- Earnings call transcript Q3 2022

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Operator

Good afternoon and welcome to the Aptinyx Third Quarter 2022 Financial Results Conference Call. At this time, all participants are on listen-only mode.

Following the formal remarks, we will open up the call to your questions. Please be advised this call is being recorded at the company's request. At this time, I would like to turn the call over to Mr. of and Manager Aptinyx. Relations Senior Flavin, Corporate Investor Development at Patrick please Patrick, proceed.

Patrick Flavin

Thank us press and for call afternoon, clinical website the President you Good discuss everyone. from the On Khanna, Financial of today's results. joining financial invite Kidd, to Aptinyx's review Aptinyx results quarter and Investors section our We XXXX. our Ashish view to third will call third our on Officer of and describing XXXX progress. quarter results. financial our operating the to Executive you visit release our business discuss conference today's Officer highlights Business Chief Then and financial development business Officer Andy Chief Chief and will

pleasure these our materially. filings statements. forward-looking this are the Any forward-looking update as turn see with subsequent risk company's only call today to Clinical line I statements on within Operations Please afternoon In Litigation XXXX, addition, my which of we financial the SEC. will and cause everyone involve to conference can Kathryn factors in CMC Act call results the differ the disclaim release for of Private obligation the statements results and forward-looking call. Q&A include and and King, the to made disclaimer and that portion would the of any uncertainties like during over this risks It's that remind statements of is to made the Senior current Reform to of statements meaning forward-looking issued the Andy. President actual the now Securities in Vice

Andy Kidd

stage primary pain. of not focused challenges pain our underscores on to its in our pipeline our and chronic result, for to the This outcome fibromyalgia past the and in chronic call. seen NYX-XXX months Thanks and programs we PTSD that in disorder. several resources. and and to August, significant use obviously not major Xb in clinical intend our Pat. NYX-XXX announced NYX-XXX resources and few you development. further providing disappointing Despite clinical energy viewed we NYX-XXX We've the in our joining our cognitive on did impairment development diversification us confidence we exist of risks. do that today's in opioid afternoon programs. potential Phase in we study which have was meet focus on The pipeline Good and everyone have as of remaining disappointment platform updates of endpoint In that current in continue that drug always thank

While cognitive associated is in in cognitive NYX-XXX disease the dementia function of patients Lewy This exploratory with our forward Therefore, platform our provides readouts we're cognitive or risks. with derived in our made August, the of NMDA a these X the NYX-XXX different data on this in shots readouts. data remaining to from clinical in chemistry we In different of study our completed largely looking stage clinical quarter in to with our study to from receptors last Bodies. study designed improving impairment goal role drugs XXXX. receptor And and and independent all months impairment mild modulation, positioning are pipeline played or dementia expected evaluate NMDA on Phase multiple clinical common progress I'm roles with over ourselves few in enrollment we've happy focused of Parkinson's XXXX. indications. expect with for all report first the

cognitive as we and the novel a into programs hoped for for late-stage huge disease pivotal few of in should signal the these impairment. could trial is position Parkinson's development study Given one positive need a serve NYX-XXX larger a enable move us what therapies that areas, to

our finalized with Phase second in half is In a with NIH on by addition, of awarded data University commence being School recently half the progress study in at $X.X of Phase and expect of year. grant also completed a on XXXX. Xb researchers we've million we NYX-XXX research through of funded next use Medicine. for in for readout in PTSD, developed and Yale, to this of Yale X a the track the patients study treatment opioid enrollment from by of end the to NYX-XXX disorder, Together NYX-XXX second year, remain of made steady the

we existing to clinical readouts $XX each provide our cash data and development operational the into of programs. over our expect million resources from support Importantly, runway of XXXX

mild and associated is the placebo-controlled of thorough randomized, cognitive aspects of with by and placebo designed Since with Parkinson's NYX-XXX function. with to NYX-XXX diagnosed evaluate NYX-XXX patients Bodies. over and impairment characterizing disease double-blinded, detail. Phase The The a this taking evaluating or fewer the endpoint safety cognitive efficacy total patients. majority a of tolerability, dementia NYX-XXX X secondary Let's the in Lewy patients, primary of incorporating diagnosis first of a and we're enrollment of exploratory endpoints. of with XX approach completed of assessments discuss time a efficacy Each milligrams study dementia treatment cognitive weeks. is is The and in are endpoints these QD August event cognitive versus have period study measure is patients profile range of the to We're of XX these mild XX in more the study endpoints specific exploratory. a impairment in with we'll

brain These learning, shopping tests was international associate Parkinson's The of endpoints by paired following the This test. the leader assessments. of six they battery is aspects of because disease. on that in continuous tests; maze, and are provided two-back identification focus tests one-back and based tests, broken first set computerized list, on cognition impaired chosen include specific in a neurocognitive Cogstate, health

the six subsets based baseline a different results the each overall attention, from tests domains; as composite test. effects reflecting cognitive changes the will scores, of cognitive are individual all each of a and provide the data will learning cognitive cognitive as score four assessed sub six placebo cognitive and assess and There of for and score following by domains We different of combine working versus executive key sub measure test, composite from The and a function. NYX-XXX. the and neurocognitive score the is memory, The of tests. sub on memory, scores well each

which clinicians', civic-plus in The performance In We're another also this PDACXX the tests, patients', instrument their performance of assessment Together, using XX measuring the function. related endpoints also symptoms is will improved related neurocognitive impacts abilities CGIS enable measures performance to that simple disease on addition sense of of improved signal and on to impairment give that assesses Parkinson's from severity the everyday to and patient will endpoints data XX to of activities the as also patient's and is performance. based what us Parkinson's of Ecog-XX a we're determine cognitive all living. impacts instrument us the scales. a to The a measuring whether cognitive functional cognitive and caregivers' shows change assessments to cognitive this daily function. NYX-XXX overall extent extent

the future assess to studies. confirmed design of see that on effect and functional improvement goal overall Our guide in the performance the to a to order NYX-XXX associated is could hope studies. then in magnitude signs cognitive signal be We and of of larger late-stage of nature

this potential. a Our would represent for with meeting will study and offer data close the this bring associated of NYX-XXX's look discuss believe we of FDA substantial. and and to and Mild immediate to potential an this next significant dementia value that the in worked of be hard We've commercial these accordingly, medical therapeutic from the clinical positive finish trial. this our in the are QX need include the reporting disease in forward insight positive NDA Parkinson's data unmet study We with results plans area, into area key to to creation at line should design year. impairment next requirements cognitive area and

is This of XXX placebo study XX severity patients' stress global improvement. with Key and on disease of XX include as versus NYX-XXX clinicians' in endpoints Xb primary in evaluated utilizing is PTSD or CAPS-X secondary total treatment Phase evaluating change score milligrams weeks currently approximately a impressions of NYX-XXX. and NYX-XXX move in Let's and QD study PTSD. patients being post-traumatic disorder in patients over the to the endpoint.

During all at progress which full sites, QX, located study the in of complement enrollment U.S. and activation of the we've pace. completed of are seen our a we've steady

individuals expected study, is is this under grant study and NYX-XXX to will announced variety As as enabling clinical Phase opioid of at issued to end subsequent Yale therapy half study is awarded the $X.X the tolerability remains million X and stages University XXXX. NYX-XXX combination later the half data in evaluate a fund X a of important safety, that It's also Phase development to or such, Initiative. begin oxycodone, of XXXX. finalization measures. assess Medicine. Phase Helping an treatment is of being This of or Long-term successfully of track the the in End is related of an is early The will initiated of will completed. which The to the development study proof-of-concept in week, was our novel pharmacokinetics Addiction of to who by outcomes safety OCD. be collaborators Last researchers NIH the interaction HEAL use Yale in use year, study by X opioids. for School the primary a drug-drug the inpatient disorder NIH set OUD. at second to second once requirement, with safety the an as report we complete the of study in regulatory an and well the conducted as study on is And upcoming grant larger study research

of withdrawal the the X Pre-clinical models measures to pleased excited grant NYX-XXX capital which efficient NYX-XXX San to the clinical in I'll We're next symptom to will hand and Phase and Annual Ashish X Diego opiate in be a Phase served potential commence the financials. now review outcome it for of will be the this Society our data to week. SfN at for for manner. the expanding presented over Meeting Secondary are OUD, foundation evaluate study study and from quarterly or scales. Neuroscience as evaluation, therapeutic

Ashish Khanna

with XXXX the the at cash end of equivalents third XXXX. $XX.X Thanks, we compared the $XXX.X million balance Andy. with quarter million to and Starting of cash in ended sheet,

studies completed of of related payments major During Xb insurance one-time premiums, other capacity, chronic our Phase out of policy to pain, and this past close we quarter, payment handful of manufacturing NYX-XXXX and a corporate expenses. securing

through and planned expenditures for through going than projections we over during forward. our quarter XXXX our of remainder cash our XXXX. our on of will this were the non-recurring quarter, year, projected existing support higher these third balance the As into Based cash operating XXXX, expenditures the burn payments in our anticipate -- cash was runway

from $XX.X of compared expenses for this NYX-XXXX mentioned, research of million in in development in $X.X were to G&A was third the the should XXXX. clinical ongoing XXXX. and our million our to by primarily $XX enable The of studies. and sufficient driven period XXXX, during centered spend We million expenses fibromyalgia. same data same studies Phase for third R&D decrease of Andy the clinical our for the compared expenses quarter, to runway reported for readouts million period of in The in quarter each around DPN, our $X.X related completion be As is development Xb the programs. of R&D quarter majority to the

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

Andy Kidd

our quarter, year from We're Ashish. to study now. begin expected later with the next in taking questions data excited impairment and Thanks, the readout with readouts We're your of from year. Phase the in move first cognitive two NYX-XXX to in into NYX-XXX happy X

Operator

[Operator from Charles first comes Instructions] Our with question Fitzgerald. Cantor Duncan

line now open. Your is

Charles Duncan

and if a you progress. Thanks XXX, these wanted for that be the study. component stage questions Andy you Super. think L-DOPA patient this or couple time but along on had questions late to on Are start our do Hi, rates that mentioned could ambulation are variable? taking with the sample lines also, characterize a and impairment, or I relatively the I on quarter in particularly DOPA may that of you Ashish. the they mild and a of decent congrats think enrolled cognitive you patients? unstable

Andy Kidd

Yes, thanks Charles its Andy.

Montreal or we will have on who MCI of impairment at And set I they are which as criteria, patients to lands, mild cognitive of range dementia. XX, assessment So, a the where part, that pretty with milder the cognitive the dementia, most consistent mild or dementia inclusion for end that's much the mentioned, our XX scale. kind is of

be tried patients severity, that from did of conduct enough motor the their of were administration motor whose they symptoms with interfere the the to obviously or symptom study the As with study, we to the tests. severe to likely exclude cognitive would

there's mean want in symptoms that of that patients will the Parkinson's these certainly how were my likely severe to confined a range would disease how patients that So, measurement have of and we are. But exclude their cognition. had long

Charles Duncan

Okay. And And question can then remaining assume all long-term they care Or that are about independent? I the--. relatively patients? a I they had are

Andy Kidd

Yes.

to the criteria some the with study, and a So not provide their may they to impairment of dementia, -- mild be have to available is function. importantly, -- that's one have have diagnosing be that or and But they that's obviously patient. in independent, all there's the may support assessment fully also to patients caregiver for dementia

if independent, even a caregiver not are the they them. will have with they study So, in

Charles Duncan

registration Okay. then assume intrigued out. about with what there Is steps, you as, it, reading state are favorite that subsequent positively. what And the have And retail or be? about is then a for, endpoint a well most I'll wondering you preferred and study or think Thanks. guess, of, studies when endpoint would everyday you registration I'm assessments I if kind let's enabling cog you function. talked of call

Andy Kidd

Yes. Great questions.

to that Cogstate sample to living. see like certainly be this from see activities the And -- that to think those living. on then I score, sensitive an trend because I some demonstration as least mentioned, the cognition. endpoints, on the hope of see the our of at the is, but would high The activities would the evidence impact are, of I improvement of would on composite clearest on we I size a daily an be different effect So we think with instruments overall like we question there improvement daily would think,

that, the function, are or which question, there's closely. scrutinize of test those it instruments would specific to the that similar all your in cognitive part that have range of what could function probably some functional is to a to endpoints be used large domain. the that study. is is of and But study. endpoints most living part all improvement combination we'll And a that that in in that in included be will for validated be a And of particular a that then reason a we'll it. they larger So of related we of more different subsequent And of are or also not because general daily element activities second cognitive then the have some think

guided And be the the see So by and to by the on. then that's endpoints next bear then be one just endpoints is time or exactly resemblance FDA. with the we would most likely the instruments that study for it would I that mentioned, appropriate discussions we'd the closest which most spending data

Charles Duncan

on months I helpful. queue forward within That's results to looking hop in back now. one, a like this from will couple sounds Okay. those but seeing of the

Andy Kidd

QX. Yes. Thank That's Yes, right, into Charles. you.

Charles Duncan

Okay. Thanks.

Operator

Marc question with next comes Our SVB. from Goodman

Your line is open. now

Unidentified Analyst

have study. Thanks taking that I only question the It's question. for is for Xa you of the [indiscernible] Hi. sort in my Phase Marc. dose line on XX-milligram for have NYX-XXX,

will forward? the this running you dose to And make pivotal data is of So another before kind expect dose reading study? start and right studies move what comfortable you a that do

Andy Kidd

Yes. Good question.

see. not then if were, primary also, and further endpoint. we answer, the that, we to warranted effect on is I doing to previous on key a ruled as which And future. in have dose. of with size based think in mentioned, discussions, was we signal single dose we we ranging I at with us efficacy finding, course, of safety, obviously, goal FDA future look But endpoints on think, study this data out the discussions And I FDA. do determine and comfortable dose The that will the finding and any depending is what help decide So will the then the

Unidentified Analyst

sense. separate Do will the long it. there Got makes patients think be you right following That duration NYX-XXX placebo? versus XX-week are those after treatment? to XX-week you And the how

Andy Kidd

time looks We the the of what will you data see series know like.

for our the it next mechanism, based time following think patients was based duration the of would few data, see series that versus the on based we're fact a up Our interested data. weeks sense looks be that treatment. again based on like. after study, be preclinical to our I we'll disease the treatment. In But this decide based what study, on on we'll on modifying the symptomatic treatment it's a But the

Unidentified Analyst

Yes. Got That's very helpful. it. Thanks.

Andy Kidd

Thank you.

Operator

Our Minter William Myles from Blair. next question with comes

Your line is open. now

Myles Minter

the for Thanks that that of based motor questions. something know But if the tests, on and or impairment of trial? taking trial do test Is following these a can't or patients the safeguards means you're that? impatience data maze Cogstate safeguards performance. question you on that motor patient like criteria, missing Maybe about there to to in screening And for rule like there this I the matches on just from Charles's the them the also perform ability CGI-S. as any Thanks. but screening treat perform is they screening out like you're

Andy Kidd

Yes. Like are to try screening patients tests. part Myles, I the that said, complete to is of ensure there able to the processes

So from a motor perspective.

in the treat be was intent if of motor the would in there missing be least missing there if patients, for be data data, the that are modified to completing study, on as talking that complete study, If at most more population. able most about So difficulties based sort the time that related they And the expectation tests, reason capacity. cognition. will for would than it of our to treated we're might then be the to any test

Myles Minter

the questionnaires of quick disease from dementia? say life I daily will Parkinson's patients know Can Because in and lot body specific you have I and Parkinson's activities these just disease patient Then of Thanks. follow-up. Lewy not of they're are Okay. you've classify a mentioned that different and their me? with numbers these a that body what for impacted dementia. maybe those know majority Lewy

Andy Kidd

certainly. Yes,

is both just include normally with well, dementia, term it's and nomenclature, a dementia the DLB. term disease, Lewy body bodies, So body the as dementia rather to confusing but and used Lewy dementia technicality, Lewy Parkinson's

with it's don't that seen commenting was number. we've on few study. numbers Lewy I that today. I in enroll bodies the we disclose So dementia specific a relatively to low But it's the patients have think

try criteria partly right either patients impairment, likely there the to the will of some had probably essentially other can those And that's and that patients did, bodies domains, in that MCI in cognitive to fewer -- study. dementia. dementia So and psychosis. why differences the magnitude into with between patients. the majority disease. Lewy other to not right we're or dementia study you're and Parkinson's study by get made the symptoms like dementia But with probably have the of exclusion right, And confounded with we in right body We Parkinson's have it symptoms Lewy the in probably to other inclusion had disease be

we're with we So comfortable we I population have patient that the think that screened.

Myles Minter

the Thanks Beautiful. Okay. clarification. for

Andy Kidd

Myles. Thanks,

Operator

with next from BMO. question Gary Nachman comes Our

is open. line Your now

Unidentified Analyst

questions. XXXX on Gary. to provide And what's be going no secondly, you. Congrats X disorder? and process that for study Thank context spending on opioid just about in Can on you're forward? use taking many Richmond color And progress. Can moving the Dennis progressing be talk for this you the you're then more forward? how patients NYX-XXX is our will you longer you [ph] Phase now enrolled on Hi, thank how

Andy Kidd

Dennis, spending, last the was we're What how going be you say? did Sorry. to word,

Unidentified Analyst

Yes.

Your spend moving forward. Thank you.

Andy Kidd

Certainly. Yes.

Ashish actually going to maybe I'm second the to question can over the Well, first Okay. pass and Kathryn take part. then

Kathryn King

Yale interaction our in are of School Andy. colleagues conducting. at that drug-drug nine University Thanks, Yes. There subjects Medicine the are

Ashish Khanna

for projected several in imagine, than And seen aren't our be going will the development in cognitive as rather of we impairments, than past quarters, you've so you'd the with regard as lower expenditures, in NYX-XXXX meaningfully pain. what to expenditures pursuing chronic actively forward

R&D trials that not than be as expect early into a lower our We We the as complete. in there the give tend cash previous guidance, to existing expense XXXX. operations you've the way along are fluctuations number But seen it'll quarter-by-quarter quarters. will surely, fund for

Unidentified Analyst

Thank you.

Andy Kidd

Thanks.

Dennis study, should maybe safety I a and we it requirement. just add as the adequate to bit interaction which speak subjects as little a the is meet mentioned, regulatory oxycodone, a drug-drug to study the So with nine of is goal

that the study large for a once will be infer of is size that study study of received probably can the that that available portion nine then proof-of-concept You the could from subsequent then the grant quite subjects complete. we've we start

Unidentified Analyst

very That's Thank helpful. you.

Operator

from Our Lee Truist. next question comes Joon with

is now Your line open.

Unidentified Analyst

this the Austin for is [ph] Thanks on June. questions. taking Hi, for

over given mind would approved. So to bar meet tests studies XXX primaries he the wondering, you out what tested on Thank time, for a I'm just secondaries of just considered of period as points XX any at weeks when question the and XX-week mark, XXX over up finding, signal you. big earlier? be a on other historical stated to vast have data cognitive shorter or the got dosing its primary the of to

Andy Kidd

question. good a It's Yeah.

in -- There stick correctly, different the over endpoints. study. So somewhat also some weeks was dose titration reverse I obviously, recall using involved was think, of mean, the if I the

haven't there approvals seems as size regulatory -- standardized be partly I as the path the effect by for two. that point as to in disease, also like what So, disease. by been emerging It's to the existing well therapies of the about would partly in the existing therapies. in be bar think used course, Parkinson's, And informed and they're obviously, Alzheimer's, we bar, approval to clear as Alzheimer's not forward, of Parkinson's in is seems see well because

just divided a endpoints. that's and between placebo the way by results difference So to different the sample, essentially active the standard the it's from deviation standardize of

little clinical higher difficult than like that, it because because it's forward manageable be a size. see would on like that. a But something going endpoints very you place to to those we trials a which we like see cutoff the more depend And specific effects. details put So, might in to simply does

So, bit the but a a us external little benchmarks, at of looking I gives think guide.

Unidentified Analyst

if then saw in just future of like just Okay. other or how scores, one the improvement, a the And or meaningful hypothetical say, two you say, the a we bit on, that? but follow-up FDA interpret even should not sub others, in

Andy Kidd

Yeah, it's question. interesting an

we that at I like domains were transpire, to would or I look one some think what be improvement, to, there it, we because think the or to two road, but if with and functional would be how which agency, that's would translation living, sub we rubber meets would on is the effect think discussions into like of see to I on improving effect to that and domains, and patient's be of FDA probably single if an say, a then That's domain how look done obviously, are that the just with of the it. determined activities could a can think at I couple confirmed be essentially, a daily interesting. that's scores that

Unidentified Analyst

you. Thank

Operator

Chin question next [ph] Christina comes Our with from Cohen.

is now Your line open.

Unidentified Analyst

patients? [ph] neurocognitive you composite I XXX. And endpoints on the between also patients MCI Ritu. have for guys, with secondary differences Latina question. my of DLB Do Hey, tests. see a Thanks question the versus scores are taking the that for in anticipate six any the evaluated we on the

Andy Kidd

good question. It's a

moment inclusion something there. this because anticipate at nature enroll difference, goal sub think to met in diagnosis of complaint, we'd we part I that look be the criteria to that terms got particular a subjects specific severity diagnosis interested of without the the that and can't the would that's the of excluding that them say was of I cognitive study at. the the

I be Parkinson's will that the look versus part dementia of bodies. MCI certainly with So dementia we versus think will analysis, at

Unidentified Analyst

you. Thank it. Got

Operator

question next from Pachaiyappan with H.C. Boobalan Wainwright. comes Our

Your line now is open.

Boobalan Pachaiyappan

the congrats for thanks my taking Hi, questions quarter. on and

couple us. from just So

tests of CIPD. tests XXX Firstly, occurring? deploying the you with these multiple relates XXX to disease progression evaluate you're discuss where efficacy, and respect cognitive sensitivity to as to cases it for Obviously, assessment

Andy Kidd

imbalance symptoms okay. have groups hope in Right active would think -- is the we I disease large adequate may was weeks, a course relatively since much group been. assuming so in an there's drug is disease of little as sensitivity sensitivity over do should symptomatic as should there group between placebo XX in last that And we general, see should our apportioned we are other that get we're drug and the disease mentioned placebo it I equally to functional we're signal. unless as group, over progression as progression it a be what in but sensitive be improvement, sample Delta, to progression neurocognitive improvement the into our the be there And drug a the should interested tests is experiencing between while the change. mostly weeks, sensitivity endpoints, to and over XX the be the think earlier, the tests since and that and less If group, the size then still between that and a that the be

Boobalan Pachaiyappan

XXX Opioid think And about the X study? Use we for in Thanks with to response respect placebo Okay. should how the Disorder, then the Phase for color. upcoming

Andy Kidd

have see you really study of but the can design that upcoming the Phase Is the study, the interaction today. we Phase when not we clarify, some X that study, have, discuss study, that, that. we study X to a -- that that on after is you Just template thoughts study, don't because mean drug but design

Boobalan Pachaiyappan

Yeah. other the one. Yeah, Okay.

Andy Kidd

-- phase The

Boobalan Pachaiyappan

Yeah.

Andy Kidd

ahead. Go

Boobalan Pachaiyappan

that's Yeah, go one. the ahead. Yeah,

Andy Kidd

the if you so to mean be at primarily then X interaction. Okay, going study, it's Phase safety drug study looking

a placebo Kathryn's if the if on on Let key measures, there's Kathryn. any relevant comparison just me check of

Kathryn King

placebo a in those them we is endpoints certainly tolerability, you PK. safety there So think expect I response a comparator and but as placebo describe don't

Andy Kidd

Yeah, yeah. Thanks, Kathryn.

Kathryn King

you. Thank

Boobalan Pachaiyappan

Thanks taking right. for question. All my

Andy Kidd

welcome. You're

Operator

time. There are waiting no this questions at further

back remarks. the closing team over pass management for So I'll call the to

Andy Kidd

operator appreciate you, thank your for your a very you day. of wish We and your you your rest questions. Thank and everyone pleasant time and all we attention

Operator

you for conference the your call. concludes participation. That Thank

your disconnect now may lines. You

Aptinyx (APTX) 9 Nov 222022 Q3 Earnings call transcript