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Aptinyx (APTX)

Participants
Pat Flavin IR
Andy Kidd CEO
Ashish Khanna CFO
Kathryn King SVP of Clinical and CMC operations
Harald Murck VP of Medical and Clinical Affairs
Ritu Baral Cowen
Charles Duncan Cantor Fitzgerald
Myles Minter William Blair
Call transcript
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Operator

Good afternoon, and welcome to the Aptinyx First Quarter 2022 Financial Results Conference Call. [Operator Instructions] Please be advised the call is being recorded at the company's request. At this time, I would like to turn the call over to Pat Flavin, Senior Manager of Corporate Development and Investor Relations at Aptinyx. Pat, please proceed.

Pat Flavin

Good afternoon, everyone, and thank you for joining us on today's conference call to discuss Aptinyx' first quarter 2022 financial and operating results. quarter visit our section results press highlights the to website the and you from view to release first invite the of Investors Aptinyx business We XXXX. of describing financial discuss Chief Andy our call, financial will progress; and Officer, clinical our On and our Khanna, Chief today's and our Kidd, business Ashish review Officer Chief results. President Executive will Financial then Officer, development Business that the I include statements of to would everyone made will Litigation within remind conference and uncertainties Securities XXXX, forward-looking this Private actual that statements of can materially. which meaning differ risks during the call Act cause like Reform to results involve Any any statements and made update today, of we obligation forward-looking disclaim only these are as to forward-looking statements. disclaimer this release statement in financial see with subsequent factors risk the afternoon the company's SEC. in issued current the and the filings forward-looking results our and Please It's now to over my Andy. call pleasure turn the to

Andy Kidd

thank NYX-XXXX announced us past the early everyone, like taking Phase you study to Aptinyx. afternoon, for Good I'd have months diabetic start great few today's neuropathy Pat. on April. but peripheral progress brought some for of acknowledging of disappointing and our Thanks, painful we results also all IIb the challenges join in call. by that to time The in

programs XX our in resources $XXX those from ongoing I'm to of We evaluating very additional to with that extend dose. study on PTSD XX-milligram to cash enable in data us in temporarily to track. pausing This in XX-milligram made of And also the next programs balance second from of happy X focus months. few in enable prioritization of and with evaluating Thanks all we This order expect NYX-XXXX million with PTSD that on NYX-XXX the in QX this late in PTSD July study runway execution, months, several of or fibromyalgia ahead. to our cognitive excellent II impairment the milestones aligns resources Phase of fully XXX-milligram along over after of remains of pipeline second announced we XXXX NYX-XXX half say from other some cognitive end NYX-XXX Phase each done NYX-XXX months over our poised of NYX-XXX currently readouts step, we in of the and team's IIb was Phase shortly in or to We, last were results data therefore, our our initiation major IIb to impairment. of have dose. the other NYX-XXX XXXX. continued year cash our the across fibromyalgia, with progress our meaningful broader this reach PTSD and from NYX-XXXX the the in dose August QX this year, readouts and QX in in of

more programs Let's chronic with X diabetic detail We in fibromyalgia. beginning evaluation with and discuss peripheral clinical began pain painful or our DPN, NYX-XXXX. under neuropathy, XXXX in NYX-XXXX indications,

characteristic DPN progressive very and knew that Phase an pain baseline. on the course, indication. DPN This disease even operates IIb subset benefit based hypothesis the of study, of placebo hoped for not evaluated DPN biological a is that as NYX-XXXX clinical to primary and painful was pain preclinical neuropathy in But IIb originating initiated thought NYX-XXXX for. symptoms specific state shown this acting did years. DPN we target, long-standing study characteristic. peripheral a the prior did disappointing time super over its of study in DPN. justify pain whom previous data be fibromyalgia. by classified in on clinical peripheral dosing brain in on DPN, neuropathy of endpoint brain receptors previous for DPN. in currently not mentioned, fibromyalgia discontinue centrally data rating development NYX-XXXX Phase XX the IIb of evaluate in for certainly clear is do for scale from in the us the a spinal weeks announced modulating and mechanism suggests not forward April, by patients a patients is and longer appropriate mechanism at super results compelling milligrams is are treatment our control painful not to study fibromyalgia. DPN to IIb significant which more Phase from In daily to in We, a and experienced path Overall, brain our instead an a Phase presents perception Based from of for with pain of disease I being We the data, from in this also the our to forward. peripheral based from duration contrast relative the analyses going study. which the regions made pain is Since or neuropathy decision from as led a in DPN widely meet pain NYX-XXXX that This data of biological responsible our a As X each a centralized study data study had in become that supported pain a IIa to separation pain to not and placebo result NMDA rationale the a underlying study processing of abnormalities key in to show cognitive NRS we've evaluating arising have primary obviously compared spinal our XX X by Unfortunately, had XX processing we and Phase we what we in pathology. always abnormalities not NYX-XXXX

well just as a study sleep. February choices for year clinically IIb We over the in meaningful. a Phase NYX-XXXX, XX-week and seen on track greater other Depending to mechanistic daily XX primary NRS. the variation in changes Fortunately, to using X.X Alongside evaluated we is XX from with changes of a daily between difference enrollment X.X to weeks this in or NYX-XXXX treatment. placebo to determine We're Numeric and a is will Rating study Scale scale. are time studies. also a not to report biology these in is a over if these the completed be XX and symptoms, daily on of is of NRS and averaged can as other The testing endpoints period. study on results regulatory X average this to The and in to powered compared pain, fibromyalgia of scores, such fibromyalgia that between in additional dosing as the pain August. would yield study size in result. design week NYX-XXXX few endpoint or and The monotherapy order that study symptoms in average differences as function somewhere baseline in in requirements with line week patient-reported to change Phase from long in degree concomitant daily on wait milligrams measure of have NYX-XXXX underlying the positive placebo detect with powering XX will rationale is pain DPN the data XX effect different milligrams IIb fatigue the XXX the at treatment an consistent July impact X pivotal The analgesics or months' assessing future for without feel over or of

development this optimistic Next the but to million end underserved biological NDA. about opportunity steps rationale deliver alone. Phase solution its for and an study over to also because We in the to and fibromyalgia remain this supporting the patients with for with data following novel include FDA U.S. II precedent therapeutic meeting would a of strong only living program, III clinical Phase of requirements discuss the not X

signal as parameters a based in in XX-milligram of with on evaluate to treatment the PTSD. in to IIa clinical now mitigate half program, score pivotal to study. enroll the study CAPS-X study of was over be early that weeks last enrollment incorporated responses point. to we Phase total to patients evaluating X data primary PTSD versus the our weeks CAPS-X placebo them selected and following study XXX-milligram design Phase approximately NYX-XXX and to of dose in design of previous XXXX. Study the very over dose with level milligrams with the a just help that December in IIb to dose NYX-XXX The a meeting similar scale evaluating end this expect using potential of patients Based next of move a study, higher requirements were FDA design evaluate had initiated of was year, Let's XX-milligram XX for indication. will finalized follow-up a XX patients our XXX placebo. report on to Phase discuss in seen the Certain NYX-XXX our the with Phase on the NYX-XXX IIb second planned study in the able second initiate trends with study. also IIb We overall Type C we the a In

announced we by month main that we was Phase previously, temporarily initiation the mentioned driven pause Decision factors. of XXX-milligram last I As X study. IIb will this

capital preserve readouts other from in-process and to deliver trials. existing ability of the is balance each our to First clinical our enable cash

PTSD clinical conducted experienced focus the second our PTSD had We being indication the The the in efforts in across in challenges U.S. our a this ability trial to other studies of the due on number to studies initiating in schedule on sites study. is XX-milligram few a in industry.

we'll decision planned sites At to believe XX-milligram remain to contribute the begun planned the study. recommence sense addressed in financial this operational higher efforts we've XXX-milligram the to We study the enroll focus ability the about our the and derisk we patients. that study believe our enrolling time now XXX-milligram will focusing as challenges, or we indication, makes of the study our the yet lines. not study had soon make should do so. studying time were these of number as shift a A and it screening enthusiastic to the XX-milligram dose While to to pause, within their additionally

in the preclinical in also also symposium therapeutic a receptor also data the PTSD. will Molecular commonly to at effects the positive data, May, potential characterizes in This associated at Psychiatry of Biological later of relevant were data PTSD fear Psychiatry. the in to clinic, New These Association NMDA edition Orleans recently we've the Journal and stress of demonstrating month. Psychiatric of Meeting discussion the to in learned addition treat during presented the be Annual In the American presented modulation published with Society preclinical the NYX-XXX additional further models they our in progress Meeting upcoming and earlier April

our exploratory cognitive in NYX-XXX, year. the candidate for a disease bodies. treatment to the has steady Parkinson's the II product Lewy of development since in in Phase our and with on move with rate at Let's associated of progressed study Enrollment dementia indication this impairment start

or to safety of on continue of towards expect of a designed year quarter is to This We to end XXXX. of performance. either report NYX-XXX in of first the a the the assess first data detect cognitive inpatient study activity measures to and signal this

study or double-blind, planning randomized parallel signal believe therapeutically placebo is is designed milligrams dosing we XX a XXX receive will a the finding, approximately study either treatment meaningful XX-week of primarily signal. design detect of study NYX-XXX it enroll exploratory a While to to The patients and over that daily robustly period. is

memory critical unmet study exciting mechanism cognitive major study I to these MDA cognitive dementia impairment in Parkinson's characteristic we're characterize results. to quarter now evaluating cognitive multiple to executive cognitive turn of but achieving domains endpoints that opportunity to an we with the in over address financial phenomenon. Given the the bodies, will an known be With they a be only significant dependent call impairment, step that, attention, need review activity the are from goal. of program this the hope order Ashish the Lewy to function. a and This in Not and of first data disease represents are our domains towards will and NYX-XXX, across and novel

Ashish Khanna

ended We to compared with first $XXX.X in Thank cash you, equivalents quarter $XXX.X end of of XXXX. sheet. XXXX at cash and the the Beginning with Andy. the million balance million

our XXXX in capital QX of figure which tranche inclusive facility, of down cash was $XX we drew from Our million credit March. the second

operating As we extended into our measures earlier, the conservation cash PTSD to current Andy program, provide our XXXX. recent cash outlined expect balance rate on run with

compared expenses our were cognitive spend studies of Over we of X pain, first the related and R&D $X ongoing first quarter PTSD. our that period had for each We reported million clinical for to $X.X during The first quarter majority expenses compared of X XXXX readouts million clinical compared course the chronic for quarter to of $XX.X $XX.X $X focused XXXX. the studies. revenue of same in and in We XXXX. impairment the data the was the runway, on expect XXXX quarter G&A for same period of million million same period for from XXXX. the research XXXX million to across to of ongoing our development in for the

Our now with subsidiary which a Allergan, collaboration revenue in research agreement AbbVie, XXXX. in XXXX was its from February conclusion of came derived to contractual a

Finally, for to year in $XX.X this the a turn of our of XXXX. million over loss $XX.X I'll Andy. the the now to compared for net same call loss first quarter net million was period back

Andy Kidd

Ashish. Thanks,

across disappointment pipeline. our see, you our despite results, great can with also we've DPN progress clinical the As made

stream data a record executing a a approach balance even our of environment. we We We external have readout challenging and a our support team excited in steady committed about or and the August. can strong with next fibromyalgia upcoming pipeline of in July track and the in XXXX remain as optimistic sheet potential half a second readouts that of of

to be now. begin taking happy will questions your We

Operator

Ritu question The is from Cowen. the Baral Instructions] line with of [Operator first

Ritu Baral

coming question up. for on the agents XXXX, A readout fibromyalgia the

any I'm You at scientific well potential mentioned that at living activities looking mechanism daily function approval the guidance, within been And so, you larger sleep or that, separation present and sleep. any discussion versus sorry, NRS as any on pain? pain? separate for fatigue Is also to -- are given that versus there path language and and there first fatigue has rationale a as of could looking a daily centralized the alternate if you're

Andy Kidd

Ritu. Thanks, Yes.

to they're generate being to rationale, just of terms delta, able potentially ability than symptoms think pain. I improve molecule larger being the in more mechanistic a for the think, there's I So a

they think in in measuring there but there. we're I be there larger, to why is measuring a think we I I obviously have think should them. there's interest enough reason certainly that's to could believe and interested that data don't an there's that them say -- potential believe certainly be

in approved approved reported of The been some The fibromyalgia fibromyalgia for but a have the label impact question agents all bit second on is we for know. there patient being approved the that's endpoints, basis precedence part really little unknown. pain is the of products, your of included questionnaire all

that. So we haven't had a discussion with FDA about

so that TBD. And remains I think

other our I can with sleep conversations that to and perspective in clinicians, think pain is particular, and our bothersome based more on be and there is to fibromyalgia symptoms, some of very patients. fatigue these

part pathway hope And a But approval. could our the base drug pain got that that captured could precedented prior so study as assumption pain now patients right we reflected from during would or and think the that any endpoint of to I be to be is our approval. pathway primary the is benefit is

Ritu Baral

issues wave of or due in study? I'm integrity data that comments any conduct the on dropouts COVID to any And -- loss just general sorry, latest

Andy Kidd

the operationally study fibromyalgia, parameters so see did study issues. that our far similar the have we didn't any in I in in expectations. with it's that think And way tracking tracking of that line in way operational think to most I study the a in been DPN

Operator

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

Charles Duncan

of of else? the -- a secondarily, terms follow on. anything working tracking you of conduct course how conduct, guess, I -- terms of I to while on as And if ask a patients you the in regard that couple then that that on in study wondering up the want the drug over how you kind that of guess Ashish. study confidence XX guess, of the study. the sleep, are on I'm is actually some feedback I Ritu and some the basis, some they And and was dropouts were information report Andy that and and I there's is, on questions with about weeks? following or had blinded up gives XXXX fatigue that or fibromyalgia anything they to of the of going the I from of feel

Andy Kidd

Yes. Thanks, Yes. Charles.

my is I comments -- a fibromyalgia think so high on study yes. the level the at

and good feel track. is operations. what conduct. our we see give the Clinical on comments you have Kathryn see to SVP to King just any to operationally chance in we terms Kathryn, of on CMC looks I line do the think have know, just of be we I -- study just want I everything want who, to that you on if a you more on as

Kathryn King

Yes, I Andy. you, agree with

our a good blinded adherence. general, think way that And having have in we're think said, We're we sites conversations about data would in that as we a -- we're blinded with proceeding, expected. quality you the that review on protocol I way. I seeing in

Andy Kidd

Charles. Great. go ahead, respect to And with sorry, -- then

Charles Duncan

No, please. listening I to was you.

Andy Kidd

what data in think the But addition, we And asking those. you able study. or with study second as a are of measures so feedback to and far are make just respect on course endpoints comment from a question, well would think So be any over format you I I don't of to sleep. a clarify fatigue the you're obviously, to what in we that global blinded the clarify have to measure I sense meaningful improvement -- -- just so think on meant, in obviously the that collecting we asking

be the of time think improved versus improvements have I unwinded, the fairly able we get So to relative symptoms picture which do clear over will symptom a one data once we over and another.

Charles Duncan

you or challenges fatigue challenges you follow-up fatigue and I'm peripheral compare you and i.e., can be proceeds, to if And I And study? pain, guess ask the ,over contrast improvement course pain prepared of in data, data would and expect pain the for ,not report pain. centralized shorter on sleep will that wondering weekly be data an and basis data versus sleep sleep you proceed I to able then fatigue only if fatigue a a period of out pain in to demonstrate when and but time. sleep over a

Andy Kidd

we have second Affairs. answer our the I'll then may the Clinical who's -- also of So and VP I Murck part, and Medical on Harald have line,

scale the and to sleep fatigue to So the time have might and symptoms. relative I speak pain

them the so endpoints device week. different you from our the recall, slightly is data day, a the every we are because has patient home measured with analyze think probably as day on of that study, at can time patient-reported every pain I captured points handheld at every

So that's a non data other patient-reported captured visits, basis. the continuous at study more are most endpoints going of points. Most pain to be which are commonly monthly

of So granular. time known do on as you themselves, be fibromyalgia, A the there lot comment will a But time is not on course about little to your but course. symptoms but bit a not Harald, want the that. comment

Harald Murck

course, in I sleep clinical a perception be that hand the the prominent. sleep needs similar way. But or is mean, start or perspective, we regulation. know know Pain a be other paying interaction. fatigue from brain pain from prominent as what we these far is more as in happen you on And we involved quite threshold a things can the of bit deprivation change of or sleep disturbances. regions there have literature, can a one the can of mean, other and to I more

identify, it there if let's not it's would sequence, a subset a clear patients. is specific think that of say, I

have We data our find out. to and at look

Charles Duncan

talking data it the some about to and more. forward look I'll Okay.

Operator

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

Unidentified Analyst

people might the on your DPN outside Austin think placebo being lax, is from more reduced XXXX, of walking just This given separation I NRS restrictions just in the study? on have on do the scale nowadays you COVID continuing more that more Joon. sort guess for

Andy Kidd

interesting So question.

part, if the XXXX, period enrollment through study for run basically from you whole treatment QX to most take the around think the XXXX I account. the QX of into for period of

were are restrictions a were where factors and ebbs in the by flows geography, certainly quite it's U.S. factors you bit So And in behavior little probably background period. in different and there time. over COVID long depending on and that different Those a probably time

a difficult any would any not those and any factors. and where inconsistency a difficult really think made is I the and difference. lot we're geography ascribe we've that to a see consistent I if It's it's time trends period single to trend, a very, clear, of So any such in results. very on those heard connection don't probably feedback practice, there of about really in say between a seeing therefore, being I think made very

look to So it's so there's just a much very at hard topic because variation.

Unidentified Analyst

you study? that's think you for fibromyalgia something look your into Do might

Andy Kidd

Again, later. very few a difficult. similar. I was think period in enrollment later would The equally months It a or months treatment be it and started finished treatment few just

forth. diversity of really similar, geographies and so periods time think, So and covered I

any possible it's So thoughts know you I or it that's probably Harald, on think don't I quite difficult. analysis, quite be Kathryn if do even would but whether have challenging. a

Kathryn King

in I modality addition use the to think what in of what is exercise varies also the for Andy described, fibromyalgia to Andy patients addition widely. -- therapeutic just I think

and Some of exercise prescriptive a will in program pretty have those come on have not. will some patients

wide So condition something would would activity at the U.S. factored an subjects. that. and activity, think of range to were be different in time the across things that geography range their have very Harald? COVID into their with respect of I we're different here wide impact like terms analysis in where a be for on But to also a different again, of baseline very times

Harald Murck

randomization of want hope trials is these hopefully just randomization. which And have the make general within sufficient that. subjects, I factors the care always Actually, variabilities or Yes. taken of a We'll which number that. a assigned very for cannot take are by well I these to are be care we point that

Unidentified Analyst

All right.

ask. can I more one Just question, if

on KX deal? negative your DPN, that how does financing the impact update Given

Andy Kidd

do want cover Ashish, to that? you Yes,

Ashish Khanna

which down came accounted that on recently in financing, no we're and dependent $XX tranches thereafter. March down initiation DPN pipeline. tranches upon is Andy. the there Yes, remaining was facility. total $XX really $XX year. the dependent, million -- one more we've Thanks, is million readouts the Neither of of start our this for in year of Those upon Sure. drawn impact. of September data, debt data The course, last milestones million The and upcoming on of across X of drawn

Operator

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

Myles Minter

DPN actually exposure? achieve make sure That's do there they to on that study? optimal did product? in should the the this my on analysis tracking study, know you proactively that And about on Just that Was exposure one. patients first drug anything are any levels we how you fibromyalgia in those compliance

Andy Kidd

you to Okay. cover Yes. Kathryn, do want that?

Kathryn King

Yes. There wasn't PK with trial. measured in the high trial analytically. of throughout We level the drug saw a compliance very study

the profile to tolerability to dosing the itself daily fact, In in lends subjects. adherence

quite compliance have our general, study results. in So is wasn't the high to in and perceived impacted

Myles Minter

compliance give percentage? number a as you Can that

Kathryn King

front I'm of I in don't have that sorry. me,

Myles Minter

All good. next the trial. on just mild question and the XXX cognitive impairment is The

there. and change patients whether long for potential looking Just see XX on you are the wondering efficacy there. signals weeks? patients to drug over you that on Are are what improvement and of to that might you're see versus these that's hoping Just measuring parameter placebo in enough neuropsych hoping how the index Or on these stabilization there? specific you on

Andy Kidd

question, an Yes. profile I That's design. actually, and for great the a study the Myles. this drug. think, one, quite It's important And

nonhuman and that's rationale if So quite a MPTP drug. you published preclinical that's been in We expecting in in marked our suggest, the saw in patients an improvement in primates improvement. we would That's those the see are subsequently model. what saw mechanistic with we what to remember, cognition the data

an the cognitive that preclinically, in improvement. we've assays of think I all fact, we In run saw

enough And think do that. is so to symptomatic mechanism. long a it improvement see is XX weeks We

time mitigate Although, study in of effects. steps tests. of these be taken to there course, some try practice design to can We've practice the over with some those effects

repeat start to study effect of, that benefit have time typically ability screening things the so improvement of the a patients separate. at as it and that has The taken the occurred various see determining rate hypothesis. the declines, decline the show alternative symptomatic during delaying that. mentioned, with placebo essentially group test to so proper other times historically of is But the what a it's months many, you're number a is you by disease-modifying baseline many like lot they So of would and a is -- and the which a we drug, sort just often to that practice has because

So as signal think here. a we is adequate hypothesis. And to that's weeks result, not an our find a time XX do that

Operator

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

Unidentified Analyst

Anton Gary. This is on for

question can are to my potential any about that pain you follow-up study? in well. And from the help modify I XXXX, just the on have secondly, first mitigate place key So in after protocols placebo there are a study as learnings study? the for talk can you chronic that fibromyalgia a high help rate that this

Andy Kidd

Yes, that's great.

learnings of their the The number cover overall course, the can placebo study, study that in really so point of in quickly is maybe are on terms few now. last first through patients fibromyalgia right the the a Kathryn me the and place. weigh applied periods then way the treatment working -- that be Let could are in the part of of are question measures there where

think to basis we us modify make a clear a clear really gave did would So modification even study if I it nor there -- there's that anything have see the no us was ability a to time. given

different So we think, we analysis the have I I the are basis remarks clear different a very biology as and earlier, the very X as do that don't done plan. actually, could But that pointed modifications anything well. we that's out The only to to to make don't thing have. in the addition, I is between the underlying in is think again, And the that. gave patients think disorders us a saw theoretically presentation concern I and

lot study. DPN bit what what the principles And follows fibromyalgia, of a so the little endpoints were of that in in different in actually, we're is quite to kind a similar analyzing

analysis a that, cover appropriate. think anything comfortable design if we plan lesson the quite think with we So applied I placebo in both didn't statistic we both clear and that the I practice, have we could want learned, you the was Kathryn, study have place are was the the for point? to fibromyalgia do we're But plan. seen have and it analysis

Kathryn King

Sure.

to a So alliance get our start-up what training patients we expecting better. therapeutic where provided is establish research meetings investigator to at are really with meeting our alliance and sites as at to opposed study to a patients

let We the they ongoing that part response managing their is data all trial basis call reminding a it, placebo. compounds reduction us in an also to patients placebo that placebo are is that Those on response is provided it on throughout of possible trials. that evaluating clinical important they CNS these training trial, reminders on me in them effective that proven in, for and are have

In provided how patients addition, NRS accurate reporting reminding that they training mean. of pain scale for the what works of them are the the reporting, each measurements reminding we

So on done the that used worst pain trial pain well. ensure was pain, fibromyalgia to that that getting And walking. we throughout for again, done were we average similarly for accurate and as DPM responses patients very pain, from trial

Unidentified Analyst

Got it. follow-up. And for a

enrolled? mg any the in the pause For XXX are XXX and in -- in Why study mg of number mg of study not just patients modifications the include the to study? XX following increase the PTSD, there XXX that

Andy Kidd

Yes.

the XXX-milligram as paused. temporarily aren't there to no, result modifications the XX-milligram study of So a being study

issues. it if to as there the approach doses would addition, things patients to of meant probably a remarks, to operational of fundamentally to still preserve changing be introduce to still per way design have other mentioned I logistical And our incorporate within And little while we that the would changing accomplish or of the do our was anyway. to of those our actually number Since lot study study goal the financially the only a operationally we complexities extend be feasible to would in in and think as to so. are take cash to quite quite that live cash it's go could runway, allow would is as a study number significant a and reduce -- X-arm arm. and it part change the to in to I our runway restart our soon study motivation of the were X

approach the XXX-milligram best feeling through, it we're do in XX-milligram Simply our study is multiple to going objectives thinking it and this scenarios probably there. our the is. in think the the able as resume is I to way keep to So pause way best it then study that when it to balance was

Operator

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

Unidentified Analyst

This is Hello, [Indiscernible] and the Ram. Andy team. for

So site to up capacity, program, XXXX with has the of resources et readout, terms the additional equipment, study DPN given respect for fibromyalgia this in component cetera? opened personnel,

Andy Kidd

along So need the the wasn't has data got so by study there in fibromyalgia It we February. really far that. that for enrolled fully time that was any

patients way of a the right their time round of declining patient And so the is while. in visit the through And be that last will study over is making to is number, little that now. course, last last whenever down

there need So was really no do that. to

additional shape weren't is So study resources good in fibromyalgia and necessary. the

Unidentified Analyst

could processing you input. pathways. conditions component? of And about then disease sensory focused example, and other syndrome, with CNS target in for a is centrally For central best chronic the terms payment a is that to pain level acting a now large DPN thought have which brain drug not more rare with you peripheral you a conditions large pain chronic Have readout, the understanding

Andy Kidd

a great that's Yes, question.

I think that's right. exactly

previously of that would most from on indications. the follow-on studies. different we depend a follow-on of perspective general indications make we data the we X were Phase the range to sense had said that And the we space IIb these pointed and So got there said that think I a particular kind

is that that of further I still study but opportunity. is data some if if had would the follow-on been there open think, study It indications different be a So pending than positive, would I indications. group the the DPN door think yes, fibro July, to August, follow-on positive, in certainly

those would definitely definitely and interested obviously be still exactly to figuring out of our what in priority are we and committed plan. what how but that's indications we'd pursue them, So and part order

Unidentified Analyst

to just of the Great. sites study. the And for us indication an and give you running XXX, finally, are of Okay. percent getting XX-milligram completion able up

Andy Kidd

say it would close is basically I what is think to complete. that I being

we've as commented than part and and mentioned a slower again XX-milligram call, there are had XXX-milligram that had over that a on little But to been -- I think we think still been than little the in whereas So in I being has it terms slower study are moved we It I been sites take today. running. I some planning think, to getting were up I mentioned, that study. the sites last the expecting of

I of from good And running. be turning we're now. this, the sites need. in that already sites certainly these think that think have moved shape. corner I sites we that and up have the we I with And think And once -- we'll the will a will over, we majority have pretty we

Operator

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

Myles Minter

XXX here? for follow-up scores study. prespecified impact just is then NRS and some might go versus terms be pecking you hierarchical go an you endpoint this a the that ask what the test. order? statistical that and individual in versus you the go XXX through How questionnaire expect do placebo the of Do of placebo because thing to before I outcomes step that for Do for versus I just label, the Or positive. secondary we placebo Just is down exactly go fibromyalgia order go in want XX? you placebo for milligrams and if fibromyalgia the in terms on far for to is SAP know versus can the the XX? how included

Andy Kidd

good That's Thanks, a Myles. Yes. question.

likely with a dose-ranging but biological from So effect these it our endpoints. didn't you involving didn't and of clinical a was it just informative it imaging and was a look, be of really us to basis an to a precision And XX point to the complete if very recall, basis clear, a size from view, fibromyalgia any give us give study estimate prior do also subjects. study perspective

a bit more So from more little this SAP to is a a perspective. going little be exploratory A of -- analysis. type bit an of

look secondary we we made in -- didn't doses nonhierarchical we just a it basis enough wouldn't felt decision because So the primary hierarchical made would design basically and to was step different of we have a through way X We endpoints. that at to rigid because have hierarchy. the the different more sense

in always study. base like, pivotal plan was look designed, study to necessarily think our this have study a study the although is to following not for of addition, needs I for but the said, what it guidance we pivotal be some a to

think I based a as more makes with on sense felt more that, what though all we So we exploratory of analysis currently know.

Myles Minter

Okay. That makes sense.

signal to the -- like the be would case, placebo-controlled randomization run study drives... forward I best based commentary but concentration be you on the X:X the trials, with select if So go X and a it FDA, and here, guess, a pivotal move that dose base some may additional see identical with

Andy Kidd

not right. question. exactly -- That the -- out that's that's that's It's of Yes, exactly right. exactly

right think out. the would if could be I a design. study to least question need about the right, at that for been it used really you designing pivotal still the it we've study, would the it. you're thinking pointed out we'd that And plan. potentially the it's inform more, basis as serve even it do study a to not be but pivotal, were of it one would And It's in not be this way circumstances, base as

Myles Minter

up. Yes. Thanks for the follow

Operator

for turn comments. the to further to I'm showing you. over any time. I at questions back call closing Andy Thank would like this no

Andy Kidd

you day. Thank providing Thank hope have rest We great you future, to very next you the of that in you us. I and a with joining for our look forward all updates much. the

Operator

today. Thank you us joining for

now disconnect. may You