ACHV - Earnings call 3 2023 | Achieve Life Sciences, Inc.

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Operator

Greetings. Welcome to Achieve Life Sciences Third Quarter Earnings Conference Call and Webcast. [Operator Instructions]

Please note this conference is being recorded. At this time, I'll turn the conference over to Nicole Jones with Investor Relations. begin. now may you Nicole,

Nicole P. Jones

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

John Bencich

you, Thank quarter joining today program. third to thanks, our cytisinicline the review the of for Nicole and status and us highlights everyone, overall

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final XXXX. trials in available early to reports study expect these be from We

able time. with the at on Additionally, review. last and from encourages we agreement become the week, agency that acceptability of with of to of key the ongoing submission was initial reached many This on during details was available FDA we information constructive, pre-NDA this FDA comments because to the including meeting held and is aren't data requirements. Dialogue FDA. this, a clarification discussion submission The engagement the this solicit an additional pre-submission for might provide NDA

around discussions is approvals provide be will to the in a of will of through discussion to an future path the pre-NDA output set regulatory are the clarifying progress once will critical market the cytisinicline how U.S. finalized. The overview the product stage We in for and position final this globe.

commercial organizations. these Additionally, points have discussions are data having been ORCA-VX with Since in and ORCA-X to released ORCA-X furthering published and JAMA. the important we was potential are

We commercial additional significant cytisinicline have program. in seen the interest

asset the will we hands maximize opportunity. of have the believe full fifth we As the a organization in to previously, commercial stated continue larger

established and to have with footprint looking Our what So strong capabilities cytisinicline partner impact capabilities health would maximize ideal that are we exactly? global and global resources the commercial offers. for an

the strong process. our are are opportunity, we important seeking that capabilities Given and U.S. substantial marketing attribute U.S. an in sales selection market

move focused on to engagement process this continuing financial to highlights will partners expeditiously. We forward are our the potential to commercialization with results. time, and over pleased call the and dialogue review with this hand Jerry are and I At

Jerry Wan

be will and reviewing as of operating the September our expenses third XXXX, for position our cash XX, update quarter I of an John. Thanks, on XXXX. providing

million decrease $XX.X for loss ended same were operations, XXXX, As cash compared compared same XXXX. In for of is down of December sufficient decreased period second and to of for ended of months our September $X.X the XX, to continued current trial. and to third XXXX wind million $XX.X compared with XXXX, the runway XXXX, us as the Phase our respect III the million investments quarter of expenses Net both trial $XX loss for the of operating the of net ORCA-X September statement company's to decreased restricted million to the $XX.X of million million the XXXX. With II cash, line ORCA-VX the the XX, cash equivalents, quarter quarter cash We Phase XXXX. expectations, X XX, short-term completion believe balance provide to with September to for to $XX.X half XXXX. into and XX,

will in an We remain in of half costs to associated expenses first as be in partially fourth The expect increase lower to operating XXXX. offset the the quarterly will quarter supportive That NDA decrease our compared clinical concludes financial including to activities other X and supporting I call NDA my activities. now turn the of NDA remarks the over back John. finalization trials preparation and

John Bencich

Jerry. Thanks,

a the I will term, efforts. cytisinicline XXXX focus development Achieve the and the where X As program. been at priorities remarkable we call, In key of has near the for we have beginning stated year our

At maintain submission define pathway First, commercial second, our expansion to cessation. We finalized the third, e-cigarette I'd support the organizations; like the discussions work turn of finalize we in face appreciate preparations confidence questions. to label for operator time, cytisinicline your and bring to change health as NDA the treatment. the with in call important for regulatory to preferred complete ability over strategic diligently cytisinicline's and this forward we public this to now

Operator

Our from Street. first Flaten with of Thank Lake the is line question Thomas you. [Operator Instructions]

Thomas Flaten

to Guys, quarter, but I the the the half, John, supportive first quarter you're X data NDA guiding studies know I just appreciate the most from likely? given with out submission, some you questions. first on taking second in respect will the of that. thoughts the that be timing is

John Bencich

question Yes. for there. Thomas, the thanks

we as look to ongoing we anything So agency, conclude the get that. out minutes the on the We're with not are refine given and other to end. and meeting, discussions final further the pre-NDA agreements able that

as final we So update have with dialogue the get future through that we'll kind a of and agency. process

Thomas Flaten

was they of coming requested surprising anything or October incremental And it meeting, pretty was any there that straightforward? studies out that

John Bencich

other few I of get agreement were as documentation that that did looking was We finalized terms on. for. think in And there's many the I a we we think on constructive. items written of pieces output, discussion and the mentioned, the we're get to looking

And we so able a be provide as we'll discussions. get through to final that update on further those

Thomas Flaten

one just you mapping me. the between in then a final submission? maybe assistance Could us give little today And question out and for spending

John Bencich

Yes.

you that this year we So of I if in can well. as I terms through of saw look you this half from the the burn will think the think of fourth third year, kind in continue expect first at of decrease that quarter the quarter

see we decline that that at projecting you're will carry looking ahead. forward kind if So of

So at good a think I think be moment. about way the would that to it

Operator

is Thalmann. with of Ladenburg question Michael next from Higgins Our the line

Michael Higgins

I more including could your from Congrats And bit for do notable that's that's regarding XXXX, of QX coming on with commercialization progress NIH conversations? vaping thanks the results with our [indiscernible] taking believe potential before If and NDA continued you complete feedback Wondering here expenses up expect be and FDA progress if the potential in first partners. in the questions how those some ask on to a along. your wrapping feedback discussions have part commercialization here. you you will to

John Bencich

Michael, yes, thanks for the question.

indication, what an of to we've X holding meeting is vaping guiding Phase the year. next been on So end

we further of terms on refining moment. timing our really provide the that, can't In that at

that on the cessation of initial forward to as moving the focus smoking NDA continue Our make kind to will sure expeditiously. priority path be

Michael Higgins

discussions partnering versus would it separate vaping? for fair cigarette Is be the say to

John Bencich

amount from coming vaping that. interest will cessation The seen continue partnering of side we discussions, Smoking a I of of fair be think to have the the the opportunity. core

of terms that's in think be to first I so piece to opportunity, going initial the launch. the And

to the the going kind of focus but And nature are it there. I near-term important, given majority is think smoking both of of be the so

Michael Higgins

ahead board discussions for of you filing. Just to clarify agency. on with factors everyone gating Obviously, the NDA the here, the have

waiting else Are on? but You've that anything out next this some studies besides got primary X agency, the drivers X reading early discussion with those X year. those you're of the

John Bencich

Yes.

X be are critical for having the that those to So we obviously were needed in key those NDA. components knew of terms going

forward we'll get this the file we as clarified, and think clarity piece to I back the the written pre-NDA feeds be into the getting think going making fully that's approval is finalize what piece. I key discussions, of on partnering minutes, able those And discussions sure pre-NDA clarify getting we're meeting. the is the out NDA timing further path we that that and and towards of exactly

Operator

is from Oppenheimer. question line Francois the next of Bridge with Our

Unknown Analyst

Dan is This for on Frank.

Any there? Firstly, terms congrats ORCA-VX is standing that particular of SRNT. give color the cytisinicline JAMA that from VX that you're publication, on out, tolerability, in also you at the Anything feedback in the at is KOL up? presentation these the efficacy sense hearing us features, conferences? Can a of coming presentation

John Bencich

over hand the Yes. Thanks to this going Cindy. to question. for I'm

Cindy Jacobs

KOLs Rigatti but Nancy are actually, stay far treatment that allows to about cytisinicline the as pretty impressed as benefit. which presenting Well, are them other even get there individuals our the the excited safety profile, on Yes. shows and efficacy more actually and

So smokers therapy in and to it's that to the of help vapors future and they profile actually safety combination a efficacy dependence. really excited their have are most nicotine the new the for of a

Unknown Analyst

to the those Great. registration And FDA the processes any with also updates readiness preparations updates front? on supply on And batch just any regard -- all Sopharma the are regarding getting track? chain, on inspection

John Bencich

Thanks for the there. question Yes.

as to CMC through So we going and submission. I be are NDA Sopharma think to the forward move attributes focus continue

working Sopharma and FDA with numerous very mock audit. readiness been As closely their historically, including we've indicated efforts we've inspection

will So that continue. work

Sopharma focus high for and will to a proceed. ready it progress as be we confident they can area continues us As a inspection. future to be that But we for be of continue

Operator

Instructions] with line from is [Operator Saks. Vandermosten of The next John the question

John Vandermosten

think different kind any Phase there All on right. much or trial that would know it's there? from vaping X smaller Are but I early, reason ahead ORCA-X. to thinking just any Might be potential the be there considerations Is it that. of

John Bencich

Yes.

ORCA-X So I and looking think good sample in terms is overall size. of of probably ORCA-X terms in a sizing, at overall back proxy

indication. what that in before, you get is Phase trial in on belief to As from terms working But of a X should single ultimate we'll the we've FDA that we'll sort be this But design, for like. is that. still approval guidance anticipate. But our required would indicated what on looks what ultimately, size is need be yes, of

John Vandermosten

doing addiction, some be that there's cocaine addiction. for nicotine pursue was as on reading and I to And that beyond that consider Is thoughts that. you Great. Okay. perhaps things varenicline it used could other something might of like types well and

Cindy Jacobs

Cindy. It's

that, trials cytisinicline on kind watch to And company. should that helpful. the that pursue those then a at we've as of our be from we're of see smoking So once areas investigators for cessation lot with of look other and what we obviously addiction through investigators and could of had and in brands supportive KOLs of interest a considering types other so approved

John Vandermosten

-- would be at nicotine and all Or you mean, know the that it's that of wondering do maybe potential had. point. get they to I own those just thought but something together, that is how kind again, you is that with and part? would talked you've And I'm your this pursue addiction think? go of conversations I early, you on buyers kind I split that might off that out lift on the that

John Bencich

Yes.

apart scale from of really sheet lot we I splitting of partners, a multiple before totality of parties, on a in So with pieces had we've in term at at of commercial interest think like discussions not Asia. this particular, as innovation looking this. ex indicated larger U.S. think of We're terms I coming in terms looking out the is this

strong continued asset is maximize Our in the partner, single have one U.S. here that U.S. this belief that in the capabilities global of a to the belongs hands opportunity does

of around it the that's of so indications. the And resolves covering up looking entirety into kind that really for. We what we're specific asset, not think

John Vandermosten

that's look attractive looking you with. And negotiate might What that in forward? approval, are on very look want hardest you the sales to force some features And target there know something and and allow of obviously, at for of those sales see have for number easily are to that to what would that talking suitors kind sure the you potential kind can of that I'm you best to characteristics any of your force you that the be this effective. layer on cytisinicline them you're there a and have work side, after then

John Bencich

at overall think this I we Yes, indication. look when

be and we a forward call primary I will to point. moving think historically, continue where it see care

So on that We there basically other be hit the focus. at can companies that think ground could point. out from kind there. easiest that's force have This the plugged opportunities an path our call and specialty into a focus addiction played sales perspective, either an CNS that having be But you reps when of more that's or existing asset look forward. could

So a number of I the a but considerations for I with think call there's us. one think key is the point overlap angles, of strong

John Vandermosten

Okay. a for? And then you any name guys or working hints looking be on on might brand that

John Bencich

we A the one gets agency that NDA This end. through not good But early that with the just blessed role. we to have something until right in review sure the already. Obviously, did is precleared we make fully pretty of question. it's the that clear components that's

Operator

back for time, the this At closing management floor to I will remarks. turn

John Bencich

ever Phase first appreciate X tremendous only It's also year confirmatory vaping thanks, coming of not joining Phase second data a in everyone, today. but placebo-controlled X interest. trial trial for us our operator, and out randomized trial, first JAMA. with in the Thanks, publication our of all and We been Yes. the continued

sits from look see to program where interest and updates organization. So proceed. expeditiously continue we today forward we the driving this commercialization providing really that as excited to forward about the We and

today. So thanks, joining everyone, us again for

Operator

Thank today's you. This conference. will conclude

this Thank disconnect you at your may lines time. your for You Goodbye. participation.

Achieve Life Sciences (ACHV) 9 Nov 232023 Q3 Earnings call transcript