ACHV - Earnings call transcript Q2 2020 | Achieve Life Sciences, Inc.

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Achieve Life Sciences Second Quarter 2020 Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] I would know like to hand the conference over your first speaker for today, Ms. President at Vice Executive Xinos, of Achieve. Commercial Jaime you. Thank Please go ahead.

Jaime Xinos

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

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

Richard Stewart

we you, review will the today's second On Thank highlights. Jamie. call, quarter

Firstly, Walker. the X data led Phase line trial, by the RAUORA Zealand from New exciting top Dr. Natalie clinical

ORCA-X will of momentum Bencich will Secondly, the plus the year. New trial. facilitating John thirdly, Cindy RAUORA ORCA-X Zealand. balance of from people And of end start we cytisinicline the to our U.S. announced comparing trial, the our the investigator-led Phase June, later the financial in Maori of the X Phase Jacobs the successful indigenous review results, trial Dr. or sheet, of the this initiating review strengthening results line non-inferiority top At the X Chantix in continuing

compared cost total, randomized of trial cytisinicline to the smoking subjects. conducting the landmark RAUORA this Natalie of evaluated or In Dr. for XXX aid. the Walker and trial. safety, to the study University Chantix, congratulations Auckland of cessation Our efficacy, The effectiveness

to safety. trial, at non-inferiority whether good and as As it was designed Chantix a efficacy for cytisinicline was least as demonstrate

dosing titration, Chantix, showed is dosing XX superior on titration, had In downward compared Chantix, schedule an days that a modified over that administered profile. total of at similar to safety dosing for for of daily schedule twice was weeks. which comparison least administered achieved cytisinicline as continuous twice dosing upward a abstinence biochemically a The on a weeks support of for and seven total of months. XX it a efficacy against behavioral behavioral followed at support of RAUORA by fact, confirmed, months. cytisinicline cytisinicline, XX expanded endpoint the at primary followed The trial effective was was showing rates days cytisinicline of endpoint, six primary that as Chantix plus successfully plus six daily by

Chantix, cytisinicline trial, study compared first results reported the RAUORA is in while tolerability. addition, The a as trial excited the that smokers to Phase is positive events fewer which this that improved resulted quit. adverse help provides significantly outcome strengthens when further evidence direct at head-to-head about additional the line as offering and showed In to cytisinicline least that X Chantix. between of Chantix, top potential effective cytisinicline the We're cytisinicline comparative for

was the Importantly, dose and schedule. modified Chantix downward match The the to marketed the schedule. milligram benefits using duration cytisinicline weeks of achieved to titration only dosing were these order XX in currently X.X dosing

results when European in Society to results that Our on this three look September. RAUORA X/B Nicotine sharing for will three-milligram smoking upcoming trial. investigator, trial simplified schedule. dosing dose, trial times a combination RAUORA subjects than daily cessation Annual be trials been X dose three-milligram to We Phase and a this will on result For presentation on at be better Based we're The optimistic U.S. use by details easier Meeting, trial, with Matthew final the observed cytisinicline in presented. results the rates Dr. potentially Tobacco additional higher submitted for Phase the have dosing primary the Walker, the and forward the clinical was what RAUORA simplified the in at of held schedule, ORCA-X RAUORA Research

Turning trial include to of risk any double X in the upcoming quarter. COVID-XX ORCA-X the commencement the underway blind for preparations careful These fourth management the assessments are placebo-controlled potential trial. Phase Preparations impact pandemic. for

be Our risk with remains and this our trial fourth clinical sites one that providers, employees indicates participants, continuous and safety our dialogue and The initiation healthcare the quarter trial ORCA-X trial priority. of continue health our CRO of the will of assessment year still in to number feasible.

Cindy ORCA-X regulatory turn updates. to to to crisis monitor and and risk real in call review involved. taking the continue precautions the design now the trial time, advice We all I'll to over minimize the to provide

Cindy Jacobs

Rick. ORCA-X learned, were successful requested specific the design, into builds integrated lessons ORCA-X FDA. trial. along our on trial which Valuable safety with The requirements trial Thanks, experience been by the have from

evaluation. the the subjects a the We subjects consulted cytisinicline in have for wisdom be three the following to quit after will These leaders, not, days, preparations self-reporting either XX fourth a multi-center, is weeks, to seven abstinence weeks the period, receiving begin All assessments their end least week will Arm placebo-controlled or XX randomized, followed behavioral will a two ORCA-X Participants Phase times of their benefits endpoint with latter treatment placebo are first will independent their support our during and cytisinicline, daily adults, arm, abstinence abstinence assigned to weekly finalizing the weekly XXX randomized, placebo will then start entire and double five will abstinence equal probability have us with The willing finally, placebo be day levels. treatment, ORCA-X, three the receive cytisinicline. has treatment. biochemical each and weeks frequently XX evaluated. intending smoking to key Starting the in to within of XX arm will XX. occur the randomize rate XX, treatment of commence opinion and weeks will abstinence cytisinicline follow-up by assessments or periods evaluate XXX Arm at occur and Similar out with of B study compared to randomly day one of switched and the six quarter. after of or smoking who then blind, treatment the of week given least a will cigarettes arms. by The then of treatment, to receive verification monthly the endpoints be six weeks X being monthly be end for to receive at that receive now of of trials quit by of XX and both XX-week weeks study assessments monoxide have smoking will study treatment. the within date for XX for primary XX, six study date, the will week set are seven smokers, that blinded weeks. quit at for carbon C set exhaled ORA-X two smoker primary A study placebo drug outcomes of six-month smoking, will and of through There weeks week days treatment who quit treatments, XXX each date are to will starting treatments. we of at

six-week continuous biochemical during zero be smoking cigarettes and have defined assessments. For treatment last three, treatment. successful will weekly as CO four weeks verification both the smoked and four, must primary abstinence six period, abstinence with point for of That weeks at comparisons, quitters the five, means

cigarettes XX-week assessments. XX quitters XX have the CO at zero and must weeks successful For XX, biochemical period, treatment smoked with verification weekly nine,

from versus have weeks receiving ORCA-X these secondary smoking site over a An sites power. is abstinence protection this endpoint for in continued The XX weeks This compared to cytisinicline outcomes within placebo will size treatment enroll secondary look end place. subjects to assumes week cytisinicline COVID-XX in as of procedures the cytisinicline separately timeframes. across cytisinicline weeks six The for from in difference approximately to outcome XX, evaluate sample and will the for additional week treatment treatment will XX six with endpoint weeks XX, XX% specified study subjects benefit clinical relapse end XX will arm. Each risk specific from of of same for placebo, reduction U.S. XX of weeks. the XX% and to for operating at per XXX a six

Phase to in support and submissions initiate the X the program. data cytisinicline non-clinical all needs data, per missing for cannot site becomes We if restricted preparing with required perspective, for weeks Phase be regulatory interactions of to subject all guidelines, required six and to infected included a our potential quarantine, be remote the procedures and site This has FDA if XX submitting to a evaluated. a update are FDA monitoring treatment trial. and now we have X or COVID-XX completed From non-clinical with testing

In final ORCA-X addition, X trial. we have submitted for the protocol the Phase

protocols reviewed November protocol. in with FDA FDA and last the statistical that X meeting of have into meeting and discussed the B from incorporated As that XXXX, final we fall, a plans the input Type Phase in

with fourth We the quarter. X proceeding operational planning final the are logistics Phase in now and initiate to the

endpoint possible in with potentially of to duration, ease weeks of while trial. three of three-milligram quarter only treatment summary, quit weeks daily, significant us the treatment, and and results. durable This the of measure X use, treatment dose The treatment. primary increase intend times allow the still for ORCA-X this are extension the has will XX the and cytisinicline in six abstinence, trial we treatment yield factors, continuous in So of this XX higher cytisinicline efficacy three regardless Phase will the simplification dosing to and both a of year, rates trial of receiving six weeks to wasn't the to of given initiate of It in dosing the extension schedule ORCA-X period duration XX-day leading of the evaluation of fourth the more of benefits. and address four subjects key period the

turn typically efficacy the rates. are our quarter and in results quit the on documented to discuss activities in As financing I remained John literature, now higher second over treatment results. and recent while will to measuring call subjects

John Bencich

provide update then million review end The financings public common $X.X announced discount at price. the registered week, Post priced at stepped pricing our financing position, previous deducting This after of previous. expenses. an a Thanks, approximately approximately two underwritten up million of financials. commissions the these and financings, to of commissions with placement the of totaling direct we to that approximately second financing like included financing. I'd closing first overallotment the cash we Cindy. will were were was only operating the $X.X provided our have that recent the expenses. $X announced from and This an million only offering transactions estimated second valuations completed in and of we month, deducting on The and share quarter no announced exercise $XX.X Last of quarter, gross stock and stock a cash offering proceeds. after the option, equity gross full common offering of underwriters of million. net net closing public million proceeds provide agent was also $X.X the proceeds Both

of strong quarter, in the addition, also X that second additional ORCA-X end cytisinicline second help we have the the an with million half set second warrants In on a Phase development we to additional sheet the maintain initiate quarter. exercises received outstanding $X.X proceeds. exercised the warrant in the going total, trial. balance year, to we as have of In provided $X.X subsequent proceeds cash for since into the seen have of approximately us start momentum million will capital The up and

cash, As July starting the approximately exercises, of cash and August third million. forma equivalents, warrant and million short-term cash the pro as with Company's XXXX, financings, we'll quarter XXXX including $XX.X basis, of of cash as investments, a were be XX, the on restricted hand. June On $XX.X well

ended million our for operations, Turning loss loss million, ended June quarter XXXX. six XX, the XX, XX, to for XXXX of $X.X incurred months of to compared as million compared Net ended to $X.X for the six loss Company June of million quarter a for June June XX, $X.X the XXXX. to $X.X decreased months net a XXXX, net statement the the ended

quarter quarterly over we Rick. to I in second expect now the concludes Phase expenses our results. call initiating of to the financial That operating lower turn As our back like advance summary the X to would noted trial. previously, remain of

Richard Stewart

John. Thank you,

line smoking potential highlighted a the the results in and market quarter true second of top with of Phase the The current as leader, future result the release with RAUORA leader comparing Chantix. - trial, X cytisinicline a successful cytisinicline cessation market, from the

leader, took direct Phase just XXXX indicate We're a for and subject, X the the opportunity head-to-head sheet. Additionally, further $X.X first efficacy that the comparison is its to compared to Chantix, landmark because the for shy The to best-in-class make course, safety cessation. which capital this we the reported continues during trial quarter progress, and RAUORA XXX- to with billion. our of Chantix, for balance trial. placebo-controlled cytisinicline of results reinforce continue market are clinical commencement strongly the to we excellent of And potential additional to smoking preparing current of ORCA-X, potential cytisinicline pleased profile a showed sales, cytisinicline global compete data add

non-clinical trial optimistic are upcoming to for ORCA-X we Phase commence prepared has progress, required XXXX, COVID-XX X now been the the well the with leading the trial the by permitting. Phase FDA of met. Phase review. in X We quarter fourth requirements remain FDA the and trial submitted data in commence of Preparations to aid The will start first start KOLs with field, for Phase X, FDA the the that of fully X

never COVID-XX COVID-XX and two the Finally, on to will Advice such cardiovascular, smokers stronger CDC has quit a impact more the now. WHO, briefly from specifically in smoking COVID-XX, or key play the smoking. I'd smoking-related to and about pulmonary, of are we of like believe the have key and other amplified been vital agencies, aiding regulatory the as quit There diseases, such to smokers. individuals future. smokers, for conditions, why quitting pre-existing with discuss impact in has role cytisinicline to implications The urgency as in

of do smoking to the a the and quit smokers cigarette role open again we susceptibility of the you us Please on health in secondly, products. result a to impact prepared for today. severe of on more it disease, and that for for joining our more never can social line of now we There so. lead is will changing smoking symptoms. rise, and good, to to the been for helping believed COVID-XX banning has lung cytisinicline vape incredibly virus critical vaping-related more and believe lung time and line. rates as them important dynamics, damaging, the appears questions. an play concludes are Firstly, That open reports Thank flavored And remarks, the

Operator

First question Instructions] of of is Michael the [Operator from line Higgins Ladenburg Thalmann.

open. Your line is

Michael Higgins

this as We along the that's of taking questions. the about here, we the year. ourselves guys. Question expecting Congratulations progress. learn look for conference? specific despite should be format you SRHE going planned confidence the SRHEE, we to online and webinar this? we How Q&A to year. Hi, be to on Thanks Thanks. challenges How given for for plan results these the look results, continued provided online to portion? seem should as to prior Are or KOLs a ahead the for for being posted

Richard Stewart

Cindy. I'll have that to over one

Cindy Jacobs

Well, we know the virtual. SRNT-E meeting will be

her narrating in that will So that for Natalie we be presentation. expect slides detail

that could interesting what period, afterwards. that I within with results. ORCA-X would it's something then And because we be asked discussed do have whether time month have afterwards would to we think you very did question similar webinar that a the we we that

Michael Higgins

I see.

day, So SRNT-E the kind of analyst an post presentation?

Cindy Jacobs

this work some in to yes, as might that have to sadly New a about more when have of We'd in you're we've Obviously, be Natalie's looking doing bit well. with Yes. night. it's of how But middle problematic at little Zealand. the the us talked schedule the

Michael Higgins

during ourselves. hoping we're right, All for well, for obviously, the day

Cindy Jacobs

East the definitely. Yes, Coast

the Coast of the be that West is. night, will think guess my I people in middle

Michael Higgins

all as EVFA [ph] hear that's can your Didn't that lot you us following Understood. something Thanks. to relate your we're progress remarks, in I for Any on study well. but a on obviously, prepared feel pain. the that us?

Operator

next Vandermosten the Instructions] of from is Zacks. line question [Operator Your of John

line Your open. is

John Vandermosten

both the million million much ORCA-X, And need can afternoon, questions. there. correctly. for Good a $XX raise. trials, remembering correctly, you'll to the given give I for congratulations then sense of $XX see status things? But about balance million more remember that my guys. how thanks taking finish another you you it think for Great also, the capital just on have me off cash your second, $XX if side the I And of And that capital the to allocated on I I'm if and was of current almost if

Richard Stewart

to do want John, one? you do that

John Bencich

execute requirements. great correct. for balance your John. a the is a on to trial. Phase X Absolutely. having we the approximately puts to sheet million Yes. capital $XX same the the call, that Thanks question, And the position memory be which X in on second close will The yes, Phase on approximately I trial And is think is million study, as $XX described

John Vandermosten

Okay, great.

close to off. this finish That's great pretty you're you So, to need what having news.

so see a generic update Chantix. on just competitor - when an Let's for we might

I providing that a generic how was just think Chantix patent is have we much might and or of for Chantix last competitor terms on out? time, the think What in there little coming I uncertainty this the on view latest a discussed was protection them.

Richard Stewart

we're expiry Yes, around that of moment June I'll looks the the XXXX. at May, What looking one. about patent of really it's like important take more is the

So extension. we're - from not pediatric be protection there's a actually plus additional to going

of competition, anticipating early generic So we're seeing part some probably XXXX.

John Vandermosten

any That's lot that. bit different little got smoking behavior. this, then a about just changes that picked Coronavirus great. of has has Thanks has have changed started? mentioned Rick, mean, people That's the in it. observations Okay, mean, I a as of great. there for been I how habits. you And up

how present? and know been have I actual a any since been trend this But alcohol. data seen health there's changed drinking I on might out smoking. have more But year people March as that there to big smoking think of you well. about have don't know I trends for

Richard Stewart

we've of always have some from think around to smoking. issues a some towards into cigarette vaping, back move improvement and reduction, we've in all shift cigarette But smoking. the vaping the reduction I or is concerns risk of quit that XX% cigarette really maintained back experienced, terms around the lung people about of it's harm that seen We've versus with lockdown plus smoking. vaping associated people who with attempting Well, were pressures disease

in right perhaps which are who So mean, smoking. it's other that moving were supporting the cigarette out those the seem reformed of back be million that idea now smokers, there it's there, XX I half to data vapors least But more area. at towards there is now. youth. more Roughly are yes, half is who

John Vandermosten

Okay, interesting. area? you shifts guys vaping And the there? closer the progress And to working there. on Interesting for last that any Any study the question in study that on. on grant getting money that were

Richard Stewart

Yes, competitive is vaping frankly, we the that concerned. funding will as to alternative a mean, process. continue NIH the far I a and study sources. didn't And substantial as believe seeking add make it's highly we cuts But we're value,

interested significantly an it's that we're So in. area

KOLs pursuing clinical our X are capital interested Phase Our trials. in But the on is that. focused

So sources for we're at vaping looking funding study. alternative that of grant

John Vandermosten

in Okay, great. queue. Thank I'll get back you.

Operator

no the time, Rick Stewart, Mr. this I CEO At would back Achieve. conference am to to further I of like questions. showing turn

Richard Stewart

Well, Achieve. talking again joining to for you. interest to our quarter with again thank supporting you results. your Thank look the in forward call third and we And you continuing

Operator

for today's participating. you concludes this conference. gentlemen, and all Ladies Thank

You may now disconnect.

Achieve Life Sciences (ACHV) 9 Aug 202020 Q2 Earnings call transcript