SNSS - Earnings call transcript Q4 2017 | Viracta Therapeutics, Inc.

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Operator

Welcome to Sunesis Pharmaceuticals Fourth Quarter and Year-End 2017 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to Willie Quinn, Chief Financial Officer and Senior Vice President, Corporate Development. ahead. go Please

Willie Quinn

Regulatory you Dayton Thank Chief or expand brief vecabrutinib description financial quarter year-end us. me President With Officer; and Judy of corporate review Thank BTK Interim for will Chief asset, are of results non-covalent Vice close Senior Misfeldt, XXXX Debbie Fox, Dayton Executive today will and recent development the you. fourth Thomas, joining Affairs. upon events, I Officer; Scientific updates. and lead will company's the inhibitor, SNS-XXX; a corporate with and Judy

will questions. We then open for the call

which Before you statements in are important factors call, that and conference press today, to let results events. or we in today's filings cause forward-looking company's qualified we by turn of release the as future begin, such with statements expectations over intentions, me do that, the that during update. today's the forward-looking let call forth statements. represent making set me company's With differ those call beliefs Information forward-looking remind could will the discussed be concerning on not intend today's and These materially accurate from to Dayton. SEC, actual we is to

Dayton Misfeldt

you thank joining Willie. afternoon Good Thanks, and us. for

event Willie vecabrutinib. was we of the patients new year will initial the Xb/X for for be other that will hope and executive us at a first to As Last data. excited study for CLL our kinase Corporate results detailed ASH, provide at position. cohort Development Last of his study expertise leader from or an we covalent broad and to a motivated of This we strengthen XXXX milligram patients you treatment we and experience to forward with have in dosed clinical and our know pharmacodynamic CFO brings joined as analyst last inhibitors. the team other as December, this patient serve a proof-of-concept who development in is July early early designed develop option BTK we're XX to Willie base Phase November, Head presented of our ibrutinib relapsed resistance an and investor the malignancies. enthusiastic as move with B-cell inhibitor portfolio. invaluable development encouraging with in progress

Looking a has to forward, continue year clinical Sunesis, focus development we XXXX to of on the the potential be transformational vecabrutinib. as for

allow We the pharmacodynamics Phase and This recommended investigate the levels dose are to the as activity safety of trial, study milestone clinical enroll range pharmacokinetics, dose need. a dose. signals continuing evaluating maximum early cohorts determine important by Xb Xb and to from portion will tolerated patient Phase consideration the that by the of of unmet as us defined anti-tumor well to escalation then over any

and progressed had standard anticipate as disease, today dose our are safety for the we lines patient before those therefore midyear; updating X Phase three progress than sick We evaluation, to the cycle, of XX first X studies rather we timing dose non-evaluable prior making cycle escalation by escalation the patient who the design, recommended aggressive first one of In whose XX or with dose very reaching treatment the completing must target with population, two rapidly. next safety. day B-cell failed treatment patients patients desperately at cohort, can our milligram in have the year malignancies therapy for who for of need least fall to steady this complete X level. patient disease In

adverse doses toxicity. event, receive dose by to required an the patient due of We had limiting protocol, one have not also is who which did number a

has cohort completed context evaluable a at six our provide treat and result, where of quarter, level Ibrutinib remain are growing a number B-cell must promise highlight better to of approximately taking to data meaningful we potential more its we second who resistance time, excited will patient AbbVie the to the address Vecabrutinib of XX% our use as patients this and but patients relevant, it current XXXX most We in on we patients. continues reported sales in at do malignancies detail ibrutinib. actions is XX Based milligram the globally Judy to we a Ibrutinib cohort meeting we now in increase, when for We line timeline are to expand rapidly. robust update. Johnson, are commonly and in update sharing were in As we believe medical as a opting of not program. treatment believe growing a and study, an & are second for about more goals X.X the dataset. Johnson option. broadly be presentation COL, reach the will formal line become to our we billion more representing the first number to used develop have to by this

submitting vivo inhibitor. as program. announced extends non-GLP nomination of favorable plan PDKX to the pharmacology of beyond PDKX the studies November on to in our on SNS-XXX inhibitor Last first potentially results IND We to clinic SNS-XXX ibrutinib in candidate, [ph], The make addition toxicology a a proprietary vitro and we we progress Our representing compelling as from continue pipeline SNS-XXX data. PDKX in development an XXXX. on inhibitor nomination for selective in based is

for scientific third TAK-XXX, TAK-XXX Low-Grade partnered Takeda sponsored is Our believe rationale investigator inhibitor Recently Glioma initiated inhibitor. Pediatric the evaluating our compelling. is development was we an kinase pan-RAF which in in trial

progress this information on trial have program We this later forward year. seeing we more this to and expect are looking to

by is supported balance sheet. pipeline Our a strong

detailed milestones updates update more X a dose call We Vecabrutinib are to Officer XXXX. including over Fox, Scientific to our the now will several in on reaching program. turn I funded key through recommended a Phase fall and vecabrutinib Judy Chief give of anticipated the

Judy Fox

by B-cell the transformation an to the who to to the bind develop ability with who vecabrutinib with required not to ibrutinib. in intend to trial, BTK those the the of including CLL covalent Xb. option Other in does for inhibitor, generation resistance address these represents following a the most overcome of Similar activity safety with and BTK, new generation those next Vanadocrox Phase the Vecabrutinib likely cancer, TKI, CLL to cohorts is has cysteine dose hematologic Dan. for with BTK see inhibitors. acquired covalent associated and you other Thank distinct inhibitor. with important of mutation. ibrutinib for treatment patients potential and which treatment, interaction to the intolerant domain expansion resistance identified include we resistance development first recommended path population, B-cell covalent strategy malignancies, patients BTK the the acquired Richter's kinase often ongoing We relapsed/progressed CXXXS [ph] study the potential in is Vecabrutinib other

relapsed investigated focus are also Although in and factory patients monotherapy for [ph] therapies the investigation combination our the CLL in drug front planning essentially is of may vecabrutinib initial line other use be we and with setting.

Xb a on rapidly the centers recruitment. We optimize focused in are leading as through order Phase number study highly progress In execution have possible, several as currently running at implemented U.S. we trial, measures this to of the to of

sites we broaden large additional Phase Entity, a Swedish of and inclusion recently to adding are additional bringing oncology the other We the lymphoma as was criteria clinical protocol in Xb. online. process center to Cancer recruitment a indications in open amendment including selective Seattle the sites, view implemented are and lymphoma the We B-Cell for to

is to prepare X also expansion engaging Phase ceased for identified. is that recruitment for recommended the dose sites are the We patient accelerated the once

have bolstered team We we'll and program support in continue to development. this to invest our appropriately regard Vecabrutinib's

the cohort into to will potentially us which very Our with and milligram to higher remain to supportive working dose XX look therapeutic investigators forward move we level. allow them complete

safety XXX and mg we see As activity the anticipate reaching fall. the XXX levels in in stated previously, recommended our to to expect dose dose

As use resistance relapse patients and worldwide. The of to of continues Inhibitors also growing. of active incidence is of mechanisms area long the remains of increase, relapsed term population BTK investigation

Xb/X to the effects virtue role ITK effort order ibrutinib other as T-Cell We are resistance potential by in better on in these of and of data update these to RSK characterize PKC, like ibrutinib target indications a cell an we including important PDKX growth be potential active Phase as investigators mention to to program We well with needs make is inhibition. position Xb/X plan some the collaborations in and members that groups. XXXX progress continue we research year. considerable in leading malignancies study we Phase beneficial and on important and activates a findings SGK PDKX functions study kinases as our putting our quickly survival, also at and the in of upcoming to look into robust B-cell the later Both SNS-XXX. will and year. of by in year meetings patients families. present cooperative are the throughout to with forward master AKT, kinase and that I'd more unmet providing to for

IND Willie pre-clinical an call We XXXX. CFO, financial I are support With the planning turn plan our over filing in and to that, [ph] studies review results. will Quinn, to to

Willie Quinn

$X.X of announced net million cash in brief this by We $XX.X and a primarily partially of from net ended end December from financial million $XX.X proceeds An the XXXX. an at $X.X in to proceeds shares of us XXXX. our in to operations was securities million million through activities. the Thank raised The common $XX.X months well additional of reduce was development to with $XX.X update million equity into expected now and XXXX $XX.X highlights for used on payment This for in corporate and decrease respectively. million an $XX.X $XX.X market debt, vecabrutinib and will year-ended to Judy. a sales I afternoon offering activities of through operating capital due the marketable at October the primarily net recap the is key principal million and cash underwritten our as million development XX, in milestones fund three you, through facility. compared give year Loss as XXXX. offset million were

development vosaroxin corporate strategic Last AML for the marketing difficult a front, it company the as withdraw are the European asset. not opportunities application in approved. made exploring the out-licensing decision clear authorization be treatment our would On for May drug became vosaroxin after the we to

focus its led increased the Following our company vecabrutinib. on this kinase by decision, portfolio

investigators and a studies to However treatment this cost can to group an vosaroxin patients. way to we bring believe continue option effective patients cooperative are help exploring investigator-led as that

we Dayton. over We development the to on back continued call turn Internally are a complete seeking ibrutinib. will to this year. focused I remain to With a that, partner transaction fund and plan

Dayton Misfeldt

Willy. Thanks

malignancies. B-cell we heard, potential which with vecabrutinib profile new has you've a an are options presents program believe unique exciting we As on drug for clearly treatment our focused and patients

our continued recruiting team. are end, a vecabrutinib fresh we With to Sunesis, the new also are that to currently organization is our We well. To current for progressing study are of executing existing additions to with we new complement urgency. The a CEO. search injecting sense high-performing energy our

this find in are let's With We Joey? our lead to for taking exciting candidate the company to next a call questions. stage. time the high-quality open that,

Operator

Certainly. Schmidt [Operator of from from Company. Cowen & first Eric line Your Instructions] question comes the

Your line is open.

Eric Schmidt

Maybe that that taking missed Thanks serious you whether event Ibrutinib cohort. I event to a was questions. noted my adverse what for the can and that was drug? potentially update or The you adverse and describe guess related for was XX-milligram was event I

Dayton Misfeldt

are X Yeah, of providing thanks to that study a at receive information remind who required this Phase Dayton. factors. which is number specifically doses DLT. too adverse specific protocol DLT sick first just with the The early a very was of comment profile the I'll an No, event, off, event, a adverse patients number drug. on The time. contributing safety a the was on patient just of this It's not this did not we're folks, where these by Eric, due was to

and we're the expanding learn into we'll as a later sharing about So patients, we're at be more going more date. profile that

Eric Schmidt

do patient or that you noted harbored progressor, the mutation know the the was XXS if not? Okay. patient you've rapid that And

Dayton Misfeldt

Judy. I'll Yeah, to pass it

Judy Fox

for the treatment the now. evaluable sample not end was because that patient we of that this mutation analyzing had. We're of believe I sample

Eric Schmidt

getting Okay. need go complete data tell I what you your the at of think mean you XX-milligram dose. Judy dosing? the And about you maybe kinase I higher. you're not to does coverage that PK/PD assume

am not some or problem, for you're So able go to --? a that's higher, I extrapolating reason

Judy Fox

Yeah.

have don't predictions of based in are our on the We in Xa Phase study So volunteers. XX-milligram cohort full healthy analyzed.

the to prepared a I'm at Based chance We'll to data on that update the analyze in cohort multiple comment have complete with and we had And so all what we the Xa. in of what pharmacodynamics we our have hand above not saw did ourselves. moment. over in it dosing saw cohort, on more the Phase XX-milligram some terms first activity predictions. we and with And note was when increased consistent

Eric Schmidt

that expanding the And would am a trial slower have I right And that's enrollment's in little hoped. you to are think this than bit enrollment been why criteria? you

Judy Fox

indications I other rapidly X think that progress will the to recommend Phase to dose. allow adding us the

that. the I behind motivation think that was

I also somewhat opportunistic. sites We've to preparing into the think enrollment X cohorts. for adding been of patient specific additional order is in rapidly Phase progress

And the see sites Xb. able the which be so at to might we've opportunity to to contribute we the took to look sites vetted that Phase

of pursue taking so And that option. to advantage activity we're that

Eric Schmidt

Thanks for answering the questions.

Dayton Misfeldt

Thanks.

Operator

Jim from of Wells Your the Fargo. next comes question Birchenough from line

line open. Your is

Nick Abbott

good afternoon. Nick in Hi It's Jim this afternoon. for

changed enrollment the of of disease patient? fast terms in terms in you Eric, Phase to criteria the the from just than avoid other really trying progressing have up following of any just patient Xb/X, So into perhaps

Judy Fox

patients criteria. the criteria, the the So have to meet still inclusion/exclusion

someone Sometimes do Phase rapidly These to happen sick patients. X. are difficult it's in predict progress. might who These things

And patients the should who in safety so and through or be we evaluation this go able But identify the happen for basically the does Phase patients patients, our cycle perspectively required X. best to period first investigators hard determining that's to our of evaluating work for provide to DLT. do

Nick Abbott

So retrospect, enrolled. it? should but that think I have could you you mean just that not do have in been predicted patient, patient

Judy Fox

the were for patient eligibility The investigators meet they did requirement. study. the the felt And appropriate

the enrolled patient. we so And

Nick Abbott

a vosaroxin term that this you will done? on or transaction do confident sheets enough Is far getting And you're done deal year. that terms aspirational of in that along then feel with get the

Dayton Misfeldt

confident that on give say we're done, I'm to in So that going I term but deal have wouldn't sheets hand guidance the we we're get able to and timing.

of a something it's another. one case accomplish In we saying believe to why this we the year is investment are that's we scenario way this be or can worst So that year. going last

So either focus down that our shut we're product move we're and partner going that going get and to completely or forward to patients, find vecabrutinib. to and on

another get So to created that or something this one way have year. pressure we done internal

Nick Abbott

to by Vecabrutinib there parties? potential to is And attempt any any interested deal tie

Dayton Misfeldt

vecabrutinib are and of keeping separate. we're No, they profile completely products, different vosaroxin stages think pretty development. different We

the we We development open. better early off partners, of a vecabrutinib potential have keeping had we but that drug it's and options few believe that are in our

kind of out to in are in point be are might we know landscape right interested opportunistically time. the terms of who So to vecabrutinib know might right talking just in to the people, strategic vosaroxin be at down just the But who partnerships getting potential now and of road. people we then licensing in focused being partnership interest the getting very

Nick Abbott

models remind multiple activity of oncology? with what outside your outside then just of reporting you and pursue PDK me you in level thank can Merck you data us for if AG to is positive and Vecabrutinib that one at indications one is in last their inhibitor relapsing of Okay, the for of enthusiasm looked this and have morning, sclerosis oncology

Judy Fox

Yes, can Debbie but have also at we looked models that can of autoimmune models and I of arthritis in comment diseases, comment. other perhaps vecabrutinib

Debbie Thomas

I'll that Yeah, the specifically we're indications just now focused vecabrutinib. for oncology right say on

Nick Abbott

Sure, I I just you have understood, far? on outside based do of the I the in drug so guess has think you oncology data potential interested am

Judy Fox

expect would I and on that have outside Based data, activity mechanism it oncology. of would

Nick Abbott

thank you Okay, much. very

Operator

the of OpCo. from line comes question next Your Singh from Hartaj

is line Your open.

Hartaj Singh

fine? for hear Can the you thanks Hi, question. me

Dayton Misfeldt

Yeah, we you. can hear

Hartaj Singh

Thanks.

of question, questions. quick Just quick couple

to anything as trial, the go you you adjustments just like a you In protocol any patient meaning the running set the of run just protocol then to that if have just have had had trial by any or still up the carefully it or have - a more protocol, it updates sort of it's having follow-up. is quick in bit to I you ongoing, that, maybe and got little that revisions protocol for terms as make patient

Judy Fox

question. good so No,

So slow that the study. in escalation indications that course It's kind really It's anything the pace criteria Lym we inclusion/exclusion as IRD case. or had through far it's in we the amended trials. then protocol. dose we of And you that to the [ph] really order far the that whether are Xb change three of uncommon these not this necessitates to to of introduce when that review. protocol enrollment, not would as so types the in some And Phase because doing have follicular of review affect is plus of to go that's BCL seen you a what three fact an and design a see outside

Hartaj Singh

the you'll just, a roughly probably of fall. guess the by a in then with would fall recommended just And adding there is centers, much. just speed to guess mean then you that X seen there Phase could the and you I getting that is I Judy. to any being to get that back things possibility dose you be we little goal, one been other are Thank with mentioned get up new timelines, all that the struggling again thanks new same very had helpful? third I Great, indications, the bit here really quarter. color of

Dayton Misfeldt

the centers, the essentially accelerate from you said, I we we Yeah. just the fall to what are enrollment. guidance believe No, actions help exactly broader and are we indications, that the and mid-year inclusion taking, adding that no updating mean will

team consideration well. And Judy has supportive her a I as investigators learned we've enthusiastic. and here think and really also other the strengthened are lot

fall about getting So to we very feel good the in dose period.

Hartaj Singh

Judy, color. the Thanks Dayton. appreciate Thanks Great.

Dayton Misfeldt

you. Thank

Operator

comes Your Goldstein Instructions] from Fitzgerald. line from next question Cantor Mara of [Operator

is line open. Your

Mara Goldstein

very the for taking much Thanks question.

Just a here. few

early this But missed XX-milligram I completed dose? on. clarify, apologize the I to Just and you if have

Dayton Misfeldt

cohort. in XX-miligram dose currently we're the No,

Mara Goldstein

of also data the at company timeframe, the midyear has having idea mid-year. to the Okay. some as relates spoken And to it

review an not interim So do these you dose of will cohorts.

terms you'll what's in just third until just correct? So quarter, of wait finished

Dayton Misfeldt

to Yeah, meaningful. we format. a we medical presentation want meeting to And that in present want be

that weren't meeting fall have. that's thought But are at period in that's really what the we there in that that meeting And we we'll - towards to so the medical looking medical be the data we'll second point if quarter. present

Mara Goldstein

Okay. the expansion trial, of you the just which then of the looks also cohorts dose portion criteria given similar potentially of the trial, different inclusion to And also indications? part the escalation the expansion for add at will

Judy Fox

think totality KOLs I finally other and we'll the X. That's the the well them input Yeah, as cohorts in very as to Phase our good possible be our investigators and from towards looking data question. define of specify

Mara Goldstein

Okay, alright. Well, thank you.

Operator

Your line next the Birchenough Fargo. of question Jim Wells comes from from

line Your is open.

Nick Abbott

Hello. Thank but know particle to I relates challenges and the they report down follow them to transitioning And you it for we company from one another particle. to X. a transition taking had lot a slowed up. Phase of it recently had

current you have Phase sites So into written the X. protocol, adding to ILB? for the X/X XXS in a the essentially preparation new protocol to or Phase submit Is the population you

Judy Fox

Yeah, written Phase so again, the X. for have way pre-specified the the some we protocol is cohort

do is wrote selection opening and define when cohorts a the opportunity year in to a first which the these of and the the final we'll identification over well likely this of will different shield do both protocol and from is, X have of we an the Phase give data ago. us We to advance where on cohorts, opportunity which

Nick Abbott

change and that now CLL you'll is be population address and that the willing ahead do things to then with like other do if then potential these populations And go just between XXXS you priority to feel separately? there

Judy Fox

Absolutely, the sorry I'm fills cohort way each to Yeah, the interrupt is separately. protocol written, it.

other. not down does one So the slow

address in expeditious to indications, we of be So identify patients we able that whatever whatever an cohorts way. should

Nick Abbott

my questions. Okay. taking Thank for you

Operator

the There call no Dayton. at over further back time. this questions to turn are I'll

Dayton Misfeldt

support on thank today our call participating Well ongoing your for you and Great. and for interest. all

a We hope at investor will and upcoming We progress to of look conferences be our you. updates. forward and see many our XXXX to Good this into number month afternoon. interactions of in

Operator

call. today's concludes This conference

You may now disconnect.

Viracta Therapeutics (VIRX) 8 Mar 182017 Q4 Earnings call transcript