ACHV - Earnings call transcript Q1 2019 | Achieve Life Sciences, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day, ladies and gentlemen, and welcome to the Achieve Life Sciences First Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions] As a reminder, today's program is being recorded. And now, I’d like to introduce your host for today's program, Jaime Xinos, Executive Vice President of Commercial at Achieve. ahead. go Please

Jaime Xinos

Jacobs, and Officer today Jonathan, Officer; for us. due Chief family Dr. joining Anthony our a John Thank and to unavailable CFO Achieve thanks to are me our Cindy and Officer; from Chief and Executive Medical Rick With Officer. Clarke, Bencich, Operating you, Financial Scientific everyone Chief is Stewart, emergency. Dr. today Chief join

Please Rick. refer on copies factors those of contains filed the current like I'd website. the Company, remind that available are that forward-looking SEC to turn only on statements, our call and vary based to concerning These Achieve documents Before results we which I'll begin, predictions, expectations. the today's everyone to could are projected. statements over may affect now conference actual materially with call from

Rick Stewart

we’ll Thank upcoming program, an provide update you, regarding milestones. development clinical today’s On recent cytisinicline plus on Jaime. the call, progress Achieve’s

subject study. ORCA-X the visit. across April a their seven year, provided with XXth behavioral enrollment centers trial beginning We're discussions, Beginning of Following times had full dose comparing that period. study a enrolled safety on quarter completed the Phase weeks. placebo. face-to-face efficacy both ORCA-X, announced of optimization is in of in support has are post the with dosing and to recruited time this financial ORCA-X titration Xb addition schedule a of record trial and X.X review our the three within were for established doses XX% of treatment trial and Since in at the XXX the evaluating using subjects that XX-day are over the a total Participants U.S. first the declining our eight smokers versus weeks which last in cytisinicline last We I will over monitored provide results. daily approximately X-milligram four course

data monitoring data focused organization Our finalization. clinical now from base and the research on is sites

to announce dose clarity we end results the the presented the of expect that want objective the have by further study provide the that, top-line for I To at Research and revisit Society quarter. repeat Nicotine on to We about of the results do outcomes. trial Tobacco cytisinicline to was data potential in of and this this February.

was was study downward As formal the findings. that intended small smoking pharmacokinetic a reminder, quick provided. and a pharmacodynamics X.X smoking but and a about this minimal were There data of not rather schedule. to The signal gave no counseling only trial evaluate dates cessation a doses and us X-milligram cessation using two titration set clear

number On by Firstly, the course in of number treatment. subjects cigarettes of reduced smoked. cigarettes initiating cigarettes groups reduction at treatment, was day throughout of XX% they the smoked average, had baseline. and this Within both of XX hours XX level in smoked sustained a of the

Phase clearance cigarettes we X trial X of May smoked meeting program rates. Phase we our clinical derisk in principal is currently the investigating Secondly, further can the a on higher versus exploring on optimum further reduction is Central XXXX Based efficacy. of a dose. and has dose outcome meeting, a the Achieve both, improve This Europe already marketed X.X demonstrated trend taking in in Eastern treatment chose in XX% milligram with This our trend towards over that subjects This a FDA rate dosing trial by design. XX% XX if under showed quit arm of million the to on X-milligram given the the and At to is worth patients. on dose schedule. treated this see quit were and better

titration X-milligram dosing be can milligram currently over the either whether or improved are titration dose days a daily XX with three or evaluating by dose milligrams. X times X.X X.X We using

and of profile key administration the trial, efficacy, are the endpoint course dosing be the elements safety For smoked in will of cytisinicline. the that treatment. is The over reduction assessed confirmation cigarettes ORCA-X primary efficacy

will X evaluated cessation cigarettes smoking ORCA-X in the to versus is trial include rate, the of significant well statistically endpoints The Secondary as safety of approval endpoint, is compliance. a which show be that reduction and smoked designed as Phase placebo. difference

statistically small per the participants powered difference show rates. number not of to overall significant given group, is it quit in However,

Central arms for these one of that XXX to currently cytisinicline, arms schedule of be a the an of a demonstrate dose X.X-milligram total schedule will in of milligrams dose, efficacy us Three while The dose finally, period cytisinicline X-milligram cytisinicline XXX treatment three treatment XXX.X for improve This discussed, total whether total XX higher administered comparison titration downward of can giving of evaluated across As and dose X-milligram a a allows having at three also dosing a days. a confidence day times maintaining arms our This or of for Europe. milligrams. scheduling the daily, is for benefit. Eastern and full over XXX of total -- delivered four increases marketed of and on or efficacy in milligrams, X.X-milligram and of safety downward more above titration on what out milligrams, the a will evaluate times total tolerability. dosage

more In administration to key may compared provide times treatment a point of for is cessation. historical for of convenient daily profile believe addition, cytisinicline a currently available the dosing differentiation smokers. the three smoking safety option We

of trial or should trial safety As an data that no and two a data concluded across our ORCA-X the DSMC, previously are or there four of as development be After select well and the as issues will dose and administration in evaluated informed analysis X that FDA. X conducting confirm safety the quarter, we to completion. committee Phase thorough the the conduct efficacy this announced ORCA-X, plans safety continue arms Phase to better schedule independent and evaluations monitoring conducted has the with

update design study. a smokers. adverse milligrams a In NDA-enabling dose be occurred. starting the as dose and single level cytisinicline study MTD critical In addition dose initiated over on dose-limiting or March, administrated planned a an increments to of a evaluated. oral in of in be -- a another single events, of we until tolerated as in to we effect dose limiting dose to levels increased administration the for defined maximum The assess have exciting Six had events ORCA-X cytisinicline XX-milligram trial X X-milligram to important progress, -- with were highest define to

the supports side the with from evaluated profile dose effect before has limiting of smokers cash and doses, profile pending an for smoking level, XXXX. I’d a on single of XXXX further available has This to a committee study higher evaluate March safety a quarter recommended dose. first protocol expenses next provide cessation and of toxicity. evidence the safety treatment dose differentiated review conducted XX, be escalation cytisinicline ethics a operating XX-milligram also update each its cytisinicline without better that to as now by treatments. of to to XX-milligram DSMC balance option of prescription to independent potential provide of To-date, cytisinicline DSMC approval. currently our been an for a like Following was up amended dose our

XX, equivalents, cash, XXXX, $X.X investments, were the restricted March and cash short-term million. cash Company's of As

second trial near-term including Our execute by cash the balance of ORCA-X the end allows of development the our the quarter. plan, us completion on to

XX, of total March our incurred of the compared quarter quarter a operations. XXXX quarter for to to of ended for $X.X million ended compared net million, Turning XXXX XXXX. million $X.X in in a and expenses Company the quarter General $X.X March to XX, quarter million XXXX XXst $X.X March $X $X.X March, statement administrative ended to expenses quarter million for develop to million, of of the loss The in XXXX. of increased XX, first a were net XXXX. the first ended of the compared as loss and the Research

As highlighted trial. enrollment the in we ORCA-X our and in expenses quarter as reached first elevated our expected call full were in March, operating during

the in end trial expenses quarter. the the over next We ORCA-X expect operating the quarters, by our quarterly two with of decline completion to line of the second

we important nicotine for So, make tremendous critically in and therapy summary, this addiction. cessation progress to forward in driving continue smoking

to you U.S. inform forward with and rest look continued and maintaining and to the critical will robust ORCA-X interest Phase momentum also providing strategic for provide Achieve. again clinical updates that upcoming our world. to potential be commercial plans our discussions in Thank you partners expect with our We ongoing X for trial future. in We data the results the of the near your in

We for line will questions. open now the

Operator

comes Michael [Operator line the instructions] Thalmann. Our from Ladenburg Higgins from question first of

Your question, please?

Michael Higgins

ORCA-X. if my Thanks Couple questions. of Thanks, guys. could, operator. Congratulations, I taking on questions for you, for

be higher will higher or agency considering the you see is you that’d DSMC back study. MTD, want be step the decision well? on me tolerated do for dose on Let dose? dose as When max tested with moment listed and it as agency okay a And at a safety, to the the and

Dr. Cindy Jacobs

Cindy. is This

we're already the actively our to the have once use if will that do we dose more FDA XX that, will whether limiting reached max dose be we our obviously have cohorts. that’s in and If QT And the we complete amendment. not So, to and we amending XX milligrams, able or to we milligrams, process go up toxicity, to therapeutic protocol in inputs super that’s we reach see the go actually of from we’ve higher PK, would to when on plans be need we to we agency submitting a and study. the

of a as study. toxicity in So, connected to kind QT we with well as limiting need it’s do dose what

Michael Higgins

a need that up protocol [ph] like seems milligrams that maybe back question go agency, you It bit request half you it here is Okay. the XX in right? before but to right can premature, my of from looks to change a

Dr. Cindy Jacobs

with toxicity, super continue we reached back input we’ll haven't we FDA’s be So, on to dose to whether changing whether up we therapeutic limiting a have then dose. receive XX, would protocol or going already if and then

So, to by right continue and then would now, we're of cohorts. process those in place everything the in amending and then three protocol be additional include July, the

Michael Higgins

us Thanks. as have Can back feed events seen point what been any Okay. we That’s should for at this feedback you? to adverse at helpful. may from or what that you point look give

Dr. Cindy Jacobs

as we dose. any that or limiting adverse toxicity I are go not are up dosing think any now seeing to really right dosed in proportional we events

events cytisinicline. really increasing adverse what know are don’t we being now by caused right So,

So, we yet. really don’t know

Rick Stewart

at I clean moment think, Michael, we’re is seeing profile. very a the what

our dose, take that to up We’re times that is XX dose, XX-milligram currently at single XX-milligram single we proposed commercial dose. if

think shows again, So, of cytisinicline. it safety I profile the robust

Dr. Cindy Jacobs

this guess, I study, add everybody to one aware. It thing us. is so should blinded MTD for I is

at six So, of the placebo. eight of dose cohort two subjects, every are and of treated cytisinicline

absolutely study events the really or placebo. don’t where we know lying treated until as completed, adverse as are is So, far on the

data safety the are review they unblinded. when actually, they committee monitoring data So,

Michael Higgins

Right.

guys. Okay. the both, most Thanks, you we you’re That’s and guys? could helpful. then, pivotal. to you Obviously, We would want another secondary on when see A flipped but noticed ORCA-X the primary and be ORCA-X ORCA-X. the that at looking I What’s if couple versus results? one endpoints there is the important

Dr. Cindy Jacobs

important of can us, endpoint to so dosing various primary is the we regimens. the the see Well, sensitivity actually

primary approval endpoint the market for important, as it far endpoint powered been statistical effect. is for significance. mean, would be just endpoint not to we it that, So, But, can a as we X smoking And ORCA-X. study see for have the that another for needs the or cessation that endpoint. is commercialization, so a The Phase X is, had if Phase powered secondary problem study is study. the I

we're looking complaisance as safety well at cessation profile. that’s reduction data, rate going then well be obviously as smoking as as at why efficacy and the looking the So, to

that when at it we be will really how decision be a going will the on we looking the move forward. we're data totality So, to make of

Michael Higgins

that Then, Thanks. is just to we need Phase those cytisinicline, X, helpful. after or likely discussions potential ahead one before the Phase answering? last me. something before partnerships for Thanks. or for consider you is That’s Okay. X look results do for If one that and

Rick Stewart

Yes.

been drug, odd and is to be know XX treated has the of years Xb think, has XX must going data. the already Phase the We for market in the here fact, key already the million this patients. is this strength I

have will So, inputs partners. X start expectation we that program would want discussions data, to soon initiate as itself. to commercialization is as we’ve that Phase with potential they the the our got expectation to is My some in Phase Xb

Xb input think we So, like But of data, it would as coming process. would the take long soon discussions, I -- they’d over have kind as start would that into the that will Phase I to conclude the how got some is to unknown. think we

Operator

you. Thank

line the Cap from John next from Our comes of question Research. Vandermosten Zacks Small

question Your please.

John Vandermosten

And of to one would it know to observations there. of on science so based more works, about side increases. But a on data response I response mean, thought I isn’t of I any diminishing be ask the returns? wanted how and just linear anticipated just things? or dose obviously, that the far

Dr. Cindy Jacobs

XX toxicity So, returns, to Cmax the have the I up going have think further into because FDA get really you milligrams as discussions leveling need the to MTD, kind an diminishing going That and off how go that given for proportionality is actually you’re and meet far far means of with the in means is if with showing we're we as dose pharmacokinetics then dose limiting do to pharmacokinetics. to don’t pharmacokinetics.

to have the move FDA why so, will we the that what that’s would be to data entire summarize point with forward best. to then And at

Rick Stewart

Xb John, mentioned think, of before, cytisinicline what our Because got of three as are exactly Eastern concerned, in Central arms, we commercially have far I is dose Phase the and what out level Europe. the of is available that’s those arms at And I as exploring. four as above

as So, to is higher we're or effect both dose be that look an and whether it’s dose equal what used to will cytisinicline, see the daily exploring if at times the terms have of well. a loading whether in you dose three as going titration currently

John Vandermosten

think had the might underway. could was and saw think at a I on coming kind it closed I you was and this know if search I be I I news wondering was that RAUORA if there Also, although anything, anything, any that’s see to But updates how trial, there. quick don’t did find still point. of along. I I that

Rick Stewart

the time. at Yes. We update don’t an present have

led replacement. the an is We have nicotine have by which patients, don’t update in actually But, time. down versus at in CASCADE led trial New ran study who Zealand, Natalie investigator the an it’s X,XXX cytisinicline present we Walker,

Operator

Thank you.

of from Group. Maxim next [indiscernible] Our question comes the from line

question, Your please?

Unidentified Analyst

could ORCA-X you ORCA-X -- see If X study you for inform you efficacy how Do the Phase dosing, results, through might this mind lesser, see X-milligram size could studies? potentially study ORCA-X? smaller design for you the the walk the study great us and with

Dr. Cindy Jacobs

that but Obviously is sample again, to and result this endpoint a but going cautious look I be possible. trial, mean, possibility. take that it is we’re you cessation, because at that’s have sizing secondary is of smoking small to when a

the to those the increased as I I is be mean and data also what’s going think, you said, important the not of efficacy is totality do change safety profile.

that the If to the we’ll go going to why have. carefully then totality all want as looked coming maybe That's have well. safety you then way profile, keep then, which increase the we don’t compliance of dose. the And two We’ll be story then I higher decide to the we're at back between will to look proceed. that to data schedules

Rick Stewart

have we trial the I studies. agreed with two that in actually design is FDA think, the principal

chosen X.X a at second is the of study one time of X placebo milligrams versus first two-arm placebo that milligrams. three-arm the study, one and a a was versus dose The is versus and cytisinicline;

expectation Our is Xb will solve the which Phase ultimate. is that

then we've we speculation well. budgeted size, to will lead with end ORCA-X. anyway. So, But, study down with in we studies. that quicker but we results the us a all potentially safety, two-arm actually informs the two-arm we doing will then that sat be until currently studies as cheaper had we probably with again that for. a may The But, would that would two of redosing could well two is another than have XXX and FDA up decision of that to would short per be patients up is make, which that terms end Approximate trial,

Unidentified Analyst

in helpful. the in you first completed you Can a will a when will second that. Got be in you’d timelines very it it. be parallel your and that XXXX the the about also or mentioned That’s towards that with you with see be study elevation this doing today, year of end be event? deck there the Phase and parallel as have And as X Would be perhaps talk you QT well. to needed

Dr. Cindy Jacobs

XXXX would a ‘XX, has to for be the after X gotten certainly and obviously Not ascending the for because plan we Phase is into first dose the complete, study study then our that event need started. QT

Rick Stewart

cardiovascular the any clear, to of studies safety just and at any Europe, all. cardiovascular shown be haven't data which And in we effect cases in we’ve seen effect that seen million is about non-clinical including any currently in base that data XX haven’t

Unidentified Analyst

one helpful expense enrollment. down? last see the base as you completing to quarter it that ORCA-X are rest that for it Should you go the quarter, for each went to and your That’s for With question of the would assume or mentioned me. for significantly regards up the year quarter the we as R&D

Rick Stewart

run some which will additional down. be until remainder But expecting the ORCA-X. expense towards quarter, of result No. we’re will there the still kind the the It initiate Once we Phase residual second go through down going end be start to we trial, year. will as X of of the a

see quarter will two year. the decrease end in three you up toward quarter the increase with and a of a coming So, potential the

Operator

I question-and-answer you. for like further the would program any Rick to Stewart Thank today's session conclude back remarks. does of to the hand This program.

Rick Stewart

Achieve. very toward We would I of much. you you again, look updating quarter. the for you ORCA-X the your the interest of end like once Well, thank forward to continued the study in results with to Thank

Operator

the in ladies today's conference. program. This Thank conclude your participation and does you, gentleman for

You may now disconnect. Good day.

Achieve Life Sciences (ACHV) 15 May 192019 Q1 Earnings call transcript