APTX - Earnings call transcript Q4 2021

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Operator

Good afternoon, and welcome to the Aptinyx Fourth Quarter and Yearend 2021 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.

Patrick Flavin

Good afternoon, everyone, and thanks for joining us on today's conference call to discuss Aptinyx's fourth quarter and yearend 2021 financial and operating results. visit our section results press highlights. to website the and you view to release invite the of Investors Aptinyx business We describing financial today's Officer, then Ashish Chief our Chief President our On and and our Khanna, Kidd, Chief financial Officer will Business business progress; Officer, review discuss and development clinical Financial Andy call, will Executive our results. Litigation include of like made which and during call to Securities will statements the XXXX, remind meaning this differ the that forward-looking Act everyone to within involve I uncertainties would cause statements of that materially. Reform Private actual conference risks can results statements are forward-looking forward-looking and update of today, these we disclaim statements. Any only obligation to made any as this and the company's afternoon in the Please filings subsequent factors and our the see statement issued disclaimer risk current forward-looking the in SEC. with release financial results call It's to turn over Andy. now to my pleasure the

Andy Kidd

Pat, Thank XXXX afternoon, joining call. appreciate We today's for you, on progress year and us good significant Aptinyx. a you marked everyone. of

therapies mission we've taken and course goal. year, to past Our is over the strides of for develop toward system challenging and nervous that major the the brain of disorders transformative

modulators pipeline We milestones and shortly DPN expected August very our in the with In then NYX-XXX, pain of are series receptor July months, data to IIb will of April. starting data chronic readouts peripheral expect timeframe. studies a that expect catalytic two NMDA diabetic for neuropathy our the we track positive or Phase from The in with is across in readouts on fibromyalgia the company. XXXX data for allosteric be and year a pivotal next few

NYX-XXX and XX our impairment Lewy from within dementia in cognitive disease next with In addition, associated we expect readout the exploratory bodies with Parkinson's months. study a of

expected development year. to PTSD, XXXX. balance is data well runway these half sheet that next and Finally, into studies fuels initiating those NYX-XX in starting second Phase IIB from of programs supported expect the by We're studies two in provide with and operational we've been a

in chronic in Let's clinical programs our discuss development pain. beginning NYX-XXX with more detail

mentioned, XX will read out throughout prior communicate visit that up, chronic XX-day data study treatment external each are a week period follow ran key completed study we've several indications, XXXX, the schedule As Phase XXXX. patient and few in last The study DPN enrollment challenging design April. of receive within IIA to pain environment DPN DPN from well I in our IIB last Phase out completed integrates our in our and during next Despite months. lessons last XXXX October. the and With and fibromyalgia expecting and in

on longer with we're duration. brain, to study. more that believe our with a time Firstly, disease stronger disease We or manifest. DPN a in the prefrontal because targets of pain processing is this four become mechanism abnormalities our response focusing within the observed We duration of years in take in population patient cortex prior patients the

a period. a addition, are month as In assessing monotherapy XX concomitant NYX-XXX any analgesics with and treatment without we

daily scale. of zero and is XX ten baseline the placebo of in pain score on study or powered to size what in using study line daily to endpoint design over primary chances is regulatory zero lower for these effect from detect ten achieve seen on between with of the NRS in DPN an meaningful. with from the to milligrams is clinically somewhere evaluated Numeric placebo NRS. pain, be XX and week would reported change statistical bound and week or and to Rating degree patient NYX-XXX is XX a X.X average variation the averaged the The difference expect The will and to to are Scale We separation that needed Depending weeks significance between X.X choices the differences, with requirements a of NYX-XXX evaluates increase approval. placebo dosing of

meeting Phase to Next discuss an of include and requirements with FDA end for would this steps NDA. study following II Phase III

Our February so for few our a fibromyalgia DPN. just of the and study enrolments months behind Phase end it's at in IIB timeline completed

XX a processing we relevant. mechanism study indication in expect as We as and in analgesics will promising week think dose, and expect our number underlying higher synergies We study, further a neuropathic and of and have week or study. patient over is steps two. with that milligram endpoint based safety clinical at This change in conditions July using with The reported the XX NYX-XXX which within If are do a consider fibromyalgia fibromyalgia. a a The from condition. primary evaluating therefore III, similar treatment averaged as for to fibromyalgia powered way is Phase daily this effects pain evaluates other we're study the not in a baseline also between targets the XX since monotherapy to expansion III NYX. in requirements start It there there the determine conditions milligram this in the neuroimaging and abnormalities In saw study believe are do into a in dose the of present in study to We biology disease with dose chronic the study with and cortex neuroimaging with average well disease XXX a brain would pain both mechanism in We musculoskeletal have is requirement August. duration DPN. advance prefrontal DPN we a development include in NDA. of on we the the the Phase IIB evaluated prior FDA similar meeting pain also our design XX be to level X next non-clinical the as are to we data no that reading the pain out is pain programs would for in to period. week Phase DPM as the concomitant and

with of a data significant both very will efficacy dollars or the A well is evidence of billions positive market safety unmet alone. Finally, the in have these profile, annual one sales into strong need we commercial pain of unlock of would chronic for studies potential opportunity and expect drug US in value a The clinical Aptinyx. substantial. the in

our approximately over NYX-XX, Phase in product In first discuss post-traumatic with with NYX-XX IIB period. in of the anticipate the of we we'll study, of developments IIB XXX first placebo this We commenced development Phase Phase NYX-XX or IIB the be for PTSD. randomized NYX-XX Next of studies. December, will the two data candidate for PTSD In from half XX study second XXXX. first patients treatments disorder in patients week PTSD XX a of treatment Phase evaluated IIB to and of with milligrams stress reporting

The the design of has NYX-XX. the in to This tested second this patients been be higher potential effective. level preclinical same dose that has study Phase except will it but as dose there's recent milligram dose for based think first, not test we on before, XXX IIB a data,

activate dose planning patients group now Phase but study, approach among we're number of We've worked study have the We for as effect. to expect factor XXX placebo the sites, first per is in IIB. Phase with initiate required, QX. been the to to we two to two different we've limits correlated milligram the IIB steps which a of and screening levels of studies minimize measures completed variability begin employing The Having the operational response all arms is lower mitigate range the PTSD April. during placebo a in and of two during

the two addition, arm, pharmacotherapies in limits to assessed control studies In of endpoint. per the and sites clinician studies. clinical number in either these not We're concomitant also variants investigators measuring should of allowing help which PTSD

placebo milligram primarily XXX signals patients patients of approximately study in to and exploratory NYX-XXX impairment and cognitive Phase associated is detect meant and II Finally, evaluating currently is This bodies. evaluates a versus Parkinson's This over dementia NYX-XXX double let's with discuss with XX XX treatment. study cognitive cognitive of study an We're placebo in of NYX-XXX our weeks blind impairment dose Lewy disease in impairment. first characterize of controlled with activity. in

As tolerability, are and executive function. with in measure impacted domains and are attention, dementia NMDA neurocognitive memory in able bodies effects well a changes battery evaluating NYX-XXX of disease we Lewy as These receptor dependent. cognitive the our and across safety Parkinson's and tests, of to

a still As since variant COVID. least at we of did in clinical late mentioned after see activity enrolment expect to readout to during this slowdown return in trial January, Omicron we We've Thanksgiving in to fourth of we XXXX. quarter able be the US data our to Portfolio study in quarter Day the first the XXXX the and of in into then February, continuing or partially from and seen normal related

advancing board pain Rauck, by on Pain a Dr. in certified for included we in made Carolina's website. the study. anesthesiology at a February This Day review is a review investors Institute an for to In hosted progress our This DPN in investigator we've addition Richard event our the and the on medicine physician pain chronic pipeline, recently of landscape available and treatment our X. Portfolio

Scientific areas formation announced urology the from pain, of comprising in Medicine, advance of Arnold School College Sanacora, of will Baylor Board also we Advisory of LeWitt, PhD work from and School with to We University leading including Abdallah Scientific Peter Gerry chronic College The State the and neuropsychiatry, Medicine, Cincinnati pipeline. Wayne Yale us of University MD Chadi a from establish Advisory MD our from Lesley as Medicine. of input and University clinical physicians researchers the MD Medicine scientific of and closely MD Board

Ashish tireless partners and our review year. moment to over the to and I'd I thank a for to Before external to XXXX Aptinyx our quarter and like employees our past over take financials, hand their acknowledge work fourth yearend

efforts data efforts. few been service research expect than critical has the to and able internal external the to vendors, very to of with that who've closely years. that partners, point advance readouts of we're who able to have few circumstances. difficult next time for clinical have a of external the contributed to sites patients we've over for ever both next we course trial mission these of those only trial XX to and our and landscape because challenging our in this clinical patients been all It dedicated our the appreciative fewer multiple investigators is in months to fluctuating look employees pipeline the in successfully forward are clinical and and This managed working We sites,

Ashish?

Andy Kidd

$XX.X with as were agreement it AbbVie. revenue over the as have quarter to million XXXX quarters Thank at we $X of in revenue not conclusion the ended subsidiary full sheet, yearend you, of research did equivalence, year cash we collaboration million XXXX. million cash statement, both tranche majority today XXXX development this The to income of month filing. $X.X million paused been II less programs we R&D to our the our to figure with source year. of those XXXX, This fourth patient we for In XX totaled spend and expected to R&D and that XXXX. each and the earlier The we fourth compared million $XXX XXXX contractual million down million the end Allergan, both concentrated R&D primarily respect in and million full revenue million of by our from At $X.X and our to $XXX Phase and research our years, to reported the of balance $X.X with and studies not in include revenues than for periods XXXX. million expenses expenses income XXXX. now year spending XXXX full was its quarter four, rise capital of of other in research in compared a compared spend million in K the the XXXX year. which the ongoing as and during a XXXX, on drew zero We and period $XX.X Andy. and any driven of in compared our to enrolment during and Phase for to $XX related the remains for fund full in in to We contributing expected, second came does $XX.X development. which have facility, year clinical fourth our G&A quarter the respectively $XX.X operations. our collaboration of credit increased II XXXX. in as XXXX, million heavily respectively followed the in same reported $X.X million related then expenses or XXXX of temporarily during year across of fourth period for early That in had reliant the Beginning cash With three same in $XX.X

and XXXX and a back and $XX.X compared net full the XXXX. of quarter net now I'll loss million over to million to the for loss for as fourth million reported a year in we periods same turn of $XX.X $XX.X million Finally, respectively $XX.X the call Andy.

Andy Kidd

Ashish. Thanks

important desperately As we moving of readouts, expected is therapies. need in few both look pipeline of pleased cadence forward the to We're continue to data as steady next a operationally to weeks, company. a the our stage approach of and better our into financially the positioned first towards to we patients that be next which well advance growth

happy questions now. to begin are We your taking

Operator

Please with [Operator instructions] Raymond The proceed. Chris comes Piper Sandler. from first question

Chris Raymond

and Hey, then up. the maybe thanks just one have for follow taking question. one I

you DPN the the July think I data first just data Andy, on it's fibromyalgia August. next XXXX coming then data, and that's have obviously guys, I So guess said now obviously, or month the you

clinical up this these think, frame us fibromyalgia. different just just close but terms these these Maybe for so to in to ask see with NRS not come the why why direct there's before, I investors I obviously clinically a readthrough again two outcome want it maybe, or should what's are but between since events, of guess, I and differences here programs question's in So the disease similarities, as relevant. we're DPN maybe measure considered and to the states,

Andy Kidd

Chris. It's question. Yeah. great Thanks a

is think before gap about you Fortunately the four the some an through. know, to important some read will are differences but it do probably it's that months I will frame read but course answer from you the helpful there not the studies we and have absolute long, suggested know a pointed that through, be or limited two too will the would so life, think you as think we differences. three be shelf we because data one and key similarities, as between There of

between that begins difference condition. main the two peripheral the as is conditions really think, neuropathic I a obviously DPN

peripheral become abnormalities classified it's starts take pain fact, my chronic in that neuropathy. periphery, It In pain by kinds and of or their mentioned I processing others a remarks, on condition processing centralization as abnormalities targets we part DPN to done characterize as central our of while a in in the established in classified based fibromyalgia, of disease the state, that in based on the that imaging inherent are been think the FDA clearly in of nerve damage guidance the by condition. studies whereas pain those and with mechanism an have kind

biology. underlying different some there's So

Of at both specific We of with of different different in also think obviously one versus course take kind dose. good we've but tried think which to have such our study fibromyalgia data to in extent elements proof different I that doses design, in concepts we're as underlying biology. precedent informs indications, clinical the but There's looking we DPN. a nonetheless two

study as ultimately, similar drug there's last, very wise, side, in you clearly biology would So mentioned, I we design between dosing some of indications elements two and read substantially to the than course are prefrontal our and I acting establish reasons better and a but say, those think think of cortex similarity couple as the brain. I also less on XXX% control the the both modulation in abnormal the through pain are why, think of a

of targeting. part the which with similarity clear a there's So brain we're

there and indications. think independence do is there the not yeah, read said, a amount complete through, read through. as between So still we've reasonable is these is we believe we I two consistently There risk believe but of

Chris Raymond

highlighted think prepared section comments. quick with you Andy, a the in timelines And up, follow that. for Thank you your maybe I just

data end year. some you the the slip think driver misreading. that? impairment Can cognitive an as could put or I year on next maybe now XXX thing last it into update, I think color what's I the that heard for of maybe I was

Andy Kidd

that's partially Chris So right.

Day as did a in still our move pipeline, of When but year, I modification think our we potentially into the we kind in across provided QX well. Portfolio we a year. of end call may were end by last possible of quarterly February updated to and saying

somewhere my as I that explain two So Day I think for surprisingly Portfolio very the recapped we The it's as it remarks probably take but today, sort US and right in reason that, more effect see a the broader outlined it Omicron to in can I we now. the between wave saw we briefly not environment, is to enrolment. Thanksgiving, after in slowdown started of did start the

and potentially in enrol in potentially Omicron willingness in clinical was the a little but see holidays studies, slowdown often by patients' bit anyway. know over you also exacerbated to enrolment affecting We trials think some do a clinical course Now we a update. we issues had in We or did on. isolate with of and Portfolio January February, the when that trial were tracking we of who staff, affecting sites, through quarantine so the cases Day having course and provided it

though I as looks since think, prior I it mentioned enrolment then, returned its back level. to has as

caused still ever that. And there's increasing so a delay, now an we're comfortable to guide That think but slowdown not I delay.

So year data end the have or QX into of year. therefore would we again, to by potentially of this next expect

Chris Raymond

Got you. it. Thank

Operator

Thank from Please proceed. Cantor question Charles you, Duncan The Chris. next with comes Fitzgerald.

Charles Duncan

XXXX could on of investigators forward in in couple for that difference your mindfulness a just and the to bit of Hi. I NRS data us chronic what frame good had I clinical NRS in wondered team. if soon. X.X particular, a programs means from afternoon, perspective of looking and seeing clinicians. Andy on progress X.X terms in in and Yeah, Ashish you pain little to terms DPN. of Congratulations feedback the questions And on a

Andy Kidd

Charles. certainly Yeah,

chronic is of ways a they a studies couple little a general? what meaningful studies about clinicians of in or I question different of it. in bit think thinking when is have about So complicated and talk clinically we pain it to pain

So get a meaningful. one of between on when times lot separation to active are considered the which described, what is they're at trying what people of degree hand, is just you placebo asking, and

on I clinically pain X.X meaningful. say, is or be I think want that one the statistical NRS same comes want convinced in the the them not placebo. I as X.X would that that to I just generally in of Day NRS see [ph] to separation. really significance a we of be in described clinicians Richard our higher would drug would of say range that Portfolio was was the lot to

on I really, now I'm what purely environment but know generally in I drug actually study actually because effects always because somewhat too the additive, artificial addition, field significant that the margin, but an Some that and not We a overlapping but is phenomena. is placebo I exactly are placebo effects think focused issue. And that potentially views clinical know environment. not

side there those since population that And lot the and And as course they this the patients for I on threshold expected profile, I options getting margin of the a rate of also answer and deciding a I'm in if pain reduction think be would, so there see commonly put measures that's of of average, And clinical what benefit real what separation. baseline or the you percentage are or potentially When or tolerability the the you're risk from I patients. about, to baseline then safety the two to efficacy to talk tends that a have will meaningfulness, of will reduction XX% response -- on XX% considering safety other tolerability is clinical in be And my to generally, reduction of few go-to rate a of out then are is, that whether changed will from potentially is there the a prescribe would that's the the better amount because and in profile. experience context drug a so more given frequently, what on lower patient, at what's patient a world. responder look What it would therapies good the provide so might expect I probably and to for meaningfulness profile these meaningful pain. used. bar clinical say sort the indicators then give a

of it be, and and important world some we I separation in focus data So to nuanced will of look there is little placebo, gets the this a on that response more the the it's from also real at sense think consistency but response. the as our show magnitude

Charles Duncan

presentation, second the Okay. it have but do I'm majority pain? forward? response year like. you sure how time period centralization being you a trial you hard as your had for sounds pattern you the steps, the through in points of time. it did how prescribing regarding, then patients or definition question kind sufficient of done And three symptom it's and that? this in How of next for the ensure practically Is not or pain terms years. Maybe of define point chronification that do in a to centralizing would it how's to patients guarding see that it And the well, this anticipate going that just of four how have and but

Andy Kidd

it's should characteristic hypersensitivity using kind tends quite measures measurement actually, with symptoms There be be characterize to been like are people lot the there of use a tricky pain. to and centralization It allergen to come clinical to instruments that of that some up question, a real who've course approaches. so a consistent centralized screening pain. of difficult on And good though of pain pain, little It's of have to tried Charles.

lot don't So we have work with there. a to

the in for better some characterized kinds addition, cord. of think centralization, sort I and amplification there's of a timeframe pain spinal of

studied. looking not we're changes spinal involving that than longer start It's it that brain, but of six happen the to may the in been the cortex, due. prefrontal cortico-limbic it months, pain at that example, for the including of parts of kind pain area around our cord might chronic extensively we're the chronification takes the an For that that's be

So the ideas trying we two I parallel. are in advance think to

to just using of into enough And duration with we're working get have, of hand enough enough, pain patients one Advisory to the have mechanism clarify then of prefrontal working on parallel passive the advance course, of can the against exactly, is there if in the really to Board, not could the sign with And the work to others just think understanding cortex using time a pain get Scientific to that to magnitude patients. I as that hypofunction study. of try a study, to in what disease. way and of So our be, try our it's those

bit it's in and So little has, been of produce of working general, to it measurable a or process a clear a nature. I that a or think, field biomarker for the area difficult something relatively

Charles Duncan

be a should needing it's of or this Last cleanly But out the Yeah. imagine to conduct additional potential really particular you steps, data read studies, in hypothesis. you next could of wanting would interesting pivotal or studies, could two anticipate two Phase question, DPN. IIB in move you that terms pivotal forward one and

Andy Kidd

to study The this certainly, did requirements pivotal. design we by as think serve trying that previously chronic the could far as data been that for out pain. FDA possible It's we follow could had laid I as

advance clarify confirm However FDA we that. meet in or didn't with to

closely guide it be the us consider an we'd case turn good III. again, as our very scenario expect follow this a we and say give design doesn't since out I'd pivotal, our certainly if possibility. pivotal, it'll So Phase could as We really it very a serve as it even that design upside to the to a

Charles Duncan

upcoming taking Perfect. luck with data. questions. my for Thanks Good the

Operator

and The Please next Baral Cowen from comes Charles. with Company. proceed. Ritu question you, Thank

Ritu Baral

Hi for guys. the Thanks taking question.

Andy, XX between DPN you're or XXX taking hit be reading the out two an analysis alpha at of I trial, On fibromyalgia? XX about, talk versus going the that taking looks to plan and month. sort the to doses? analysis similar Is next in and you and study that's you be and guess analysis looking fibromyalgia going the between primary Can very statistical the are you was the it two the to mentioned the blended a otherwise placebo the XXX

Andy Kidd

Yeah. Thanks Ritu.

the a XXX is think are I XXX The its and So PTSD. two fibromyalgia, XX for doses.

fine. that's So

to we So yeah, and at our so look, plan. really much stage, I get don't too XX XXX want think analysis in detail into statistical this

as certainly I all main clearly with it interested guess say we what would wouldn't are objective, everything is which two our So expect I to I performs an of then and see better, about think our out. think anything a certainly ordinary doses out prespecified SAP I strategy a III? to restrict clearly laid would my I these SAP. and view will Phase in right not now. too be just the just of I'll many We're there. prespecified in details comments sharing be

Ritu Baral

very that And comment at NMDA you're those conditions with of intriguing about considering then ones some with talk pain a made can you that especially you conditions the you're Okay. other about have rationale considering need, least unmet rationale, that around modulation?

Andy Kidd

Yeah, absolutely.

these simply chronic the of So, a pain abnormalities. prolonged rationale some of on experience of lot causing pain conditions will based have a

is So, field. open wide a fairly it

we interested in preclinical induced chemotherapy two And there to where that have very pain the two. to try in on. musculoskeletal these or are site, that studies in are published neuropathic including data are some range a in the other and clinical data think types and in will in of year we we the help be published us we last the on think certainly I Certainly of at particular from of so interested osteoarthritis we indications different those conditions, looking data and preclinical conducted neuropathy prioritize. I

two we I in think these be that driven somewhat data go those see the how studies. will prioritize we by where we indications and

Ritu Baral

Were in question. last IRB screening COVID start there Is very delay significant that And, Was any issues, the there anything for etcetera? XXX in it. Got quick the study? related? milligram PTSD

Andy Kidd

study we very not because a sites said, weeks again, ready. to few this Yeah. really running. the of your at just point I I but related It IRB from point No, on get longer initiated mentioned external driven side is place to of a particularly Thanks It's be first longer, and much COVID sites in was with and obviously stopping Ritu. what COVID tell view. like there operationally to taking issues, partners question weren't by has clinical had actually as wave just everything key a to delay the impacted up and hard our

in a is one everything obviously change I greater developed. on and there other attention just few a studies is and more that's because think because a there therapies of welcome are that PTSD that studies being years I the US ago. other sites many other so complex from prioritizing the few there's of backdrop And there so a are a is out a little as it a shows the means And few process bit out think that much there. to there studies reasonable and it But amount more

So probably up very things, don't next getting look significant few screening and company really delay not we running weeks. in think those the to we and of and forward a

Ritu Baral

taking Thanks questions. Great. all for the

Operator

BMO. proceed. you, from with Ritu. question comes The Gary Thank next Nachman Please

Gary Nachman

complicate indication and just single fibro or doses Thanks and if the of milligram End considered DPN milligram make the guys. XXX separate meetings when going the Phase is for efficacy, indications two since milligram Also Phase XX together will milligram, be the on chronic would XXXX, pain And XXX XX with a XXXX? will each to planning you them or DPN fibro, II of in have the sense it for that program? III for is both show better more

Andy Kidd

Thanks, Gary. Yeah.

makes opposed it to to on we're DPN the with keep meeting, two have the data. around So separate as first FDA interactions. for now waiting probably sense to fibro moving right We more point think planning

protocol, or there we anything the sure anticipate and would data inform that. seen though, fibro a DPN and Given had able to FDA certainly there if would off the the kicking we would make there incorporate of be to meetings data wouldn't be if that time was fibro that timing study before likely

too question It So take to DPN, away meet I from we makes it's that. label With far sense certainly too, be rushing with will to timing the do think of upside a capture wouldn't separately say. ultimate dosing, difficult but it and and DPN. bit little on ahead respect to

discuss language. believe would I guidance we'll we think it be I comment be doses think effective sure development label but that with would any I'm that And think And would was FDA. past has kind themselves is the whether drug a there's back. difficult different guidance why would something label of would a It and was, it's was in on that that actually whole for we reasons framework challenge Not indications not that. would some something that of the discuss FDA. be that with pulled to achieving sponsors a that the I thinking be being one the to with different pain like of to many different chronic had optimally prior foresee broader question broader on I say FDA. being question there. challenge, that I, FDA would possible a I that availed

Gary Nachman

lit bit what for think do in body little Lewy patients Okay, to XXX in show then know maybe in in at point more great. side you asked explain cognitive thinking and see? just And those you're able what be and Parkinson's what we between impairment, of of efficacy rough dementia? on the what issues but signal I any group. And to from the with a terms this patient kind be the been then COVID might you're that XXX will hoping on the you've either past, patients

Andy Kidd

thanks Yeah, Gary.

we don't it on And, a terms think goal a split, preformed of the bit. the I around specific very split. that in depends have expectations, So little

then the to criteria. a consider to have different you prevalence, forward step likely exclusion You also at look the then who's but pass in clinical trial participate and inclusion can and

versus a there of terms I hope respect yeah, would of expectations that Omicron COVID wave with like Lewy making sites patients I us and it's think, wouldn't bit difference, saying, right a also little do down. of With a mentioned, over It I particular, how in dementia now is there and that specific than further December all different slow little Parkinson's there. certainly to patient Parkinson's dementia issues potentially representation with tell site have looked NCI, difficult other much to that's a groups of go any January, exactly for bodies. we the to So with I reasonable behavior though, that and of with really staffing. enrollment think like an is was of

majority populations, the study The XX, study subjects the restart the obviously the of of it over generally we'd it XX. range be that vulnerable including vaccine been in the and we're As more XXXX until cautious we've expect a XX -- to age didn't end in higher I to restarting those mentioned after rollout age is of but in range. towards would this the little

the haven't it And as any I possible. set And going be that an as And we've interactions and slight that efficient there's to make we had, think, take the patient so in the willing we've, and are protocol site I think to study. tried generally than been other that how sensitive over slowdown part holidays, issue well. to the seems to that patients sense up

and attention memory in attention paying quite will drug also on on known are more do see can signal, like. some tests, be of tasks looking as trying cognitive help IIB on implement studies, think the or function. function more that recommendation characterize how shopping which we'll what need particular sensitive, of the profile known with Phase In things straightforward, forward to see tests, signature Phase looks Parkinson's you neurocognitive that like of cognitive are different also domains, the the I to endpoints impairment is Groton fairly in efficacy those list, tests, used series to terms are types phenomena, widely studies a the the Mae be disease. and are well targeted most back [ph], in really different we're be measuring that working two executive this think six that'll the different so of NMDA have international been of And and dependent the have this tests. to and we and neurocognitive on into these easy that as to patients based we does cognitive then for we're that And how and move will endpoint, performance And select improve measures in which we see the these us III to probably that studies, right I come to those specific of cognitive profile more

Gary Nachman

And quick, taking you much after down more tap last just That's KX? million? to last $XX left the Okay. into flexibility Ashish, how the How one facility on it for is do credit with much helpful. Thanks. have

Ashish Khanna

Yeah. Thanks Gary.

facility $XX million. entire the was So

another took down positive $XX more tranche March we down that after accessible that in milestones would noted shortly million $XX signing $XX The upon lender. million. first as taken with data million leaves agreement We've be I and mutual

Operator

next Thank question Please The you, proceed. Marc Leerink. SVB comes with from Gary. Goodman

UnidentifiedAnalyst

It's Thanks for for [ph] line taking Marc. my the on question. Zury

I NYX-XXX. So, regarding question have

us remind current other cognitive for any Can several discontinuation trial? studies NYX-XXX be could evidence stage can are there DPN far you products ongoing to versus so how MDA signal its entering efficacy this new remind impairments. mid there that the differentiated us observed? indication support NMDA safety other And about this So in secondly, in and rate products. product Are

Andy Kidd

you. Thank great. so with start Yeah, Okay, let's XXX.

dose we very the measures depletion have The very so And first caused deficit single the from study similar primase neurologic course that this study, cell created different in So marked sustained what few that by all far back preclinical levels. improvement of to called is evidence in cognitive to we of neurotoxin. a sustained weeks for saw by NYX-XXX evidence preclinical. rapidly actually before thing disease. here range by our to returning cognitive neurotox is cognitive we using so seen right across a have efficacy interesting and of create is reversed performance. is But study the and a largely, inpatient that was And non-human a MPTP was think, of most, was that a that I now. of deficit We're piece for impairment is in Parkinson's in just

very was exciting data. preclinical it encouraging, So very

most different also the that had some data from was translatable We probably models various but kinds, preclinical data.

the that study the was of a did decide, controlled that placebo designed couldn't excited because in into our very XX take we or kind be really and convince less were So week conscious meaningful. would partly decision any task double randomized a blind first be would it drug We patients shorter ourselves of study clinic. we to robustly duration, robust

we've that result only as data out seen that you any studies. of in are cognitive a MDA few an there label from other often targeting that, open the mentioned, So but those a of are smaller as there these impairment, is from far compounds so modulation

And so promising, but to looks say. it's it difficult

I what think is. efficacy of degree the really

of our compounds clinical and good so our conducted. certainly So course know of others. more in stage been of far know differentiation, we profile do we've has that about the compound those with our studies tolerability we than all and safety that terms the of We about compounds very all across

seems I So clean targeted fairly certainly ability that continue. to or may of drug addition, to we think that hope enable areas would And would effects in on our improve without else. anything cognitive a impacting the hypofunction have that symptoms NMDA focus

can those rate again, So for I certainly what because don't really about focused With drug about XXX much study respect and the think mostly to but specifically we talked can compounds, discontinuation as say, that's a to as we really know haven't other we're lot think be test that do XXX, on we will good improve and process in the a XXX, cognition. of that's DPN.

say of before right discontinuation off had would planned the kicked in-line the actually technically is the projected we rate it broadly of pandemic, at have I projected seen we the what course think with because I beginning we a And before pandemic. study discontinuation that. and the study

So been I study proceeded. think with from we've comfortable pretty the has how an operational perspective,

UnidentifiedAnalyst

That's very Thanks. helpful.

Operator

proceed. from Thank you, next Marc. Please question with Truist Lee comes The Joon Securities.

UnidentifiedAnalyst

for Good evening. This is taking my Les for have Thank I you question. two. on Joon.

pending have then learned under initiating the on you dose. month? pivotal next studies for you. would mg the First in VPN planned notable development plans month strictly XXX early and XXXX PTSD or could VPN data the criteria And to that you've any Thank dose the that XXX, I from milligram differences are screening as you've second data if And a XX partnership next internal. it consider you for meeting that initiate may, patient the AAN possible the is your as

Andy Kidd

your I'll XX. I'll Ashish then take answer the XXXX So on question and XXX around actually partnerships.

the XXX For trying we studies sure the PTSD are in make two that same. are to screening, essentially

terms in element, minor particularly is want one. very exclusion of The the dose design to main principle same. criteria, inclusion, So, the the are be Really there we obviously differences.

are So possible. to as the same close as

the XX I see. to expecting we anything weren't we've learned milligram don't So dose in think yet that

to study's protocol. any XXX do of studies, make we we to think the make certainly, we I or And would milligram we both yet. think to made we changes both, seen were that do haven't to any the need them well modifications, tweaks and been progressing likely that so I haven't throughout those but

XXXX answer partnership the question. you I'll Ashish, let

Ashish Khanna

Yeah, Andy. thanks,

see best therapeutic Phase I think clear application that a to before pretty this more served if something be broad certainly IIB point the I that a the show with been commercialization. would probably capabilities. that that be some we think therapy the profile pain we've of that prior hope believe partner well is larger established we commercial has with in consistent And and would would commercial and to we assistance be explore at we that

add always can these in advance programs to preparations. those two noted team that the we're from, value a or we're IIIB the have next that We rapidly and, and prepared offer already different open Andy's that to is patients phase be risk anticipate don't toward shareholders. done to before more take those partnerships more would programs B in that as already well poised the development after from underway Phase dramatically responsibly and steps we value IIB with optimal that can Phase we've what And to

engage the term that certainly evaluation open something to a of path, we're So that, partnership opportunity on down data whether in in the or the R&D whether near we'll wake high road represents the juncture, it. but of an value that's

UnidentifiedAnalyst

for Great. clarification. Thank the you

Operator

from comes Please Thank Laura you. question next Securities. [ph] The proceed.

UnidentifiedAnalyst

I'm is wondering when allocation, ask into pain previously guess REMS how I but play be readouts, with to thinking many for essential, asked, to going just Thanks you're little question. might come taking but a XXXX, And safety much I one chronic VPN portfolio and might about differently respect afternoon. the agents than when obviously the Good data bit get a consideration of programs. we efficacy have this FM

one tolerability be up if might XXXX I then II have there's Phase in differentiating from for of anything the a informative terms curious safety I'm that perspective, follow readouts in So and you.

Andy Kidd

are, side chronic about think of are of and, those pain thanks, also more are obviously that Yeah, things to be some, know, but definitely patients that less dependence some some and and I range quite a range of, concern issues, the general you things dizziness. you're is common abuse serious, And treatments can like with with right. then in there effects serious and There know, some from, Yeah, issues Laura. bothersome and the for or very safety current they you some dizziness and potential.

looking that adverse think events. data, are course, serious with of there know, that to So sure, aren't I in think, those as be we'll things you the at concerns main looking usual, make the we'll or severe any be

haven't We had in those obviously our studies. prior

is that there know, That not And case. moderate that that so in that'll concern. the be common. be and that that is will is more a hope mild also an events, even again the but then important We is thing adverse at, and expect you look to anything

I our placebo similar adverse and in has very studies profile seen moderate group. think and to the event generally prior what mild been we've

to and physicians quite think together, certainly from And I would of at data, of differentiator for potential would abuse course, see the liability efficacy for willingness underlying reported or would there's so that know, And would know, do, for for We events or important adverse anything we the be that as we course, we really risk any no to that that forth. patients you potential are carefully to benefit On there's view. look abuse determine you do their of so in like a point for, perceive know, that. this hope persistence for huge you that findings a continuation be of that provided well, broadly. good of be, that but of therapy those two to see potential with prescribe

haven't that's another as well, anything be and So the thing we again, looking in past, at there. that seen we'd

if would factor a of be as, got area. that, we disease And So three so on hoping be certainly we bill you as areas. a this those health in as clean we, it for would mentioned, possible if as we'd that very important

UnidentifiedAnalyst

of scenario, would readouts I then year the while successful of get kind X, there helpful. closer super DPN quick so. from a How terms or X allocation do from resources all That's advancement you is up with you. just indications positive a X ahead Andy, assessment X in know, X maybe program Okay. proceeding follow pivotal XX you a if best the X presume X case progressing, a the forward more of you we guess, you and be, fast know, FM, would in you're programs? Thank a, a advancing are should prioritize X or be

Andy Kidd

can partnerships in assume ethnic I we will for of finding Yeah, you of will by know, we make pipeline course anything that know, or concern be it mentioned, number so terms will the, that about Laura. make Thanks, we external the, studies the there make you financing Asish would happen it of to shouldn't having like between there, certainly or prioritize the process advance, happen that that. reduce that are and any in as

dollars in the do molecules the in I still we to, keep that That's as of timing be by I and have, quickly finance. probably quickly it's the positive addition, to an as well. in XXXX catalytic and, continue in sure the think investors IMD longer would But and think of mentioned to because and our progressing run, would have to lot moving we that areas in keep as impairments still think keen way that of We over be. VPN would pipeline also in of mechanism be data term. question the XXX we phase into not cognitive other possible with I in indications in longer of we we the move pipeline. would this for company. want do a the we we apply we country, making as would think, the I quite as absolute, XXX view immediate something expect And I a in this run. sure can And and those and as a the probably forward And priority in I in, our or thousand as in both pre hugely rest can potential in, remarks, my to understood make PTSD we'd three longer moving is fibromyalgia and think

Operator

proceed. William Blair. Thank The question Myles comes next Please you, with Laura. Minter from

Unidentified Analyst

on I've Thanks got miles. Hi, quick this for two questions. is for the Sarah taking ones. line the

comments you then trials? And XX? you're in a pain so, you week seeing if And I've if in can on First, to that. an pain four blinded from week chronic data improvement the are second a monitoring scores got after

Andy Kidd

Thanks. Sarah.

are So the conclusions draw that. no, we trying not scrutinizing from data and to blinded and,

answer. So that's a fairly quick

the draw we'll when see set. we'll, to think conclusions eventually non-blinded we the get data I

Unidentified Analyst

second Got factored powering powered the was, the it. fibromyalgia or the measures And for one the the study study endpoint? study in outcome was was Thanks. design, only for into then secondary primary that

Andy Kidd

Thanks. Yeah.

primary for Your, the, the, endpoint. the the primarily it. Got was powering you. Thank

Unidentified Analyst

Okay. Thank you.

Operator

from The H.C. Ram next Selvaraju with question proceed comes Please Wainwright.

Ram Selvaraju

on is, Afternoon, Andy is and the ma Ram. team for

active to return you physical walking. X patients has with scores, to regard something you're for and pain meaningful XX a bearing work and kind X average on think more some recedes there firstly pandemic of painful DP as is So pain monitoring? daily do fibromyalgia, in And the

Andy Kidd

would the has within that country. you of heard, to in aren't obviously pandemic March, Thanks. hit you don't months’ Yeah, period time as three patient of widespread think that those in different that individuals I parts working the of is that specific, and each been jobs that and way the in different know from including phenomenon a reports know, for a quite different I we've types for today know, the and of different of XXXX course specific study a

difficult some, been very normal, I So that. the as of has not very and on, it's time course have people on some been have think on, Again, some kind to different. working generalize

consistent a heard cause concern trial. anything, patterns. That haven't widespread was change that's activity synchronized concern We of in a to clinical a a about in been or mainstream kind enough

So our it's, or been it's about something radar have a on a we that good as question, concerned that's it's but concern. really put not been

Ram Selvaraju

initiation were there they're two a trials? concerned staggered XX two this? to you milligram dose on to XX kind I'm they versus was then patients The the or, blinded about and or, of the Okay, dose X doses the or knowing the one a good And patients reason you previous to all know. know, high secondly, of

Andy Kidd

studies will of be so one yeah, So each process site will at process. the the in be that only

enrollment we be won't patients you that's a think in anything the don't that. factor the something of or it So that's know, like

had staggering, partly we recall, was in with think it, of as off kicked were XX the going fact forward we terms may with that to I it, were of, already And tested dose. We as, as, when the kind already anticipating able more it to do dose. the studies, the move you that that to milligram back we would we quickly. move

had So like having things drug to supplies other things, ready actually we physical the among mundane that. the just matter fairly of go and existing of

because with factor it though then them possible. way as because see quicker that, So And to we other of sense be made this one as them certainly later, be that more to efficient felt the study sequence study the start product. and investigational as and quickly it of would

to partly able dose. we quickly with XX move more yeah, So milligram upside it so decision more an was actually was, the partly, were that and a it

And so one We term really April. have screening although they the were far we'll think study, concerns. XX don't the staggered as in longer milligram XX start I milligram mentioned, and any although we

and have and get we we majority than thought the enrolled size this activated, completed. sites slightly taken goal, course of really of it's had the get to the the most point the at up running, get see don't but think of important is to I concern on study don't a longer which some we

Ram Selvaraju

clarifying. for patients in And Parkinson's of report interested know, I squeeze and, I in one great. a Okay, was can more large percentage them pain. you Thanks if

pain your X, X, improvements experienced by in in, you know, trial. if the prefrontal with similar in X significant PD you reporting being with wondering possible targeted was think hypothesis of you've you a are regions, I any So patients kind patients cortex PD if with given pain And have hypoactive that

Andy Kidd

pain we we of in it some question, changes interesting. the a get say may of in specific reports course, obviously that thing we're the don't of that sense be as not interesting screening not soliciting and be shouldn't we're we, an measure the it's for for Yeah, have sort of that in the obviously aren't, will well, study We of presence there But It's exists. overlap in pain to study. whether kind study. may I

interesting, area to look yeah, interesting it's So an at.

Ram Selvaraju

questions. Taking Thanks. Fantastic.

Operator

you. Thank

the I back to time. remarks. End like turn call to over for any Andy questions at We have no this of would further including Q&A

Andy Kidd

to and a Celia. line very you, Thank on thoughtful attention, your everybody pleasant And thank We wish the for your everyone we you appreciate evening. and time questions.

Operator

fourth Thank Aptinyx results you the and concludes quarter conference XXXX for yearend your call. financial That participation.

your You may disconnect now line.

Aptinyx (APTX) 24 Mar 222021 Q4 Earnings call transcript