Viracta Therapeutics (VIRX) 10 May 202020 Q1 Earnings call transcript

Ladies and gentlemen, thank you for standing by and welcome to Quarter First 2020 Sunesis Pharmaceutical Incorporated Earnings Conference Call. At this time, all participants’ lines are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions]

I would now like to hand the conference over to your speaker today, Mr. Hyare. Par ahead. go sir, Please,

corporate everyone provide and today Fox, us. me the of and review for EVP, details quarter provide on first our brief thank Dayton Misfeldt, financial you pipeline recent will are Dayton Judy Dayton & joining Judy Interim will Research more will With then Development, Welcome events, a CEO, CSO, of XXXX. and overview

all the call for for be We available. will will open then which questions we

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

let that, over to the me call Dayton. turn With

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

hope both foremost, on front-lines, everyone so everyone develop to who as to as vaccines. working staying COVID-XX we would healthy we both like gratitude to is and First hard the those working address to on and the extend pandemic, our is well the treatments and

of prioritizing ongoing business safety companies globe our with the while the maintaining us employees unique patients around working Sunesis, are continuity. and times, At we unprecedented trial, We are presenting in and vecabrutinib challenges. in our the

line Bay ensure Phase area sites conduct the closely our FDA trials we guidance and the of place in orders from have in clinical our were worked As issued with this Xb/X activities in employees CLL home you San working during such, mandated in mid-March are trial our pandemic. to know, Francisco and the on vecabrutinib that in with have been shelter

vecabrutinib still We on from our Phase on we in programs. and for patient, the XXX-milligram as this assessments as to cohort remain vecabrutinib make follow-up cohorts PDKX expect well time, continue study initial who treatment. progress quarter, this the of both lower-dose response Throughout from Xb assessments

is have but address. in delays to due from will for we there vecabrutinib to the work COVID-XX impact However, potential development

will and the from and of the provide steps assess We situation the next evolves as Xb emerge. COVID-XX updates Phase data trial portion

combine SNS-XXX. We encouraging we inhibitor classes. results continue study advance an several drug vitro PDKX In in can to reported proprietary synergistically our from indicating that March, with SNS-XXX

by IND-enabling SNS-XXX a of end We XXXX studies the an are for with IND completing to target file

the detail turn to call current to over into will I go that, more progress. Judy With on our

Dayton. Thanks,

patients of three We as XXX-milligram. We trial are will Dayton first of we on currently cohorts, cohort of see Ib/II response clinical across in vecabrutinib. benefit quarter. the seventh XXX, XXX Seven are results mentioned, assessments the Phase of have cohort XXX-milligram and and the evidence treatment this

XX% reduction their assessment normalized cohort, One a patient response currently and In with for from XX% is second XXX-milligram in five in burden, had patient assessment in currently is was scheduled disease is observed or disease completing XX. of response a stable a on parameters. treatment CLL This in the cycle patient with tumor heme continuing three June patients. reduction stable improving The third

burden. CLL three a with two response In reduction patient patients disease XX% cohort X, of assessments first a the tumor including stable upon have in

investigator on as benefits. request Some receiving patient have X. treatment in and aggressive is remain three patients disease treatment that are cycle by the patients remains All on

be quarter. for cohort the assessment expect to second response available We this

patients safety Cohort remain three XXX-milligram lymphoma In patients, of with cell four six with treatment. the and evaluation these the CLL on cohort, X, two mantle and period cleared

note, in patients decreases than with steadily lower has we levels stayed have those mg in and an higher consistent. seen treatment have cohorts the and is exposure dose the higher longer in increase Of dose on the been mg well very cohorts. Vecabrutinib to dose cytokines tolerated XXX in XXX remain

and We are conduct meets paramount ensure have COVID-XX actions taking the appropriate aims. we and these to respond are to the to safety pandemic. posed steps by the trial our challenges the studies Patient

COVID-XX has that risk and necessitated at minimize personnel. to on changes based implemented patient sites protocols site that

patients Some accommodations study as rather remote There from staff telemedicine, conducted in requiring to patients to than being directly visit working come assessments study implemented. to by monitoring receive are locally drug remotely been are are study and site has distribution and possible to drugs. sites

with with to the Remote how clinical and Phase steps we visits as study, conjunction the next sites will on in challenges we these collection has had receive we evolves. an timeliness pandemic Ib of address are additional from data impact working evaluate data

be move as providing we will forward. We updates

to be Turning also SNS-XXX's to PDKX longstanding our PIPX-independent and breast, potential lung, other with SNS-XXX program, inhibitor a in of and oncology prostate and PDKX, community. interaction is novel can many inhibits target overexpressed the malignancies integral other of first-in-class hematologic interest both and PIXK a pathways in signaling cancers. PDKX

lymphoma CDKNXA We in associated particularly in cancer, CDKXX, or CDKNXA KRAS mutations gene, inhibitors with KRAS many different also with recently cancer shows breast the lines. that sensitive Aberrations tumors to are GXXC, are recorded cell mutant in SNS-XXX synergistic combined of who deletions when types. and with activity RBCLX SNS-XXX in vitro.

and program KOLs, for malignancies. plans a hematologic progressing of IND-enabling solid tumor discussion establish number we developed the that are as SNS-XXX are with clinical SNS-XXX characterized and further through preclinical and in We collaborations

plan preclinical coming the expressed program second half look The the to enthusiasm of months. advisory universally to clinical in investigators forward we have year. approached and in assembling our findings we for have present We the boards the

to call review over Dayton now turn financial the will results. to I

$X.X while operating liabilities. quarter, million of loss XXXX, resulting operating in the the same of continued million vecabrutinib and quarter the budget. in used Thank with $X.X developments, operating first compared first changes SNS-XXX you, we and $X.X the Judy. in from XXXX million was In to period in as our Cash for primarily net activities in assets

quarter at the first sufficient the position was our get milestones. Our to $XX.X million, of end through us next cash

for pursue may the opportunity. We future seen, his in another of our Willie thank have here Quinn, best him luck recently you endeavors. company Sunesis left Financial his wish him to at As efforts and Officer, Chief the

Our as Principal team we strong remains Gullotta in accounting biotech Vice Accounting and existing Tina leadership our nearly her years industry. ago Officer extensive to promoted in Tina experience the two Sunesis appointed and have and finance Finance. joined President, with

COVID-XX to I during business our and this industry-wide acknowledging conclude entire continuity impact the am team to would like time. and I commitment maintain of flexibility remarks unprecedented of proud has demonstrated these the that

questions. let's With that, Operator? to open the your call

from line of Kim from question comes [Operator Oppenheimer. Justin first the Instructions] Our

Please Your open. your ask line question. is

the Thanks on reaching further the the need sort additional enable while of clinically-effective stand to are progress there any certainly to the escalation, dose be mg. sort able you once study escalation afternoon expand trending curious, which But, sort the to of a also questions. but I get Good study, everyone. by taking appreciate or for and cohorts. you escalation paths protocol be that forward either exploring The dose, to to well was looking at XXX initial before those progress results, just seems I would changes

answer Judy Yes. I’ll Thanks ask No. the that. question. for

Yes. Thanks for question. the

if more cohorts expand allows dose one allow So, the confirm And is escalation. to the or a protocol, for to to it as us decision dose currently made dose. we recommended stands, made plans have

protocol. we So, amended have the

I us of cetera? just sites? of maybe, expansion might number dose Okay. clinical et be work identification the of whether done there XX can any Great. And you need approvals sort And the Phase II what then, is walk increasing know, listed, dose, through IRB to process? follow the it's currently,

Yes.

have currently XX feel that’s dose to expansion. complete enough we and So, a we sites

So get required approval what with committee to be doses to would investigators expansion occur. and really a to step safety expand that and that review our that might go to meeting hold at

patient Okay. of baseline maybe And last my Got sort it. Thanks. question on is just, characteristics. then, the

are less ASH those by you or of give the weren't can For severity they where maybe more of with prior recent disease a or included high on the the sense patients, – characteristics added recently us a population? level whether consistent treatment, the in baseline more of lines that prior maybe update,

give seen number patients. have two had that patient and we’ll few that pretreated patients on we note and or heavily that are who we’ve of TOL of heavily MCL did patients then a details similar So, more population. more a pretreated. are And We four less

hop And Thanks in queue. I’ll very back much. Great. the Okay.

Thank you.

Our next Marc comes from question Frahm of line the from Cowen.

Your line is open.

my Maybe thanks just for question. one. to Yes, last taking on that follow-up

doses the purse what be protocol amended doses, first You then within protocol? guess, those from second, contemplated potentially would will want you mature doses? has I you are at mentioned that the X, to cohort looking now allow to for what higher to high been And

a think I few Yes, clarifications.

an open need in So, go to we process. additional But in processes will to a are some order cohort. additional the protocol

the the we'll understand discussion when with the have think data warranted. I see we escalation investigators, better is and whether

support profile if would Did exploration, the Certainly, do. additional your choose we everything? question, of missed I Or safety sorry. one answer to that's dose what

and now to – it X to X. fact that you seen want keep that increased go you've higher? of lead that comments, your in to cohort guess, further? Yes, mean, just as Or to exposure the do Is I cohort need kind in the you you what's would scenario seen it a feel response – is prepared going said with you've you that want to you’ve I

capped a want on dose higher that much out because to Therefore, haven’t exposure? you pretty than to you go one,

I decision it’s think dose discussion be with from number and feed think of I to will that will Yes, that of escalate. any be going a different will factors of some to investigators. come And into that from some us

aren't moment. there the – criteria not it’s So definitive at

Okay. Thank you

further this There continue. are questions Please no time. at

and quarter. call update Thank on afternoon. our an you vecabrutinib today. to on our for trial participating look we this providing well forward Stay Good everyone

participating This concludes today’s for you conference. Thank today’s on call.

You now disconnect. may