INFI - Earnings call transcript Q3 2017 | Infinity Pharmaceuticals, Inc.

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Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Infinity Pharmaceuticals Conference Call to discuss the Company’s Financial Results for the Third Quarter of 2017. My name is Glenda and I will be your operator for today’s call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session to follow. this being that request. at advised be call recorded is Infinity’s Please

and Infinity. I your Senior Jaren Relations introduce like Director Communications for Investor Now to Ms. host would go Please ahead. today’s call, of Corporate at Madden,

Jaren Irene Madden

Clinical Officer; Welcome on during Senior about our here call and development our potential and the may to Kutok, release projections. Perkins, morning today results up objectives, Development statements our issued this progress review are open everyone. business and Vice financial quarter Executive make infi.com. today’s therapeutic our product call Adelene to forward-looking this Thank you strategies Officer available third President; our afternoon Dr. results. take plans Bloch, website candidates, note to Please Ullmann, Dr. including call, Q&A Glenda The at we’ll Chief and following plans good clinical and and our the we President, our our Claudio is financial strategic that our remarks. discuss Dansky recent here details future press With is also Larry for Chief and questions expectations me Jeffery of Scientific and

and on due otherwise. future, we a report, views differ not you of may Form we what may of whether as filings, the that the XX-Q with and the events other information, These in materially including the future result them represent may Our make in results the caution as in or new described quarterly number update we only for statements to quarter SEC. of today forward-looking our project we from of today, a considerations factors, section XXXX of important risk our third factors

Now I’d call like turn to over the Adelene. to

Adelene Perkins

thank our recent made joining in and including pleased selective team report Infinity development. IPI-XXX are to at for gamma Today, Thanks, progress novel first we’ve with in inhibitor. immuno-oncology on you represents everyone IPI-XXX, selective a our us. we within oral is gamma afternoon The approach Infinity, which Jaren. Good only on clinical entirely class PIX-kinase PIX-kinase the inhibitor focused is and advancements

As macrophages role new in suppressions, immune publications reducing IPI-XXX to a reprogramming promoting major resistance in in late response targets and to unique an to crack plays overcoming described two checkpoint blockade. and antitumor XXXX

our are We PD-X with immune as solid both multifaceted and inhibitor, XXX advanced with X/Xb combination Opdivo approximately in checkpoint evaluating monotherapy clinical study in tumors. IPI-XXX a Phase in a patients a

that for cadence study We've first Friday of trial components the clinical escalation the XXXX. through and recommended and starts and which of tests of study the readout combination data of dose the steady The two second dose advancing significant the progress that two continues combination determine year monotherapy made this components expansion. are this monotherapy for

trial mg dose PIX-kinase escalation the complete as XX well initial with the we adverse very go As be are this is and once dose tolerated our forward maximum drug in the of daily gamma. sustained a monotherapy and portion and can of our with both class forward limiting events. To on as that monotherapy have dose first was that IPI-XXX suppression no profile tolerability monotherapy serious a the reached end favorable the completed was no tolerated toxicities demonstrating not as declared IPI-XXX study related as potential to dose based Because PK/PD goal at well medicine, active to pleased development. we dose an in taken of a demonstrate

heterogeneous the meaningful population heavily nature tumor look goal forward treated. the important portion being of pretreated effect the all-comer immune for to an that We activation patient show is and first Another of IPI-XXX study particularly this of induces from response given the new escalation Cancer agent Society data abstract late-breaking our Immunotherapy SITC during this call to in November or of XX, Friday the the presentation monotherapy Meeting. of and of a Annual the on dose session translational review of clinical presentation the solid

by that's we to has will to directly established. of us from XXXX a.m. an Eastern The investigators cohort execution in know why of our which our initiated dose and a.m. study early enthusiastic are of investors investigators start to the X have morning a possible to the X the will XX% our one of We to is collaborators. and effort We're date foundation We expansion and for sharing Time. August to We reception Friday by we to and support generated our about collaborators focus the team. study you of the analysts already program our made the shift we, and monotherapy and also from nearly Infinity the one and enable enrolled. tremendous been encouraged cohort day patients, the escalation XXXX been in this scientific hear expansion data forward portions investigators, appreciate and rising it's in look host

We are combination the by complete escalation combination, cohort the of XXXX. end forward for upon initiate year. And dose specific go to we declaring dose expansion on the will track the this multiple disease

Our XXXX. continuing progress starting positions in IPI-XXX with our the this steady flow throughout trial data XXXX and later of clinical from to us study this week

November the IPI-XXX this Friday, through going XX. monotherapy be data presentation the of dose from escalation especially just First,

Second, we the biopsies. and clinical tumor report XXXX of data translational first half which will monotherapy study from to data include expect the compared in portion of importantly the expansion

the first XXXX, Opdivo. insights possibility also may And is response also from of of more from to readouts to data combination present in study great fifth, disease so preliminary data data evaluating [indiscernible]. completed Third, expansion with cancers specific half additional multiple in An to clinical momentum. add half combination biopsies XXXX in of data cohorts our in expect XXXX evidence the cohort activity plus several half The of tumor additional testing plus translational mature second with IPI-XXX dose of IPI-XXX expect and including be additional the cohorts and combination expansion the there feature types XXXX. in across multiple the from Fourth cohort data program escalation compared clinical of distinct we also has we we to first of the anticipate important update Opdivo. and

We do who resistance with forms be develop and will by continue do the patients the respond date need available to including are cancer typically that to of progress magnitude to very pleased not immunotherapy, treatment immunotherapy immunotherapies. who the existing driven current for options better to for or for have patients could not to respond of well

may on seek IPI-XXX role continued And community over I'll better now, to the treatments focus as with important warrants to it company's turn experience IPI-XXX the bring to direct we to that suggests have an Our call play and patients. the Claudio. in

Claudio Dansky Ullmann

first is selective gamma inhibitor microphages within importance of represents is made new in our in compelling bring an we will clinical the this I new the immune emerging morning SITC This in the field this micro study and all another outline as Friday. Adelene. at have clinic immune-suppression. suppressing present of the the a environment progress targeting approach PIX-kinase field would IPI-XXX what Thanks we tumor approach and reduce oncology. Within to

or demonstrates pro-tumor data tumor microphages an reprograms or phenotype. to PIX-kinase MX associated that preclinical IPI-XXX Our MX, gamma with from anti-tumor targeting an

clinical provided inhibition to preclinical four-part well IPI-XXX the that Phase as for Xb activity overcomes checkpoint study. our inhibitors. the enhances as rationale of checkpoint resistance demonstrated also findings We These

Adelene are develop. the and once pharmacokinetics IPI-XXX in [indiscernible] continue monotherapy Opdivo advanced we given the serves pharmacodynamics our to with daily solid is XXX trial patients a in to encouraged that foundation As tumors. safety, strong combination evaluate as designed to a and as and mentioned, The with of study approximately monotherapy entire for on dose-escalation portion study of IPI-XXX has the which orally

pharmacodynamics during session Friday MD new X:XX include at of abstract by presented XX being daily. monotherapy oral SITC at David mg Our doses Center Cancer IPI-XXX treated Eastern the Hong with p.m. late-breaking safety, XX and activity data from ranging mg to is on patients pharmacokinetics of from and XX from Time once agents will Dr. and Anderson

data studies Additionally as in dose initial will the reporting of cohorts. we two will be which biopsied of important patients serve analysis time data the in samples expansion an early will followed for from translational monotherapy by first These escalation. be the the failed step samples obtained

there data clinical as progress trends translation their and presenting and well clinical poster addition summary will correspondent [ph]. the presentation be a In poster as to

monotherapy Moving the of on very well our completion to progress of trial escalation. the enrolling is of expansion we are study cohort in the dose the making are we attribution nearing combination the and

daily anticipate this once class dose are at mg Within last We that enrolled month. will patient Opdivo. evaluating limit the period [indiscernible] in escalation currently toxicity combined XX the dose combination the assessment continue Opdivo with IPI-XXX currently cohort in dose later we the

to us combination Opdivo cohorts include homogenous initiate our types and patients treatment recommended declaring IPI-XXX We with biopsies. cohorts are will of looking cancer. combination of expansion the forward because in pretreatment expansion it enable our and on mandatory All dose of plus activity more cohorts specific also to evaluate

We cohorts this the have hypothesis. fifth to specific test selected

see This very biopsies of the and numbers of time hope the many biomarkers product. with to tumor portion dose environment micro forward of tumor anti-PD-LX the emerging therapy. expansion level. cancer neck, IPI-XXX we few triple [indiscernible] have represent our anti-PD-LX of not trades, in collaboration our another those initial who which explore hypothesis of with received infiltrated Recently cohort look to trial populations [indiscernible] patients previously data benefit more or from designs or counteract and effective to I you patients clinical could to overcome for portions novo enables expansion escalation potential a outcomes negative you in our dose correlate approach We at our Bristol-Myers cohorts immediate in patient is on that The of the of success direct to Opdivo of response cohorts, de needed our a addition must melanoma, with that therapy. demonstrated to inhibitors. morning. This patient IPI-XXX improve [ph] plus more study activation have for complete study to large first the resistance that for and inhibitor treatment to cohort checkpoints options preclinical breast promote anti-tumor of our at the expanded today Squibb anti-PD-X hit SITC evaluate carcinoma of IPI-XXX The microphages to shown Reception Investor test to us escalation with the to vision non-small a is lung of the of head with data squamous cell result tumor the this cell often IPI-XXX tumor at For the therapy. critical September with the can for response. anti-PD-X the have that patients cancer, demonstrated IPI-XXX with is Friday. trial check on market steady a These designed monotherapy sharing and exciting

results Now Larry financial will review our the for quarter.

Lawrence Bloch

you, of therapies enthusiastic The about Infinity targeting very team Claudio. is IPI-XXX Thank in oral the which immune-oncology is few macrophages. one the clinic

first-in-class we Infinity a clinical selective foundational has made in and while the is strong year is We've IPI-XXX. one IPI-XXX discipline. this believe only been inhibitor Additionally maintaining progress for development. important a PIXK-gamma This and

data our safety four current meaningful quarter of deliver cash which XXXX. first within the to study parts expect and into We our clinical activity from extends of all runway

equivalents from While include from payment duvelisib. financial $XX positive that XXXX million summarize it XX, securities as at $X June quarter regulatory million I'll now first September this received cash to cash This the Verastem end for not we of million balance study following at for not approval the flow payment XX and $XX.X results does which the XXXX. Verastem of the October we the received from million of does payment third expectation quarter. XX, $XX.X had we compared readout our in includes of cash upon available reflect $X of DUO total the potential cash, the third from million the [ph] Verastem XXXX. At sale September

for statement, income in from We in million DUO quarter million revenue our of related for quarter to revenue related any and study was of XXXX. net activities XXXX. for share $X criteria. compared not quarter for third loss loss diluted $X.X third quarter expense obligation last was to of $X were to or same of our million the quarter note eliminating IPI-XXX. to million was did loss of is offset and compared for which $X.XX The primarily XXXX to the to Verastem Takeda Takeda for period the restructuring compared the $XX.X and payment Net meeting $X.XX million decrease the the to XXXX. exchange the from $XX.X XXXX million XXXX of was to third issued on million same prestats R&D basic basic during The $X.X record diluted per R&D million the file restructuring our Moving for activities. all expense royalty for share decrease per by period administrative expense the in the $X.X in $X.X General common to expense loss of year. G&A common for due

that guidance we financial provided Our January unchanged. in remains

current which exclude sale loss existing cash equivalents our from business cash to net to the XXXX or ranging on and runway million we from and $XX a we expect to that operating cash We Based plans, securities million of a million XXXX. funding activities, provide development $XX expect with first additional for into and $XX our end $XX XXXX quarter balance cash, available to million. anticipate investment range

which Infinity of of IPI-XXX. generate study we seek advancing The progress to analyst Importantly, study. parts our activity far reception includes the in we is medical our focused clinical our share as needs I us this translational cash made Friday hope will from all safety data to unmet and Hong ongoing you presentation Dr. and are cancer expect that from and upcoming review data in here, of and IPI-XXX. investor data will many see have year very we escalation four we've morning team the our the on of with address experience pleased join of with or IPI-XXX dose enable us runway webcast in monotherapy by so you his treating patients component to David SITC

lead Memorial Taha senior a Additionally, at and one and macrophages author researcher at of clinical Nature signaling work targeting of gamma with rationale the will the papers PIX-kinase who our serves Kettering IPI-XXX. laboratory Merghoub, [indiscernible] Dr. Sloan address for

coming we’re for our patients. take We all progress IPI-XXX. throughout from components SITC, as of Beyond your questions. meaningfully for of improve reporting positions to to year the And to we readout forward data our now, this options seek year study XXXX us look data over treatment happy

Operator

[Operator of our Blair. you. from from line And Instructions] William Thank question first the comes Xu Katherine

is now line Your open.

Katherine Xu

other that you. the IO good Yes, the what that data just [ph] – helpful? mechanism show of agents could in indication be on morning. what pathway kind very also XXX TNBC comment cohorts for PD-Xs I’m initiation are current the sort or besides whether be that could and hi you to Thank the updates. kind [ph] supported will of and other any you curious Thank IO of for the

Adelene Perkins

Sure, thanks Katherine.

are right We have with and immune-therapies. the we're can mechanism complementary macrophages the co-stimulatory of and by to other evaluating focused on So in that definitely factors. virtue of the now other data on study some the number be interested with IPI-XXX mechanistically checkpoint and an that anti-PD-Xm, the with it believe preclinical but synergistic we show combining

first unlike which question which broad cohort XXX of was see And are a on your types combination other are so to negative tumor so are [indiscernible] we included range in that that the like could the in checkpoint those the populations. ability rationale resistance checkpoint negative blockade a increase types and rate overcome as for that To the cancer therapies. showing strong are breast not as cornerstone XXX as patient response the with be triple responses of triple there are inhibitor the that to combination might tumor

Katherine Xu

SITC. at to I you you seeing forward Thank and look

Adelene Perkins

to forward look I Katherine. seeing your Friday

Operator

of you. Securities. Jim next Birchenough from from And our question the Fargo Thank comes line Wells

is line open. Your now

Jim Birchenough

[indiscernible] taking for Jim. is questions for this thanks Hi, the the in

would data AACR? question be a with SITC So time more compared meeting last could you reported incremental on little at what give first at color what’s the the

Adelene Perkins

XX escalation, the we we an escalation. dose on on now a At once AACR We evaluable. patients Sure monotherapy time have the XX the who were through we had also completed day. up the that have so update so dose patients at provided mg the data

So provide patients patients. the have we those as sharing time on for we'll those of all XX be and the who is we of of translational and are will on data mentioned tolerability, a PK/PD, patients, XX activity Claudio so the all very the XX update first the what evaluable for for efficacy an total

And will is first that's of time be IPI-XXX, immune blood we're so from evidence treatment this the sharing we're looking for peripheral induced that data. by that activation samples of so

Jim Birchenough

very resistant That's that the to. helpful immediate is that question mentioned PD-X think and is the you they prepared another for it. combination will in had cohorts Got be are which required I patient remarks prior therapy it of the the

would be proportion dose So escalation of current actually that who what just cohort curious fit the criteria? the patients for

Adelene Perkins

is immediately at extension inhibitor will the escalation, for with criteria inclusion the prior dose the so mix Friday. to and that not cohort. we one Yes, their presenting a be the have to checkpoint on so progressed It we exposure PD-X on the a patients at respect patients had of criteria applies enrollment requirement, of

Jim Birchenough

it Got and last question…

Adelene Perkins

you want add Is there anything Claudio? okay. No,

Jim Birchenough

for last is data for I you initiate is monotherapy think any do any to to combination cohort before have the it's item, end sorry, a from escalation start there to example expansion combination question really dose, Right, escalation year dose study? the for cohort the see

Adelene Perkins

come No, gamma forward. have activation that the - have to go XXX and we have in the to spot key take forward so dose dose monotherapy that with from looking immune it's is declare which us cohort the combination will believe well we where for much full and response dose right activation dose like did suppression to that and a determining combination the escalation induced gating that tolerated, we allow sweet PIX-kinase combination have we'll will that initiating that of and be expansion we appropriate factor we of to

Jim Birchenough

very you, guys helpful. Thank

Operator

comes Rama line from Thank Morgan. next you. the from of question Anupam JP [Operator Instructions] And our

open. now is line Your

Unidentified Analyst

the Eric different for focused how looking combination Anupam guess to I'm I'm Friday. data macrophage potential you're forward some for approach XXX I'm thinking Hey whether the I about mechanistic Parts the XXXX involvement, approach about it's that in in be should kind given of to whether we think cohorts PD-X how also slightly focused as should versus histologies combination that approaches? tumor either of dose on macrophage thinking data any morning. much from to this the particular and or And and just some going you're combination taking wondering - from then you [ph] as of there separate be for similar cohort? through about but there portion seeing trial also enrolling CSF-XRs? alighting escalation initial the the think wondering we're are expansion tax taking It's modulation are presentations Thanks being on about questions data we updates taken particularly just expansion read with thinking with we the from Thanks. that secondly, get guys. is kind about we

Adelene Perkins

then if Jeff macrophages and of targeting if see where conversions while MX of Sure, tumor from maintaining macrophages that that some believe Jeff MX of anything is number that? so there constant depletion macrophages other to the we targeted preferable you and anti-tumor is to MX Jeff the we to collaborators that the you to other approaches tumor macrophages add. relative anything add the would macrophage microenvironment approaches. work the from unique with the have reprogram IPI-XXX pro MX I'll begin is and to in our unique shown to have a we

Jeffery Kutok

think Adelene. I that’s No, right

Adelene Perkins

the going completed half in that and dose Okay between of XXXX will escalations will the have patients diseases that dose lung is in we the we're the values will patients expansions melanoma so will will who cell biopsy. and and breast because completed data that have be that on The be through inhibition the be of who neck are dose more patients it patient expansion based PD. the cancer naive be first head suppression we and cohorts tumor cohorts extension the will the dose have the gamma the into cancer, question and and will escalation triple be all-comers difference second non-small is become of the real - data forward and the tolerability, that the PK as homogeneous the will on and checkpoint solid will checkpoint for then a be population with and tumors expansion reflected to resistant the data that be it set revealing about Claudio one the evaluating of your escalation highlighted those then PIX-kinase on paired is negative taking

the presented be determined the will haven’t sets which will of data, data but a at. function be we be different. So maturity meetings of the those It the will

Claudio Dansky Ullmann

to clarify would question. your I further to Yes, like

our know achieve shows closely and good we've referring So patients that's cohorts the you in we’re type to first be so with to all data Adelene in from sites as what simultaneously, patients our already be tumor of decide data the next indications the sure year. are will up see going many a together of working not focus enroll we what the we're was and will possible, for half and had to all will on and of them authored present as to what the - a trying as in flow to we make particular we able and all amount very then investigators that indication each will

Unidentified Analyst

taking Thanks for questions. great. Got it, the

Operator

I'm further you. no over the turn showing Adelene I this closing remarks. for call time questions. Thank back to like At would to

Adelene Perkins

today. week the later in for and by on person data the good morning. report thanks Thank We're this of for new a IPI-XXX from We and Have working excited our of very Phase Friday and team joining about data day clinical the join or we and have us providing is study urgency everyone with review sense focus. great hope our call and the translational opportunities you. I a webcast you'll our with

Infinity Pharmaceuticals (INFIQ) 7 Nov 172017 Q3 Earnings call transcript