NLTX - Earnings call transcript Q4 2017

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Operator

Good afternoon, ladies and gentlemen. Thank you for standing by, and welcome to the Aquinox Pharmaceuticals Year End 2017 Conference Call. At this time, all participants are in a listen-only mode.

Following the conclusion of the prepared remarks, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, today’s conference call is being recorded. would turn I to call point, Mr. this like the to over At Director Investor Payne, of Brendan Associate Relations.

Brendan Payne

like to Karen. you financial December On I’d XX, for you, and joining welcome Thank Good the us. behalf morning operational results XXXX. of year to conference call our and for thank to discuss everyone ended Aquinox,

Mr. President Joining are Mr. Development Troupin, Finance and Officer Medical of Financial me David Clinical Barbara Officer. Vice today Vice Regulatory and Kamran and Chief and Affairs; Chief of Main, CEO; Alam, President Dr.

During up today’s Phase will an begin will And business with a discussion update events. financial with with end XXXX with subjects session. clinical provide X recent will Dr. a we call, Mr. and then year a XXX Mr. Main update interstitial rosiptor of cystitis/bladder pain LEADERSHIP wrap trial or of on results. syndrome the our IC/BPS. Q&A call conclude Troupin with then Alam will

As Litigation factor numerous forward-looking a of our development reminder, today’s outlook. to our the plans by other statements differ those those these and due XX-K Act in Actual research discussed indicated XXXX, Reform recent Private statements forward-looking regarding and from financial including include risk including under and statements may of results factors conference the call will most Securities section SEC filings.

assumptions Our change. expectations could and

statements even turn future, we to the now obligation so over David? these specifically in that, do views if our While David. forward-looking we change. update call elect may any to And the to I’ll disclaim with

David Main

afternoon, everyone. And Thank you you, joining thank good Brendan, us. for and

inflammatory years to journey a on on the better inflammation been several effect we've past know, you As understand rosiptor pain. and over

Aquinox opportunity are clinical QX diligently in like working with trial. research overcoming Phase partners all recognize reviews trial expand CP/CPPS this announced clinical delays year. potential year of and at way our X to XXXX program targets, We IC/BPS closed in in much data reducing female date recent valuable trial much applied conducted. initial York, rosiptor to use surpassed learnings We debilitating IC/BPS. closed announced for placebo February held we from enrollment subjects of and from new At X LEADERSHIP of on patients February on female XXX trial results and Phase have clinical pain event threshold trial learned subjects to remain are XXX had with these on now X track Regulatory mid initiation team and revised in symptoms were advancing. Phase X this by urinary pelvic Analyst in our the LEADERSHIP it Our XXX suffering the take provided forward In looking are rosiptor's and of the largest call, New guidance. to this officially our has year. of our a enrollment we trial from of in we am some work selection ethics to ensure for initiating of I data our in to to on our we our we met site clinical our well say syndrome chronic I'd early pleased And that and or prostatitis/chronic our the initiating this submission, plans providing and controlled XX. ever the top then hard site achieving Investor to and this rosiptor that line since early and pain

patients whom million needed. with are CP/CPPS therapies the diagnosed FDA urological more United males effective enrollment of trial another approved and once we treated. commences. millions CP/CPPS with is one treatment which condition of announce in will States; And desperately are estimate of specifics no patient We the debilitating affects for

of of quickly I'd you expert Medical commercial Medicine Aquinox's discussion the event Commercial who and of enrollment XXX for and rosiptor Business thank Aquinox's Cystitis professor those Philip final Dr recap Head the Abigail Dr. details Interstitial in Stanford patients overview time US co-chair recent Day our and At trial, of will like of Dr. clinical & Advisory program over New update the Investor an held from an Now Leadership in the to opportunity University a Board landscape Analyst and on participate with Chief before diagnosis Urology shared Association IC/BPS. provided of perspective with at treatment York. the provided prospective Officer took who the the to Troupin very attend the passing to School clinical the in Troupin and just Ms. IC/BPS. current Hanno, his Jenkins, on

who And so pass to yet to will have investor.aquinoxpharma.com event over Barbara? the the at recorded link listened opportunity webcast visit And website to Barbara. like our to or not I not the featured. with you did prominently the call anyone attend that where invite has I'd to find

Barbara Troupin

David. you, Thank

urinary with of hallmark For disease thought urinary affect and/or urgency the US. disease, IC/BPS including five plus a of those is who nocturia. chronic the familiar are in pain is bladder by or frequency some million one symptoms less characterized adults story additional symptom the to to bladder newer the or IC/BPS more

also there's sensitization While between in an XX bladder inflammation in populations. with leads to determined central LEADERSHIP doses on over an is is in collected LEADERSHIP fibers in subjects involving XXX data in pain diary. the electronic a efficacy of week and bladder based and by has etiology baseline and three-arm, XXX Subjects definitively a nerve safety remains not the XX-week of to XXX activation years. XX will the who which a with of Europe. believe conducted XXX placebo originally disease treatment extension continue was and to extension many pain IC/BPS for also Hunner Relief to fashion placebo compared the anticipated to therapies for some opportunity extension state female is that XXX both received one-year safety affording the satisfy men female daily endpoint disease rosiptor multicenter, This in The RCH primary the for sensitization. of XX new symptoms followed treatment opportunity the during pain although subjects no interplay who experts X subjects are period in safety been numeric bladder FDA LEADERSHIP change subjects in a this which was XX-week, treatment IC/BPS database point two of scale medical the for LEADERSHIP consists to be unmet an of approved also and an participating largely XX and of will cases in need without from -week a to their data. had for stratified transition the for the trial. clinical designed exploratory treatment of designed data by Canada one but enroll their participate period from recorded include long-term Phase receiving X in rating requirements treatment. maximum at period be all minimum the XX period rosiptor. the two and accumulation dose, period active while as the on will lesions the part to those analysis rosiptor, while period assigned randomized, subjects patient blinded includes primary randomized double-blind, population to XXX of LEADERSHIP United States, being trial placebo-controlled,

early females males closed randomization recruitment of for target As XX on met. Enrollment David with officially a XXX XXth mentioned after XXX the females closed and total February for the trial was enrolled was of in XXX at XXX expectations February. and have our event remain Overall, Investor Analysts the baseline figures trial of reported the LEADERSHIP consistent patients. demographics our met the with and we

trial in We will provide XXXX. report final the data third from the quarter of demographics when we baseline top the line

presentation we forward While the the data top to look the trial. of of and analysis completion line of XXX period extension and to

IC/BPS planning Committee a package potential the patients Xth year. in IC/BPS Urologic last a building division towards next positive actively was of the Reproductive steps on registration what FDA's for products meeting following disease on state Advisory also by are Bone rosiptor held December of and we believe with the We

we've a the for has than additional IC/BPS drug clinical since diagnosis NDA engage that more At FDA safety the was discussions an years on request and database available considerably treatment will with Advisory division since last are from to requirements with from in XX online the subjects Minutes meeting continued how for also landscape contribute LEADERSHIP requirements. in approved or changed Committee the the IC/BPS ago. the and upon X trial and we preparing XXXtrial/ are designed Phase our confirmatory minimum, well aligned exposures We

our parallel in towards total XXX than Phase next help required be and As soon will our our trials with and CP/CPPS plus our us to noted run some plan and plan Phase believe X that trials necessary earlier, and exposures. including Any to one-year X&X the trial ongoing trial sequentially. initiated we exposures be the count and subsequent satisfy six will rosiptor LEADERSHIP requirements, these will months complete trial rather

way trial designed enroll the initiating Finally primary as maximum trial endpoint David Phase term. CP/CPPS an and mentioned, is we pelvic are of on daily our to male with pain. CP/CPPS exclusively X the with to a The in near population rosiptor well

scales such frequency. include NIH the and measures chronic endpoints subscale, symptom pain index urinary as health as as Secondary relevant Pro sexual of prostatitis well

medical I'll high and financials. our role program As year like to of Kam the plans condition. XXXX the year remains IC/BPS a data in of our the and models urology space. the is thought that was progress to clinical this end preclinical an pass and our for announced look in call the reporting continued with from that in also August, support call biodistribution at an rosiptor we development have and in ahead. discuss inflammatory potential mid-year over data described prostate With over last rosiptor, to data need component unmet include Kam? months to when forward XXXX area treatment our we busy we CP/CPPS

Kamran Alam

December primarily to as December Cash, results the XXst, XXst, $XXX.X to ongoing long-term as year trial related year driven Barbara. from short-term increased in investments driven rosiptor decrease clinical XXX Aquinox by the million for LEADERSHIP the operating million December increase primarily rosiptor expenditures for expenditures with $XX our cash primarily $XX.X XXXX of was This clinical IC/BPS. $XX.X and XXst, totaled million continued trial assessment $XX.X compared XXX for for XXXX its LEADERSHIP costs, trial was increase year XXXX. increase fees December primarily to and ended XXXX XXXX. market This by from the $XX.X and pre The compared Research ended December clinical XXst, million XXXX. December personnel $X.X of professional the commercial administrative for expenses increased expenses development $XXX.X ended the XXX. year XXst, Thanks loss This December higher XXst, of and loss was Net to to equivalents million LEADERSHIP its XXst, and by the activities XXXclinical million continued the million was a increased General XXst, driven net and IC/BPS. activities. for was million December as increased ended year ended of Aquinox related XXXX and year ended IC/BPS.

We continue call with back XXXX XXX additional the clinical on to David. to that market will least and at account. pre into top-line expect us carry data mid beyond preclinical, assessment With trial, from commercial taking manufacturing, and that the to I'll LEADERSHIP ongoing the development hand activities cash turn

David Main

Kam. Thanks

to So forward a on with be to of LEADERSHIP near-term progress for from development Aquinox keeping development XXXX decisive and apprised rosiptor. XXX horizon. investors year top-line look the data for the promises of We clinical

committee forward the recent We following regulators advisory mentioned. further also to engagement meeting with with Barbara look

forward. our clinical on fully with path So going aligned rosiptor that we're

support investors rosiptor and essential the this in grateful. Aquinox are of both development exciting us exceedingly which been in we Our for point to getting has

us on thank continuing top-line So you to announcing while to they data forward joining again you arise. we other And we the to today. XXX all can questions. later important open now for call as event this update year, look Operator,

Operator

[Operator Instructions] Thank you.

Needham comes the & Alan question of from first line with Carr Our Company.

Alan Carr

my for them. A questions. of Hi, couple taking thanks

burn extent a of comes what when but you you that wondering what have relevant pain to I'm have chronic primary it them extent it is to One secondary as to as endpoint. for urinary the prostatitis, is to we frequency syndrome? saw XXXX, indication or roughly with a then respect bit what should bladder in Thanks. is pain to in in more? little line also cash burn XXXX compared it and be And with that

David Main

the with Barbara, first. deal want you take we'll question those? Well, do prostatitis to Great. chronic

Barbara Troupin

Yes. thanks for the Certainly, question. Alan

of pelvic CP/CPPS of is terms pain the in So syndromes. chronic the one pain

others as primary So why chosen as primary, like the we've pain as factor pain IC/BPS, the which do then we endpoint is and see secondary.

So of is it predominant driven. symptom pain still the is disease the

like So have some be urinary, do lower patients is tract one. pain going also other the urinary prominent frequency, symptoms to but

Alan Carr

symptoms outcome urinary common chronic in How symptoms symptoms are and the urinary is prostatitis?

Barbara Troupin

that and know a that I in I can't I you. the at would for number but individual, they percentage are There's give some again exact it's so an similar apologies. have don't them I common say symptoms IC/BPS. the variability urinary to experiencing moment, by you

Alan Carr

all it's then right. burn? the And No,

Kamran Alam

mentioned, mid the are the us we're being XXXX we sufficient obviously current trials at that greatly In depends and get into burn, those, Alan, much as cash year. run, specific wouldn't with burn we from but where I on difference and have to expect the

Operator

Our with Guggemheim line Adnan of Butt Security. next question comes the from

Adnan Butt

Hi, thanks question. for taking two. have the I'll

it the on study. Phase of First one of waning that Phase ever concept does pain. exist and X Did it threshold? does waxing, the see if that This you spontaneous in X reach point

David Main

that? want you take to Barbara

Barbara Troupin

that so that some waxing are you the so but diaries is our collected part diaries that averaged. and that are of reason doing see we pain waning Yes, do and data the daily

the you and a for can averaging at endpoints. your smooth because you're of your a as look variability time, each endpoints that you week collecting some at So of daily

waxing waning week. in you're So that groups you on over see whether in averaging does help with with and the a both or it placebo so active

don't a data. your disruption look kind at that of You ability see to in

strategies any effect that minimizing to of that would have. entries feel two the and we daily comparison So if repeated placebo

Adnan Butt

time Okay a does Phase that can be just on study when expect and X? readout that would this one to from then say into at prostatitis, taking you and you what

Barbara Troupin

so XXX using dose for we I with we're that's milligram have greatest the planning Yes. can information. dose, the which start on the dose, the

when of readout give more if expecting David, guidance be I will that you there. any dose the is in know, to later study terms XXXX. that for But study, in we're that and So don't want plan specific

David Main

Yes.

I be previously. think in sometime that as it'll done XXXX we've

the until and about more running period data, wait specific will on But be and to sometime we'll the in get then be rate, a of good of trials time some on really the will enrollment for granular We it'd timing try handle we XXXX.

Operator

line Fitzgerald. from the Our of Bill Cantor next Tanner with question comes

Bill Tanner

Thanks for technical viewing of success the rosiptor to or And subset. as had you of the what wondering one to is studies maybe taking from the be if at guess to PTS. as increase you're CP/CPPS I wondering please. as sense and you, might relates the looking an I get for it would the at IC/BPS probability you questions. sort look of XXX Barbara a or had the I'm in totality that follow-up the to guess XXX I'm be going And CPPS. is optimism a data maybe CP/ I effective male it then

Barbara Troupin

Yes, certainly.

preclinical start would from rosiptor. from the have in effect condition fact prostate the I mean I with pain us So that we to that lead you an a models that using believe get data would

to are with. a as this also knowing us So well the inflammatory preclinical of with led what pain as CP/CPPS with condition models, combination is component, those that begin to embark an indication on

data us -- say with totality that in the in I be and the to think men agnostic pain, look or should and data because males would encouraging will would I think females. you across at to inflammation the help just be at looking data that, you're I XXX program but not

Bill Tanner

enrolling in same move of or you to trial IC/BPS? a or it's the pretty wondering subsequent needle think that's but no, the then potentially X you. Okay, but Phase top-line would just patients positive obvious in on sort impact thank kind you sites think for enrollment really I'm an have of answer positive helpful, I it's maybe second the obvious for And pace data think studies. you do contemplate or a do to then extent from CPPS the guess of What about XXX. CP/ that as either And maybe going kind top-line, straightforward what

Barbara Troupin

Yes.

possible. activities, our literature data we data readout into that with meetings the investigative also be that experts. and of would scientific sites share certainly as the part as getting into We'll As data the quickly

I think definitely does Association. closely worked give enthusiasm. with Interstitial also the dissemination the positive of Cystitis We've pretty data

that data to to we it the was clinician patients So that addition they releases or press up in would likely had would get positive any the pick community. directly

subsequent of help be our enrollment definitely hope in trials. to would rapid it So the would that that dissemination data

Bill Tanner

the you a that make and question in be modify the may might that design And the that there would one of results last studies. contemplate anything subsequent

was of looks and enroll rosiptor get to more there like it effective the perhaps if what towards example to patients if opportunity the perceived be physicians reluctant a clearly the they would For be wasn't might to skew active treatment. it

Barbara Troupin

the We study a reason that Yes. job IC/BPS from mean subsequent learn of the this optimize we've we to placebo ever study, that run information. to controlled greatest probability The if there's that And of And help largest have date that part the of I next certainly the we the done done is will we want design the collecting that that nice of has baseline that sequential want of characteristics. in the us trials fact of trials things success. trials. sure set make design XXX the is

we everybody account. the positive do on regulatory challenge active need you a of for to would control. definitely So unfortunately Again, an trial take certainly want the still And with placebo that will into be purposes, arm.

So while process. all that's the consent unfortunate that's informed of part

unlikely would of to getting So of the got have control doing understanding an placebo patients what closer But active be to trials we we able until would drug stop that approval. be. it's would probability

Bill Tanner

Got it, okay, thanks very much.

David Main

is David. this And Bill,

of add efficiently getting of help and data Clearly would site these the learned the important of a most are Just we've awareness couple as but some about done trials enrollment greater things us, aspects more identification. speed. around having probably

now. we've a that lot through been I So think

maybe of probably to the database met additional end modulus positive a to for the So They sites run on some we now familiar be that from that it's that We inclusion, things a us really some still enroll trials that with we has nice be start the And of have for starting would enrollment clinical think done study. with bigger criteria a safety the publication. one could pivotal that speed, that complementary day could our familiar thing, won't generally for Barbara regulatory just be used patients we're have but are That's population wouldn't job these to stable change much, of of probably that continue and have impact a able the our perspective, to a to criteria. would the at interesting information add purposes. and them. and very but her biggest about is maybe team gather to we and exclusion

So we're of capturing the of patients the ways pivotal also trying of to from think well. are trials more like as screen that failures

Operator

comes of Lee with the question Arlinda next Our from our line Canaccord.

Arlinda Lee

data Hi, for of a guys. just you're earlier set and kind my of population taking question of for be should hoping Thanks curious may I'm see had we what questions. on Thanks. question. the from data the male third up --what it quarter? kind one expect I following a to

Barbara Troupin

Yes. Hi, Arlinda.

would could and differences and study female, do your population data, So say of and similar will any secondary male to our studies or an are will subsequent you hope or that will by you female look endpoints if for efficacy if be see we there that levels to because powered female. from primary agnostic able but all the male females that currently responsiveness male exploratory sex at safety do in is be goal is our the that subjects, be analysis to like we

similar first those wouldn't show that to So you males. our and would is have just our with This that exclude goal males. experience to are be

the them not goal to be And would in to so divide future. our up have

Arlinda Lee

were you great. end? enrolled that many did then males Okay, had the there, say in And how

Barbara Troupin

XX. I sure front in me number make right have I Yes. that of

Arlinda Lee

color XXX what also what with XX the data you any on and third on kind Can on patients then that is lesion. see of And scope the give proportion Hunner we females in the a quarter? us of lesions? then enrolled Hunner of might in

David Main

is Yes. David. Arlinda, this

to you, verbally presented some one what very top it analysis wouldn't to trying repeat want the the direct Again, I Day the just back the answer. because be, Arlinda be line just probably get directed if include. In all we terms because concrete you slides place what that Investor from where confusing. it probably to of the thing you concretely all to could -- Analyst said That's that's for and of it'll will Barbara it easiest

Barbara Troupin

at until we release we're Yes. -- look And that won't baseline as data. would again be because I the top there updating line demographics we well

current the So legion. look at most of absence or that's baseline presence the including Hunner criteria

Operator

today. Thank the I'd for you. And turn that conference like Payne over any back concludes our question-and- closing answer for to comments. Brendan to session

Brendan Payne

for questions. if to said continued who earlier, have joined Please as we support to and us when additional all you contact update. I to with Just you hesitate we our thank want this look any their for call. investors have us everyone a David further don't for forward speaking Otherwise

Operator

disconnect. and program. your Ladies a great conclude thank This you conference. today's for you have does And in participation the Everyone now gentlemen, may day.

Neurogene (NGNE) 12 Mar 182017 Q4 Earnings call transcript