CRIS - Earnings call transcript Q4 2019

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Operator

Good afternoon and welcome to the Curis Fourth Quarter and Year End 2019 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 Chief Financial Officer, Bill Steinkrauss. ahead. go Please

Bill Steinkrauss

welcome earnings and fourth and quarter Thank to XXXX call. year-end you Curis'

begin, everyone to Before the would earnings I we encourage financial related of quarter year-end tables. website release fourth and Investors to our at our www.curis.com find and XXXX Section to go

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

For additional filings. details, please see our SEC

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

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

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

James Dentzer

you a clinical the XXXX us Thank you, further for program, our expansion Bill. joining and formative reported in promising for progress Good was Curis. data We in for important laying CA-XXXX XXXX. thank today. groundwork afternoon year and everyone

with oncologic approach our established that retooled We sustained portfolio. position And the Curis to momentum valuable VISTA, to of we partnerships future. for a meaningful our CI-XXXX into our well target, the addressing addition

also people many COVID-XX pandemic to the of aware, globe. the across and the to evolving the medical you It challenges unprecedented As innovation. forefront presents are has importance brought of acutely necessity

to At than dedicated of ever therapies more targeted Curis, cancer patients. are bringing we to our our mission

running our efficiently monitoring related we as developments focused to business closely are on seamlessly and We can. as COVID-XX and we remain

MYDXX with kinase including and Oncogenic reported study Conference development of our macroglobulinemia, of the we ongoing exciting program. our drugs. like DLBCL, non-Hodgkin's with I'd our December, IRAKX lymphoma, data patients Phase Now, cancer from I refractory or let's ASH treatment to CA-XXXX the and inhibitor jump programs Waldenström's IRAKX for preliminary mutation. clinical relapsed for targeted with next-generation escalation into At dose patients start in

underscore activity results CA-XXXX the novel patient option These patients. targeting that IRAKX this as in a anti-cancer data provided in to the serve first and population therapeutic potential these ever evidence for for

were that ongoing. report dose still and dose tumor reduction patients these patients has is milligrams ASH range. to was six pleased advanced But burden. at XXX of The study a five of evaluable study daily The twice levels we in mean reduction experienced higher, into the At therapeutic XX%. the in

patient One milligrams enrolled a XXX to dose daily, patient then milligrams XXX of we Waldenström's, these in patients, escalated the with observing daily. a example And at study strong single nice twice provided twice escalated twice the dose really are of study. patient again XX the to was daily. response This in milligrams

exciting. That patient very response With overall dose each is further patient's group in is increase as response in the dose a dose, tumor reduction whole consistent burden. with this seeing with this the is seen individual

daily and We tolerated are the currently maximum X XXX-milligram the evaluating twice recommended will we patients and/or dose continue escalate dose, dose to dose at determined. the is Phase until

We expect data later and from study updated this year. efficacy to this safety provide

AML/MDS highlighted presented study a Conference half or that spliceosome XXXX. potential treat CA-XXXX. We the who target have acute oncogenic as a to to ASH at direct Also with of initiate plan December, leukemia IRAKX, the therapy of of syndrome, were first patients the that in myelodysplastic long-form myeloid this or data caused CA-XXXX mutation in

AML/MDS to for and shaping spliceosome year data is potential CA-XXXX, the looking we patients this certain CA-XXXX with mutation. of efficacy to explore short, and we be one up updated to clinical are in forward In are a excited and busy

and venetoclax. we X our earlier of fimepinostat to Moving discontinuing program, today that combination study we Phase announced are our fimepinostat

development. also interaction this drug-drug of would an combination to next not warrant from did did the see we the we advancing that stage combination, not efficacy Although any observe signal

have we market alignment will current CA-XXXX a future subtype characterize Given conditions tumor the CI-XXXX. with focus and analytical help fimepinostat. development pandemic, as our any to with of and biomarkers research resources on DarwinHealth decided guide COVID-XX Ongoing to clinical result opportunities

progress on corporate business. our of XXXX advancements by the clinical been recent complemented side in Our has

Over partnerships and well position longer we multiple collaborations past Curis have months, that few initiated believe the term. the we for

February our PDLX. we of amended this inhibitor our an development orally In available and VISTA CA-XXX, of Aurigene, collaboration year, the and dual for with agreement partner, commercialization of

radiation Xb/X in enables study amendment and to combination with Phase This in non-squamous, a large cell CA-XXX lung non-small randomized cancer. patients fund conduct Aurigene with of chemo

to the royalty CA-XXX be U.S., in and in rights to will India commercialize rest future the CA-XXX outside in EU, maintaining in Asia, its and CA-XXX world to in rights return, In Russia. rights on Aurigene receive full and of while payments receives of Asia. entitled the existing Curis develop Asia, addition of to sales commercial

This advancement and agreement expertise for Aurigene's CA-XXX, update to us our allows collaboration resources support late-stage the to leveraging while clinical development. of CA-XXX

setting. cancer designed lead the year, We of the antibody, a clinical option license continue that signaling this to with CI-XXXX, is anti-VISTA to an meaningful monoclonal compound, into entered and In target pathway. agreement ImmuNext VISTA a for stage believe its we including development in and of January antagonize the commercialization VISTA antibody

development this VISTA are escalation for study it initiate of cancer. a the CA-XXX from to We hope plan of of leverage excited Xa/Xb particularly as this pursue experiences by CI-XXXX year. to prospect later provides the us opportunity the the We another pathway and support of CI-XXXX Phase to to partnership our treatment dose

mechanism identify subtype fimepinostat. collaboration January, We tumor this and understanding fimepinostat. to with our DarwinHealth in and a future we announced biomarkers collaboration potentially for the will any opportunities deepen Also characterize believe alignments development for scientific of MIC

Capital $XX care-focused efficient clinical we high us to Bill a but transaction walk that to the in candidate. February. this will a at Aspire source want support through from the long-term development on deal details, of capital touch with and gives health announced institution level, flexible the million I our Lastly, an

an important we ahead us. year are We as have cash pleased runway extend transaction with to our of this

financial over to the now a of Bill? I'll fourth for year the and our quarter. summary turn call for results Bill

Bill Steinkrauss

Jim. Thank you,

For compared loss as or the to and or net and per loss $XX.X basic XX, net million we XXXX, $X.XX million reported share XXXX. year diluted $X.XX diluted of in a ended share December a basic per $XX.X of

quarter as we diluted the XXXX, fourth per basic to loss basic and a for net $X.XX reported compared and share $X.XX $X.X of of net XXXX. million or a the per diluted of million share In or same period loss $X.X

XXXX, quarters the XXXX million for of for $XX were respectively. Erivedge. $X.X of comprised Roche's for ended Genentech same primarily on million as the compared net $XX.X and of Revenues year XXXX sales to XX, both Revenues and $X.X were revenues in and the period XXXX. recorded royalty December million fourth million Revenues for periods

Operating period as the XX, expenses for XXXX, were XXXX. million in $XX.X for period million the quarter same to the XXXX. $XX.X fourth million $X.X the of year expenses compared were for Operating for in to $XX.X same XXXX as ended December million compared

Cost third-party $X.X amounts due million year for of to ended royalty December and XX, revenues for the compared XXXX. university primarily Erivedge as in sales XXXX, licensors patent period were same to Genentech connection of million Roche's with the $X.X

to same of for period $X.X the in revenues royalty compared as XXXX quarter were million the $X.X of million for fourth XXXX. Cost

the to in resulting the from same employee-related which XXXX. for year for decrease $XX.X were primarily headcount quarter occurred XXXX. The December due to in the a reduction, as period expenses, ended fourth million expenses was $XX.X R&D XX, of million XXXX, compared lower

same by the $X.X partially $X.X was Phase increased to decrease trial. ongoing R&D quarter consulting period compared expenses XXXX. manufacturing, for X This as were for for the million clinical, our and XXXX fourth offset clinical costs million of in

as General combined stock-based to for compared and with the and lower were expense XXXX XXXX. service same $XX.X due The the and personnel lower million legal XX, decrease to professional for million administrative expenses ended December period was in compensation expenses. primarily $XX.X year

$X was year XXXX, Net both of million compared the fourth were December ended expenses period the as XXXX XXXX the quarter to same $X.X $X.X G&A XX, for expense million for other million respectively. XXXX. and for

other a of loan resulting of $X.X sale March of Royalty of Capital. the portion in XXXX a Oberland the with million, to Healthcare Partners, extinguishment Net an from loss Erivedge primarily expense on conjunction $X.X royalties debt interest repayment imputed of million to obligation the of consisted

expense million $X.X of the net fourth other million For $X.X quarter XXXX and was respectively. XXXX, and

cash As and we securities, half our million, of XXXX. us our cash, to expect XX, the equivalents, of which to maintain investments marketable totaled $XX.X enable XXXX, planned second December operations into

the made to common extend our have time we future our time on announced $XX during limits. common each cash of to order runway, up to based purchase sale. stock investment million Capital. will certain subject and an Aspire purchasing committed at initial period, $X in Under In of million price Aspire an purchases a to the market February that of $XX deal, at XX-month to we into request the These with made a the terms from million be additional time of agreement entered shares

our or share of it of source for that shares We warrants, other classes for further no agreement an based amount shareholders. accessible with capital to on Curis There market facility us sale are associated timing and the the deal Aspire. we is pricing. control and common This of provides and derivatives, this is a feel great

for like the I'd open Operator? call that, questions. to With

Operator

We will begin the [Operator now question-and-answer Instructions] session.

from Our ahead. JonesTrading. Roy first Soumit with comes go question Please

Soumit Roy

are for you Thank everyone. guys safe. hope you the staying and question Hello taking

to in AML we mutation? the of be quick driver a this are on going in Just thinking should setting? reposition the AML/MDS XXXX Is one you mutation IRAKX inhibitor. or And MDS

James Dentzer

you, Yes. Thanks Thank for Soumit. in. calling

So, then that hand little Bob I'll more over start let to and a take detail. me a at first for

course, data a like and that the so large been gotten a initially BTK everywhere about $X that. data drugs IRAKX and very far terrific, market today. the we've and lymphoma of the goes inhibitor, think goes the at I went combined they billion looks And we that's because preclinical excited space really it So, it That's space, the suggest and non-Hodgkin's has well. commercial

is [ph] historically The has uniquely of a perspective. AML/MDS at is a been as very that It market, BTKs a research a that to thought while go. spliceosome ASH presented This heterogeneous that positioned identified press IRAKX place that regulatory that there of off has was smaller, in disease, the specific that mutations from new, by can't at disease. physician lead an over-expression Einstein is

a And In as if would this by that target with form addressable of we is overexpression a having the very AML/MDS mutations his story work long population that the very can oncogenic. application, that okay, the are specific of half drug. the can IRAKX. be attribute is specific we where Short-form FDA, population in that can to our take patients, can we those we identifies long-form genetic suggest uniquely identified

to that So, regulatory path. quick a should lead very

strategy. the that's So,

we drug Non-Hodgkin's the it can the and that can impact flushes get so of tumors that we lymphoma and saw this really course, activity advantage of research and the works off in out preclinically, that path anticancer taking do regulatory is a down to add very AML/MDS hot the Bob, large potentially accelerated to commercial would market. path. that? identified a then, press' like you

Robert Martell

been the a they for how long these question. And it's time really but mentioned, been out That's last it that spliceosome Jim. it's regulator are known prognosis These AML/MDS. really Thanks Yes. for poor mutations that in discovered recently, patients important of quite that's IRAKX AML/MDS, is just primary Jim as have geared only actually year been for regulating fact, some form. the long-term in turns expression this in

can leukemia form cells pathway, fairly these and drives prevention differentiation the which the drives constitutively cells this basically for CA-XXXX. is and active NF-kB of And is leukemia also target with really of essential effectively -- this survival we pathway and protein down traffic the of shut through of

a yes, as will a we it driver that forward. take mutation. And we definitely registrational target is yes, that path So,

James Dentzer

so me NHL got looks on -- with the think we've let terrific. side, far the close I so data

reduction Obviously, those But point us. cutoff tumors. looks really or of to and then accumulated XXX later really commercial we're for in a that we've the at mean since NHL doses present XX% five the getting year. six ASH, strong patients the data patients. -- were therapeutic We're a story we're opportunity at in So, excited as higher, at are we already milligrams shrinking of

clinician. of positioned advantage it approval commercial development, uniquely the even way smaller think the get side, to of should market, the drug where our though it's the a excite expect press be FDA. quickly. we excites can that know We we Even hot On take a in regulatory more the seems to we to

Soumit Roy

Absolutely. for Thank progress. on taking question congrats the all you the and much so

James Dentzer

Thank you.

Operator

Instructions] [Operator

The Rashid with go next Threadneedle. Please Columbia A.J. question from is ahead.

A.J. Rashid

Erivedge Two with pathway That's coronavirus with question. doing if anything discussions and they've Jim. to them related with any or Thank with I'm taking hi lungs? respect had couple its been One, IPF, the Yes, you wondering the on a respect the for Roche the to of IPF first the was ago, by in in to for years the you. infliction researched space. else that and/or you've question. if space Erivedge issue Hedgehog

discretion to related to Aspire PIPE be purchases is considering might respect other measures The to you And price? financing. second share question number with two, the something Aspire support purchases the that, What you and made at that company's either Aspire you. is mentioned the your or the then that non-dilutive in future discretion, public will the that or after that or be would way? be private market either is Thank before open market conducting

James Dentzer

you, Thank A.J. Sure.

So, Hedgehog and pathway, a been I Hedgehog first and among it scientific Erivedge go. lot community might about there's on the excitement think of pathway where

pursuing And longer been I last that know of pass in drug Genentech an initially, Roche that that But and was frankly, opportunity, of can the had with that are that, I I know course, but that had in the as haven't they part MF looking also I place no IPF, a believe past. at quarter, research I they setting. might them. thought have conversation in that the that

be to I'm what going our to, course, can the comments disclosed. limit publicly Aspire On transaction, of

awfully the not, really we in think I'm the coming, pandemic flexibility that did. the course, the glad did coronavirus the need for country this for and company hindsight, of our gave and we and we time see scary certainly I It we facility in freedom frankly, financial world. placement put but

we of upon do trials ongoing. use to expand facility the make and that to plan have certainly We that

public We data. have, And yet not to know, study. forth patients go the exciting. was you data we that really of add that course, at put we've with as also continued ASH to prepared that We're to

flexibility data and those discuss to hand question. mature very transaction pursuing of able that more this financial take as Aspire the to over having as course the both afforded of But the aggressively your you advantage well, year. Thank by to the AML/MDS becomes be that hope data for pursue of in it and much we

A.J. Rashid

Thank you much.

Operator

like the for Officer, I would remarks. This conference session. and question-and-answer the to concludes James to Executive President Dentzer over our any turn company's closing Chief back

James Dentzer

Gary. pipeline In laid XXXX, we term near-term the for positioned and successes for you, Curis groundwork growth. Thank longer

new as and We build to result are about our opportunities of a and the CA-XXXX eager to collaboration. are with successes on excited initial available several us now partnerships

for focused look advancing to As we on are CI-XXXX. and XXXX, we programs our clinical CA-XXXX,

of Before I'd team their participate Curis, the well for patients in at like family we Aurigene close, trials support. at and our who our all thank commitment ImmuNext to as clinical internal and as and partners our and

Thank you again updating to call look you forward our we today, for and joining soon.

Operator

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

disconnect. now may You

Curis (CRIS) 19 Mar 202019 Q4 Earnings call transcript