CRIS - Earnings call transcript Q2 2019

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Operator

Good afternoon, and welcome to the Curis Second Quarter Earnings Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, this event is being recorded.

I would now like to turn the conference over to the Company’s Vice President of Finance, Bill Steinkrauss. ahead. go Please

Bill Steinkrauss

welcome and second XXXX quarter Thank to call. earnings you, Curis’

find everyone I company’s to to XXXX begin, tables. we related to release website second and earnings would www.curis.com the Before of encourage go financial quarter section the at our Investors

I current everyone during may expectations to These are management to and the which are certain remind forward-looking subject uncertainties, materially. results be beliefs. differ making statements, like and risks based would call, also that will on actual and our statements

additional please see our For filings. SEC details,

Joining Dentzer, me R&D. Officer; Martell, on are today’s call with of President and prepared remarks Head Jim Executive and Chief Bob

We will the of also end available be at the Q&A call. for

call I’d CEO, to Curis’ now turn Jim like the over to Dentzer.

Jim Dentzer

clinical joining in and at and our for earnings milestones we confirmation of CA-XXX key of can you, first clinic NHL, quarter XXXX for in for for update. second business announced us CA-XXXX safely look achieving data today the of efficacy venetoclax. afternoon, combination Bill. our you that programs data mesothelioma Thank Good last call our fimepinostat regimen clinical each a the everyone, in patients At end three and of efficacy in tolerate year, goal XXXX: for thank and our

and is studies Both our the for fimepinostat The in today track. NHL. CA-XXX first are efficacy big news on CA-XXXX look at

QD milligrams milligrams XXX daily and XX a cohort in patients dosing studies, TLR Phase cohorts or BID, CA-XXXX orally at small X of and milligrams turn, available XX we is cancer-causing in in twice dose reminder, began first-in-class, following burden myddosome study, once signaling the our BID tumor pathway. BID. or reduced preclinical As by ongoing activity, which, daily inhibits a in in first molecule at inhibitor and milligrams In inhibiting QD XXX IRAKX, the which, escalation

the patients enrolling currently in XXX-milligram cohort. are BID We

What’s the pharmacodynamic with really since our signs in study now good beginning dose date, last efficacy dose-proportional To has exciting clear the was of our update drug in CA-XXXX pharmacokinetics that safety, inhibition to year, models. patients and at preclinical target. advanced of has demonstrated levels where this observed is exposure of cohorts

we safety, look at and to data as and PD focus begin from PK now So expand our efficacy can well.

we in to we today now multiple levels. point, excited that burden announce activity tumor we seeing reduction multiple are across To for are that patients anticancer with hoped the dose

cohorts the With in as see to still clinical of dose initial exciting cohorts we develop and, and very they we’re in it’s caveats the patients results course, middle low hoped in small that dosage the of of escalation, would.

have we dose, this dose or determined we MTD, not identify in study we As yet we escalation are a maximum Phase until tolerated continuing MTD. dose X the hit or

from to data this the lead In at working conference. our upcoming with we investigators present medical are study an meantime,

but benefit we With from or will the MDS. the advance to NHL this CA-XXXX that we think leukemia, efficacy and or into in myeloid science positive from today dive study, later, decision Dr. is behind clinic the population for news acute our study syndrome, CA-XXXX. into our Martell also myelodysplastic another the might this AML, announced

can are in summary, the year other venetoclax of combination patients In this in that regimen with milestones safely and initial with fimepinostat hit to big three the a the for and clinical mesothelioma CA-XXXX, milestones: confirmation are first and two tolerate of we CA-XXX. data our excited we efficacy track efficacy have clinic treating on patients for

to to review over With clinical Bob in detail. Martell turn the our call greater programs three Bob? I’ll that,

Bob Martell

joining Thank you, afternoon. Jim. for Hello, everyone. this us Thanks

is myddosome announced the bit a a that today, more on CA-XXXX the for program provided depends Jim me like we be the inhibitor high-level of downstream on I’d Let the is little background of and in signaling, TLR to overall. the myddosome oncogenic to pathway, of known IRAKX, This nice receptor, data a but which which start tumor-promoting. with or overview CA-XXXX. Toll-like B-cell provide component leads to proliferation. pathway, critical an

currently therapies Unfortunately, approved targeting this no pathway. are there

shown a So models, have as signaling with patient-derived xenograft In large xenografts. potential TLR it therapeutic and production CA-XXXX, that we lymphoma we this block models activity to in vitro, and in as diffuse well cytokine B-cell have in represses CA-XXXX anti-tumor tumor pathway. preclinical exhibits

patients in study including lymphoma, DLBCL with we’re with lymphoma, the three sites As U.S. diffuse per cohorts. currently study at least patients X large and I’ll Jim patients study in of dose running Waldenstrom’s as refer participating described, escalation a dosing with Nine Phase Macroglobulinemia. enrolled going in are forward, CA-XXXX B-cell relapsed/refractory the to in

patients dosed as of once XXX continuous milligrams Jim the we’ve twice started milligrams at mentioned, have Initially, dose escalated cycles. to we reminder, a all up As in and daily XX-day our way XX current daily.

also, The profile. the with importantly, anti-cancer pharmacodynamic and of twice-daily X recommended study’s of activity pharmacokinetics, also pathway. signaling shown Through and clear and the in It’s reaching of the CA-XXXX of dose. pharmacokinetics inhibition the evaluating XXX-milligram to evidence safety safety this clean strong goal dose, pharmacodynamics dose-proportional oncogenic in Phase shown addition tolerability has CA-XXXX and

dose in with up have In promising, data clinical anti-tumor patients our ultimately upcoming data new an until evidence addition, tolerated dose. define greater on CA-XXXX activity recommended our and seen to maximum moved Phase and dose we continue initial activity we we’ve in present medical we conference. across of We studies. observed the levels at X dose very escalation plan our This several is dose as for

a called Cell This dominant myelodysplastic myelogenous enrichment. in syndrome, or IRAKX potential specific IRAKX of cases UXAFX is strategy recent the of form we This also for IRAKX-L. that the IRAKX-L. MDS. represents the publication majority of of AML, cancer-causing quarter, in Nature of This or induced also patient describing in Biology variance splicing leukemia, paper noted factor acute splicing The also and the mutations a highlighted

also as CA-XXXX myeloid IRAKX with a mutations. with of for UXAFX potential inhibition and the treatment expressing present patients with IRAKX-L option findings These malignancies

CA-XXXX forward updates further to potential the study population, our then on for we’ve and as decided this these molecule into trial program of clinic the providing Given we in indications. AML to protocol this this we initiate first MDS, finalize and bring the in look

like and targets through I’d essential the on move malignancies This are protein in inhibition derangements our of in cancer. degradation of which PIX-kinase MYC simultaneous mechanisms. the several manifest MYC due histone transcription to two enhanced genetic fimepinostat. Fimepinostat both targets These are program, is to MYC to levels many and HDAC. anti-MYC Next, to MYC. enzymes both deacetylase, or uniquely

degradation. reduced seen of repression of in of ultimately overactivity often lymphomas of MYC results a buildup amounts This in causes lymphoma. the protein in example, PIX-kinase MYC excess For and, GSK-X consequently,

On MYC the any for other cells. hand, transcription important new HDAC cancer is of in

drives We of have targeting example, synergy Inhibiting MYC, excess when that and protein and HDAC on MYC shown and transcription, MYC HDAC. the translocation depends in gene both process others For increases of degradation. inhibiting reduces simultaneously. PIX-kinase synthesis MYC HDAC PIX-kinase

We have and of in able enzymes same both these that are, advantage the and in additional the shown in in fimepinostat have both to the fact, in of molecule preclinical models being clinic. both target inhibited,

of large be This that MYC-altered overall a has path shown initial we with date, lymphoma, anti-lymphoma this median response a studies prognosis. with months. discussions agent duration combining lymphoma, of with the particular is XX.X response will in most rate most drug. the approval XX% actually B-cell to over year, to clinical an fimepinostat in the a challenging diffuse a patient Based our fimepinostat on with group expeditious believe of the FDA, In

growing enough agent its anti-lymphoma of defined will specifically also Since due to delayed action, slowing types allow as MYC lymphoma adding lymphomas, us by hold. benefit an of and alteration an with bridge growth Because long to in to strong as most rapidly is the mechanism the fimepinostat well is fimepinostat’s create this a of double-hit of this is to this patients somewhat lymphoma, allow take Bcl-X. for benefit one deadly

Venetoclax Because diffuse that we’re a drug with B-cell binds and itself, large lymphoma. of By combining this, activity venetoclax venetoclax. modest only acting and in fimepinostat inhibits rapidly has Bcl-X. is is

trial models relapsed/refractory including the of designed suppressor the and lymphoma. those when synergy pharmacodynamics found is with MYC double-hit patients with preclinical with evaluate to combination combined we However, pharmacokinetics, in lymphoma. double-hit activity anti-cancer safety the our The in of fimepinostat, and DLBCL, current the the dramatic tolerability,

planning and the received In study. initial the XX daily. both the study of cohort, in XXX as doses milligrams agent, which milligrams year. dose plan data X daily. fimepinostat of identified, study to this are These until and the are have finding patients on molecules. received we activity venetoclax to fimepinostat a for in of to been dose has patients expect patients the of recommended continue milligrams two and We full Phase doses report that enroll of second In from each clinical cohort, venetoclax XX demonstrated cohorts first We milligrams agent the single XXX is

is program first the CA-XXX, VISTA and oral targeting PDLX. Our molecule third

because with in clinical We are high first disease. targeting anti-VISTA the oral the currently mesothelioma only trials levels of candidate of currently is molecule this PDLX patients VISTA and expressed in evaluating currently, CA-XXX clinic. in is human the this this molecule it in extremely

this our cells and is VISTA on with immune are incredibly and an candidate cells. We tumor infiltrating oncology expressed highly developing Aurigene. is important partner, in target

I are study patients with These patients anticancer not is previously and these Phase VISTA-expressing in curable. been CA-XXX high Our treated the evaluating mesothelioma. of have efficacy

cohorts. patients and across enrolled within two the patients We’ve U.S. XX six randomizing sites study the UK into

the X,XXX second Patients The are progression receives cohort the milligrams the first daily dose cohort lower not XXX who crossed and at milligrams or dose over of to do high daily. CA-XXX, cohort. respond receives experience disease twice twice then

look to year-end. pleased have We initial forward clinical are enrollment reporting of before and XX these to patients completed data

That clinical sums programs. up our ongoing

detailed initial excited forward are look at presenting and CA-XXXX an on meeting. our upcoming data We medical data by to

fimepinostat make and end in initial before on programs, great continue programs both we’ll progress also report of of We data these this also year. our the and to CA-XXX

discuss call With to that, turn Bill? financial over the to Bill now quarter’s I’ll results. this

Bill Steinkrauss

Bob. you, Thank

results. Now update on an financial our for

million For period. prior $X.X loss and or were and year $X.X of reported a basic $X.X diluted XXXX, the net second net quarter we a to XXXX, million the loss of or $X.XX the share of per quarter $X.XX basic and Revenues for share compared million per respectively. $X.X of and million diluted in as second same XXXX

$X.X Research in compared to revenues Roche’s of in for sales The XXXX. net of were XXXX of period XXXX. periods Revenues were expenses expense Genentech $XX.X the the the million royalty development decreased quarter primarily and and research was same in to second as due on the Operating expenses. $X.X compared to Erivedge. and decrease XXXX million period quarter of employee-related for $X.X second for million million for same in development recorded comprised expenses both as primarily

was expenses administrative for XXXX. lower to administrative compared period The expenses as and $X.X this driven of XXXX compensation in personnel, by million for and quarter the primarily in $X.X stock-based second legal same were general General period. decrease million in the and

was for same expense Other for XXXX million as period $X.X XXXX. $X.X quarter of in the compared the million to second

of For non-cash, of quarter with XXXX. future quarter expense, XXXX, the royalties interest other expense Oberland the of Capital the of the primarily in sale second related first consisted we completed to that imputed

XXXX, the our totaled upcoming cash, into are cash and should for three As of data half and XXXX. equivalents equivalents outstanding. investments June us beyond common XX, of XX.X that shares stock our cash $XX.X approximately maintain million, operations of and our enable existing investments We our there programs planned anticipate of million each to catalyst second cash, and our

call that, open Operator? With questions. for we’ll the

Operator

Jaffray. from the Chris session. The question comes go will ahead. Please now begin We Piper [Operator question-and-answer Raymond with Instructions] first

Chris Raymond

Can question. Yes. the a using like little the tumor we of formal first little of measure a of in maybe of your think, see little the Jim, I maybe be – bit or trajectory criteria, or and to reduction some what could thanks could you are describe, first a the at if all, about be higher more I of the – bit sort cohorts? talk able data. to a thinking I’m these Bob we is, these seeing responses? asking Cheson XXXX you you elaborate taking all, responses, on response bit sounds wonder you are you’re I guess levels. some It should Hey, can provide dose for Guys,

Bob Martell

Yes, thanks. This is Bob Martell.

based mentioned, we preclinical levels dosing we are potentially as So efficacy where currently at our see to we’re data. on expecting

measuring tumor we’re so efficacy a look information the of one And different at sort of tumor today we in size. measurements. And factors at which looking of that is is burden, variety burden tumor presenting

tumor a diffuse So for simply we measuring lymphoma. oftentimes large a for looking have, B-cell tumor, decrease. And example,

monitored We – can either tumor and have of measurable increase. lesions, therapy course those reduce it or over be and the

reduction is case, so And factor. tumor an size that important in

includes studying are the Macroglobulinemia have that patients of Some that Waldenstrom’s M-spike. or we other diseases

that’s burden. way And tumor another so of measuring

seen dose reduction across So multiple looking levels. tumor we’ve at variables, those

at in the data, as safety have the burden patients the formal at present description general, the meeting. that to in more we meeting. will data each with level, an standard for two an using as example, the the of efficacy XXX-milligram We For are malignancies, detailed where well tumor criteria efficacy of data be again, three upcoming for plan three dose decrease. presented showing are we responses. But upcoming But these reporting of

Jim Dentzer

Thanks question. for the

Chris Raymond

we Should ASH? assume that’s

Jim Dentzer

Yes.

this Jim. of targeting the Thanks December. So course, generally for in is but, ASH Yes, we’re is question. year-end,

the of be the get want do ASH going under question’s that most as but, course, makes that to, all of where the the updated come from of could perspective, present, down and really have we that’s So – to go? going be it’d my sense great that does guidance if investigator. The So to we the we data ready to well. investigator to

yet. course, a get testing through think and was, we full this we for are. see that we’ve have data that? I we so at that data what we’re everything much XXX-milligram far, that of of we patients we presumably answer that, PK/PD? today, really get cohort. is don’t more seen already yes, were did XXX be And, course, the to data today So have the see the it’s There’ll at PK/PD. hoping for point, we of that’s have halfway what in we’re of plus the hoping full safety Did the more where We exactly earlier year data that to two announced we where first wanted the we for is But

we And, of answer yes. to see the tumor starting is strength? to are course, And that

don’t make small of cohorts. too this. want Now to much It’s we

three about people You’re talking cohort. per

no. people of I’d are for tumor The thought future we say am if three But exactly conferences where out future release, expansion. we to that’s seeing today, we I Hold are we’re say with the going and So yes. get seeing reduction, two answer’s answer’s ORR, what XX% a especially and hoped? that for we

Chris Raymond

great. don’t One question, more mind. you That’s if

confirm So patients. you this was that mention I or Bob patients? I to Waldenstrom’s had DLBCL heard study Did think it you patients just Waldenstrom’s

Bob Martell

too, Waldenstrom’s the MYDXX Well, because of a mutation, thing activates emphasize in study very to the enrolling activated. about I patients we’re discuss with actually did And Waldenstrom’s. so Waldenstrom’s who I the it’s think patients from that’s but regards in to have study. to XXXX, it meeting, require going are interested on which that majority mention those know really are patient because the important in at this doesn’t pathway have population the strongly patient unique that, obviously, really upcoming to selection oncogenic. order that this is we have significant myddosome detail, And yes, certainly, Investigators we very patients

Jim Dentzer

for. spectrum precisely Bob’s leads point, have is of MYDXX Toll-like then of is see the pathway mean, overactivity broad a oncogenic receptor of are hoped. going data lining said, the directly, exactly It’s myddosome, of overactivity we’d great well we’re getting and because right both, interesting really is the patients But it the so some do be of we’re Waldenstrom’s altered, point, patients as compare right, way There as maybe actually MYDXX-altered, without to the with, when broad we’ll leads XX% the this could if patients. find we’re we and then within to Yes. to love I some we pathway. swath see. some patients Waldenstrom’s that I – to some which just the targeting a Since we to the think very somebody hoped ideally, contrast. the comes patients majority, to to it’s I up minority And But patients to front. of it’d even be happy the to are myddosome

Chris Raymond

Thanks, Awesome. guys.

Jim Dentzer

you. Thank

Operator

like back closing to question-and-answer conference our Dentzer I any questions, over session. the for remarks. to Showing concludes this no would James further turn

Jim Dentzer

and a execution and too XXXX In year, expenses history. for We fun, it’s to we we Thank team too. Curis an sounded our partners at bit than of promised promised a our that, we staffing knew be set in Curis, and frankly, exactly achieve X.X I’m sit and studies. yet We transformational would third, exciting had clinical turned year by of ambitious here and and And to productivity last very key achieve We more out our lot goal. separate it expectation. be results our Aurigene the continuous proud today, who soon. almost at our overachievement, quarters yet and across that to milestones clinical benefiting we XX-year we clinical we’re and our QX you, operator. from patients thrilled an our increase look on updating would of in beating ambitious, we see board, call here later and you or for trials. clinical Thank you three a for and hitting the and I’m for us are in again their forward families joining participation everyone every cut

Operator

The today’s you Thank presentation. for concluded. now attending conference has

disconnect. may You now

Curis (CRIS) 6 Aug 192019 Q2 Earnings call transcript