ACHV - Earnings call transcript Q3 2020 | Achieve Life Sciences, Inc.

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Operator

Good afternoon, ladies and gentlemen and welcome to the Achieve Life Sciences Third Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Executive Vice President of Commercial at Achieve Life Sciences, Ms. Jaime Xinos. yours. is floor the Ma’am,

Jaime Xinos

Thank you, joining everyone and thanks for us. Laura

actual Officer; we statements statements call documents everyone Jacobs, vary call Bencich, I results Medical which Board to on Accounting website. concerning will of our and expectations. affect today Clarke, of only forward-looking of the Please remind Dr. Scientific filed Executive have Rick President Achieve’s company, available Wan, Stewart, could Officer; the over contains SEC may from John. Chief These from Directors; Cindy On to are now to projected. based the the Dr. those Officer. factors conference turn Achieve, materially John I that Chairman that on like call are Principal today’s Officer; copies predictions Chief and Anthony current and Jerry refer with Chief Executive would the

John Bencich

Jamie. you, Thank

very we last including Directors the our operations. as involved we the strategic of Tobacco certainly ORCA-X Research the into that continuing to quarter. will review have details Officer be is I finally, for of that Chairman third versus Phase Chief had recently our and Co-Founder of the a company’s data presented in Meeting, our cytisinicline end of and & remains team, and a the Society on Chantix, Executive busy results of of quarter to Stewart, initiated third Achieve’s we Operating financial announced CEO and of transitioning head-to-head discuss results. European at CEO. serve changes from actively To will Board our September, the trial former RAUORA begin, Financial Nicotine and Rick from exciting management We call, month, X today’s at study On announced role

Co-Founder of Achieve’s Dr. has Additionally, the Senior Wan, held Achieve, Chief former previously Officer. Accounting our Jerry assume a Officer serve position Director to Anthony Clarke, by role Clarke. Dr. been we continue Officer. Principal Cindy that will of Medical as Dr. to of of also announced Accounting Scientific Chief finally promoted Jacobs, the President, And will Operations

While changes which international Rick travel in are by both restricted in some part and were time, these playing the pandemic, UK. they has Tony, expedited for the were who for based

While to our leadership perhaps our our our in team I the trial. has of hand our conviction great Cindy? smokers. discuss and most end, that ORCA-X management initiation to structure promise of that Cindy cytisinicline has the X to change quarter dedicated Phase remains clinical would realigned, to of like call compelling over mission highlight millions To the of lives in the

Cindy Jacobs

Thanks, John.

our share in We month are last excited that Phase we to enrollment X ORCA-X study. began

support at will placebo X that evaluation. followed enroll randomly to a placebo-controlled or and a placebo study adult evaluate both of reminder, evaluated. primary smoking the be of sites two to that randomized compared treatment. in at for one All weeks, ORCA-X double-blind, X cytisinicline is endpoints weeks Phase rate the receive weeks XX three trial of cytisinicline XX month to The will endpoint treatment the treatment will XX the by XXX As a XXX arms: a) of will times arm The and in who of in end has outcomes weeks independent monthly a for XX X X be will abstinence assigned of during placebo, will primary the either following XX cytisinicline. subjects X receiving be of c) arm arm cytisinicline, day then Participants smokers U.S. week will behavior study. who ORCA-X each placebo, or out b) receive weeks of subjects weeks receive weeks arm will X ORCA-X receive followed who XX of There will

For both cigarettes treatment. smoked the last of means continuous as X primary carbon-monoxide X-week during for the defined with endpoint weekly abstinence weeks have be quitters That zero must absence will treatment smoking comparisons, verification XX, period, smoked weeks the X, successful weekly period X at at assessments. XX-week and and weeks biochemical with assessments for cigarettes quitters must zero X treatment verification carbon-monoxide X, biochemical XX the have XX successful X,

or placebo Importantly, cytisinicline over the to arm. considered if an both show be successful, will efficacy the study the arm benefit either of

end cytisinicline specifications treatment in subjects of outcome the The risk timeframes. in look secondary XX the our receiving same compared second of XX has reviewed cytisinicline cytisinicline. endpoint weeks add evaluate nicotine these XX significance compared will related was statistical and at one subgroup additional treatment ratio and cytisinicline continued last week exploratory of The to XX placebo X.XX weeks recommendations, relapse. a also to and September absence the final favor relapse will endpoint weeks end those evaluation nice after initiating XX-week in two to to an reduction smoking subjects ORCA-X for that X withdrawal protocol in time and week a Phase trial XX% to to outcomes minor for to analysis weeks only X of of XX prior from a FDA receiving had week from powered provide X treatment additional An study size least over of sample both are assessment. at at to show cytisinicline at

the been forward now I turn evaluations completed. study John. actively when With enrolling study been call when again, to subjects the all updating randomized all to back and will have have now subjects look over you we

John Bencich

Thanks, Cindy.

of trial been recently, European Chantix The than comparing in at cytisinicline as shots cytisinicline September. trial Meeting have to of that and or investigated cytisinicline of absolute smoking conducted difference that the need ORCA-X a Most to a no quit rates from from was Results for duration external primary field treatments as were duration of longer that in was compared that treatment, continue both, X but study relapse, that of studies, XX the which demonstrate endpoints As on study the would and first to stop to less have head-to-head you to of of and is those being And design they favor showed trial that which weeks. presented anticipate. our what that treatment We cessation. at have can cytisinicline, the thousands the efficacy treatment XX% for results weeks option multiple two the is the the we own ever ability The a quit goal evaluated see, non-inferiority smokers experts study risk non than X SRNT be would a cytisinicline’s in patients X.XX% treatment superiority. by to only the the half have beneficial improved a these weeks Annual The RAUORA only result of to treatment trial in comes successful lower designed the provides with cessation improvement for it in relates offering chances trials on smoking X.XX of help the is in another a slightly not endpoint, total enrolled we was but met This XXX to towards trending was equates the rates the therapies Chantix. have existing reduce to smokers key to differentiator. compared smokers. numerous RAUORA ability clinical quit not rates confidence inferiority pre-specified the of quit, or Chantix. believe smoking

to months importantly, that smoking compared the to likely indicating risk Chantix. at approximately quit X relative arm More X.XX, were the cytisinicline was received subjects have in subjects more X.Xx who

were we were per these less While for historical achieved versus we using improvements with towards than milligram meet trend in significance, the trial. Notably, the did the threshold not Chantix, X.X statistical superior of target encouraged enrollment for titration the the schedule. one-third downward efficacy dose cytisinicline efficacy with the

simplified As administered X discussed, arm Phase times the schedule, the dose Xb was trial. treatment is which a most higher milligram efficacious our daily three in ORCA-X using ORCA-X on

We when will RAUORA RAUORA continue the Also even more cessation we favorable for and that potentially observe in dosing than Subject result compared profile side to observed smokers from what and nausea, reported is effects, of smoking a was to the effects. patient majority cytisinicline and convenient their RAUORA. Chantix. dreams. and full what better of cytisinicline one rates effect are in insomnia the that to with abnormal optimistic be data simplified not Chantix and patients We course side from treatment reason side to research less in fewer due statistically significantly therapy with claims number complete including know experienced do is

data RAUORA, of from affinity binding potential also the Cambridge meeting believed cytisinicline, help X-HTX X,XXX-greater that to side receptor explain which in the to results. of the over increased and effects. clinical to efficacy. Chantix now cytisinicline were receptor, SRNT University In will Chantix that financial profile. and best nausea vomiting has X-HTX Research the the of differentiated experience side that smokers having support By activity very to role the to call elucidated has be third recent the cause effect discuss that of at we both in to on cytisinicline’s presented class the generated, Overall, with addition showed a fold development the been while continues comparison Chantix. the safety study of the data pleased Jerry are which is of rates possibility can turn I may to the quarter

Jerry Wan

exercise deducting closed of over-allotment of $X.X public exercise proceeds million. million $X.X for In deducting financing then in on at $X.X gross review full of our placement proceeds outstanding the and approximately provide recent net In cash public million Thanks, no $X we third share Both price. proceeds. in financings quarter our third these of have only. the John. closing underwriters’ The In commissions concluded approximately approximately common the provided approximately discount financing. quarter financials. I Year-to-date August, and the financings We after received would commissions saw million and we proceeds a proceeds. of closed equity agent offering operating warrant third provided net completed warrant we that exercises. we stock million first we of like position operating financing The $X.X transactions update $XX.X received million were In cash an totaling after the was expenses. to from closed two July, cash to option. million expenses. quarter, XXXX, XXXX, direct previous with in an registered We and $X.X underwritten gross

September of the restricted equivalents, XX, $XX.X cash million. As and were short-term cash, company’s investments XXXX, cash

XX, the that investments reflects offset in quarter our October. financings to during two the we initiated XXXX by trial Our completed balance be in ORCA-X it the September cash allowed

XX, September statement XX, for million $XX $X.X of company the decreased $XX.X $X.X for months the compared loss incurred million XXXX. to our XXXX September XXXX. Turning the as period loss million period for of same operations, net the for XXXX the Net X of quarter ended net to to compared a to ended million loss in same a in

trial. of our operating We with X the to expect expenses our initiation quarterly increase Phase

summary Our our over to randomized That the of turn quarter study. financial to like John. subjects into would concludes now are results. the call back I the third

John Bencich

Thank you, Jerry.

you busy and can exciting third we had an quarter. As see,

focus continued the Our of on will the program. X Phase be execution

continue the in ways explore partnering expand opportunities additional cytisinicline. we potential While parallel, to to for for and

funding to indication vaping As to users initiate address be non-dilutive discussed seek epidemic. future could addicted of in a e-cigarette nicotine trial believe the previous a and in calls, we this continue cytisinicline help to

perspective X The that hosting remind week Professor Time. hear of Rigotti, KOL to XX, at Finally, on event ORCA-X thought cessation, to will Harvard smoking Nancy our primary virtual will November roundtable I we and including firsthand like from fits event the Tuesday, cytisinicline, School p.m. cessation would Medical development everyone XX the a market. smoking feature be within opportunity their program leaders Eastern of in of This field in will at experts esteemed next an and closing, provide it how Dr. on Medicine excellent investigator. the

registration details of be prepared Additional found IR information our on That page the can the remarks. website. concludes Achieve and

now will open for the We line questions. Laura?

Operator

Higgins will sir. live. you, come line Michael the Go now Sir, [Operator ahead question from from line please. Thalmann. your of first Ladenburg is Instructions] Thank Your

Michael Higgins

you? are How guys. Hi operator. Thanks,

John Bencich

Good.

Michael Higgins

as Congrats taking going there, lot a heard for well. press I on in is on start comments with the there Couple questions. your release the mentioned in and Thanks underway ORCA-X. also COVID the you on

to a it essentially on making couple – questions COVID tougher how of it’s that guess it what’s Just makes obvious enroll. I

so how COVID. far? other amongst You that in On on Thanks. keenly far? How there behaving hand, motivation sites are seeing aware with this greater difficulty heightened more a likely balance be or is and the to the is the risk that preparation are motivated patients there are for greater seem they be so to patients was

Cindy Jacobs

The sites have actually have and trials the been sooner. designated and clinical even they and patients open enrolling through of Most actually essential have to start been running wanting businesses sites our year. been

motivated been So, very – some they this have on these actually get vaccine been COVID started. of They to trials. sites have

are the ramped activity get the from perspective, this just up rolling quickly. on site study So screen excited they finally believe and to really

is metering to everything that think should the on just and enrollment year. we So, there in site then I the ramping that used plan are subjects. as the a there far procedures problem sure to, after don’t I are we make processes say and all new that now up interest the right that as goes smoothly is

first as the a are year. for actually of metering So, us after we until company the enthusiasm that

Michael Higgins

Right. Yes, makes sense.

I two September, think like some that. secondary, with were adjustments, the again? thanks. quite and while hear have sounded some FDA Cindy, there you nicotine evaluations Okay, I clarify measurements. in you mentioned relapse Could some that what you the didn’t all are withdrawal those of It check I here,

Cindy Jacobs

Yes.

statistic we exploratory – was with final protocol they October everything add actually they Type did the came November, review and of protocol, only withdrawal B have really them that just an that for a meeting, and the the and in it. was review starting all analysis timeframe analyses to for us they in the letting know to that one and We We to FDA two back remind July fine. have week changes at them asked X so do protocol, assessment asked minor another a the send last you we planned to objective nicotine us on in

So two we and felt running and the them especially made been that assessments confident went. the and and changes safety the and efficacy those pretty minor vetted only we issues all primary had endpoints with and well the off we just

Michael Higgins

the doesn’t the there final it soon, design, I how here. that? COVID, in if kind adjustments the have one Thank [indiscernible] have through could CLL like sounds could to of a you meetings face-to-face be Thanks. confirmation, then have necessary for way like to for that. very any if is along need And there happens It the virtual we walk us confirmation sound a for

Cindy Jacobs

and at positive that to out Yes, we can have so really that if were case a medications ability do send so and them send also we as evaluations subject they to car own we can home worst the their these as have up in on could drive to their they monitors looking in scenario, actually that, have to study to – assessments CL COVID came the them. for actually home do it drug well be virtually

those virtual for So besides having looked at well we subjects. have as that, home delivery as

sure So, have we data. of make at looked don’t missing have aspects really trying all to we

to Now, and discuss data FDA – that, prior lock. for data, even to study do with have study final we missing with though you missing database plan plan a have also any if that we might have issues data we analysis

Michael Higgins

you. insights. Makes sense. the Appreciate Thank

Operator

you. Thank

will line from Street of Flaten the Lake come from Markets. Capital Your next Thomas question

please. is Your now ahead line live go

Thomas Flaten

Hey, Thanks for the questions. guys. taking

show there superiority. Just be she want presentation, on opportunity cut tools to the and models could different perhaps another an might done do to Is data know? RAUORA Walker’s was follow-up some or SRNT, that evaluate there ongoing was go whether that Dr. not during of you back that statistical to use mentioned and

John Bencich

are comments we aware based the not of there. of think that I Yes, presentation Thomas. Hey, kind on the during of status her

ultimate publication moment process. We what think data. at is the currently looking of that’s know are I for we the the in

published and are that ultimately manuscript. to coming a we is so out looking in data forward seeing And

Thomas Flaten

the enrolled the, is you I is be enrollment, do to think fair assume Great. we and that trying partway year, through question just when about assumption, just next of then have timing to to fully it follow-up kind second of on And fair should follow-up the quarter data? might the a

Cindy Jacobs

get hoping the Yes. end this quarter. we Actually, that we any were interference, could by the COVID enrolled first without of

there it two. enrollment, So, is in beginning be delay the then some of would quarter if

Thomas Flaten

any And finding you non-dilutive to final Okay. in program? on advance quick that one financing made then a one guys progress have ORCA-VX, just opportunity

John Bencich

we that. currently So, evaluating are

We for with that we well we an getting think match opportunity that funding have trial. identified up grant

that’s pursuing that deadline is next right for what are at of at And we so The the beginning moment. it the currently year.

go will are and for we the sense pulling that we currently so ahead and together And thesis and the it get makes documentation why submitted.

we So, will happily soon I as think that, on further have we updates provide. as

Thomas Flaten

questions. taking Thanks That’s for the great.

Operator

Thank you.

will come line the Jason of Group. question McCarthy Your next from from Maxim

line Your ahead please. Go is line. now

Joanne Lee

are and you Jason continued enrolling questions Joanne for Hi, your into know ORCA Lee on could X was updates my I call the taking later just the patients is if preliminary guys. if progress. Thanks this you time congratulations of study any at This But sort started wondering month. Phase for we guys the McCarthy. at provide and on forward to guys last this KOL I look any Thanks. month? there could data upcoming

John Bencich

far, of enrollment than be report Cindy’s else we to So, update in outside so have of anything don’t target. terms on on earlier, we continue other update to

second are end enrollment related everything quarter, been between some but our now think target. enrollment metering the quarter has year, and the again, up is but of are might COVID far delays to push target on there year. if the We I that end of first that And of complete by next into the the so

Joanne Lee

seems time first timing you. guys to on smoking? you really Could be people rising cessation to stop forward COVID to to don’t could was general a relation mentioned just you Thank because impacted how mitigate delays ‘XX? in just by and when smoking fast And enrollment quarter it that in completed by want Great. COVID, be you at able were

John Bencich

grab Cindy, you to that one? want

Cindy Jacobs

because especially hospitalized. symptoms, worse sword, a smokers who they Sure. have individuals actually are if Well, can actually, it’s double-edged are

In KOL to are fact, this into be the far we detail event at next in going going Tuesday. more

if perfect more timing that are KOL So, this experts, that event from next interested plug the in of week. it is hearing a tune into you to and that

Joanne Lee

you much. Alright. Okay, got it. so Thank

John Bencich

Thanks, Joanne.

Operator

you. Thank

from will John Vandermosten question line SCR. next Your from Zacks come of the

Your line is now Go please. live. ahead

John Vandermosten

everyone of promotion enrollment are afternoon, call, Cindy questions of build to of Wanted ready sites year? do ORCA-X, Good open rest your of to as XX the have and the now a and only Jerry. initial on few opening off to beginning the all the John the some for and we welcome them the on or enroll congratulations, with

Cindy Jacobs

them time. of and all streaming No, open are at this

John Vandermosten

Okay, from to results the we great. And showing to then superiority. want great also that quite recognize are RAUORA the trial close

that goes I think put presentation financing? it of really out. point out that that the you at a the to protocol attention the bit will has structured? talk for positive didn’t Can and looks was it that view. wanted live Zacks trial. big get in I you I also that like how that been able enough obtain from to thought was are that a look about assuming be When previous vaping

Cindy Jacobs

general about design? you this talking Are study

John Vandermosten

Yes, exactly, trial. for the vaping

Cindy Jacobs

subjects smoking XX will and smokers are are they a is cigarettes, XX vaping. so who XXX XXX, two so weeks. one a the have be not study vaping and the been, these Yes, cytisinicline for placebo who only, will it receiving to prior are vaping with XXX most receiving randomization, subjects frankly, Of of

will weeks not getting and placebo cessation XXX comparing have cytisinicline, weeks be pilot This be arms, reduction endpoint, what go not and is but risk going study. vaping the very XX at looking relapse X the XX actually much of with is ORCA-X to you of XX really XX-week So, and three because vaping I treatment, measuring getting as more a a weeks to are similar doing, XX we the weeks of everyone will in study. comparing will, for we will and to but with it’s

John Vandermosten

be the used kind think to it X, or that conjunction used of Phase approved approval as could my get gets that with could in for Maybe is a Yes. next which trial possibly additional that question, ORCA-X a to to get perhaps way so an that be, I if to Okay. be that going well? it’s

Cindy Jacobs

X subjects, indication. XXX as discussing Well, obviously, one FDA is there an them but significance, it’s a can additional bet that vaping be if indication, for we statistical as follow-on Phase would you that for supportive having with only trial

John Vandermosten

guys. Okay, great. for me. that’s you, Thank Well, all

John Bencich

Thanks, John.

Operator

Alliance Thank Your the [Operator from you. Instructions] come will line Global. question Jim next of from Molloy

is ahead Your Go now line please. live.

Jim Molloy

I questions. Hey, really trial? the am question on both your A it’s quickly two successful on or for a X.XX for both guys. taking the quick value trial, for them is the then endpoints hit? the Thanks either p saying cytisinicline, think know which beautiful, will all And I on one, to had to do it’s given follow-up be that of the of you one likely if maybe the the you more kids mechanism pick action of are

Cindy Jacobs

yes, are both beautiful. Well, we right. them That’s do think of

it’s you at the value when So, look two p a sided. X.XX,

to have one value. you So iTop p sided understand

placebo, X.XXX So at meet, obviously being successful be study cytisinicline for than less. endpoints or the If both the p is statistically value both better X.XXX endpoints. has less, or to of those

better. the weeks Now, if than level X.XXXX be significance is make you one does XX weeks value the I then you might if that treatment be of that, X endpoint more you that lower not a have at significant. think chance look does have less to would p of endpoint guess other to have

of of risk are individuals significant, those XX-week or to betting, would X to weeks smokers going be that So, take the take significant. might of weeks go stop choose can treatment is that smoking want relapse from for X we be be actually more to are longer betting XX the their might will factory take that we them of to the Those treatment. who weeks, reduction are one give both but only it bet, significant might that and if our some them flexibility

Jim Molloy

think the of that in of Well, in follow-on the which or cytisinicline, strength that, placed part shorter the maybe you the the trial, Cindy, answer. And a therapy for side thanks lower of duration effects?

Cindy Jacobs

are to if withdrawal. going smoking top the you on are helpful, have to of to no one side be certainly, side nicotine trying really the lower likes effects very quit Well, effects because

a that I success. stop smoking that if So, is X weeks think you

Jim Molloy

luck Best of taking for thank the and you questions.

John Bencich

Jim. Thanks,

Operator

We question Michael Mr. Higgins. you. a have follow-up Thank coming from do

Your is please. line now ahead live. Go

Michael Higgins

Thanks.

from Just permissions course. am you to this required week? see a week, should is have happy that’s – But I RAUORA, be studies next from a very get great is there, particular are some obviously, get a as bit for was the we you got insights the Anything back event will with again next the guys coming you depth coming [indiscernible] the us next year. designs week. go I list understand are information happening, anything of moderating. what to new to and more certain of there, event new will most anything really ask versus spectacular some different we from the in KOLs a we ahead there and look Thanks. cytisinicline, in of obviously, but here follow-up

John Bencich

Phase mitigating helpful. the of and think X analysis deeper That’s we are around into of trial in I new mechanics further well in Great. the Yes, that on terms the effects doing to as dive related pieces the of place some the the from a information, planning pandemic. of endpoints of as I think

when terms option I leaders smoking information know about on cessation of the the last great is are out data or a not what some got noted you we is to there. think positive time get space to of of as this talk these of really terms space. the space group in landscape we in we together think on opinion is field I again, anything key in and information, But more going of RAUORA planning we needed a books helpful September new coming their got got why I in just I of have terms reviews experts in And get always before, this think think is in elucidating lot new of letting the in this I a why prior out and treatment important.

in chance that. think it should gets event. So, I everyone tune to in Hope a for real all be all, that great a

Michael Higgins

That’s And I some e-vaping on great. discussion opportunity further assume. likely the

John Bencich

Yes, indeed.

Michael Higgins

Great. Look Thanks it. forward guys. to

Operator

any questions I John Thank would to for back you. Bencich time. showing at further And am conference I the no turn like remarks. into Mr. this closing

John Bencich

Great, our Thank us for the joining to you forward next future. updates call I on providing again. thank Roundtable. everyone in progress for KOL again we tune Thanks chance will to a in many additional of hope the you. get Tuesday We as you look near today.

Operator

joining Thank This you, much again, concludes for participating. so everyone Thank for and conference. thank us you sir. today’s you

You may lovely now disconnect. safe Stay day. a and have

Jaime Xinos	Executive Vice President, Commercial
John Bencich	Chief Executive Officer
Cindy Jacobs	President and Chief Medical Officer
Jerry Wan	Principal Accounting Officer
Rick Stewart	Executive Chairman of the Board of Directors
Anthony Clarke	Chief Scientific Officer
Michael Higgins	Ladenburg Thalmann
Thomas Flaten	Lake Street Capital Markets
Jason McCarthy	Maxim Group
John Vandermosten	Zacks SCR
Jim Molloy	Alliance Global

Achieve Life Sciences (ACHV) 13 Nov 202020 Q3 Earnings call transcript