ACHV - Earnings call transcript Q3 2021 | Achieve Life Sciences, Inc.

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

Operator

Ladies and gentlemen, welcome to the Achieve Life Sciences Third Quarter 2021 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 follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to your speaker today, Jaime Xinos. ahead. go please Ma’am,

Jaime Xinos

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

Jerry results may have from statements Chief filed only will that contains actual are President John. forward-looking I On of factors now website. Officer; Directors; on Officer; Chief predictions Please the projected. the which today These everyone current Anthony with affect Officer. Chairman we on Stewart, and Principal copies company, to John Executive concerning Rick documents Medical and materially Jacobs, the are call statements vary remind Board Cindy turn refer based expectations. call SEC that Achieve I the Achieve, would Bencich, those could our today's of to Accounting over conference Dr. Executive available Chief Clarke, of Dr. from Wan, Scientific and to Officer; the call like

John Bencich

call, the the including provide trials, Jaime. will an results. overview On you, and progress provide we on great ongoing today's our our are QX making an update upcoming Thank financial our on program, clinical we ORCA-X development of cytisinicline study,

receive the placebo We were either June to over XX-weeks milestone and of in smokers daily placebo. Let's subjects evaluating of cytisinicline All versus completing cigarette dose times the evaluating four reached efficacy year. cytisinicline monthly cytisinicline cytisinicline of weeks rate that placebo. in X randomized of successful follow XX-weeks begin milligrams ORCA-X Phase then six clinical or placebo, one followed of of the an safety was assigned three during two at in States. and of three the United weeks smoking last will ORCA-X trial completed key cytisinicline XX three six subjects our a be The evaluate either are XXXX, up. at of period study All has if ORCA-X, both trial over subjects followed adult treatment, XXX of show now end in with enrollment have to of weeks and and is ORCA-X weeks in this compared our treatment XX-weeks. of of abstinence to study placebo. sites initiated ORCA-X the of current October benefit XX-weeks matched by independent to the efficacy arms endpoints of target are and both out will or arms efficacy in primary of treatment. six XX-weeks All the six cytisinicline

patient to of last top-line occur blinded December in will completion data end the remain until has of the XXXX. finalized And database the last to and and We visit locked. by study been follow Achieve expect up until evaluations, all XXXX. results the be of announced first-half

We trial towards are packaging trial, ORCA-X ORCA-X, site to underway expected study regulatory criteria. we selection. Similar in the for as trial supply, launch subjects look currently be ORCA-X, into with safety full clinical Phase the randomized placebo. To ORCA-X, and in trial well cytisinicline serve efficacy updates employees to to either drug design, progress coming are anticipate CRO, our new second the to statistical Phase undergoing finalize one time months, the three X planning as submission approximately study for required and will and the and have arms to cessation of Additionally, six X the additional will support providing clinical you initiation. for process selection smoking the we or compared and forward completed mirror support enrolled ORCA-X early U.S. to by to determine three is the operations which the of cytisinicline to and XXX safety XX-weeks ORCA-X clinical we efficacy the proposed profile evaluations of hired and XXXX. administered ORCA-X study ORCA-X initiation

into FDA vaping investigate of for IND We review on plans our completed e-cigarettes cytisinicline nicotine and users. ago progress cessation or the for has that to excellent cessation. our are their a as application We making treatment acceptance nicotine also expansion a few announced days e-cigarette just

execution enroll complete operational awarded clinical the trial phases, previously such e-cigarette As in with non-dilutive is adult NIH X is as two activities, protocol ORCA-VX of to enable the study. The the the a grant new process, $XXX,XXX these identification to and regulatory The expected initial will to funding secured of site million trial, have subject grant approximately and by we discussed, grant clinical related of $X.X of stage which the nicotine amount receive cessation costs. submission is by of to awards IND Phase to used grant next U.S. assessed as ORCA-VX ORCA-VX funding under Achieve in finalization, the and completion the XX% in vaping of for to approximately users from total which milestones, offset authorization XXXX, costs trial NIH the the early the to XXX will approximately cover NIH, of FDA. expects Upon

e-cigarettes ORCA-VX to of alone. the than in second the quarter the expect more are study XXXX. million users XX indicate there adult in of United We Recent initiate data nicotine States

therapy. new a to are help expressed more Of prescription be are indicated with can quit half would specifically less long-term these Currently many no In products XX% roughly completely. viewed urgent than than interest safety also XX-months. a have users addiction, by desire to there combustible seeking quit. as e-cigarette users harmful their in of historically e-cigarette remains Achieve to indicated they e-cigarettes controversial. quitting, those in quit While treatments cessation now vapors research within more sustain interested nicotine Since conducted cigarettes, a been

development cytisinicline proved may of So opportunity. users quit cessation we e-cigarette to for good. who this commercial for offer see option growing successful, unmet this as an If our a be to nicotine seek new efforts population

meeting. data cytisinicline Nicotine had presentation two quarter, for at Finally, European we the Tobacco in Research on Annual Society the third and

of this the cohort, treated with study onset quitting to placebo. placebo with abstinence compared This days sustained are data seven cytisinicline cytisinicline an to successful trial. showed to with first our the set took determined it time in X in Phase The sustained that ORCA-X earlier analysis new evaluated achieve of to smokers who abstinence smoking a XX-days abstinence placebo. for median at compared compared In smokers

times titration a believe regimen with for smokers treated more than regimen. within appeared a this were rate of XX% Chantix. X who The daily both seen in cytisinicline have subjects. earlier compared varenicline effective be received Smokers placebo than previously a failed from for had early of in XX.X% dose We presented on day evaluating for the including three treatment to to XX.X% XX-hours quit the saw repeat activity cigarettes efficacy concludes our cessation of first the Chantix analysis with Data previously We our bodes onset milligrams speed well for subgroup PK/PD where of week overview failed the greater in abstinence recent initiating for ORCA-X also who we development cytisiniclines and study, commercial X treatment. prospects the reduction highlights. and consumed product. three additional times demonstrated smokers of who Phase the and of in That pretreated the smokers outcomes studies, programs cytisinicline,

our Now financial I'd discuss over the like Jerry, to turn to results. call to

Jerry Wan

our to third I'd review our of provide quarter John. as balance on XXXX, then an update September like financials. Thanks, cash and XX

$XX.X compared XX cash short-term $XX.X of as We XX, equivalents, the and million investments cash company’s current September restricted cash, to of believe million cash XXXX. As our balance was December of provide costs and but ORCA-VX planned other to does the such ORCA-X. This sufficient costs trials, trial, is for runway into not our as include includes anticipated XXXX. the ORCA-X clinical

$X.X for Operating company months ended increased expenses nine XXXX in the ended in the $X.X X September incurred be a Net September of nine million, in fully to of trial. in ORCA-X XXXX. $XX same elevated million period ended XX of to third $XX XXXX, September a loss enrolled continued quarter, compared Turning loss compared statement we to to XX the net months for the Phase XX as to operations, the our the quarter million for our loss as net million XXXX.

in and in study, the of quarterly I of We back the financial will are fourth of a results. turn the now line trial of advance quarter, with XXXX. ORCA-VX in anticipated expect completion in summary expenses call decline and first-half the our initiation the concludes of That over John. ORCA-X our operating ORCA-X which to to

John Bencich

so you, been year an continue Thank as on our far incredible Achieve, for deliver It objectives. and Jerry. to we has milestones

begin. execution of healthier monitoring We And made the and to specifically X Thank enrollment, for to users, smokers in make potential Our us and activities that treatment, first-half on ensure that crucial regard both cytisinicline is ORCA-X trial clinical of as again reaching today. we as are as completed towards significant progress are lives. significant data in finished in ORCA-VX, appreciate those a you the of has support soon studies have want impact who for operation and cytisinicline on goal. ORCA-X XXXX. has announced to we in for continued results focused And being live are plans Phase possible work to your and lives the U.S. subjects believe joining e-cigarette we to

We for line open will the questions. now

Operator

first Michael your line the Haug from comes And of question Lake Capital. Instructions] [Operator you. from Thank Street

Your line open. is

Michael Haug

at And Michael This impacting question hearing My is community about calling you Flaten. what Thomas in is from the Good all? recall Haug, recall? afternoon. Chantix is patients are for first the this

John Bencich

been that a lots what's earlier on because full the I of market. on in which Thanks think Chantix, from is going drug that fact carcinogen just It market, summer the the potential and Michael. a four found been the announced ago lots products. withdrawal with withdrew tracking they was or that three nitrosamines, were this obviously of weeks question, the they the remaining a handful for We've they

is was that it generic available. the now for that first like know summer look But it FDA was does we not the this by on also approved market. Par So Pharmaceutical. And saw that available currently is we

is accessibility product think with the there, we generics So while still starting no is launched. longer come Chantix to with being online there Pfizer's

Michael Haug

why there very of sooner? ORCA-VX the was second start Okay. in quarter any you chance Is That then elected was to can it start And helpful. ‘XX?

John Bencich

turn to me ORCA-VX that to the the Let second discuss initiation next Cindy of year. in quarter over

Cindy Jacobs

X XX-days time. timing really back X for the funding more then have for go Phase as And what is milestones the into they It's estimated for Phase actually the clear the to get NIH review to their us to funding. and and

So just have the view this default, quarter, by what our end milestones we completed. by we'll of

X our have will We grants through money. Phase gone

And year, start. So March as that's if end realistic by a funding. the quarter we're the then this submitted at February, Phase X this why really then probably two looking second get get of have we we to

so the government, Of still course, this it's estimate. is an

Michael Haug

That's much. quarter. for Thank me. a all on Congratulations you very

John Bencich

Michael. Thanks,

Operator

comes Oppenheimer. And with François from next Brisebois of your question the line

is line Your open.

Unidentified Analyst

François of behalf Hi, taking thanks on the This for question. Brisebois. Dan is

those per any Just of following the into updates question generics terms of that as nitrosamines in relates the up now the to Chantix? about coming on the with some market generics, Starting questions. are to it issues with ongoing

John Bencich

Yeah. Thanks, Dan. Good question.

So did they where from Canada, were the were on the showing out the as FDA updates only that an generic Pharmaceuticals, not for fall, this in earlier where Chantix this also well put nitrosamine levels Apotex Par levels but line. did indicate in exceeding limits, they some as those

So, generics we this Pfizer within haven't from are seen that of any but anticipated spec, terms resolution in the we of update know issue.

for we go market. forward, to no there's being the but estimated continue back we'll on time monitor as currently, So Chantix

Unidentified Analyst

along terms add milestones? Thanks. in that? the question, And the for on finalized, are on of in you milestones can you achieving any those protocol Is as anything ORCA-VX, the second far color how a

Cindy Jacobs

protocol cleared Yeah. have they the with in finalized, us of for FDA IND Actually included review, the is that was part it protocol. so the to

Unidentified Analyst

questions. Thanks the for taking

John Bencich

Dan. Thanks, Yes.

Operator

the next of from from Instructions] question line John Zacks. Your [Operator comes Vandermosten

Your open. line is

John Vandermosten

guys with commercialization? talking Or eventual Cindy. of the that afternoon, Does wanted the your and the related change dynamics cytisinicline of might there up guess, voices you Chantix start to about might Good John, question negotiations Good to going players extend Jerry, is I who have for the to others I eventually? to again. some hear it out the pick generics, to out soon, too market.

John Bencich

John, good to I overall – think connect. Yeah, thanks,

market help the a our poor it's in for been us. interest potential box a It's product has high somewhat does found positive net carcinogen withdrawn market. think, mean, disliked I generic from main having another and a and rates I some mark nausea years a think the generics vomiting the product doing. in the prospects what the create it, what varenicline think branded think I over abnormal I tolerability. and think sense, now we on always into fact from the additional overall, for dreams to I just we're long-term I we just warning one And knew a launching net they positive on that But in of the and would the issue, is us. be

I we're seeing today think, specifically with the probably data it any and relates going to than, important I is more X least Phase what be think, to as in ongoing generics. dialogue, the the market at ORCA-X

John Vandermosten

And as Is companies there? Very the well are there is Okay. in good. And out foot other vaping There that trying on clearance. congratulations of anyone you've seen? pursue to bunch working that else anyone have I'm wondering if study that market else a the space. a

John Bencich

good that else. moment, at the We is think anyone at the indication. a aware vaping Yeah, of Yeah, moment, pursuing specific question, John. not one only we're the we're

the market. there on apart and I quit. very people others, for in us be think with And would to market NRT the so specifically trying like indicated product help in today, I those But some set think are this product having powerful a would that the market be would Obviously, surely us.

we're step But trial yeah, in next about that. going. initiating IND first the look to year. getting we forward that So was excited that

John Vandermosten

great news. that's Yeah,

the was, way The saying environment use other thing that you to recently all to of bring R.J. an tacitly Reynolds first that, them Does stop want for electronic this cigarettes cessation the as kind a authorized smoking product. as at I smoking? FDA can the change up

John Bencich

them market, full No, year marketing shifting, with marketing I we've it oversight applications. took start if saw an tracking been anything e-cigarette ongoing the of FDAs been orders we has FDA. from this. to back these just received think the and denial dynamics, products This on respond and to development of number likely over I think the be kicked the it's And a market huge back, number kind

at day, may So the away. it's the not the but somewhat consolidated be of end going market

has it clear, FDA the like and candy they not made think I the do flavors. fruit

it's at or of is otherwise, cessation looks So there like play going will to I But the some be whether e-cigarettes, limited. we forward. think for smoking market of that day, the that as end a in be go it's

John Vandermosten

Thank John. great. you, Okay,

John Bencich

Yep. Thanks, John.

Operator

next from of Alliance Global And Molloy Partners. question line from Jim your comes the

open. is line Your

Jim Molloy

for And to early the but done kind thanks expectations my Hey, of have taking on filing. walk know I run Could it's get that John, and NDA trial. question. through top-line to question ORCA-X on here sort you potential data? I the forward a of rate look

John Bencich

Yeah, Jim, question. thanks for the

on study the of of next preparations indicated we're call, kind we as on. underway planning well we're ORCA-X, So early is actually in the terms for that what initiating year

actually of important get I approval think to this we like an an waiting getting that well of FDA, that think, going our and trajectory for which before NDA timelines, trials accelerating timelines perspective, data we're which will forward. point data and ultimately initiating we get going to from where the overall indicated, as for submission of things it's to But this in product, is important into the at kind looking And we trial. study approval. set it, for is terms that that underway that, we're I the a shorten and not why ORCA-X initiate second to is controlled for sooner two launch

Jim Molloy

going And to the of quitting smoking kind helping on the as it's of get Year's thinking initiations crest trial? New ORCA-X the on of ride is, similar sort and resolutions well, to the

John Bencich

seen And a over to great absolutely, the something in cessation out years in the I Yeah, subjects think smoking recruiting be that time been Jim. that's market, we've has trials.

to a great year next out being for the early study. us be with would place ORCA-X think I be

Jim Molloy

see in Can with rates in bit you you little in you you for late, to a the a R&D down about touched earlier I hopped should for of how about on sort in rest apologize. had run then R&D? Arendelle for I Can in of dramatic kind call, first-half bolts the ‘XX kind year? went? and quarter. we The the that little of line the of nuts of changes And the the or the and little Maybe get bit year a G&A XXXX talk of versus talk expectations

John Bencich

QX in QX. terms to so level run did would bit, similar a little a in Yeah, of expect in that see decline we rate,

this So of the saw the is largest of really middle first a little half with was bit kind the less year burn than portion year, through ORCA-X, which we of what the of this year. which

with trial So when big fast you year ORCA-X, to running once this a component ORCA-X. be we of kind forward similar next we're to size of year, a that initiate will what

of we middle as bit into we up ORCA-VX think, the So, see as year, and think layering as as I will get as of QX, off well I ramp the on. get next roll we into study, a a a well then ORCA-X in

Jim Molloy

Thank Excellent. questions. you the for taking

John Bencich

Jim. Thanks, Yeah. it. Appreciate

Operator

showing to for further questions I'm the no closing the And call I'll back At time, hand Mr. this John remarks. in Bencich queue.

John Bencich

And today. being thanks, this ORCA-VX made us year. We're to do headed next Obviously, with Litty. ORCA-X Thanks, and year. where of excited everyone we're kind for announce joining huge progress

things in results looking we've roll play updated So we're we lot to a as as into year. go. of everyone next moving forward And got we keeping ORCA-X forward

So and thanks, everyone continued for appreciate support. joining us, we the

Operator

concludes you Thank Thank conference and this gentlemen, you. today's for Ladies participating. call.

disconnect. now may You

Achieve Life Sciences (ACHV) 10 Nov 212021 Q3 Earnings call transcript