Earnings call transcript Q1 2023

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Operator

Thank you. Good day, ladies and gentlemen, and welcome to the Achieve Life Sciences First Quarter 2023 Earnings Conference Call. [Operator Instructions]

At this time, it is my pleasure to turn the floor over to your host, Nicole Jones, Investor Relations at CG Capital. Ma'am, the floor is yours.

Nicole Jones

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

John Bencich

us. thank Thank to you you, joining for and Nicole, all

a we II results clinical placebo-controlled Just ago, statistically from for e-cigarette our cytisinicline trial, randomized significant line weeks positive top a nicotine cessation. cessation few reported first-ever resulted vaping groundbreaking ORCA-VX trial compared in benefit treatment to Phase for the placebo.

that approximately cytisinicline who tolerability. vaping safety showed study Cytisinicline to received quit exceptional Results participants Xx to likely continued for were those who also and compared placebo. primary received more demonstrate the to endpoint

pleased students nicotine. million weeks, that U.S. adults e-cigarettes X.X million published middle of use are from high percentage to very growing are vaping use with use continues With the X.X%. and The be vape school are school for to by cytisinicline indicated roughly to CDC and indicated the and in rates recent dependence. indicating increasing. e-cigarette nicotine reports recently recent options We Data their concern. seeking people Nicotine win who XX CDC a another for overcome in increased has

medications a XX in X nicotine for found desired naturally of so. use and And for cessation. derived of participants to quit. overwhelming specifically to segment solutions number who them using treatment look be to do no XX% survey to quit completed the e-cigarettes, the there vaping a help in and would vaping this in majority people prescription interested using As e-cigarettes to next months, people an indicated that are We currently, use start continues grow increasing they of to

the announcement, line solution hand cytisinicline treatments, a to ORCA-VX become statistically believe in need SWIFT top epidemic. the the enrollment the now in over we unmet results trial vaping unique help this data for that To and to we recent on the Based will significant the recent address to touch through on call observed data, more opportunity has clinical growing the Orca-VX I Cindy a more go detail. results to this from

Cindy Jacobs

Thanks, John.

As study to cessation, nicotine cytisinicline results the for for Phase that month do shared powered cytisinicline a treatment as this daily times ORCA-VX line Orca-VX top Similar was we even weeks. not last to for X designs, that. vaping dose showed significant statistically X a proof-of-concept II our XX though mentioned, Phase milligram benefit evaluated III

the weeks ORCA-VX were was XX completed XXX in XXX randomized at approximately with in X a total X:X sites receiving U.S. ORCA-VX randomized X subjects a subjects that XX and of clinical such for cytisinicline receiving placebo. ratio in months. enrollment

were stratified quit placebo. who previously odds of XX% The who funding received Medical or for past vaping as Nancy the average self-attempt higher Harvard Dr. and was quit methods. was subjects tried with based XX to results subjects history put showed endpoint smokers. half the on to Approximately received of had to as to vaping age Subjects identifying the NIH. cytisinicline investigator ORCA-VX supported and last the weeks of or of X.Xx all them on vaping grant wanted served primary treatment of subjects the vaping the School of primary during likelihood had study, via past and NIDA compared The cessation X Rigotti study. by smoking ARCAVX former from subjects

for those for p-value statistically X XX.X% through cytisinicline-treated cessation vaping to placebo. continuous received during rate The of was X.XXX. XX who with XX.X% endpoint weeks was This significant weeks a subjects X compared

Importantly, cytisinicline as or they clinical also been gender, age, and observed whether not. and past such benefit had all trial sites participant was race smokers demographics, across

XX.X% was arm. adverse moderate, events mainly cytisinicline in very to reporting safety, the reported there subjects who and adverse with well study. Regarding expected, of Adverse no tolerated received were XX.X% as of placebo serious events mild compared during events the subjects to were cytisinicline

to As will are findings providing more. and the are the now top these on forward John. learn turn results, we our analyze line continuing back I we to details call look as data to over additional

John Bencich

Thank you, Cindy.

efficacy trial is second ORCA-X Our Phase await as we results this from the and report X ORCA-X times either or quarter. approaching, ORCA-X reported III previously milligrams NDA-enabling later rapidly XX X of the milestone placebo. which design highly and trial. expect cytisinicline successful eagerly with to next compared our daily study, weeks for the of mirrors tolerability X The key is evaluating we dosed

compared as is endpoint, evaluated arm Biochemically be will independently placebo success and of the ORCA-X last will if benefit or during arms compared the weeks verified similar either continuous a be to cytisinicline to placebo. abstinence be show both treatment. Each the primary to determined and arm statistical of X will the treatment

data the over Our this review and NDA, turn our our quarter cytisinicline U.S. the application, now to the continuing to I'll quarter. later on efforts in call focused for to preparations are results support time, for a Jerry drug At or preparing readout for the financial new this now

Jerry Wan

Thanks, John.

at incurred operations, $X.X to quarter of of of same compared the statement net XXXX. a as net quarter company the a for loss of $X XX, for million March loss the Looking XXXX, our ended million

in $X.X higher XXXX, XX, were the expenses operating of expenses quarter to III were quarter fully only of fully quarter Total Operating XXXX. the during the period III subject ORCA-X in in to enrolled XXXX, ended last compared II the and quarter visit and Phase Phase enrolled. as compared where trial ORCA-VX to their the both March XXXX trial March for for Phase XXXX increased had Orca-X as as the our completed last same same first the $X.X million million was

in of the completion the We anticipate studies. line X second our with in clinical operating the expenses to quarter, decline

March December believe of until back call balance $XX.X late XX, As cash equivalents provide as company's current to John. restricted We cash of the now XXXX, XX, million compared with I'd XXXX. way cash, million is turn to us to over like the one XXXX. $XX.X as and cash were sufficient to our

John Bencich

Thanks, final March, of the Jerry. A direction Board quarter highlight call. announced support to refresh In first we our to from conclude we company. future today's the the a of Directors before

and Duty, as well Stuart pleased capital Thomas to manufacturing. each Selling and Mr. the Tom extensive markets, pharmaceutical King strategic are science industries as Board. marketing bring We welcome to across the sales Mr. and life transactions, in leadership They Mr.

to not Martin Dr. years Mr. upcoming achieve and our Moyes standing like reelection also at thank Mr. Meeting strategic June they would will of Jay and Joseph, Don Annual to Shareholder for as be We service X. guidance Mattingly, their for on

we exciting over have within turn will quarter for continue of We upcoming and the to with questions. XXXX, expect many and this appreciate to first the I the ORCA-X support, the readout. We year now operator call milestones achieved your continued

Operator

And Instructions] from question Flaten [Operator Capital. first our comes Thomas Lake from Street

Thomas Flaten

any NDA us could then we be John generate? you completing realistic like items need there any preclinical forward, what of that you ORCA-X path or meeting that FDA or and moving appreciate I to pre-NDA still with for respect sense think a if submission some of an give aware data with timing Cindy, you And there to should that, critical be? you are would anything Great.

John Bencich

question, for the this Cindy. hand over I'm Thanks Thomas. to one to going

Cindy Jacobs

Sure.

been we've results. with So results waiting ORCA-X for ORCA-X

for mean that we're year. this we can we FDA. going though, to with target to meeting. I Now coordinate obviously, meeting would need a the pre-NDA Timing request

to is quarter find the of we'll get figure X some of X quarter So that we that end be time, kind going we at when at but scheduled. out or

and times finishing in X by will completed this up studies X a all steady-state all the of a NDA actually are the study. PK looking on we things X TQT up for concentrations end with another milligram like renal finishing impairment. have actually that them year. These the need things be required study Phase at are also have day and I NDA of PK We study We that the for a

So first of together. at we're the NDA next time coming half looking year for at the some

Thomas Flaten

know Excellent. the as looming year is Because on John, debt repayment any for I update the of the end refinancing? well. at potential that

John Bencich

Yes. Thanks, Thomas.

debt a path is in formerly dialogue SCB, been now, that at the think an we've movement getting do so SCB the folks some there with we towards on facility. side, Citizens refi On Bank. of or And extension

least on that nothing So discussions but had far front. to do announce positive we've are think we so today, at the

Thomas Flaten

one-timers final or sequential like in uptick And I one are bonuses of bit was if there that. stock-based one anything There a in quick then maybe a their was Jerry. curious just G&A. comp or any for

John Bencich

want to that take Jerry, do one? you

Jerry Wan

Yes.

January. the was just it have Sorry, on comp I that at onetime just Yes, of we annually grant there. was the stock-based beginning

Operator

our question Brisebois from from comes next And François Oppenheimer.

François Brisebois

we're here, in read III the to to quarter. previous thoughts compare you one where that should ratio-wise. in it would the first expect this we The any the what terms this ORCA-X I had on ods expecting maybe ORCA wondering, was data Is just that's something of you shown out trial? Phase

John Bencich

Yes. Thanks for the question, Franc.

a what terms in think we terms those ods firm I think don't expectation of look ratios, of have I might in like.

the go end the NRT the for when sit X of kind the end. at today to at and range to existing in market think at products, of where higher low we you ratios they're When I look varenicline the ods X. of

I ORCA anything for so range ratios above, X win. think we least program seen we've So X. far, the odds in or see a as cessation, and that at And being smoking between

with in going we've an discussions of leaders space, X benefit in So ratio requirements. be this meaningful a to the from we've the of had anything benchmark is exceeded setting. kind clinical ods key those over But this opinion

François Brisebois

manufacturing And you obstacles terms stage to the now? stand getting any helpful. -- just here, That's on process overcome give manufacturing, where what's of going Any Okay. on any right side? that can the or you in as to then color we're

John Bencich

working on CMC hand-in-hand who the been will so at that record with of front. manufacturers On Sopharma, the we've our colleagues be side, over

been, readiness. X tracks. say, the FDA So I has just in would is parallel focus inspection One

to filing. So we an that's something NDA on as focus march to forward we'll continue

as the then the and through kind process track the supply be getting all all preparations other registration way would chain activities batches and final up chain, supply And is of are well. packaging stability those through making in and then on sorted, sure on

François Brisebois

And of Great. ask to many then side? but here How need it, we a on you maybe forward. steps to I Is this mentioned label can Okay. vaping going vaping, -- sorry trials about would get if if the potentially lastly, expansion? kind approval

John Bencich

Frank. Yes. Thanks,

the belief what likely the guides vaping of back this that approval indicated when under our FDA released market an a trial a or we That approval ORCA-VX on expect results, we side, being in for is as the of the having is already the smoking would On III would currently for Phase couple indication. weeks be single cessation.

So that we're result I just significant ORCA-VX, a belief. And by expanding reinforces our indication. think the effectively having statistical from

Operator

Higgins Our next Ladenburg comes Michael question from from Dolman.

Michael Higgins

on sense might give we us investors with second the in Congrats that see including the start data We Can come QX. and progress out through... as ORCA-X. Question you here the ORCA-VX. here III, look on in here look ORCA-X to at QX cytisinicline, the see Phase when any timing to for calendars,

John Bencich

The we've we be I firming guided this would closest of to quarter can think to the for timing quarter. and second that ORCA-X, half the up second get

middle after time that be any So of in trial play. May, result the would of kind

Michael Higgins

presented the Also on was XX. That's the XX-week question Okay. you on III, data a that helpful. Cindy for at Phase certain

or at expectations cytisinicline You compliance noted pivotals? to and Orca Curious varenicline how your XX% weeks. that compares both for XX

Cindy Jacobs

Yes.

compliance is think good. I actually quite

may as think trial a than a in be obviously little the reported. actually is It being behavioral varenicline well component I follow-up a higher probably period. that of as continues throughout have the you clinical component what it support

Michael Higgins

increased That's vaping. cigarettes interest in with interest seeing an how one in investors on they're there's society. curious helpful. vaping Obviously, relative your conversations making. of And area their then to across

John Bencich

question. interesting Yes,

with ORCA-VX, I think $X think appreciate treatment the growing. beginning is just about just and butter people bread users potential e-cigarette to has we I doing cessation to the to here and million. smoking which on are expand validated the saw million is side. been the that And into has of what been no segment of from options $XX we've here what available up the a in currently U.S. latest We update increase

move no options, So with strongly this right the that's think this as segment quite available -- we to a is the I able and as think is growing we've course to And been we socialize resonated trade ahead. results.

Michael Higgins

to seeing question. forward I Look organ. the appreciate

Operator

Zacks. question Vandermosten from [Operator Instructions] comes And from our John next

John Vandermosten

Jerry. Bean Johnson

and preparations any But it you're that you're Our that out order or make pricing work guys stages, of are the to that that that. position. work you a is your in partner to help something do going on kind prep to reach are packaging makes work negotiating or that stakeholders final some do to with perhaps I with to outreach know As labeling, also sense you're belief partner to sense the key there to to do? making planning to sometimes for Is commercialization? going

John Bencich

Thanks Yes. John. the question, for

potential commercialization sure areas that supply prep, the final blocking together key the making one of the all and distribution. packaging On we've is got way tackling chain, and into the all through

again, track. in that's the planning early lot to of phases sure on that a So of we're make

moving piece would looking say be would ahead market on that the other I side. sure make to is the access we're at

all favorable covered. cessation very still that make to fair a ahead FDA-approved those that ready we the Now we required Care contracting there's mandates category the work But pieces all to in is given that's sure know a Act discussions. amount place, be can move get we're smoking Affordable so products that this of with

So I'd primary of the areas those focus. X say are

John Vandermosten

in discussions regarding lift with the FDA the for labeling, And preparation time what's there? line that

John Bencich

already labeling on advisers with outside begun the some so the would look what front, On label we've working like.

ORCA-X will early that's days. So into feed that.

So hand. that important with that's the need submit NDA. that piece But we we'll an will in

bulk work over the done course So of will be of the XXXX. that

John Vandermosten

finally to a or me, in then? done Got yet branding terms for market work it. And any how on you're of going eventually directions

John Bencich

brand Sorry, name? the question around it a was

John Vandermosten

other on any down I go? it's mean, yet, know worked yet? the any work of out do thing where challenging that I exactly. Yes, to a all probably anything names you've there. with that indications Is might But there

John Bencich

Yes.

have approval it FDA exercise name, clearance NDA. did that brand through final that. been with submitted have But from until process. wouldn't on get We on it's through an own gone We we get we to a and preliminary

that So that is ready we're on least piece, for. another at commercialization the front

Operator

the last this time. that would for I remarks. to to And back now turn management be appears to like question closing at it any

John Bencich

joining from It's quarter. soon trial to for this We everyone, portion forward thanks, with XXXX. been of rejoining the and us operator, exciting ORCA-X you Thanks, today. later first an look results

support, and continued the to appreciate Thanks. talk So we'll soon. you

Operator

does This We today's thank for you. Thank participation. conference. you your conclude

may at time, your have wonderful You and disconnect a lines this day.+

Achieve Life Sciences (ACHV) 9 May 232023 Q1 Earnings call transcript