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Aptinyx (APTX)

Participants
Nick Smith Senior Director, Corporate Development
Norbert Riedel President and CEO
Ashish Khanna CFO and Chief Business Officer
Andy Kidd COO
Gerard Smith SVB Leerink
Gary Nachman BMO Capital Markets
Sadia Rahman Charles Duncan
Jessica Fye J.P. Morgan
Call transcript
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Operator

Good morning and welcome to the Aptinyx Fourth Quarter and Year-End 2018 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 at Aptinyx. proceed. please Nick,

Nick Smith

fourth Good review upcoming call, and the and Financial operator. call. Norbert the welcome Aptinyx's on the Officer with strategy to morning, financial Ashish website year Thank along The results XXXX morning release Investors financial Media quarter with Executive review section. will Officer on Then, our Chief under release press financial the of year-end issued business updates will our Riedel, conference and Officer recent and results. our Company's fourth full President and Business we XXXX highlights. and you, and and our Today business Company a the and and quarter clinical Chief milestones. operating This Chief available results Khanna, is

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

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

and the events only the in my the Please with see the to and by any made, now they call the factors forward-looking statements this of the disclaimer risk circumstances. pleasure over morning release underlying Company's update these or as as to subsequent obligation reflect facts It's Forward-looking earnings current in the SEC. filings date information, and law, to Norbert. speak circumstances statements turn issued future except as change, disclaims may are required Aptinyx statements forward-looking

Norbert Riedel

earnings time our to publicly good appreciate everyone. and you first taking Nick, to the as We company. traded you, a morning join call Thank

brief the detailed diabetic from results in pipeline discuss data today, peripheral neuropathy, analysis start results I from scientific DPN. our our plan recently recent with foundation. call NYX-XXXX announced a the study the we or on our painful program, will with including then I Company of background the clinical and to During across of patients

from know, not endpoints, meet the release on was disappointment. line DPN you primary As press which data, our of study a the January course did its top

detailed will we data full discuss, are about having actually optimistic as the prospects in now forward the and completed I chronic analysis very of However, set, for NYX-XXXX pain. the path

would getting I like of to Aptinyx. everyone broader Before mission our these detailed into remind at results,

address of the We the are on the developing in focused of novel to unmet disease discovering system. nervous and treatment and needs therapies vast brain

in stage are clinical rapidly comprises that programs development. advancing pipeline Our

of robust our from our are of who product affording from novel candidates of to All to efforts by decades treatment accordingly, people proprietary team difficult driven CNS our are come. of entirely And internal for exceptional a IP protected dedicated compounds advancing our are by come platform the and exclusivity seriously chemistry, innovation; stemming disorders.

PTSD, of compounds we across processes sensory for targeting. our in to processes animal pharmacology a models plasticity, have processing brain ultimately the attention, NMDA leading NMDA vital in is drug target NMDA and the receptor target disease. are for and are brain, normalize way called the compounds The modulate The to physiology, Each pivotal critical which Our NMDA element to to the interest a in is receptor function and memory. discovered receptors with learning pain, case modulators. these are enhanced our been others. underlying most in discussion associated of targeted regulate cognitive to-date, receptor impairment NMDA and They chronic But underpins including and drugs agonists, compounds and our mostly synaptic preclinical numerous are indications CNS in core receptor, in receptor. bind NMDA function. resulting a developers They normal abnormal of disorders, or antagonists which uniquely and decades. biological, receptor NMDA compounds the many pure of receptors developed differences unlike

mediated preclinical launched NMDA address enhancing modulators molecules. synaptic plasticity. by only We a few stage disruption Aptinyx novel of in this Our receptor XXXX the with middle

marked Now, later, be of in This product a programs team half years have challenging X the CNS on targeting of of X. and and we Phase another candidates proud the could productivity study patent I to successful closing and issued initiating XXXX and our two level this remarkable are four just three on cusp a pipeline. is also efforts was our These of indications. IP Phase not we of more across the results progress course, in our by significant June. point. Aptinyx, year This of initial state clinical to a get year, of past offering built robust back for the important additional public with

clinical of of our candidates are composition product covered now by stage IP. All matter issued

Now, our let's discuss stag of clinical each in some programs detail.

active NYX-XXXX therapy with conditions. Phase start already from had two from first studies offered that in even at electrophysiology safety volunteers, will healthy confirmation excellent which in only in they is XXXX, in We human engage pain Coming had but pain chronic NYX-XXXX the for the NYX-XXXX that results reported established in as pain. mediated processes developing present chronic, and an a we profile, X not into central also very dose long-term high that we readily NMDA and are linear blood-brain concentrations receptor it These level. November But and it NMDA mediated. is predictable a peripherally in receptors pharmacokinetic In mediated the effect pain system. XXXX, ample NMDA particularly of very achieves nervous the receptor and Chronic profile crosses important acute and different barrier with in processes. had downstream

that be of reported the We were results, processing central in it characterized symptoms, half But, a compelling biomarkers. NYX-XXXX fibromyalgia, with a and and pain year. well. analysis and pain central We connectivity perception [ph] Alongside known alleviation we as acute manifested that with moves, the the the biomarker about patients study in we of burnt the complete in and as and activity central the the effect life. when of report of addressed activity plan to well as highly this evaluate we in processing The last study. in by regions improvement through brain. processing receptor is pain in Lyrica techniques statistical available in in and by can subjective this the internal the brain to normalization central NYX-XXXX that as the imaging imaging resulted pain of just perception believe this seen quality same We pain, improvement who are becomes result changes to results mechanism pain of found pain patients Our their this be these active in significance our is that this pain are of function. these December approved interim these of in that this with consistent pain from Lyrica, we these responded associated patients precedent results, only first [indiscernible] the the and cognitive pain. positive imaging in processing. showed for very study are change XX on in XX These demonstrating Based symptoms central the and the we neuroimaging drug this the changes full study. not centrally NMDA increasingly study these of The peripheral fibromyalgia. endpoint a investigator patients, to significant just study, fMRI to other symptoms objective biomarkers analysis comparable In to fibromyalgia of of in on fibromyalgia, exploratory improvement primary statistically patients study processing. NYX-XXXX series in In of images and saw actual know using confirmed reported is

our Let’s now the DPN. NYX-XXXX study discuss patients completed painful in result of with of XXX

that four the pain. did path primary forward While in endpoint, questions the meet study inform critical not did its it answer chronic

asked had with And saw we DPN is and in safe no treatment-related First, to profile events, a adverse tolerability patient an NYX-XXX similar excellent overall serious event NYX-XXXX safety if that adverse we placebo. population. and

we dose the And and the most level greater is identify XX-fold our exhibits studies, dose activity future preclinical from dose that effective projections indeed the there Second, work. XX-milligram appropriate see with across looked if level range our a as than dose aligned to did we others. for a

of use the that endpoints pain quality including evaluating understand life, dose Fourth, common magnitude we response activity relief. function. pain NYX-XXXX. shows we that the XX-milligram patients’ the inform if had sleep, endpoints, Third, parameters across saw if symptom wanted the to we and And as and endpoints activity or of various of comorbidities we the chronic are NYX-XXXX wanted to to across know characteristics likelihood there evaluate to well multiple the as

for and that detailed have a periods that set. significant just have the announced for treatment the been is It of we we conference, statistically As clinically from revealed first analysis last NYX-XXXX Cowen who week time, of patients meaningful. completed very from and benefit the suffering full DPN data at is experienced time longer

how analysis and deduction derisked dose statistically January, in was the following the has average XX points pain study on Numeric data in further results daily, didn't from observed milligrams group. DPN In week the patients in dose to best endpoint analysis informed Scale the further XXX placebo the study This painful top-line our X.XX three in gives pain. separation strategy was of the subsequent set namely in than four greatest the from all the us these milligram study. and the of an Rating we reported at on XX January, readout although readout showed that tested, significant better the levels Of see milligrams questions. has XX, placebo, population, in So, placebo, that a NYX-XXXX we XX-point and total with full study. separation In answered XX- the of from top-line primary in

concomitant the analgesic were represented the substantially from placebo pain that X.XX a to saw in showed placebo secondary endpoint observed we the a quite we increased concomitant as of XXX greater approaching the points, patients who separation from key well endpoints. Further, total taking subjects not half clinically In these on from on medication points difference. that the not study Importantly, average points point as and analgesic patients, meaningful separation patients a X.XX about primary a population. reduction medication

important in future Although be achievable, steps. new very difficult, plan patients initially we be turned not quite all as considered observation to conmed out an to on

four, did the may patients. improved in effect plateau Another [ph] We larger with a week the that required see of manner as final treatment. week reach the a endpoints, duration studies, key Across four a XX treatment XX-week not dose a usually was effect at for the across therefore the finding longer of linear milligram multiple weeks. such the drug study effect

many data. Of rich patient beyond dataset this course, of top-line provides endpoints the with in study a size first the

are of saw population, in the the improvement clinical In the in of placebo. advanced the effect who patients, over the study exhibited NYX-XXXX very last after first acquisition more DPN for the pronounced XXX analysis X.XX-point patients for time and a NYX-XXXX. revealed population group. was more four DPN subgroup points endpoints. scores well relevant of of just sub in effect significant mechanism medication. is placebo. These reduction patients This significance. overall has concomitant increase, further we to DPN XX baseline pain resulted week, diagnosis that [ph] the these to the pain for announced study above As across incremental a of improvement from other patients patients effects increasing DPN threshold advanced taking we dose to is of large NYX-XXXX in And years, an these that week were X.XX DPN, even full were in milligram sizes, as of statistically In diagnosis points data advanced not of scores This the in analgesic represented X.XX XX-milligram or with four

centralized mechanism and I earlier, perceived works pain. patients discussed increasingly when is the these prolonged to As experience processed pain address chronic that that essentially

as a relief group is treatment. rationale usually would why in benefits this there a So, patients to experience that circle of of patients treatment mechanistic experience to response symptom very This greater is from NYX-XXXX. strong not does

are studies from in often reason. they DPN fact, this In painful excluded for

is years was for of handful patients four this patients. allowing this not observe just to a And rigorous study study. a a had the patients NYX-XXXX in analysis benefit these of a half small future of for focus practical of of encouraging. highly subset longer, or this Nearly and DPN in So, diagnosis

we of efficacy the these on not robust DPN patients worst these importantly, pain, consistent, was daily across interference measures observed just walking, on very in improvements endpoint, and sleep showed endpoints one the including NYX-XXXX Finally and others. patients advanced pain

for to as results these sound We Scientific with greater presenting have have scientific the a potential. Milwaukee DPN that I this provide foundation a painful looking and fibromyalgia the we these just therapeutic further on of detail in strong Meeting experts DPN findings, and to by potential differentiated early pressure NYX-XXXX clinical Based plan overwhelmingly in tested studies excited the and and regarded in We're data are analyses highlight April. and findings shared, now investigation These and we at and year. of forward its informed have these about Pain compelling. are they independent number conclusions totality Society of American in later initiate clinical that

needs believe a that in the efficacy are NYX-XXX Now, PTSD to over the has mechanism. suffer therapies many disorder. unmet United to marked X with PTSD It let's post-traumatic that program of address States PTSD. are treat to our by inadequate is the significant potential from available NYX-XXX effects. that turn differentiated side alone and million in in In people stress estimated We the

study. NYX-XXX very models core and enroll In including is PTSD. study patients comparison who study We in NYX-XXX in dysfunction traumatic receive that acceleration will dysfunction plasticity will be and to have consolidation parallel compound extinction. record or or the periodically learning underlying address in that approximately the either study The initiated the in We memory as patients a this XX-milligram is patients. NYX-XXX sequential, we reaction and which By response highlight these extinction seen PTSD, PTSD. preclinical of memory mitigate develop may extinction with this eight-week event, that an synaptic a fear over is associated in course with of at in of placebo patients announced non-traumatic and subsequent learning learning The response fear result to of stimuli. and who that compelling our is of February process a processes, anxiety models natural first enhancing demonstrated the with XXX results is to of design the placebo NYX-XXX in able and

CAPS, are on the the study effects PTSD as NYX-XXX is or both PTSD including the evaluates in symptom as Clinician-Administered symptoms diagnostic tool anticipate various which a We reporting study. a of this multiple and of in standard evaluating XXXX. endpoints, endpoint Scale data and We across first domains half used PTSD from

volunteer evaluating study dose nearing brain safety, tolerability, exposure X now in to completion are we pharmacokinetics Moving NYX-XXX, which the we are of and multiple levels. Phase our the healthy spend of

its the to We study We first our report patients data to later this plan efficacy with this in from study NYX-XXX half of cognitive to year. in expect the and into Parkinson's evaluate impairment. take X first safety Phase year disease

While and recognition people impairment United an disease efficacy symptoms, of that is about for some to the the suffering therapy in these loss patients. of them States is one impairment Parkinson's, million Currently, there's the Parkinson's only by that approved its disease. X form from there cognitive suffer offers it motor from Of characterized estimated cognitive often is the it increasing half neurons of dopamine modest with impairments. cognitive most of in is the Parkinson's in associated

rapid restored was reverse levels. very cognitive saw excited seen the cognitive of we In following they for On are several based preclinical, NYX-XXX We on prospects that translatable neurons. have relevant, on and effects that NYX-XXX compelling able in resulted model These cognitive of disease [ph] including back very depletion impairment performance the model, results dopamine of some Parkinson's highly baseline in a healthy to months. non-human this primate. about measures, deficits was improved we to were

with and encouraging motor us did to not Additionally, findings this the it study, on not in and numerous and CRO in experts work model interfere used we L-DOPA. including compounds any on symptoms, effect field, the it. highly These negative years antiparkinsonian with the NYX-XXX are has of other did we have saw that has evaluated which impact the for

later eager initiate patients. I We that to to mentioned, are this very as NYX-XXX year. plan evaluate we And

clinical our will we objective clinical expand preclinical is to XXXX, in findings on this ahead, acutely from execution, and past the Looking focused on be year. overarching and

candidates pain, We by clinical to year. call end cover and full-year in fourth our and that, Ashish of our chronic each financial expect this and four the studies development cognitive advancing Phase the PTSD, progress product With the have to our I now over will X across of quarter are turn impairment to of results.

Ashish Khanna

XXXX. to of used June initial our you, Thank in XXXX. operations press increase fund release cash offset proceeds of partially million of this $XX the $XXX.X the end Norbert. In from by cash, equivalents at of morning's this XXXX, primarily we cash at and public compares to due offering investments announced million in XXXX, to XX, was December This $XXX.X million gross

readout with into As operating deliver very we that the development expenditure in you and quarter our were compared as XXXX $X XX, busy for Revenues same in period heard, be cash to capital on our expect programs, million all Norbert and clinical XXXX. of studies the $X.X to we ended will the clinical for million XXXX that December sufficient just are across current our needs mentioned.

the For revenues $X.X as in million period same $X in the compared million were to full-year, XXXX.

was to million $XX.X are $XX.X revenues $X.X and associated don't triggered We over pipeline, from for X million, X molecules made operations, with NYX-XXX. from Phase of XX, some they the expenses costs and representing expenses million periods R&D our in work Phase Allergan’s primarily G&A The novel million do were the $X increases platform. fourth $XX.X the for in as collaboration growing chemistry have year quarter AGN-XXXXXX, XXXX, option increase The the for and needs discovery driven compares research exercise our but these on for respectively, traded those exercise $X.X in same in from of for XXXX of support well the and associated G&A respectively. same ended and publicly were our a our from of increase with million including Allergan. work fee offset costs, on in Allergan's the DPN, payment discovery fees the fund reflects This $XX.X an government and and acquire full-year obligations increase was early option Our primarily to expenses as the revenues full million our rely research and increase and the by driven with and we December platform a to earned in we which professional to work Aptinyx. compound R&D The fibromyalgia, primarily million by $X.X from the of XXXX personnel XXXX. XXXX $X.X to becoming and compliance NYX-XXX across with healthy being progress a XXXX. periods company. million both volunteers, NYX-XXXX quarter to XXXX, and organization and expenses million grants for

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

full-year the over I period the With same $XX.X XXXX, to the questions. for turn will that, operator call the loss compared for to For in the million of million net $XX.X XXXX.

Operator

Thank you. [Operator Instructions] Ritu Our first question with Cowen. comes Baral from

open. line Your is

Unidentified Analyst

gap] follow-up. [Audio Ritu. I analysis? should first a the And from expect My full kind of question. fibromyalgia my taking on for Thanks have is, readouts what for we question detailed

Norbert Riedel

Yes.

subjective are course, with to that analysis we and patients. you and perception neuroimaging also I others. pain on pain endpoint So, study markets pain secondary of The processing. is was of fibromyalgia associated that primary done the mentioned biomarkers have interim XX But

study. we so, the learned next for study to inform And what looking its interim results, after delivered we were

of I look have his the set the confirm to the by and We will mentioned, just a data the year middle same the namely that nevertheless patients additional study to primary at small. a just bioimaging of bit a regarding roughly, and as or secondary almost larger number marker patients the significance, of a not information as more was quite endpoint, but statistical number I because mentioned which endpoint little achieved the complete

of as for readouts well. So, we look that will further on course

Unidentified Analyst

was, any XXX? have for X it. you the my of design second question do And initial Got Phase drop

Norbert Riedel

Could you the repeat question, please?

Unidentified Analyst

Phase X… The

Norbert Riedel

think, No. understand this. I Yes, I

very of X. So, still are X good. at that Phase I tail-end The mentioned Phase study to the looks you very, we

We quite And the design. study protocol. as share specifics and will later actual we are of the the But, to course disclose the ready more not it, I yet mentioned, around this year. starts we as initiate study

Operator

SVB next Leerink. comes Our with from Geoffrey question Porges

Your is line open.

Gerard Smith

does differences? I study wanted are larger highlight Geoff. depression This everyone. And Hey, for that some for on a thinking little patient thoughts I’d selective thoughts Thanks Obviously, medication. your Allergan and it like ask bit more study? your mean, for this you failed taking rapastinel question. use can on all requirements at what indications, in or background severe opportunity program Phase different to had its disease the mean, change then, be Gerard a that is on pain. just we the also to the about I can your about depression versus the to your announcement I X DPN? learn of population, for more more different assume would I guess,

us give on more you Thank little could that? So, a bit detail you.

Norbert Riedel

has high be with you. would my pleasure, shared because it That effect the another that I to Yes.

So, rapastinel. with let's start

think, to had conclusions When very placebo multiple analysis. the I at X in not large because about a early I MDD studied. only however too X, I studies, it's rapastinel in top-line Phase data we Naurex, clear active know our on following. between will say the difference and deeper study indication we showed the Phase that the a we study, and draw

the design so, indications, noticeable effects the studies, Phase of the these where it effect. helpful differences for control course tightly, that of placebo understand And course, placebo as our would in I study across very to placebo the recommended DPN that. particular of of from was some a have these in Allergan as we it pretty you in X know information strong to conducted. to and in relates know But, I pretty are on board point, that general, enough impacts they're because we at lie upon be this of look CNS really that there core that And indications, don't at are studies to

we to next all rapastinel I following studies early important way. in the On it believe it multiple with this Phase our studies. you study, So, did, had shared we the X, results and strong mechanistically when first study from very I say. in a too very with learnings DPN, so informs in the that we delivered X little think But, next Phase

certainly concomitant We on not know we those have patients. readily medication we because will patients can now that recruit

longer have patients a of XXX population XXX We a out that patients. will We mentioned disease. with diagnosis of four-year is

So, and it's it's possible readily to a group these find not small patients.

We will do a longer study as opposed to X weeks.

on compounds, it approach XX-mg the because several the And most of XX, not We we we occasions, efficacious more will the dose traditional we have study, which you as then, would NYX-XXXX. was addressed we focus, course as that lastly, increase was we as we had mentioned, incremental consistent further and of the dose dose, as seen and actually benefits XX-mg dose. mentioned that XXX our all is XX-week And as so a I not response from and on have preclinically know they clinically that actually what U-shaped helpful, do dose, plateaued dose. at namely higher before. the our weeks, a XX because done XX-mg a of longer four is study, We which dose effective seen with also suggest dose that if range at

the best be And indeed turned there no So, we be know targeted really was the to to best dose. out helpful dose that to dose surprises the are it had XX-milligram there.

the next study. for are those parameters So,

Operator

you. Thank

Nachman from with Capital question next BMO Gary Markets. comes Our

Your line is open.

Gary Nachman

the portion you it is little years, described do morning. what market might I'm Good APS? what showing where groups sounds a on cutoff advanced behind results Hi. you on you better four Any have other that at? the data other data I I'm you XXXX, you DPN sure On sub plan that something more plan DPN there's additional far? what cuts see looking mean, And more curious the arbitrary that. from than of then, at guys decided greater thus on cutoff? but Any of used? that how

Norbert Riedel

thanks great. Yes, Gary, terrific. the questions, for

And we further community various relates data scientific the the and yet So, us about additional here from at actually APS that to to have details on our for brought now. points I also the another that will it more make data weeks meetings sets. engage as up medical to two presented with expose there we opportunity

that will mentioned, least I about meeting bit up data that validate I scientific I shared continue with with Milwaukee. quite we have you, done As in for and at KOLs the a you work XX to the of like a would you I let kinds that longer when some at DPN. important say, there do all on homing diagnosis in this, to look analysis and us think the full but notes, parameters subgroups are of of

of it total the all, subgroup almost population; so in of XXX is very large First XXX, a half. a it's

this is if chronic it, all important most the our time, are about something mechanism based sort that Second, basically is being profile think that our in where you on brain we have mechanistically when like based the relevant. with active mechanism you in that's your and [ph] pain infant, you to perceive will, centrally most you have which of a where signature

for just needle for action that directly We some and look look a haystack. -- looked of didn't signal. science-based in we any So, of kind inform or very results. a analysis We basically didn't parameters mechanism for of basically

And becomes out, years out, of so, years five you two actually DPN, lastly, and of you look arbitrary And I out, see When that I'm think I the linear part an and their one DPN years patients out, out, longer. you look four remarkable to years a little year diagnosis and of you treatment diagnosis improvement lose. didn't is want a appreciative three actually it that. seems mentioning benefits as that you said at important then, of

years at there of four not sort like our the because focus from most the the and arbitrary that it's I cutoff patient logical a of the gets it large least of to it's next effect include four plus, and so, a just it very collected sort is years pronounced in the point is is study. think then it same all relevant population of like a view We before that better. And looks seems and highly

Gary Nachman

And market that portion assuming chunk big the I'm than four Okay. greater years since study? portion DPN of of a a big is your was diagnosed? what it's

Norbert Riedel

Yes.

So, be between itself it’s study what study, guides more. saw that. on we would I think in It XX% the XX%. say, may us I to somewhere the and based

And unfortunately at don't literally all a people in have to patients therapies, have those segment large maybe for time. of And seem the high a very much it really so, been market. that’s that importantly, and long because benefit that existing course, most scores, at they from and very, pain those high,

I clinically otherwise. treatment So, resistant population a largely think highly it's of relevant patients

Gary Nachman

more And on learned couple DPN? do make want PTSD just XX-mg given I'm Okay. And study, advanced more then, the said Would dose disease at it you just Thanks. with fibromyalgia. to just finding you there you to that you’re what compound? patients with in also look using the with curious, mechanistically, didn't sense dose. a why

Norbert Riedel

Okay.

Andy about we the So, how PTSD then I a can with back little we to And sense come of can are start study. -- going you of giving bit it. a

Andy Kidd

here. Yes. Gary, Andy Kidd

And the are some think DPN also read in that and we will are from important there then, through apply some differences. study fibromyalgia, things that we learn -- to fibromyalgia. I So, clearly some there

that One already know the after very while. there obviously beginning experts from is typically be things that DPN been diagnosed. to so, from itself, clear fibromyalgia late, the a right we the that quite when process, And a with that’s fibromyalgia fibromyalgia in fibromyalgia, fibromyalgia is of also compared fibromyalgia we experiencing pain for perception tends discussing pain is to the with key disease and the pain fairly diagnosed And disease of different. know state patient

be presentation as probably abnormalities processing different have a period some set DPN longer we central because chronic Norbert But, cutoff than or it little is period have pain diabetes. little diagnosis four certain to don't like to greater heterogeneous can know the a a fibromyalgia takes patients years. mentioned, of little to they for certainly of a it’s a this anything obviously predominant. become and will we in time. being that of more for So, DPN, envisage kind equal The In you

respect. that in indications different are there So,

Norbert Riedel

Yes.

so human And consistently able we pharmacokinetics studying really translate data are been and our fact dose our study and exposure to across on one preclinical is extrapolate brain into designs. we PTSD, it have accurately including clinical Regarding that the pipeline XX-manufacturing. based

as And very than XX much several and needed, and so, XX the range, XX be of enough, confirmed if dose that more and discussed the be may we right nicely. results actually I issue pretty not times, DPN, that use is DPN example should probably the XXX dose,

but it enroll respect want the meant is of large population. safety this not a signal study finding and with relevant actual preclinical a exposure PTSD it in So, overly because X in to in dose do accurate that is enhanced therefore where to to primarily inform a looking a decided to that a study and people Phase makes to explore measure projections be we human subjects, [ph] confidence XX-milligram we study are for we should patients making number for, the clinical from and it that see brain from with [ph] dosed to study next that be

Operator

Thank you.

question Charles comes Duncan with Our Cantor Fitzgerald. next from

line open. Your is

Sadia Rahman

either Hi. This you questions. Charles. further for there DPN? rationale pain precedence other other Rahman looking And indications, at baseline looking and looking after for in has in or also, at Sadia such subset discuss is or a Can pain diagnosed DPN trials? brain or Is other taking for those quantification clinical scores metrics? sub on my for markers there for the Thanks been population evidence is at

Norbert Riedel

lots that to heightened, it pain the and that it have that relates regions, certain take chronic perception to pain, processing So, in when is in sensitivity endure do pieces. is of the a that brain of you regions, pain. as it, there supports also it brain well-defined I With of actually let's evidence, call respect several and work clear you

the when so, that's the approach the NMDA mechanism at more as look an that action, pain provide and And you we're plasticity itself. pain we our of of taking being mechanism centrally most our manifested receptor like triggered, becomes perception, saying chronic a actually much benefit with when NMDA can modulator really it is mediated receptor

so I call to processing I relevant. not able a example cut brain other perception markers I of fibromyalgia, states. understand also I across relate And see are from pain they this chronic think, probably is perfect you to shown why phantom important that best that's very we give as It really and at can been has pain. limited to limb that is it, component what normal these,

So, state replaced and or an has when that it mechanism was no hip or replaced, in exactly been that have is you that we are patients that when an pain joint over the are you or because itself have longer chronic there that limb case pain centrally sense amputated limb pain that time knee the manifests osteoarthritis is often is pursuing. the in quite continue nevertheless that to

And question of last so, part they studies done your other it. to [ph] answer that the of

script my longer mentioned those have be a with considered very benefit. difficult, much exclude patients, to them it if duration to primarily longer, I tried provide not they think impossible, was actually I because that therapeutic to in actually

have. therapeutic there And They Because not pain are for patients. a in so, be aligned modulate pain. pain, us from efficacious seen and perspective of central mediated it's really NMDA only patients requires the nicely action they is cannot to opportunity, very of they mechanism of plasticity, molecules fibromyalgia receptor that important for not acute have our alleviate the like the that most compounds are with the but manifestation a analgesics which we peripheral also

Operator

from comes question next Our with Morgan. Fye J.P. Jessica

open. Your line is

Jessica Fye

about see than XXXX you XX-mg there. less I placebo think to my Hey any had those for just When follow-up over DPN Good in benefit we morning. the the years, four who wanted Thanks patients? questions. patients data. taking dose did on in

Norbert Riedel

really like moment of wow, wasn't followed that we the Yes. I that I’m up. you don't it to at anything question asked a went what when of XX-mg our two data linear pain three progression you one dose. plot you the years, four years, in efficacy in with the data, our year, improvement years, five years, a across remarkable diagnosed than see ago we an Jess. less mentioned Gary see. DPN patients see Thank of from When arbitrary you, a look cutoff sort glad year,

is of duration spectrum with continuum And a patients disease. so, the of a continuum efficacy in increasing or this of

discuss. at And next the we so, meeting key show will and message that's APS the also that week

I audience by make. I sure this point particular make is so, confused our that want And to not

enough focusing are patients on spectrum this that they in be time a with had for of are well-suited as increases. diagnosis is DPN a diagnosis for continued mechanism actually time for We particularly it have that confident on a of us long to DPN action, but

Jessica Fye

Okay. think like that seems greater pain lower well. driven placebo seems a -- in want you mechanistic really there. this drug-driven years, is effect factors I it that to would guess, benefit increased much more population, we was see Curious combination I by it had the drug confident of the of response chronic that than about that a and was group it four when a be a effect feel as kind of know chance that not finding? there. more But, to to if somewhat

Andy Kidd

Andy. Yes. definitely Jess, It's a combination. it’s

population. was So, certainly the patients think it's that group much I think the important note to also total in of that than we and drug effect larger larger in

placebo reduction effect. was That's right. unexpected. not You're some in There

scientific to with published of see and drug of it's lot patients treatment and disease. of these line are a and as less input with that times. is data often patients expectations placebo in There more longstanding mentioned, in of less Norbert a a typically I more a As think our advisors also regarded effect refractory any effect

to drug effect and of what And encouraging. placebo very so, when reduced and a is effect, is somewhat larger we see this that us very pattern striking

Operator

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

Norbert Riedel

you, morning. operator. taking to for time thank everyone questions for And you, the Thank join this us your and

our and the has further from clinical forward the the of made findings product development XXXX, look NYX-XXXX presentation two We year. proud team key the our believe our including of inform recent of we in study We progress about derisk over are of tremendously completion of the X upcoming past our exploratory fibromyalgia, our our And clinical studies the in to results the study of further and of Phase detailed look and forward to the for and of readouts candidates. readout weeks in possible treatment system. good We very to brain X first participating. providing robust the for We the at good And our NYX-XXX. nervous and class from update APS, upcoming you throughout for Have remain committed pipeline to you weekend. Thank XXXX. across a again execution day study options you. suffering thank our patients of Phase diseases now, a best DPN

Operator

you joining us Thank for today.

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