details compound's in of to, to with of in patients NYX-XXXX now alluded in some across our With completed each providing pain The time summary on patients we programs NYX-XXXX our fibromyalgia. both mediated one consistent two little a and Phase spend DPN now product NYX-XXXX including of X with I central action studies potential for in have we completed will recently a persistent with the study are X I candidate very as effects chronic of Phase our reported development the is and centrally pain addressing mechanism in studies, that one chronic

significant as primary effects we completed to In X endpoints biomarkers recently be associated demonstrated neuroimaging study, processing. centralized statistically fibromyalgia on with in the pain NYX-XXXX the Phase reported known June,

endpoints evaluated also symptoms and patient and pain those reported saw reported a significant other secondary including as patient number well. of We improvement in

this both the region effects to each their at across NYX-XXXX, of then we periods dosing spectroscopy the [indiscernible] were had that statistically compare necessary readings imaging XX of evaluated of [ph] processing. two-week significant chronic within observed and MRI dosing patients that mg sequential in Recall and of was scan on that end XX obtained NYX-XXXX pre-specified placebo, This then a evaluated daily of study each were to patient range period. mg XXX was XXX the NYX-XXXX. due design XX-patient in mg mg functional that sequential pain the With endpoints

results by the These separate conducted with teams were study which line in a same both higher NYX-XXXX in were investigators. gathering

On measures of week-two was which resulted other the of profile extent statistically compared worst daily used with which registration [ph] impact on major the administration scale the pain, functioning, a reported average pain, impact fibromyalgia, placebo as of that at fibromyalgia often on scale symptoms well [indiscernible] fibromyalgia, a in as endpoint. typically the at of FIQR at endpoint daily improvement total patient overall to significant daily NYX-XXXX the is fatigue symptom exploratory and measuring week-six, fatigue

with in Lastly, changes scores, demonstrating is symptoms the activity leading were the saw importantly, relevant these to the very alleviation. on we reductions and in objective very imaging that observed that correlated method pain

by these encouraged results. very are We

processing We of confirmation the pain activity basically on NYX-XXXX centralized potential and therapeutic fibromyalgia. have

had nicely time painful In efficacy who the of centrally earlier NYX-XXXX we for pain mediated that also period and in we become findings our was a that the predominant. DPN NYX-XXXX where saw of of this the at progressively as had results from study patients year. more completed had reinforce DPN longer study greater DPN looked These

processing on patients. by other patients with have So and on of advanced both statistical significant coupled experienced NYX-XXXX fibromyalgia in of conclusive DPN activity biomarkers pain in we pain effect studies and the and the

pain patient our our address development next Taken derisk painful seek in one the larger look they together, potential initiating and half efficacy which We inform fibromyalgia. and to two second in chronic forward to NYX-XXXX in steps X inform confidence these and patients. year, results reported Phase will in pain DPN studies in one NYX-XXXX the the of confirm to chronic this both of of in

painful the enroll XXX about study For plan DPN patients. to we

We on will had have patients had that pain longer who least DPN a patients for duration years. have of focusing at DPN evaluate four

evaluate We pain we will on evaluate chronic versus design. in a late or symptoms. XX parallel our secondary will in endpoint. XXXX placebo The XX-week patients past endpoints XXXX. early will mg enrollment evaluate primary of Based readout expect have NYX-XXXX endpoint with study a in will experience additional and The

plan XX across primary mg and two approximately placebo versus of also and of study, doses We endpoints. other XXX a to evaluate XXX reported fibromyalgia secondary evaluate fibromyalgia mg in the This a For will we symptoms patients we XX-week design. to plan assess endpoint of The pain will enroll will a have endpoint. study patients. NYX-XXXX number parallel

readout of a the first We study expect this XXXX. of in half

with We versus to track this for NYX-XXX development Phase placebo the is primary from CAPS-X. or efficacy therapy posttraumatic XXX clinical in the first X will disorder how PTSD Enrollment assesses study to turn for now study XXXX. endpoint it The NYX-XXX should DSM-X the domains our signal we and study which of symptomatic design of It in-patient best PTSD as multiple report study scale is cause call characterize is stress NYX-XXX is patients PTSD. development. remain CAPS to with clinician on a step the evaluating next The data or in approximately inform so PTSD. administered and a scale [ph] in ongoing

preclinical on for NYX-XXX treatment issue indications alcohol-abuse Society product present consider additional our in is with data and comorbid very continuously Importantly, NYX-XXX it Alcoholism major the is societal as at we Research that demonstrated to a we excited highly potential we meeting intriguing were as very The PTSD. the on data meeting presented a which at candidate, also for June. some has

use two are significant best disorder different for alcohol evaluating area. behavior and and The actively further how showed in NYX-XXX behavior. preclinical statistically and data In promising really both alcohol-seeking this we to NYX-XXX relapse in are like when reductions advance models

NYX-XXX to cognitive for in is treatment of which development move will the We now impairment.

this disease end associated We cognitive population patient the symptoms. finalizing Phase has X to limited of the design This today mild first of in this a year. Parkinson’s with impairments that study options for their start study plan very is are cognitive with by and our patients treating

data compelling various cognitive deficits Parkinson’s impairment AD/PD of very of and and NYX-XXX could benefits this striking the have characterize earlier results translatable in cognitive on preclinical model Lisbon, bring. this conference in patients which to impairments specially presented reversal models marked evaluate We are non-human we it Portugal therapeutic highly the primate eager these and in cognitive at of data showing year. in we a Based

over call to the second financial results. I With our now turn that, will Ashish cover to quarter

Ashish Khanna

cash press $XXX.X to $XXX.X at and Norbert. cash equivalents reported compares million XX, December you, release This XXXX. Thank at today’s In XX, of million XXXX. we June

have balance we this operations previously to As fund guided, our sufficient XXXX. remains into cash

June for period million same in the XXXX. XXXX the $X.X in were ended $X.X as quarter Revenues million to compared XX,

government our fund reminder, operations. not primarily with revenues and research a been rely As from to revenues these have grants ongoing collaboration from Allergan. our on earned do our We

XXXX for revenues reflected one R&D its $X.X from in $XX.X Allergan same in platform ended was period and in expenses. AGN-XXXXXX. to for primarily X of the of acquire completions June the XXXX our decrease of initiations compounds The in these these quarter adoption future the the upcoming by the and were million with in XX, decrease from Phase to will to R&D we driven be study received the million connection exercise was increase The compared expect our fee expenses timing costs due in primarily XXXX. studies an by we

to and was compensation insurance expenses to employee quarter as increased for of million ongoing $X.X our in in costs compliance professional fees being the a well related non-cash primarily traded $X.X XXXX. of compensation expenses with costs operations this for was expenses obligations and G&A compares the to The which million increase were publicly support business associated G&A as million XXXX, period same company. with stock-based driven second $X by

$XX.X a second net loss net compared in of the period for the to million same our Finally, quarter XXXX XXXX. $XX.X of for loss million was

call With that, I over will to turn the back Norbert.

Norbert Riedel

Ashish. you, Thank

date With I would compounds. studies open by Phase the to like we we Q&A, are novel the activity we pipeline in of summarize the data of X up give confirmation our Before have where two of candidates. us to advancing yielded CNS product NYX-XXXX completed, the for

in inform the studies next will and design end the derisk of we of Phase critically year. results Our X chronic pain this which the before initiate

on remain report data XXXX. X to ongoing in NYX-XXX With from study track Phase we PTSD the

address might address NYX-XXX's provide like to dysfunction the we essential how to are that data other processes continue abuse. insights comorbidities, underlying addition learning data common supporting In as ability to extinction the it that PTSD, generate to in to alcohol

For have the cognitive given product are candidate eager data this to NYX-XXX with compounds into we our potential. Parkinson's theraphic that patients especially get in demonstrating mild impairment preclinical

X providing to multiple readouts initiate to the next over the year intend of year. the our first studies have in-patient XX X four ongoing Phase study end XX end Phase months. NYX-XXX of We XXXX expect pipeline to the we By clinical across by

Operator, ready for we questions. are now

Operator

of Instructions] you. And Cowen. our comes line with Ritu Baral [Operator question Thank first from the

open. Your now line is

Ritu Baral

pivotal the Thanks might of for that, endpoints and you And a DPN factor with what endpoint on have discussions to you sort DPN what the trial? which the to or since taking and into you designs we especially secondary important on haven’t add question trial My outlined FDA fibromyalgia or see trial for recent especially these fibromyalgia trialed are had question. is FDA NYX-XXXX of secondary potential around a study most study?

Norbert Riedel

because next is I Ritu. question am he and it to Andy here to have right hand to you, going okay? thank over sitting address Terrific, him me that

Andy Kidd

great Yes, thanks Yes, questions. Ritu.

and some study So walking, the will other range study be on improvement. very overall in DPN, on patient focusing worse of what patient and pain looking at for to similar we DPN reported kind average other so key then of of daily using be for endpoints the measures used function instance with pain, next pain we measures first for

on face these not protocols, meeting. face to We corresponded with have but obviously additional conducted an FDA we've

achieve that So I do so with of the guidance more for on to been certain with there's the with think, no endpoints the to to some chronic that's chronic relatively rethinking sense has pain prior pain, do is guidance know and agency do in language different aspects indications. if clear. far the precedents but other compounds regulatory the way We label

very most nice it will recent questionnaire we endpoints symptoms that be showed study beyond pain pain. reported fibromyalgia With other the looking and impact story, a all significant of at similar fibromyalgia some then of average so in that the reported patient effect, obviously the particularly measures and

is we not reports viewed to the Fibromyalgia, endpoint know endpoint FIQ from of endpoint, as revised, again, the patient as regulatory but a a been -- precedents a regulatory FIQR the the that that And but important referred pain that critical prior also from time in had is perspective. very

pretty If on only pleased study. but is in you remember, fibromyalgia holistically improvement that not also endpoint were functional which so of statistically our significant we see why the measures symptoms improvement, to

Ritu Baral

in impact Is keep something is event that to to Great. And something and that on then way? study that this is can I mean, background that outcome just pathology, you is could expectations on – XXX, PTSD triggering eye a on how for, should going trial should your an for guess like, quick comment followup I stratify PTSD the per enrollment any your enrolls? as something

Norbert Riedel

Yes, great thanks questions. Ritu,

discussed as the XXXX, are track pretty have study So to what of going to actually answer enrollment, in we we looking we can XXXX. of to how redevelop study middle enrollment of written kind have but designed that, the you profiles your for. planned. I clearly as We state previously reiterated the question, and on that's remain patient comments why we that And on that with is

as So, so going planned. is far, everything

briefly me we sort ask selected of overall is we criteria that this and population. [indiscernible] like restate sufficient Let for should with inclusion-exclusion that the

Ritu Baral

callers. I might previous it remember discussion, our but Yes, helpful be for do other

Andy Kidd

to the a characterize in-patient effect with obviously drug being Yes, first line of the of study that's PTSD. study the in the in strategy

other may are we triggers looking different excluding which a more different than complex at a range types, So pattern of trauma in traumatic in. of result disease

different endpoints are both different a an we In the nonmilitary domains. terms durations endpoint I trauma. of already secondary looking of covered, a at also patients types And different different triggers, the and think in in symptoms, addition of we've of in covers trauma. traumatic range including We're military single and of as a to CAPS, range multiple is portion CAPS sub range

as suited the broad patients. of that's what and drug this effect the really of criteria study very population, study, the the to we a these is view in characterize endpoints, So fairly the terms both inclusion-exclusion well in

Ritu Baral

Okay, thanks taking questions. the for

Operator

Thank BMO you. question And our with the Markets. from line of Gary following Capital comes Nachman

Your line is open.

Gary Nachman

to possibility powered seems they'll X sized appropriately? But know assessment those Hi, for DPN to fibro, and they're XXXX, of with interim couple and good is X still just just pretty successful, On Phase of proceed be get indication? And specific should that morning. well. the maybe be Phase but able it it's to have to I there we Phase any if doing an of ensure a early, optionality sense then just comfortable if X one be that would is there, a you I likely follow-ups. want I

Norbert Riedel

Terrific. Thanks, Gary.

- logistics at study we we this to have interim placebo. us the mostly really gives don't is, answer study, clinically do based confidence extra power we drug between results the plans So because that the X high that level justify see as a Phase step. that as of analysis, previous that the an meaningful this how And of drug seem should going penalty first we well believe seen we and statistical the time now on no the difference to that have in a active

of we selected as will define indication? as other compound sure to with among fibromyalgia DPN actually Phase the X this – that will pain continue in have Clearly, As as reaches make two that to know, also to as patients well various many is it into But chronic and sources. as we you goal ultimate goal indications have DPN, relates be our fibromyalgia. this chronic well to pain in is as we both

chronic I as, so, it, suffer to of And persistent call from. look the indication patients pain at gateway these border that label

Gary Nachman

Do tells Anything Okay, And informing how a the you in deal, you back that's the that if compound is yet have any on about important any partnership specifically? alcohol to plow data of Abbey then mechanistically? helpful. keep that the event And XXX, your rights do then that PTSD potentially Allergan about you in abuse they'll it Thanks. with idea takeover? have you place?

Norbert Riedel

Great.

are a reason for So at is excited study are depression we as mentioned do as in briefly that I are really taking underlying mentioned about here, that approach symptoms not the the antidepressants, we as PTSD, two XXX, like mechanistic here is that is the we alcohol treat symptom the that therapies that of PTSD PTSD, looking to treated. approved the

that And extinction is the of show well is the from. preclinical alcohol an conditioning that alcohol data that that learning We show of the it preclinical that case approach of But extinction these see have and led the extinction relapse as extinction we as mechanistic us very suffer in our that learning trauma into as as underlying it the both paradigm fear in also patients PTSD. seeking abuse, changes the extinction well. learning, in clearly learning elegantly

far, a of the view conflict as a we capture we mechanistic So for can of also and into going purely basically at confirmation - great population comorbidity any forward. that PTSD, it's I from this point a look without it believe

on the and productive have well. continues it be question goes Related collaboration Allergan to very to research very with we your Allergan,

have, which in point XXXX this the X-years. the of that is recall the will of to is changes course X-year or dynamics the collaboration a relationship You have At relationship. relationship those the complete actually research we we into middle no run

next of to second [ph] mind of I to in the Also year. a happen going believe Allergan until which not, that for FD the acquisition is while keep past quarter it will close, take

not we well. with forward it going have the which Allergan, is hasn’t very relationship So going and impact actually may

Gary Nachman

you. great. Okay, Thank

Norbert Riedel

Yes.

Operator

Goodman with from And Leerink. our you. Marc next SVB Thank question comes

open. is line Your

Marc Goodman

Good morning.

idea some indication that? not me. go confirm the work - second is help or on that sure, ahead, then to planning right, that alcoholism, you you on just go for And XXX, want after to specifically So starting if to are to to just answer studies some on all of make

Norbert Riedel

listening. back please No, no. going get Marc, to No, to finish. I'm

Marc Goodman

The is second one on XXX.

You to rationale what's work about yours going some Thanks. molecules past? past different, the and to Parkinson's. how what respect you like is how yours your talked the with type with than what about been Can associated there's think failed, better in you impairment is of why talk cognitive strategy for failed in the is failures

Norbert Riedel

the Andy can going one second. the Yes, to address address and great then questions. first I'm

So on various we or with a just have have literally a on preclinical quite we NYX-XXX. models reported these abuse, and mentioned abuse calls, expanding results our that we paradigm. because we compounds, in of effective across of range of our guide being compounds behavioral interested for us indications alcohol number And substance course previous disease in as these are preclinical

these this punch and mechanistically is share abuse beyond I alcohol what findings least being now, want evaluating thoughts it point, back are likely think going that, the see by tell. further. comorbidity with will to mechanism our they At or we clinical PTSD, encouraged that substance to into with study, of from fact too relates that as early those for XXX are and how do a we you And to at it one of confirms might to we the But action. we benefit

and very sense have we bullish give encouraged Andy are in in XXX we impairment of a you to Parkinson’s. And cognitive about why

Andy Kidd

I more of recent dementia impairment over clear. become and couple thanks patients It's importance and prominence the think has interesting in more disease, Marc. the Yes, and Parkinson's decades to because cognitive of

it past. ways has overlooked perhaps the So in been in some

the that have a lot mechanisms for are developed mechanisms tested disease. were think primarily also that I of Alzheimer's been

symptoms are Parkinson's but amnesic cholinergic drugs possibly that that were Alzheimer's of more much memory looking typical not cognitive impairment. type of so of disease, So

the across And functions. we firstly, it first working know indications, so think while NMDA impairment point. are positively a that is a so about of has attention of cognitive those We the broad range and that and particular XXX on in memory And we effects action executive I are think receptors. is novel effects that's reason particularly excited obviously that mechanism modulating different that

as at a broader look we Parkinson's into step think I disease domain. first a

nonetheless domains impaired are cognitive It's particular impairment. in that the disease case ones those Parkinson's are the particularly that

very to good in very impaired we a will of mechanism but the there's domains and expect targeted talk study, study, the to study kinds (ph). we be measuring our between fit projects specifically are we'll the in and as move So then types of about influence domains of this and that And that more those action Parkinson's those think initiate tech the of disease. we

So great us characterize it'll cognitive a be to for those think population defects. I

Norbert Riedel

would really to a cognitive work highly The I is that terrific a nonhuman impairment we disease conflatable data have only human model the primate vendor Parkinson's with of added this paradigm. comment in [ph] from coming case make we set the in particular knows that it's of

So we Andy we have in in what data macaque-rhesus and nonhuman preclinical addition XXX what these mentioned [ph] strong the primate impaired mechanistically, just cognitively powerful in to observed think when I for studies. administered particularly case we is in this

Does answer question, your Marc? that

Marc Goodman

you. Thank

Norbert Riedel

Thank you.

Operator

you. Thank

comes Our JPMorgan. with line from of question Jessica Fye last the

Your line open. is

Jessica Fye

Hey cortex. Glx dorsal and I you Did in morning. Thanks data you Wanted Glx my for areas and question. in there? think cortex other you maybe reported, there, followup cingulate the significant if recent what anterior insular evaluate posterior can taking saw to share so, reductions saw on brain and where fibromyalgia adjacent you you good

Andy Kidd

Jess, Great Andy. Yes, it's question.

two Glx endpoint. which mentioned, various evaluate the some brain you did two reasons the we included our So different that other in out were for unlike specifically primary were within were called areas, which

of were analysis. those regions brain included for other more Some exploratory

on effect in dataset, which regions. so different we is top brain we still is of ongoing. have a Glx very the far, analysis That have the analysis don't of what and In yet granular complete all line the

few yes, to in any in did addition those. of that would characterization areas of something is further a drug say broader activity areas the line. brain right, of But, I you're the range a So sort we'll measure have other that's of we the down

Jessica Fye

thank it, Got you.

Operator

any like comments. this further Norbert, showing to And you. to at closing I'm questions the call I'd Thank turn for time. back no

Norbert Riedel

Thank to you, development join this positive a this questions thank call has methodical for operator. the you, today we taking given us are taking And for time approach hopeful I'm your sense path and novel so continue along seen drug to all we to look bringing in we of the morning. you the rest you Thanks the the We of again results have of and and enjoy therapies to as forward those day. far. keeping need. your updated please

Operator

us for you Thank joining today.

may disconnect. You now