ACHV - Earnings call transcript Q4 2021 | Achieve Life Sciences, Inc.

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Operator

Good day and thank you for standing by. Welcome to the Achieve Life Sciences Fourth Quarter and Year End 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please the advised that today's conference is being recorded. now today, hand Nicole would to conference I speaker your Jones. Instructions] like the to over [Operator Please, go ahead.

Unidentified Company Representative

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

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

John Bencich

and today. thanks us everyone joining Thank you, Nicole, for

During cessation the today's the and call, we program ORCA-VX status studies. nicotine ORCA-X, including and for of ORCA-X on the development cytisinicline addiction, will discuss updates smoking

overview provide year Additionally, end of results. an our QX Jerry XXXX will financial and

and as adult cytisinicline at of serve We are with Phase X kickoff smoking United confirmatory the XX XXXX trial, start registration off marketing great second ORCA-X will for initiation smokers our cessation. January to evaluating US. cytisinicline enrolling announced ORCA-X of Phase approval now and required clinical are the in X We trial of across the the in a in States. locations trial the trial for

weeks placebo. arms if biochemically to receive of period X the duration standard or arm weeks receive the in XX the followed a determined over placebo, market compared sooner for be ORCA-X placebo. XX personnel FDA importantly we Bank of expected. randomized treatment Similar not Silicon to ORCA-X our a of By the importance ORCA-X, timelines three capital of only are additional dose options. seen the one our the of with reducing trial of our evaluate onboard successful expediting than capital were arms approval. initiate we Valley to for in today, and efficacy securement milligrams operations critical overall and hire in cytisinicline have to this to with statistical placebo. throughout will the weeks requirements millions behavioral December, cytisinicline. treatment successful, the compared competence Given program, The be clinical three three help additional of quickly submission trial but weeks we able be last in treatment ability daily either and overall to safety success and will of accelerating from the to trial treatment weeks either show abstinence arm compared of placebo of the measure X All of primary and six be or to of six weeks weeks will will Each subjects arms of verified four either support continuous a be during both XX placebo, cytisinicline assigned to also for development will the to ongoing cytisinicline benefit treatment compared This participants design cytisinicline and the cytisinicline to outcome in independently is times looking in the XX be study ORCA-X or trial, will of smokers cytisinicline by

recently have months assess of trial surrounding of through subjects are Secondary sites abstinence the continued the recruitment conducted activities launched clinical the six treatment. we from study just rates now and to in number a be outcome city measures will enrolling start locations. All

we who on to hope look trial the sharing details as the are and seeking who information throughout the smokers from on forward additional this habit. trial interest great seeing kick are year. to We more We progress

locations. we at in was you, the of ORCA-X last like trial, the with ORCA-X anticipated XXX US enrolled highly This enrollment six in To Phase month awaiting adult Cytisinicline XX line smokers completed, are the the in smokers. results clinical first the follow-up recap, trial from eagerly trial last to the X on and completed trial subject summer visit in last December requirement. year Moving

no conducted part conduct As data event profile the favorable. safety. safety monitoring independent concluded an OCRA-X, of reviews, there study pre-planned included and They safety adverse the which and committee study conduct five also regarding remained were concerns

study orca of follow XX. Cytisinicline Beginning the COVID was monthly at two performed abstinence week Then, by well the XX smoking occurred week the treatment. treatment biochemical and study week for the progressed rate of placebo six regards that both XX, exhaled for second members medication of primary carbon abstinence treatment. durations compared a finally, to abstinence assessments smoking pandemic. self-reporting the two monoxide independent abstinence treatment, will similar was blinded These had weekly efficacy, up are the has study challenges to of weeks week evaluate endpoints commented DSMC verification Additionally, and that by smoking with at despite for compliance abstinence the XX of assessments through excellent With of weekly occurred XX weeks assessments of XX, levels. and

the This abstinence during weeks for required primary XX-week verified biochemically treatment, four last week of weeks is abstinence for abstinence measure both comparisons, at arm as endpoint five, FDA at six the smoking the XX, For endpoint is medications. approvable smoking XX. for defined four, and abstinence arm, six is nine, treatment and required the is at the weeks four-week three, conducted continuous cessation abstinence meaning XX, continuous and assessments

weeks. with assess XX at Secondary versus placebo designed the weeks week at well continued with benefit risk relapse to XX endpoint treated abstinence treatment to to ORCA-X able XX be as reduction in smoking for Cytisinicline demonstrate at XX out of Cytisinicline was follow-up XX% arms continued compared compared weeks six of over of long-term subjects to in power end Cytisinicline. a the of to comparison both measures as placebo, week abstinence from will outcome

we blinded Completing outcome. to topline ORCA-X, the expect evaluating which the our results then, e-cigarette nicotine of the year updates X in be the users. on quarter to is the on this for second treatment trial of as Cytisinicline to status continue Finally, development ORCA-VX, is a we program and until cessation announced Phase remain

data smoking for approved cessation to cessation is to e-cigarettes specifically United in the ultimate our partnership no with have Based the the vapors users e-cigarette than ORCA-VX last Following the Health for indication help of XX% more the collected significant of XX IQVIA, therapy that to that we numbers Institutes of the trial. approximately expressed With vapors is goal quitting. an this quit. from survey options the National expand users nicotine or Achieve in population. who approval, want help and to grant execution awarded of a announced in to NIH support a need unmet available, label year to was States, treatment We currently growing on million of the later There interest quit. adult Cytisinicline

the e-cigarette November. by preparation related enabled submission of trial first of to addition a was operational the FDA IND, which phase the activities, to specific agency accepted the new of cessation, in In to the grant funding

approximately grant. to of enable ORCA-VX activities of recently released the the expect year. this second to we submitted million of the to initiation and Pending the the our trial associated quarter with their $X.X be outlining documentation have first the stage the award review, NIH, We completion of of the in of phase grant second

over call our Treatment of and with turn Center Jerry our ORCA-VX strong to General at Director discuss of results Hospital. Professor As XXXX. Harvard approximately reminder, that and led at subjects School Medicine be I’d XXX Massachusetts is the a Dr. financial Medical we'll Research by like position we the designed enroll and to ended now to Nancy Rigotti, Tobacco cash to and in

Jerry Wan

I as December provide our Thanks, an update like would cash on John. XXXX. to XX, of position

quarter for of our review as XXXX. expenses well operating As fourth the

cash debt of cash Valley restricted of of was down we equivalents, provided December company's cash, Valley at in the compared to quarter of over we facility due prior to investments as million, Silicon $XX financing XX, and Silicon $XX increase December. agreement which closing. September As The our XXXX. $XX.X a Bank Bank million the total closed million in short-term $XX.X were XX, million cash the drew

Bank January Silicon As trial, balance year. allowed John sufficient to is which funding provide this in from XXXX. current mentioned the us of ORCA-X we accelerate into initiated runway has to Valley earlier, We cash the believe our

loss costs higher Now increase of the with XXXX, million, we associated expenses turning the Operating XX, $X.X ORCA-X statement Total anticipate of incurred net $X.X on $X.X the ended to for net same ended compared operating trial due million our increased XXXX ORCA-VX ORCA-X quarter trial. quarter of increase loss associated to ORCA-X to operating XXXX, in the during for for operations, XXXX. execute a million pre-initiation the December the million with to expenses of as the quarter a both expenses further to the XX, fourth to of $X.X as and our along quarter trials. XXXX. compared with costs We quarter as the same of XXXX, company December for

the the summary the concludes a to grant back turn to the be That through a NIH. As reminder, from funded trial cost approximately of call financial a from our half over ORCA-VX I'll results. expected John. are

John Bencich

on you, heard, to program of deliver ahead on conclusion, we time the you've continue Jerry. milestones In and as schedule. ORCA Thank or

the expected continued enabling open Phase first next safety launch line and now readout in believe, ORCA-VX appreciate your cessation. in X better our smokers and to with live have support We to lives. and line for excited current and of quit treatments, of Achieve to are will along questions. data We cytisinicline efficacy healthier will offer quarter, the We demonstrate with best-in-class continue vaping successfully

Operator

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

now is line Your open.

Thomas Flaten

given have quick that you on guys. have capital ORCA-X the driven trial the sites you ORCA-X, designs to do the by something Hey, good to afternoon or moving be of hand, Two is that number that with forward will expanding questions, on keep results? the respect

Cindy Jacobs

You added more ORCA-X sites. have sites, want no problem to actually with more looks sites, the need at remind you, during me that's we we have get Actually, If we where needed we John? targeted more to additional would two sites, to looking now we pandemic right the XX enrolling timelines. like were it with that we need enrollment our we're that, because will and

Thomas Flaten

the completely? – coincide VXis to Got the the start two things to the is of it. that And with with intended study those ORCA-X that are release then of respect de-linked

Cindy Jacobs

ORCA-X of the our Phase just the X so starting NIH we've the Phase funding of They're de-linked completed is completely. the all now getting phase one, really second just our waiting for on we've to we're the to vaping trial. to release start of based grant documents that And in funding. phase X The put the

Thomas Flaten

it. Excellent. you. Thank Appreciate

Operator

Thank you.

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

open. now is line Your

Francois Brisebois

taking Thanks questions. Hi. the for

Just a couple here. of

to be that's saw little just ORCA-X, terms less ORCA-X So and think patients anything a very, else there design. think very different? differences at they're in all? any similar of I I clear, between Are I maybe

Cindy Jacobs

The exclusion exactly loosened less one only difference is at the There clinical design. three. criteria bit. the exactly that required just a otherwise, Otherwise, be been little same. yes, the But it is visit was same really day may is inclusion it have

Francois Brisebois

competitive either Okay, – Depending then based XX terms know on of commercial do do the oil six you or weeks, hits mentioned it be the on have or But any or just weeks hitting or you both one other six weeks XX would potential? great. on or And either you that, considered in whether successful. weeks landscape? thoughts the the endpoint

John Bencich

Yeah, thanks. Thanks, Frank.

a XX In I'm will both. weeks, six all that's not mean, much. it And I and love of, matters XX ideally, that I I or sure, expectation have preferred, on our we'd competitive to X think it think hit I from both is terms landscape. think whether is

the a duration group And I longer in that and shorter think resonate, to quit. particular is that profile see continue with or comes have heavily and going think relapsed multiple what safety is treatment. of slightly regardless smokers times cytisinicline we'll of to better to tried tolerability pre-treated a I of

Francois Brisebois

and But talked a in just a sneak a really safety. placebo? one I been can here, versus cross is hasn't difficult with the efficacy there head-to-head saw can the about if I'll maybe comparable terms you in to we Chantix then and similar that comparison other us on beating you just design Chantix. But I in listeners being rail of And the do Great. do than be of maybe help a last know, the efficacy, it's Okay. remind or other

John Bencich

and way over sure placebo, Yeah. that's odds think looks question, typically drug the is way placebo. Great magnitude in I'm for we are into that been over I at historically think are from the that three. I the It's benefit, at of bupropion bupropion, the and below at when the think NRT, And NRT of was options and before about are their which market. of under treatment we today, looking varenicline the known data. have in and those benefit one currently two to on effect look mind everyone's one on the terms market available Chantix just an the it terms as varenicline. And viewed this And withdrawn going is what's to basically ratio, been of best just is

is that lots help out that. trial mute of across design multiple placebo odds Cochrane is hear from looking ratio the I way what placebo. and others to the demographics, between opinion the quit really space in a Xx the there's trials key But And the range, there been we've that's be subject publications But group I trial. in so like what differences that for baseline over over multiple is we're continue Xx benefit articulate to trials, this. do a things leaders we and for to this rates think, on only And seen think at that depending needs looking and from the

Francois Brisebois

you Thank right. All Yeah. very much.

Operator

you. Thank

Our next Zacks. Vandermosten the line of question comes John from from

open. is now line Your

Richard Hantke

John. with call. Thank two, and will How you. kind are and want discuss the Richard in just our is I to topics everyone. that calling you? then Hello, Hantke after Actually, of, for follow-up this John you I got John

and the more that aware came patent, I more anything reported Pfizer, understand of guess in drug generics, some that that things then any to and obviously on XXXX there’s So of that caused off And contamination understand down commercialization? of, what revenues issues, the do just Chantix. was first kind The how first my have road and were that in that disclosed terms picking we how down up questions. that and decline maybe XX% might performed? any your idea you're but you some is affect set there's it they of we translated

John Bencich

Richard. thanks, Yeah,

in So two of with compounded factors revenues, Chantix that’s terms there. been

probably that obviously, think started to first last and withdrawals Chantix launched some and global The that then I was more hitting was fact Chantix. limited market is year pulled that early year first, the went withdrawal full from Pfizer importantly with last generics the the summer of

the brand is So market. the currently no on longer

So of products decline there's how seen and Chantix, of anyway. it's is revenues. generic not it's there. list do to that a terms have sell in any of is real in a why the first stub of market seen price don't sitting to off I reduction being monitor. continue combination the think we've about period generic performed. we we've the able terms opportunity out here. It in know -- the XX% but will that We something the We think I don't details read From what was

known the another combine of we back of smoking down you when road. need relapsing products and with today, the into majority indication going And covered. Affordable I be that of to market. most this Care fact with patients mandates this there I cessation beauty the generic even a that that think always we've treatment going will efficacious are the Act out product and still option were the launching the products us, smoking think that kind For is to be And

strongly continue opportunity the still market we So feel to about here.

Richard Hantke

Has trial then on you on or QX all understanding grant, that my in launch expected receive question, trial X.X that up through backed I to in track John second is expect for schedule? the million at And you. been the QX. is that is Thank Excellent. everything the that you the to --

John Bencich

question. Good Yeah.

that's So we on continue to believe track.

that We grant currently out with stages We've milestones, showing were are we've logistics that working submitted NIH. initial of were completed through the under the the the grant. the the documentation that set

we from for which next response the trial we're And million can NIH the that the itself. funding X.X for just awaiting into the proceed unlocks so phase

to on So the yeah, move are track, to everything at grant that with NIH the moment, the remains beholden ultimately process we but forward.

Richard Hantke

a All other it. John. of you. after for That's the right. get call. enough He'll Got now, list got questions. hold you. Thank He's knowing a Thank

John Bencich

Very Richard. good. Thanks,

Operator

Thank James line from Global. comes question you. [Operator from the of Our Alliance Instructions] next Molloy

Your is line now open.

James Molloy

can I process? the sort Thanks a Was of you for color much that US discussions going second there question. data are Hey, on that the outsiders and provide taking partners how in how know for quick those my the had John. on question quarter. nature potential looking partnerships. of any in on will I depend the looks

John Bencich

good Hi, Jim. question. thanks the for Yeah,

terms this going to that and to trial. be results of a potential we get up have to in commercial is we're parties, as into results And there ORCA-X expand looking of in running the to uptick process partners. So, continue a think, to more into will would an we have year for we continue to and ultimately but continued we this of here get an terms in will expect ORCA-X we with and conversations think into going data in closer forward commercialization, interest get work to the individual we will And data have seen data. be we we our not the part ORCA-X process big outreach push I ongoing that I interested or But yes, outreach details, think that. and from hand continue

James Molloy

it's sure. people to dropped the a believe of just given pretty spoke, on market with be expanding Great. on the Chantix. bit out advantage beyond that, And be I to sort potential you a AE many speak given we think I AEs a we maybe Can Chantix? But about good little versus -- touched time last significant how question beyond looks the number one for what

John Bencich

Yeah.

I hear tolerability So profile existing really safety clearly a profile the for products to differentiator also hindrance is key that but patients to continue from for not we think uptake. is the and Chantix particular physicians, only a and big in

without adverse interested that So tolerable a that events that do easy couple utilize is the product product And hasn't cessation. I a years, and fact I the with be here. you see And to are is a new more think, within to been XX we when in. and to there something opportunity think smoking just that's real that over grow the market patients there

I and expanding think the There with been cessation is data we help that grow. And will vapors opportunity long I them globe. consumption cigarette today. the uptake, no are quit those e-cigarette to the think globe term. yet. market, points dented around there's XX been across e-cigarette it e-cigarette million think hasn't indicated and recent products because a tapped and that's, into has I really into we're currently an that's which came to around as where And why smokers know tight well billion ORCA-VX about excited It's the but that was not X that that to over that's rapid users users today market looking there's indicating one go over some continues remain

So I combine with see should that product we with ahead of together, resonate markets two think, those when large us market you the a patients.

James Molloy

the taking for questions. Thanks

Operator

questions. this At remarks. the time, like showing no would Thank call back you. over to for I closing turn Bencich John I'm to further

John Bencich

for support everyone of the us continued today thanks again Achieve. and and you, Thank joining

results, excited ORCA-X are which launched be ORCH-VX around about to the execution the The including confirmatory expected the right second of lies trial. continue the and continued ahead launch us, what of corner. ORCA-X recently in the We quarter for

the updates again So to as thanks today. And provide us continue things we for to joining everyone progress. look forward throughout year

Operator

Thank you This participating. for concludes today's calls. conference

You may now disconnect.

Achieve Life Sciences (ACHV) 10 Mar 222021 Q4 Earnings call transcript