ACHV - Earnings call transcript Q4 2023 | Achieve Life Sciences, Inc.

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Operator

Greetings. Welcome to the Achieve Life Sciences' Fourth Quarter and Year-end 2023 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

actual statements contains and Good a us Achieve call operator. on by and statements you remarks. I'd may to will are remind those only Jacobs, from forward-looking time, thank and our documents website Bencich, Wan, to to These conference and today's Thank Accounting like and session Principal Achieve afternoon, the current projected. following Life predictions, joining over may Officer. Management that John. President I Cindy filed company. At Dr. today. From Executive based factors affect available results on refer joined that this Medical materially Sciences, turn for vary Officer; Chief Jerry for will with you, call expectations. be Officer; everyone, Please concerning Chief Q&A we the everyone John SEC available prepared are today's the

John Bencich

thank financial was providing significant as on and Thank year along regulatory us with cytisinicline you, key joining the and marked Achieve, for year transformative XXXX, financial clinical, and program. XXXX development for you quarter the results milestones. Nicole, ended for Achieve's a updates discuss by we fourth

and nicotine cytisinicline dependence, the for commitment cessation Our remarkable progress, to for ahead. smoking we're has developing and excited yielded year

timing. cytisinicline's completed observed again highlighted reported ORCA-VX trial for over conducted step with which and and tolerability instrumental in demonstrating vaping ORCA-X to efficacy submission the cytisinicline's in States we promise cessation, review patients. Furthermore, we the in helping public effectiveness Phase this FDA treating ORCA-VX been have in dependence. cessation Late treated million youth the additional and III alone. requirements our United treating nicotine an the results The currently smoking adults pre-NDA health XXXX, have and During address year, to from significant of million in II X.X potential NDA announced challenge, which ORCA-X for benefits last and trial a with trials, vaping emerging marking pioneering in Phase XX dependence confirmed nicotine meeting cytisinicline for

need agreement with the that meeting, FDA that was that proceed data we efficacy to submission. the During they on requirements, would many the February XX open-label sets At expected calling requirements year, from additional data agreement this have the for exposure single perspective indicated for time, including of to a meet reached our an would sufficient turn towards are program of FDA lifetime exposure of over of data, beyond over clears study, receiving the for call which safety multiple a open-label assess reached patients repetitive the of long-term the which long-term weeks nature now we cessation and treatment attempts. In cytisinicline to driving Cindy design we smoking further due trial. and into Cindy? chronic risk initiation NDA to that ORCA-OL study will study the detail safety exposure an go submission. I path to with this on the planned the cytisinicline forward the courses

Cindy Jacobs

cytisinicline threatening administer objective will for longer-term for either novel data obtain cytisinicline Thanks, period have Based single-arm or prior of minimum to a who will for with III ICH the treatment submission. And cytisinicline open-label X-milligram cessation. that follows clinical smoking and products our treatment for at II the exposure agreed to subjects months ORCA received in our year. the to weeks up data chronic them X The will anticipate data Because of safety enroll FDA, of than and in the or with cumulative the participated discussions allow to study exposure this ORCA-OL that quarter the initiating X year. FDA with vaping safety trial X of X/X in approval will to then will the to collection exposure U.S., to The X exposure on up trials, was X cytisinicline the participated study ORCA-OL in and at study administration diseases. of cytisinicline include a EX longer that TID participated of Phase of ORCA John. cytisinicline who be study second studies repeated XX primary we all have year. Phase or be our This exposure already NDA data for X exposure for on of will months NDA this faster cumulative of subjects at NDA have trial this cumulative agreement approximately submit intermittent XXX treatment for period time long-term require a the to data X in on the XX open-label safety a the clear subjects for XXX support for with prior use studies. of our which general submission. locations they already treatment, subjects non-life in months exposed least safety We cumulative guidance of year previous we our

are these potential to of have participants. conducting sites now All clinical actively been engaged and outreach

XXX importantly, for were have quickly were meet stated, in those currently to that prior previously We X there months have the treated protocol participated previously the more sufficient we we in ORCA studies to X over than exposure and up ensure who with subjects As subjects X,XXX trials. have with at the year. long-term subjects X,XXX in enrollment that cytisinicline to

enrollment closely study and We enrollment. will progresses the monitoring be to as determination final discontinuation make a obviously study rates on

expectations, and we are an be year. And in in of believe NDA position half the begin distribution vendors as on quarter key and we track include based to our possible. contract second enrollment in services, we as These and the contracting a drug onboarding efficiently quickly CRO, lab the to management, safety this partners monitoring data execute and current We study ORCA-OL have our to on our XXXX. first and of partners completed will with submit

results, study and assessments time, such endpoint for FDA longer-term purposes of the determine for exposure serious adverse the observation Although not specific the to an requirement success of an incidence are with over trial. be assessing cytisinicline for assess will events only will also objectives as are or we exposure. safety to efficacy These

to will our finalizing requirements year. conducting anticipate the end-of-Phase this meeting submission addition role we discussions the a II treatment finalizing NDA indication, continue III cessation. regarding FDA cytisinicline's Phase with e-cigarettes We In cessation for smoking a protocol for as our and

grant We funding our as label support III to will will III NIDA, an discussing indication. Since back explore the e-cigarette for the obtaining Phase we received a will Phase of from NIH continue Phase non-dilutive call the expansion a advance be and to John. single John? we trial turn to trial II support continue ORCA-VX planning. I for cessation adequacy over now

John Bencich

with results. additional million the proceeds call as to clarity ensuring upfront on strength includes upon and XXXX, us advance over study bolstered of all to initiatives, on milestone-driven discussions. I the provide will turn and who connection the our an half In to in our $XX This significantly balance Thanks, $XX.X clinical now robust that and announcing in financing partnership including the an of while overview first continue details February, up warrants. Jerry, to strategic will FDA NDA we initial we funding sheet submission Cindy. our latest targeted initial gross positions funding exercise of a financial ORCA-OL requirements, of in $XXX.X NDA equity up million the million financial of additional financing an

Jerry Wan

Good Thank quarter review you, on fourth to update recent cash like our provide position everyone. John. then afternoon, results. financing would first an I and our and

upon and proceeds of cash, to cash million December month. stock December up included million. closed company's initial to the equivalents with down milestone-driven and capital XXXX, an quarter the key to the to well other initiated cash corporate in fundamental and the concurrent totaled $XX.X This [indiscernible] warrants. After placement a February registered quarter, be care support few, as trial, cash XX, upcoming equivalents cash, equity warrants As end investor, investors company's we gross $XXX.X to PROPEL health second as be equity XXXX. the of well common cytisinicline this to half activities effect XX, announced in a $XX for private NDA such December would will a $XX.X Subsequent up for of million, of $XX.X clinical been strategic the and upfront as ORCA-OL approximately restricted clinical cytisinicline to forma million cash fund financing also of as research submission earlier XXXX, the this were the of be and used year $XX.X the development the development existing offering million as the million have Bio, from additional and of transaction that It business, new with purposes. of restricted XX, of financing, used giving XXXX. will to and pleased we as of and This anticipated direct the as name pro XXXX and is was exercise working of of first Sopharma. Proceeds fourth and from including Franklin which Templeton fund related expected clinical offering the general

second potential $XX.X financing ended States. With We anticipate and for to us in obligations full, milestone quarter extend to initial for million into now the to into under XXXX, outstanding and are of year repayment turn term and operations, proceeds were XXXX, issued will respect including and I'll proceeds from the warrants expect December was our call the fund my and million, exercised half fourth the our XX, through respectively. in part the expenses ended runway over operating net the potential quarter the XX, XXXX, Net contingent approval of cytisinicline concludes the as of the year United If back of XXXX loan. convertible that loss recent the $X.X million would debt total financing the portion respectively. That we of call. these $XX.X fourth John. of $X.X our statement December million,

John Bencich

Thank you, It year. been an eventful Jerry. the has to exciting and start certainly

trial. and Medicine address and reviewed new to consistent from Phase Phase share cessation. trial, from to solutions NDA complete III and Society School, the was investigator adequate Dr. Rigotti, were Data II deliver vaping treatment X In who the on for shared privileged at ensure specialists we our financing we completed and plans nicotine from prestigious week's have to Phase researchers, the III data primary Medical from of Meeting. results our ORCA-X trials our commitment of highlighting and findings reinforced an for Tobacco were at Research audience with dependence. Cindy Annual and the ORCA-VX III presented development Nicotine and impressive last our which trial Harvard dedication the to completing FDA the findings ORCA Nancy with presentations ORCA-X cytisinicline, nicotine Professor to addition finalizing of to resources Phase II finding Phase

we Additionally, to abstinence, trials, smokers approved high from to strong for delivered from levels in participants presentation and of reported showed FDA. which smoking the and a a willingness to sample of other reductions experience post-trial insights our survey, patient recommend small findings cravings smoking, and provided ORCA-X quit, directly highlighting consumed cytisinicline by looking cigarettes a both in ORCA-X if which

X/X felt Importantly, very experienced respondents or almost of that effects few they side were manageable the side effects.

is of believe benefits this of key continue X We cytisinicline. differentiating the to

As or the that are available key are medications. take with we unwilling effects side know, to not smokers remain many reason currently compliant

providers sites. remarks, your of and care collaborative appreciation I my for our the my to would trial up wrap efforts their trial I for express at like participants ongoing support health and and our continued As

So advances devastating X help in our individuals a decades. touched not smoking who in many belief truly remain us steadfast and have cytisinicline millions make of treatment been of profound have to can that the of almost the seen any by consequences impact personally

productive Our preparations, into priorities year ORCA-OL and clear: NDA line of commercial for for cessation, finalize the will dialogue us for joining the prospective forward balance open today, you continue e-cigarettes for again partners. Thank and we continue complete with submission now the path the remain this study, expansion questions.

Operator

Flaten of [Operator Instructions] Capital. comes Thomas the line Lake from Street with question first Our

Thomas Flaten

nondilutive read? in program there anything correct be an implication seemed absence do comments, of Was you your not that a funding. on in the Cindy, that the vaping to would

Cindy Jacobs

or getting looking don't I nondilutive at only nondilutive additional funding. we're Phase be grant trial able to Well, complete think we're going funding. the to III with

Phase have with we with probably a grant have NIDA of half what it by the funding both. paid of and we'll it half was us. to mixture So to had was similar II, But

mixture So would some there be of that.

Thomas Flaten

X quick just done compliance Is it. And study. then anything the Got dosing OL patients on being of monitor the to instructions? ones with there

Cindy Jacobs

with with same of Oh, Phase the our OL tactics we you we as making they're kind study mean as as sure did compliant, have III. far the compliance

We will have text messaging.

We to tablets were giving need the that packets. out will in. They taken. them review will be bring We'll

with is the being of Phase study. all in the was that done that III OL similarly applied So

Thomas Flaten

And patients, burden what then they like and the visits follow-ups kind often have that, come things on related how of in being is to and for placed to that?

Cindy Jacobs

is did and through weeks they thing. weekly, Well, They're out for study. monthly they the monthly only the then X instead afterwards, that they're which nice first OL coming in in XX of start coming the and

Operator

question Company. Francois with comes line of & from the next Our Brisebois Oppenheimer

FranÃ§ois Brisebois

help you line Can first launch? NDA understand filing 'XX us potential approval here half the to time from and

John Bencich

Sure. for Thanks question, the Frank.

put again, us Cindy in the the forward requirements next. completed position the enrollment least quarter second this driving or really on on open subjects, in at We indicated a NDA clinic this we're the late year So ORCA-OL for right depending trial towards call, the those submission, to now, the have in early initiating of year. of could think, as that --

that the months would half put so position would now, a to accept, on XX first review, And be to for cycle, file put NDA of this XXXX. approval months review of us in Right would so half a X XXXX. which get standard first

FranÃ§ois Brisebois

there OL Great. doing why efficacy of at terms push Is the looking upside on trial, of And what's Okay. the that? the here? in --

John Bencich

Yes.

need this the exposure This respect a could they safety efficacy from that could leveraged specifically be planning. for interesting. us We trial perspective, payors, don't our for to FDA. fine which for of of But that publication, is for with trial. FDA, this So out there's come is data, for lot we told they solely longer-term think points trial efficacy future other data of is out think

with robust could relapsed, in are a management For on quit they some example, happens duration. XX get that study future. how previous the at to into longer again as if dosing extending efficacy but what play more well point a had quit weeks as a of Does that patient treatment, to back again, in cycle likely beyond lead going life to

some we I So there's perspective, trial. could interesting efficacy think the learnings of out from an ORCA-OL that get

Operator

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

Michael Higgins

agreement the FDA. Congrats again on the with

so as us feedback to So can patients It far. like beyond you John, the give sounds the if some have their responding outreach. how sites are

many so to patients are reaching how XX U.S. many out feedback Can some what you mentioned are You opening, sites. how and give us the as like far? are responding

Cindy Jacobs

want John, do to to me get that? you

John Bencich

be would Cindy. Yes, great, it

Cindy Jacobs

Yes.

the do into to a sites, the they've started was guess coming this the some and because at we the satisfied So study. we by reach I enthusiasm thought week open-label out XX that back presented of treatment to that afterwards, of lot the participants, and Phase they the surveys that's last were all getting of were surprised this month an was they for they meeting are III data very did helpful. and very SRNT not

getting in this positive study. -- yes, are we And probably that, for are responses open-label so indicates with positive survey that they participating

Michael Higgins

the approval. for, what can Anything What information post efficacy from the scenarios help kinds week, terms so from since if hear in with efficacy December this may discussions and doing trial. Curious that looking FDA last surprised you in in we as from not of chance a the which the guide may is looking your reimbursement you've the discussions here us you're of had may with that that. have share great. last certainly trial? of news be what not but how news light to FDA Yes, that to for with open-label That's currently presentation payors and that saw to you

John Bencich

payors to is the Yes, approved number years. a the And that over payor does had mandate last covered. Act X Care discussions the be mind of X with or in medications FDA Thanks, Sure. think I Michael. keep X thing cessation smoking front, we've on Affordable all that

we'll like look is an I trial, administration. out with ability, the repeat the from this what being I perspective, the mentioned to So open-label at categories of said, access think that happens before, X better there. With have

success retreatment up and points So of as again second with payors All lack both of we success used and those success approval sorts an time discussions can side treatment of other and on to having initially in then be product. those of leading the the initial this data perhaps or have around.

I So we the with I can we sets important are But as of get, further think that most be those community. pieces. payor in dig data learnings could the other think probably interesting the kind that we leverage with there

Michael Higgins

sense. if follow-up, makes is quick visits. I That the could, One monthly

the just in you adjust and you more to before, along If than that out Are and way as able trials. try as were reach the different seeing they aren't find weekly the patients often? them previous it's as compliant that to because to

Cindy Jacobs

And monitoring the Absolutely, regard. that's will that in be we yes. X of things

Operator

from question next comes with Saks. line Vandermosten Our of the John

John Vandermosten

there's were the the How how and trial, since do to this the does work planning other to FDA you that inspection first many the all preparing work for -- affect a them? with the Sopharma delay with relative expectations on

John Bencich

for the thanks John, question.

So as for of will Sopharma of and be X to be readiness. key the working about FDA ensure inspection continue to focus we've areas spoken further, us with

with gives that This So effectively preparation months that. XX will of continue. respect timing to another us

with from could minimize historically perspective. at approved been by inspection perspective looking the drug additional that that both risk of to substance we that and Sopharma. is be are FDA could Sopharma already CDMOs any One Groups items an a side from that side have product working drug continue with

Sopharma working So their continued at site. with the that that's in we're something to work in addition

John Vandermosten

news any new generic an eye last observations had know I options recently. and update how that on over an don't saw, on I that And on the us. the side Any progressing. you're several months? I that's of seen varenicline have for if for we generic then And any you keeping explosion Great. know guess, or

John Bencich

respect With there on generic generics market believe the to now. varenicline, Yes. X I are

expanded So first who to over market. the beyond the has was last XX months, Endo, that

continue varenicline some we Clean monitor there's Chantix an annual recent to to data the run suggesting in as of IQVIA XX% left on $XXX for some something off. So market that was that was have roughly north data we're And And rate seen brand a we somewhere points. million. seeing where marketplace, I we proceed. believe discount that's of what from the generic

Operator

Bergen. next Our Zuo comes Ilya with from the of question line Freedom

Unknown Analyst

Meeting. Annual any ORCA received presented Notable Could concerns on event, the they and have program results drug? any community feedback potential you share the the use [indiscernible] about Evicto, professional of from chronic of

John Bencich

[indiscernible], Thanks, question. for the Yes.

talked we trial did as would driving phase We So reception not behind that's present it from strong results very Rigotti a our at see say, were I think meeting candidate continue General. Dr. product cytisinicline with able market. by well X received, then last Harvard else compound as the There's to near on a the program anywhere on of from here. have the ORCA-VX call, we to bit different data sets the III have and week. Nancy Mass Phase we presented the going very that overall, I development and lead to we really much the SR&T

that's I refreshing. So think

I decades. think is in new option treatment X that options category a viable seen very needed a hasn't is this overall, that the nearly and treatment a perspective in option any

program as the overall, great, a that a years. several we've I the to So reception last we for lot input warm over this look of very think developed from folks

Unknown Analyst

for requested studies? X safety from FDA elaborate previous by trial? any to in changes on compared please. being safety the open-label made Have protocol Could parameters endpoints And me, the to the more you

Cindy Jacobs

similarly pretty I open seen looking the or X treatment And adverse looking after it related haven't in serious at any those events, the related emergent adverse any Sure. adverse of but Phase any of we did much in in problematic laboratory adverse after emergent of events. and Phase the just They mean, of signs. kind as events, endpoints IIIs, we have primary, vital events, label most all general at be clinically that, that, a serious treatment then significant III just studies. abnormalities would have we these as we -- objectives

Operator

question And from again our Thalmann. Higgins next with Michael comes Ladenburg

Michael Higgins

with conversations us throughout this your you FDA and NIH vaping, that know get what look want the Can like year? with you help going. may that I to

with and just discussions. better all happening your been had trying the for with and full But your You've there. to sense timing the that's hands get vaping a OL program

John Bencich

Yes.

is So with agencies. to meeting going vaping Phase focus II be of the on end the the indication the really

we're end we've So the ORCA-VX meeting forward. now that II the agency. to complete, clarity of able with the trial share Phase under to path get Again, on an got the that of guise

As we on be label the that required we've will indicated what trial III need that. expand before, a is but to e-cigarette Phase and single belief our into clarity open nicotine is cessation, up

this So second get this that clear half for a high hope of in something priority us is year the we'd year. and beyond to

Michael Higgins

Okay.

at X Sounds ready Do the being It Is that understand for so good. trying sites like and into have the board And sounds fall? that summer then open manufacturing point? on months is to are the you to second and forth. this go supply the OL. here coming manufacturing. in enough still Just

John Bencich

Michael. Thanks, Yes.

to manufacturing packed this in the and made initiating the folks On coming process get trial. the is gating and to ready The the for here all into in the tablets weeks ORCA-OL for probably the that we're and item have been clinic clinic. blister of centers the things, back getting side

the is so track here to we can ORCA-OL everything coming in move forward on weeks, initiate the trial. So that

Michael Higgins

Awesome.

Okay.

And finally, cost sort look compared we had And a be gauge the that. to the in to and then may good. Congrats ORCA-OL of to noticed than or I but Sounds and X. how expected. frequent less OpEx assessment get ORCA-X It's trying we an on some lighter then visits. ahead to longer, as QX was

to come comparison trials, in sense how a this the out. may cost get to trying Just

John Bencich

the basically $XX that XXXX million With roughly will for XXXX. over as currently ORCA-OL, Michael. course to Thanks, we've this the in respect come trial estimated and costs Yes. a of

bulk what less those patient and what doing we've the businesses a of similar costs. are And visits is seen in as the the while studies, Cindy longer just the is time, articulated over is very in recruitment we're cost previous So overall consistent. these to period visits studies of the of frequent, the number our of

patients So will in the are therapy. come and their the complete enrolled bulk of as the expense

So part some of bulk of year. cost off and the that we'll next drive kick it the through QX here then see of in first

So helpful expenses. the hopefully, that's modeling out in of kind

Operator

the turn session. have John the call over I'll end reached of now Bencich the question-and-answer remarks. we And back to closing for

John Bencich

Thanks, get us thanks, trial. proceed forward joining all progress Thanks everyone. look We've providing huge everyone, continued clarity amount to made continue as FDA additional the we again, we here and operator, with and to in look today. for forward from recently ORCA-OL the Appreciate of and to support. a really move quickly contact. forward stay updates to And

Operator

today's lines disconnect this And Thank for your participation. time. concludes may you and you this conference, at your

Achieve Life Sciences (ACHV) 28 Mar 242023 Q4 Earnings call transcript