ACHV - Earnings call transcript Q1 2022 | Achieve Life Sciences, Inc.

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Operator

Good day, and thank you for standing by. Welcome to the Achieve Life Sciences First Quarter 2022 Earnings Conference Call. [Operator Instructions]. I would now like to hand the conference over to your first speaker today, to Nicole Jones. Please go ahead.

Unidentified Company Representative

thanks, joining and operator, you, everyone, us. for Thank

Accounting Achieve, are John Jacobs, forward-looking available Bencich, the Wan, and call like Executive for contains have remind from today Principal Jerry prepared and Cindy On Q&A Chief after will remarks. call we Officer; everyone Medical that Officer; statements Achieve conference the Officer. Management Chief I'd be President to Please based Dr. today's materially only to expectations. on statements predictions, vary with projected. over These results the company, filed factors from actual documents are copies those concerning of I'll website. to the that refer now our affect and Achieve call may SEC John. which current the on turn available could

John Bencich

for everyone, joining you, thank us and Nicole, you, today. Thank

reported not with could events kicked better in helping the could previous long-term smokers of more excited the in cytisinicline bring adverse challenge to cessation. for endpoints and Phase reported. profile successful month, probably new not of outcome last and safety across ORCA-X many smoking for heavy We remains cytisinicline of the of forward. failed, treatment the a As have habit. single-digit successfully treatments whom and the you've tolerability option best-in-class efficacy that III primary heard, And trial impressive XX-week rates a highly cytisinicline clinical X- arms. secondary be The both demonstrated we succeeded Cytisinicline timing be the cessation

more nearly smokers Smoking murders more dollars combined. from offered than have regulatory care for a who treat than car smokers approved increased despite addiction. the billions there providers XXX,XXX very the alarming to lines XX%. In accidents, in over statistics, quit For peak $X been and kills than XXXX going leader still treatment cessation There not spent before health health nearly and attributed the have CHANTIX, over X calls the FDA in in XX while in every first roughly COVID-XX dropped new these U.S., aiding the accounts generic, drugs smoking in sales Yet to over AIDS, pandemic, each and approved alcohol, cigarette deaths billion million billion and time advances, it market. category, care of year. year with illegal the year, alone been was years, the more during clinical withdrawn was in U.S. sales decades. generating people $X XX by which in nicotine to those sales is market last few and U.S. the globally XX%

While it successfully has more been considered treatment effect its profile. the to potential helping full its quit never currently available, to reach was due side of most efficacious it able people

more to support Phase than belief. treatment in with a this placebo high randomized profile III adverse best-in-class in the have now than of we cytisinicline Insights more full from headaches from smoking avoid study due always more of to evidence, opinion the completing believed of XX-week nausea, In smokers attempts. to year. CHANTIX in the had reason be that prior effects, on groups. Based and majority course we headaches their appears half the quit multiple CHANTIX offer prior The suggest could proof of population fact, the participants or X% starting were from incidence of prescribers and primary cessation prescribed event And have U.S. the trial, leaders and our a sleep a such disturbances. side a when is than arm used each ever the less and research marketed, smoking that alternative, active nausea XXX as only of ORCA-X tolerable in smokers CHANTIX and

odds higher ORCA-X addicted study in the to highly pandemic. execution were compared Xx addition, the the of during to despite ratios placebo. the a population end we observed the rates our at In impressive And odds unprecedented, quit of and are quitting X treatment of with trial

are to The XX-week X-week of and finally, treatment be the both cytisinicline courses smokers for We treatments. provides a therapy current smokers. to it is appeared abstinence effective to and X- highly therapy for simply, of option than that has that XX flexibility new and achieve seen duration cytisinicline. quite their is is excited indication half treatments in see shorter with option plan And ready We an solutions. to hope approved believe finally will who This of new new the to new treatment provide a offer to hope not are option quit. years. that doctors need We millions smokers any more a

Turning to to Cindy I'd findings to it the like readout, the over top ORCA-X key the trial. to hand review Cindy? line from data

Cindy Jacobs

John. Thanks,

compared smoking endpoints ORCA-X behavioral standard evaluated study. this X The X effectiveness As trials of duration adults cytisinicline XX also were placebo X III weeks success both either for X smoking of robust to X Phase we and mentioned, in XX of are primary to weeks placebo. report X had by the and for or cessation endpoints either statistically cytisinicline for randomized safety weeks of received of with All placebo. weeks John and cessation trial. the the Study weeks evaluate weeks to multicenter received XX that followed the or and weeks the cytisinicline cytisinicline X is results designed and in weeks ORCA-X in milligrams X secondary pleased independent XX and participants clinically primary for support first both or X arms, of study cytisinicline compared of evaluating randomized taken significant placebo cytisinicline treatment is for trial of placebo. of weeks daily The abstinence compared duration smoking U.S. treatment X X the for to of to subjects times XX

by smokers the For FDA's abstinence continuous weeks secondary medications. remains as evaluated measure approvable during those completed abstinence smokers in ORCA-X the trial on study XX weeks enrollment smokers years smoking week compared of X abstinence of old week XX XX quit had cessation X to quit defined had cytisinicline prior of to cytisinicline, to were about XX quitting treatment. June years, attempts by smoking day. of XXX odds the corresponding clinical last was meaning statistically endpoints highly verified with for week only XX.X% cigarettes been smokers quit Xx XX X% placebo, likelihood who to comparisons, endpoint smoking a XX, pack biochemically year. smoking X-week smoking smoking endpoint smoking treated was both X.XXXX, population average, for primary still less abstinence for placebo. successfully treatment p-value the of locations This was last and through The After but On of through X.X duration. significant. with of X of a or This had of or of treated week odds in compared resulted than X with ratio treated in an with smokers depending at a it had

only had p-value Xx to smokers weeks meaning ratio remaining of weeks treatment, endpoint weeks, were compared treated weeks And of and for at of an odds an treated quit that cytisinicline less than with of also a had XX.X% with the smokers of secondary was those to of This p-value quitting treated X.XXXX less again, with in smoking compared with X.X to with smokers gave after ratio XX XX the only smoking treated nonsmokers cytisinicline XX.X% X odds XX-week placebo. of X, smokers of a nonsmoker cytisinicline, For likelihood at cytisinicline treated X.X% X.XXXX. resulted XX a After placebo. placebo. observed. than compared had X.X% This of

secondary of cytisinicline a X.X% an after at of X.X treated treated for remaining X.X% endpoint remained nonsmoker cytisinicline with compared XX the XX For ratio weeks with with weeks X to at X.XXXX. weeks, nonsmokers X-week treatment odds only a This gave p-value placebo. of

reported in the events top emergent Turning of all the similar ORCA-X, treatment adverse was line adverse and arms. frequency safety X to in events

to only more cytisinicline The insomnia, events headaches events the the with very common single or continue and in in nausea. dreams, tolerated see most of X% We of digits. adverse study that abnormal occurring is adverse participants were specific incidence well

than dreams, slightly insomnia As frequency compared as the mentioned, headaches were placebo of only frequency cytisinicline placebo. The and higher the in arm the abnormal arm. of to higher arm in the treated John or was in nausea cytisinicline-treated

tolerability remain approved, when a cytisinicline, that critical the treatment to that for has concludes of differentiation believe and expect treatments, point a We results. will available new of That smoking become the from or view potential preferred currently overall cessation. standard gold

data and forward look findings these future. submitting near publication to review in continue the for We to additional

John Bencich

Thanks, Cindy.

of the very of ORCA and cytisinicline strength are ORCA-X seen program. excited the the the throughout with magnitude We effect results about

both for higher of dose ratios for what reported treatments. particularly duration the improved continue when treatment We reported smokers. outcomes proving XX-week for been available and hypothesis previously see X-milligram that our have ORCA-X we longer odds for cessation the Efficacy has a that to for efficacy the X- cytisinicline, exceeded was given strong arms consider

U.S. is Our participants II XX evaluate to in initiated over of compared Phase weeks X in placebo. year execution and ORCA-VX enroll and times users. trial and a the at III aims of to dosed this focus either of X the smokers ORCA-X X daily enrollment to trial study was cytisinicline now to of that X confirmatory of randomized the to to XX and X January similar milligrams or initiation sites arms in turns Phase ORCA-X e-cigarette will ORCA-X period the XXX ORCA-X be clinical

ORCA-VX adult of we in Phase the second II grant XXX final Hospital. at the funding quarter, nicotine the study NIH. ORCA-VX, School Treatment this Medicine and pending of expect in Regarding users U.S. Medical to at Rigotti enroll will by approximately General from led Center continue Professor of study Tobacco initiation The will Director and the Massachusetts Research Harvard e-cigarette Nancy be of release and Dr.

received activities for of as we and site of to tranche clinical regulatory the identification submission clinical critical and NIH new funding IND the operational FDA finalization, reminder, e-cigarette to a protocol complete the As grant the indication. first cessation such

turn treatment. population this call is Jerry and the million tranche cytisinicline's are the to of of be an of initial approved to adults e-cigarette to grant completed have to treatment number currently the and for would addiction no over are there continue submitted and in ability the nicotine next U.S. ORCA-VX The now effective options We study. initiate activities funding our exploration our specifically the believe exceeds and on safe NIH We indicated growing like update. documentation financial for awaiting these population. ideal XX users the I this required to

Jerry Wan

well John. an Thanks, our would quarter. as I of as on operating first update to XX, review XXXX, the as expenses position for March like provide our cash

provide investments million as runway $XX into our March to XX, million to current cash company's of We balance XXXX, compared cash, and XX, of equivalents, As restricted believe XXXX. short-term the is were December $XX.X cash cash sufficient XXXX.

the In in our reported debt connection received facility and to addition capital XXXX. million have down in incremental put ORCA-X the of Under Valley the place agreement, have we from the over next in to December discretion results, drawn access we also the Bank positive approval with access under cash capital months. amounts $XX balance million to that Silicon course an of date. remaining at down can XX No our be been the $XX drawn now to

expenses million Turning XXXX, company same statement compared for first for as Total The Operating $X.X of a XX, We incurred and trial the partially $X of ended XX, we the XXXX ORCA-X offset the with the the trials. compared in ORCA-X operations. March XXXX. further on in $X March quarter million ORCA-X XXXX, the both loss as of to due of the expenses to second quarter XXXX operating of quarter million of the XXXX. to half increase with anticipate a as quarter This to $X.X trial. to costs lower initiation the was the ended execute quarter of net same our the expenses net operating loss associated XXXX. was of our January for for decreased of ORCA-VX of completion million in

summary cost over John. expected of NIH. our back funded half to to I'll a from financial trial the approximately results. concludes grant ORCA-VX the call are from the turn be That a through As the the reminder,

John Bencich

bringing in second Jerry. overwhelmingly cessation. a The to Phase positive market new, large you alternatives. forward We continues well market. continued safe We be significant III significantly our to today look believe questions. certainly to line in addiction We you, and smoking and and for way III of for Thank continued of your long effective the support. new on I Achieve you a this profile, compelling progress. This differentiated overdue monumental time study that forward further us shorter now open cytisinicline's ORCA-X bringing to treatment January, of positions efficacy nicotine is us and treatment will treatment results we for our for and safety in with make our impact course initiation updates Phase a well Operator? the underserved are on need joining appreciate

Operator

Instructions]. comes [Operator line of from first the I François show from question Oppenheimer. our Brisebois

Unidentified Analyst

for on Dan is Frank. This

Just potential a partnerships. quick question on

strength the what if moving and could partnership to ORCA-X are ORCA-X, Any those How on you you discussions that? Given of I'm color as any wondering forward to look color you want start add add they going? like?

John Bencich

important Thanks the here. attribute Yes. for an Thanks, as along we here. Dan. roll question Obviously,

partners from going trial. potentially we So line as to top we we're this the with partners. instrumental extremely furthering potential discussed, acquisition the ORCA-X results be in excited just about really is the and And think discussions

This but we that's is encouraged so the far chance a think had have something early I data by So to the date. not happen this days. we're to still to discuss as overnight, going response is

So to I encouraged. but that, think again, on more we're come

Unidentified Analyst

That's very helpful.

one Just still still ORCA-VX. lines they quick to you to and are that the track receive starting the NIH on a from receive on the in Given ahead $X.X of how NIH Are quarter? time on second million track work, ORCA-VX? you

John Bencich

Yes.

our study, ORCA-VX moving we on before we This initiate So trial. grant the to first funding through forward NIH is require will that with. we're that grant the come

by things logistics of initiate the track the of So on on but trial this midst we we anticipate do we end NIH are and quarter. can one, NIDA this in that so the with that are

Operator

Street I show Lake the question Flaten comes line our of from next Capital. from Thomas

Thomas Flaten

it out of get discretion? the any at to there that Just purely hurdles are on curiosity jump is your need money? to SVB, through you Or that

John Bencich

an it. down. we've under with proposition the have place date, at the incremental So having take belt-and-suspenders we is as been new our amounts thanks, some of But of were to to access of be any If which million to to thing liquidity terms agreement not requirements a take discretion we in question. Thomas, good -- a come to kind the with there It strength would $XX down, was data. the the to for put

Thomas Flaten

expect can And it. an on we Got update when enrollment ORCA-X?

John Bencich

Good question.

in ORCA-X January year. this So you initiated of

And along I encouraged so we're moving enrollment the to date. Things think well. with are

quarter we year. of end here would enrollment a think couple the weeks I by of on as to this we of had complete indicated call anticipate the ago, the third

just won't So XXX centers, giving is in be U.S. lot in target within a a I the granular reminder, number think this we updates probably the subjects of of that, XX trial terms as of patients. in across the But all

Operator

I Ladenburg from comes Michael question Higgins from the next line our show Thalmann. of

Michael Higgins

or think that on study we underway? again the of that spoke to just interest any was ago, do out? X ORCA-X you're aware those. on results, if cytisinicline get Wondering is It inbound weeks congrats investigator-initiated study ORCA-X that now there's you are And you'll

John Bencich

question. the for thanks Michael,

new trials. any actively So in cytisinicline involved at the not we're moment,

ongoing are amount around are to of continues interest be there significant and this a is We aware that compound. of because some

we to or as something we not do we will I would and with. get that it's whether support think get involved I think So like inbound, assess

Michael Higgins

can course. any plan But PI, Nancy a out? your as X sense those weeks And would publication. trials, in part the work that you to mentioned make of ORCA-X you get being Dr. ways being out? towards prepared You other to of remarks, journals ago, Rigotti It did any this

John Bencich

Michael, Thanks, Yes. question there. additional the for

So to weeks. we assess information get of points over will additional I points are that into get And out the additional out, data we continue here as of out still I ORCA-X data the getting on think market. other points, I that we'll coming more more ways think think ourselves data

this that number we we that Cindy think of data get line in the weeks are ago we full I announced think as data quite get of to couple we sets be a articulated will to But along. call, a out we think as of points the so data. on work top be could want do beyond I last there move had see strong this Nancy we swift manner, the interesting there. a as And can published with that results

Michael Higgins

look forward those. one I here. Last to Yes,

on very it How and confirm both you've How you Do here you called a same the Just the file got week? review them file and and XX-week is to XX hit work is similar XX-week language does X-week the it's the on the for filing, endpoint does ORCA-X Or on end points Varenicline, X as assuming X- we've do primaries. end strongly work which data? out? the point supplemented by application? where having

John Bencich

over Mike. to I'll one Thanks, hand Cindy. this Yes.

Cindy Jacobs

it and for as as being Yes, would durations. far week approved X treatment week both be XX

Michael Higgins

Interesting.

So of would the assume? labeling, to show Varenicline the even XX I it have but comparator you and data, XX-week can in X, terms

Cindy Jacobs

Yes.

mean smokers -- their to as get for I So trying we're this really flexibility as well physicians.

as Nancy was by treatment, them pointed As obviously smoker the and smoking more motivated weeks. the had And weeks be took weeks, think, take and X-week were they more to on that want X, they would nonsmoking a very weeks, X ORCA-X and didn't weeks, longer stopped X a then individuals X showed success do we to if quit smoking. X, the then and more become X nonsmoker. I It any continued had treatment. they get certainly, X out, treatment by

So long and to smokers their treatment. how gives wants it really to that physicians individual the continue flexibility on

Michael Higgins

if of on, looking they timing? ago, July on I data is so, heard patient-level the -- weeks that support and kind we're That's that And really this longer And we that will think helpful. that. they're June, some success the the comment for have. I see X your case? that Is more

Cindy Jacobs

Yes.

week. is prevalence have each on we'll what So rates

wasn't. each can was who So a nonsmoker as who see and week you

to within It's varenicline you treatment. do individuals it's be more stop similar higher X to we continue get to no weeks smoking very placebo or the regard. that not data will they But of those so for XX expect switched X X is that they for those weeks, show they that individuals in because in cytisinicline. that as relapse another And to to was that risk what stayed there have of treatment on if to

kind those of will be endpoints -- publication. in that So and the information

Operator

the I show from Zacks. of comes question next from John Vandermosten our line

John Vandermosten

you are $X wondering, that that the interest, research. it Is they drive John, from there year. doing Pfizer you think And get your to like were that to anything commercialization that you per there -- factors get were billion in sales important? some was what did key able sounded I'm that helped particularly them is think

John Bencich

where at least one it that now Yes. historically, a think single things hasn't Thanks it we has CHANTIX Like which about generic over from CHANTIX ensuing in. months. I seeing for calling that the John. one, available. over Good that we're a been taken is of mean completely, now run I withdrawn rate been to is of million but still kind is sell have on XX fully question, $XXX the market I do and interesting, the has now, think

encouraging us been And on point So is because a that it's all to I inferior have of for historically if for think an at like hands. is albeit our amount price it product do a than on practical a fair lower pace, effectively we sales. better product purposes, looks

treatment long hasn't well. I mind in was And been frankly, attribute having a bodes as option. other term. anything product CHANTIX and years a in originally that launched, There I big to cytisinicline think for XX piece the of new potential originally over know think that for since was is, well I keep the new that just

of up market. it as very given and a just about efficacy, improved got a profile So strong safety compelling shorter the tolerability Cindy set the very I to and product a should course well think significantly treatment, be talked we've that fact on

John Vandermosten

$X a it, And you think a Or smaller of all takes to do it Okay. think then too? do we could company get that that big pharma kind about? billion

John Bencich

get I efforts. the what mean, think you you lot some what I out Yes. to a sense, in get you marketing in put in of

the without I needs a there just even take that do. said, I so ways think that the think to the result is simply, And market capital smaller would are same of in to size should really of market out going percentage being level think after the gate sizable pharma large, of still a large with I revenues. this quite

partnering consideration. our is at and continue look a here. as role what there into we'll think range we I kind I as And think that take So discussions well, might of be all

Operator

showing I'm John call time, queue. the to closing At CEO, would to I in questions Bencich, like for the back turn no remarks. over this further

John Bencich

as for our Thanks for today. us you We again Thanks joining forward joining and XXXX. continued further move support appreciate today. on you. forward throughout your Thank we look to progress updates us continued bringing again

Operator

participating. This concludes Thank today's conference call. for you

disconnect. may now You

Achieve Life Sciences (ACHV) 13 May 222022 Q1 Earnings call transcript