ACHV - Earnings call transcript Q1 2024 | Achieve Life Sciences, Inc.

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Operator

Greetings. Welcome to the Achieve Life Sciences First Quarter 2024 Earnings Conference Call and Webcast. [Operator Instructions] As a reminder, this conference is being recorded.

I would like to hand the call over to Nicole Jones, Investor Relations. Thank you.

begin. may You

Nicole P. Jones

President Good for us operator. joined and you prepared Management Cindy thank John Wan, Officer; Thank Accounting remarks. Q&A Principal From afternoon, session Achieve joining Officer. Jacobs, Dr. Officer; today. Chief be are Chief Life for Medical Bencich, Jerry available you, will Executive everyone, and a Sciences, by today's we following

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

to over I'll the John. now call turn

John Bencich

the Cindy required filing. for key filing. Critically with discuss our highlights, the of reaching FDA just and today. first the timing exposure study long-term subjects data Thank us cytisinicline our number update the review the NDA months for everyone, Today, including discuss XXXX NDA the moment. will ORCA-OL initiation NDA you, financial the and exposure on for of on quarter status on enable Nicole, a joining and to agreement provide with performance we thanks, X of an will the agreed we in submission, necessary

of battling dependence in opportunity. our for financing The demand confidence from submission, new through the NDA in cytisinicline's manufacturing Achieve million Concurrently the with investors fundamental nicotine the importance the FDA approval ORCA-OL cash partner the participation health decision, financing Sopharma. The of to financing growing execute enabling market runway and we including included care to into $XXX and successfully up demonstrates secured investor trial beyond. provide NDA cytisinicline

The this the the interest cytisinicline as week. approximately from many And adults earlier daily JAMA as enrolled to read, incredible II during cytosinaclin in it for you quarter. published use the e-cigarettes and dependence in desire ORCA-VX The Medicine cessation markedly vaping the ORCA-VX of and visibility in who will drug XXX results have trial Phase study trial months. was been were of this Internal X quickly nicotine included raised has There quit. for of

that to cytisinicline east of those with cytisinicline odds treated XX.X% The the XX.X% achieving placebo. of abstinence just results quitting than cigarettes more compared doubled placebo show participants continuous vaping compared to receiving of

our exceptional. was well was in seen tolerated compliance other As and trials, cytisinicline with study incredibly treatment

struggled in If students adult the first who cessation. many and estimated high prevalence XX do and The and tried rates increase, half approved, vaping vape approved FDA-approved have in million evaluated successfully. for reported the of to U.S. More who million e-cigarettes alone. middle cytisinicline quit to school continue would use age that to it and is and e-cigarette X of adults specifically interest be quitting treatment so than

We of our plan on this requirements. expect discuss a label to II discussions an Phase to the year and with clinical meeting later vaping for end conduct to cessation FDA further expansion

profiles. Society the trial efficacy quarter, achieving presented and Tobacco ORCA smoking in ORCA-X with Meeting. at Annual Nicotine and from III The first the Phase in detailed cessation have Research for our safety Additionally, program we citosinaclene's demonstrated trials on favorable consistently results and tolerability ORCA-X

These their in to who of completely their and helped smoking cytisinicline, in noting quarter X sytosetically been quitting success For cravings. them successfully of Of the things, half. who attributed those respondents it participants first time, Of over these from III that amongst responded, we smoking cytisinicline. our treated quit the approximately treated presented trials. XX% with subjects, survey not participants quit did other cut had in results reduce Phase XX% had

showed interest those trial. the into Nearly to Cindy's recommend others Cindy? This of including quit cytisinicline notably, on if segue and using participants, who cytisinicline all to ORCA-OL in XX% completely willing update again, great were participants of is did the needed. survey a not

Cindy Jacobs

John. you, Thank

the for focus study. update track first expect initiation preparations the with am begin that next pleased plans I our within on the been and has remain the Our to most for we of quarter ORCA-OL the importantly NDA on few on weeks. enrollment submission, guidance, to

a As of on is reminder, ORCA-OL that a long-term single-arm safety study open-label collect the use the data will cytisinicline.

months the FDA with as submission. Our data safety cumulative NDA cytisinicline XXX of treated to part is of provide subjects agreement period for minimum of on a a with X

to prior of provide on or has pool of generate subjects at X enrolling year. and FDA to our cessation period approval, weeks for the will in allowed least total Because cumulative or subjects to previously exposure Subsequently data treated expedite either will X a from this us product XXX we trial the allow data. required exposure with XX long-term cytisinicline time smoking vaping for treated

need from on the have of subjects they only study We X recruitment those who open-label exposure prior for submission. another on the of are months to the as X first focusing treatment would already requirements cytisinicline treatment fulfill X-month received months NDA

packaging the XX As been site. planning from sites more with have of conducted completed visits with we the initiation treated to been vendors, of our to conducting contracts operations preparing to clinical are who ORCA-OL have have the at subjects planned drug the which an studies. who participated product Meanwhile, partners participants and for for all is and All in sites also those completed are earlier be of update, our scheduling are trials, were and X,XXX than our previous the cytisinicline outreach previously the and interested. X,XXX clinical shipments

who previously be the the being planned the eligible. Thus, enthusiasm the should primary are open-label been over X that ago. of that for there not X X/X swiftly reason have on who the not feedback we lost continue the in for want eligible subjects only is participation or smoke vape completing We Even trial, their XX% cytisinicline-treated about have be be to after believe of remaining X% for the free, for to been enrollment subjects trial Interestingly, from years contact trial. those treatment X% even high prior to achieved to have XXXX. contacted to is interested, received or considered

in update an to we summary, NDA anticipate initiated. expected first the of look the forward in an been enrollment half and providing as submission in forward moving continue coming are and So has XXXX once to weeks

Now Jerry I'll for for financials to quarter. over review turn it of the a the

Jerry Wan

focusing like then outlook. Echoing strategic points. and Thank an John's you, operations financing afternoon, financial review forward I'd on financial update and provide Good everyone. quarter, implications the status this for activities earlier and Cindy. our current our our on to

direct and potential a concurrent common boost worth collectively raised XX.X of successfully stock registered warrants. private $XX offering of with an we up placement up quarter, The to This receive secured to million million million. significant a the to milestone-driven the additional amount financial upon exercise was with initial a warrants, of $XXX.X

clinical infusion we including and continue resources necessary plans NDA our development ensures that pivotal This the the ORCA-OL trial to have cash recent effectively, our anticipated submission.

XX, March restricted our million. of $XX.X equivalents cash were XXXX, cash and cash, As

the anticipate through our warrants Looking initial second net financial from exercised, anticipate this XXXX runway forward, that and will potential milestone-driven half extend the operations If we financing proceeds the the in our U.S. XXXX. it fully will well of of we are cytisinicline into approval sustain into

same expenses statement and company million same million compared quarter March to of net million as quarter of of for XXXX. million for compared to $X to the The regards incurred first quarter the net the operating decreased loss the a XX, quarter $X operations, total of of our of ended $X.X for XXXX, In a in to XXXX loss $X.X as XXXX.

initiate We expect and loss expenses over ORCA-OL as our we increase to coming operating the quarters net study. the

quarter to milestones and position towards a continue market. meet a are our upcoming summary, strengthened and strategically. our In clear has prepared journey position both forward, and cytisinicline our path this well we financially bringing strong to With cash

That now the John call for concludes my closing update. I'll back to over turn remarks.

John Bencich

reinforces the FDA preventable in ORCA-OL X remains and the We've reception submission had people a killing activities for on NDA required in for XXXX, death start of year The particular, the but the provide execution to to trial. clinical at vaping the Jerry. presented million recent nearly Thank dynamic only a cessation. and of promising each the our our of data not advancing smoking capital those published JAMA securing in cytisinicline of and U.S. resources SRNT also community's for as requirements you, positive than findings globally scientific leading X.X those million cause highlights with Smoking recognition validity deaths more of potentially medical treatment of discussions

caused pulmonary smoking. role pulmonary in lung devastating other exposure disease, as disease disease to cytisinicline families. chronic as diseases, patients creating by or highlighted and future reduction consequences smoke various and their is cigarette primarily well to Smoking perhaps cardiovascular obstructive a by and secondhand contribute COPD, cancers to

death double leading is the which costs adults U.S. million is associated According to CDC, with future. report in to with nearly expected XXXX. offset better options smoking. sixth costs overall people annual billion, COPD COPD the quit XX of estimated XX% of current in has rising the rates reduce the related potential the $XX of patient COPD the of to U.S. with the diagnosed smoking nearly to Providing and by cause

and XXX,XXX U.S. Heart to leading those, the of Additionally, States. to such XX% due Of for of the smoking Association, the stroke. cause in are about cause is making as According smoking. deaths heart deaths all year, major disease cardiovascular American attacks a cardiovascular disease, cigarette accounts it United every nearly

validate impacts mitigate reduction urgent need and cessation years treatment there to These effective in new statistics cessation public has XX of of for vaping. nearly the smoking currently disease treatments, agents for as the health no particularly smoking approved no and FDA-approved importance broad cessation e-cigarette the been and

help dependence We critical can the It achieve preventable and complexity specialized clear is crisis play necessitate costs health interventions. this better patients. health in increases role long-term cytisinicline a and of care for believe outcomes nicotine

of our are clearly For XXXX, the priorities defined. balance

our submission expansion smoking We for further completion ORCA-OL and obtained preparations on FDA for the continued guidance enrollment e-cigarette the cessation NDA and focus indication. will cessation study. into continue of of initiation for

to trial can option want your express impact that those the by In support We our continued participants our to of committed health providing new dedication care my providers. of the closing, dependence. their nicotine a affected significantly lives I and shareholders and to remain gratitude for therapeutic

today. again Thank for joining us you

We questions. are eager and for the to open progress, we'll our line up now continue

Operator

Instructions] of is Flaten Street. from Thomas Today's first coming question Lake [Operator

Thomas Flaten

Good afternoon. I appreciate.

sites the was you enroll? and about contracting. contract was that that. status related XX made to Sorry just and little contracting the under of to the those Or you're all I comment sites you with Cindy, confused. vendors ready a the about the other Are mention confirm I to wanted using?

Cindy Jacobs

sites ready roll are up all the couple to to of contracts. their of weeks. They're finishing them next The within be going No.

Thomas Flaten

or follow-up subjects about X,XXX XX% and that's interested. vape and I you identified understood math rest Great. . the were so lost just X/X I to free correctly? of And previously X,XXX smoker, then not X,XXX the those of were Did that catch the

Cindy Jacobs

Yes. contacting still we're doing X,XXX. we're the But what is getting all of

of we've those getting contacted which So that almost is them, to most Yes. close

-- each just subjects. we're we're contacting more week we go, So as

those for the very pleasing, there XX% week are And interested. X%, numbers so they're contact they we And are was not the or which smoke XX%. lost that those free, or is only X%, the XX%, numbers subjects, they're vape because not a eligible about as keep Again, about rolling with during get then contact maybe either actually, us. in

So in the X/X are for about sites calling making with obviously, yes, we consistently and are individuals participating are have screening. were contact, interested

Thomas Flaten

to of from them of X,XXX, perspective, comfortable feel if you're enter starting will with the And XXX able from group a that you then the study? be statistical that actually just

Cindy Jacobs

we're studies for a summary. overall open to Yes, numbers subjects increase of to but those integrated placebo on going subjects our spots the safety few exposed also to

Operator

Michael is question next coming The Higgins of Thalmann. from Ladenburg

Michael Higgins

FDA the the balance with solidified Congrats the again enrolling sheet, progress on ORCA-OL. agreements on

the you more them on you the study. go like just will are to sounds that study come reenter granularity to, back of all Regarding the the just understand from comments those to have out interested X,XXX and prior actually a But to of follow-up the or you X/X that that the so I think wanted percent that and cytisinicline. of as latter, back reach willing into from of question. gotten it what

Cindy Jacobs

through until loosened really up process and they been know the trials, on exclusion screening that inclusion and the through the study. on that for the open-label just the when prior We already we've criteria go note, inclusion criteria. it exclusion won't But Yes. starts they've

going So let's it is rate put that we to screening the be don't failure way. high, think

Michael Higgins

many placebo. patients, you they placebo on then that And for about patients will with the follow-up Okay. in potential into now those a on your the how comment be reenrolling would handle since on -- and the ORCA-OL run going how expectation placebo these do

Cindy Jacobs

There individuals in no they in our the for that previous on trials, prior be cytisinicline placebo would be of time. exposure overall. first will and cytisinicline subjects X were the with the These placebo. seeing and are who increase study open-label overall would on

Michael Higgins

maybe that big X months? have Okay. of months. -- then Makes is dosing you sense. been after What those your a I sudden, so them you got and all treated that going many thought placebo you have been how is it What for were How -- X treated number? over pool? mentioned do

Cindy Jacobs

I don't monitoring have have and that currently as and into the the interested. be they're exact are the come treated. we're been that they start numbers Those that trial called getting going things to

as exposure link getting open a their that in that so do can the the the link level study. we overall We treatment they're already will label have treatment prior the we to monitor

Michael Higgins

working for to partnering others, How before But your shipments that X interested partner you're increasingly, coloring or development seems feedback Lilly your have drug small, seeing the and big patients affected here John, in curious we're virtual it the then most just physician these with. that partnering approach. has it connections you in And sense. because discussions, go, Makes been that. on leveraging just and your and -- can I Pfizer direct I see it's discussions Okay.

John Bencich

Michael. Thanks, Yes.

I X the on ongoing. the the come I'm particular, new are kind during years, will techniques have pandemic. to in specific and so effect that of But digital comment any are today So utilized into and virtual being not able last discussions over or that techniques say

the it, And attributes those Our be we're category. used where We right way obesity, larger gotten finding looking from some moving really think that in think indications, tailwinds diabetes, are this launching. as I are only out involved areas the of continue. this move that we the are think is about approaches will think great a We those think, similar get have like for. needle the think of in the to awareness forward key I pharmas will other call tools critical. to cyst sort that, And that

Michael Higgins

wind Yes, partnering here. I your real as a back think it's you're at

happen. see to great it So all

Operator

The Ribas next coming is of Frank Oppenheimer. question from

Unknown Analyst

on is Frank. This for Dan

Any enrolling expect certain subset at do sites, trials? higher of based on them the insights you Regarding from do factors? a distribution board. share rates that the on sites XX expect you of previous the you can previous Or to based these sort sites any equal saw be the across enrollment you

Cindy Jacobs

Yes.

obviously, getting using their higher sites because whatever the subjects they back in study, enrolled, data the studies, did were sites in. Of So basically, coming enrollment those only others well -- was very in XX these XX these the are than previous rollers there of that were are previous all the sites, subjects, subjects the some also than management. not in but that the

the So although be enrollment. sites prior obviously, there in will to differences due their

to and with be already sites quickly expect all We up contacted. the subjects running

Unknown Analyst

-- in visits potential and is the trial remind X III. what you quick in patient many terms monitoring Could frequency just or us and compliance this challenges trial? follow-ups -- this on the the particular versus Phase foresee you And Great. of follow-up. of

Cindy Jacobs

Phase weekly the clinic visits the the it's treatment fact, visits treatment were during in label, XX On weeks in clinic monthly open visits. IIIs

actually is that over the year. visits spread So basically XX

visits. So far it's as the onerous clinic as not

in and place of to far lot the As accountability. drug as drug are same processes the procedures a accountability, monitor

in the subjects them. the subjects, they as think what compliance get sites far the what know being I the time help they the to the company study. free the is the the and By stay commitment that's -- of screening the and during on them through to as as know of vape -- for smoke and protocol the asked is and well form, the in as they the will the quit commitment with study, important informed consent

So of the sites the subject company. study the I commitment as there think compliance in the sides, will on the on staying both be as well the

Operator

coming Zach is question Vandermosten ]. The of next from [ John

John Vandermosten

you. and of them of in at of the trials and Cindy are there different Jerry. All John probably there that bunch they're I seriousness. -- right. Thank bunch was of are after a looking some levels a And out vaping

cell Some measure help on in to at stop SRNT using what and vaping with phones out teams are serious that. some your going maybe if other any are that are there? time seen to looking varenicline conferences them vaping you've there just And that I'm just using some of wondering, are and and around, around poking the -- trials other

John Bencich

Thanks there. question John. the Yes, for

a Something we monitor else we we're what seeing studies the out earlier controlled see terms moment. smoking any than at happening overall, run moving with but and from what vaping this trial at frankly, serious just continue significantly the And really landscape. The readout that did continue see I it as think to on being to the anything of in in was there real and monitor, cessation space. going another less respect what in we with needle smaller just dieting but is week not this else published isn't really we SRNT something ORCA-VX to we

John Vandermosten

Okay. in Or that that product Was varenicline? that's. was other some

John Bencich

I academic varenicline out was that of most It for would what's And vaping. done a lead again, indication to and actually there say, trial. an is would driven company-driven not, being

Operator

is from question of next Zubkov The coming Freedom Ilya Brokers.

ilya zubkov

into My drug taken months drug finished in taking NDA can the the long least You've study previous the final include duration question are does correct patients I'm is, how to to of the misunderstood. matter if it taking me, ago the Nortel exposure. these only for drug statistics studies for in at mentioned months X-plus get that a have take patients for who in previous X to

John Bencich

Yes.

looking cumulative So what the is FDA treatment. for is

which question getting is your doesn't be what continuous, have is I it at. to So think

X we that today years months they of someone get just and X saw incremental if would together. drug or ago, total exposure So XX weeks add

weeks, adding as as those treated cumulatively. incremental we'll of have been subjects that so we trial start until were exposure weeks And XXX exposure the months in bring the together they whether X part OL patients, previously, XX X get just for -- that we of the

ilya zubkov

beyond And Do safety more X cessation. require separate in least Okay. the e-cigarette from to possible for at of a weeks regarding FDA smokers. cigarette data you long-term expect me, extension population label XX

John Bencich

question. Good Yes.

both a part and a the as open-label would they now trial, this our think for with that is here FDA we're indication. around needed piece So trial the this One of running But indicated indication that study I smoking key will for discussion be both. vaping work

to So a subjects we for have is as new which study not will well separate this run trial vaping we exposure from trials our indication, a are allowing vaping longer-term why the as smoking trial. into both

Operator

us question-and-answer Bencich to session. for the over the brings turn floor back to closing to of end comments. the like would Mr. That I

John Bencich

we Dana. coming proceed progress to updates additional Thanks, particular, this weeks the We made and in forward as look as year to initiate enrollment in trial. look we tremendous providing in the ORCA-OL

thanks us everyone, for of for support So continued today Achieve. again, joining your and

Operator

today's this Ladies concludes and gentlemen, event.

log the time, may enjoy your the day. rest and disconnect webcast and You lines this of at your off

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Achieve Life Sciences (ACHV) 9 May 242024 Q1 Earnings call transcript