INFI - Earnings call transcript Q1 2018 | 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 First Quarter of 2018. My name is Jimmy 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

I your go Kauffman. introduce like ahead. for Now to Jayne host would today's call, Please

Jayne Kauffman

afternoon release Thank results today note of President Kutok, our plans to our during quarter XXXX Larry everyone. projections. financial our make you, Bloch, our With and this clinical business website Perkins, the potential first at future this good may development on issued our me Chief is available including results. therapeutic Officer. to Officer; our here recent review Jeff of details and call The we Adelene and strategies Chief about infi.com. discuss that Welcome forward-looking strategic and progress financial our and and Jimmy, plans, objectives, our and are expectations Dr. product press Please today's statements Scientific afternoon, Executive call, candidates,

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

to would like Adelene. call to I turn over Now, the

Adelene Perkins

oral reprogramming to immune from including the suppression role the with in are activation. everyone. plays IPI-XXX continued on are at reducing function, Good IPI-XXX, selective an Infinity, macrophages our in targets inhibitor. making Today thus unique and to report increase pro-tumor we PIX-kinase-gamma and a we a immune antitumor afternoon, our first-in-class pleased developments progress

in and of features a We're Cancer a approximately last IPI-XXX, Phase Xb evaluating of are data as SITC by inhibitor study important in nivolumab, in clinical monotherapy both meeting Society with in tumors. Immunotherapy the the quarter advanced at robust immune very or solid encouraged PD-X fourth demonstrated IPI-XXX IPI-XXX. with checkpoint year, in monotherapy which three XXX combination we shared patients We a the

is response an First, and very inhibitors immuno-oncology patient durable clinically as as have having to checkpoint a monotherapy, from of IPI-XXX agents active with in objective a is ability monotherapy. This an demonstrated showing objective response mesothelioma. achieve the aside significant few

monotherapy. well is dose maximum tolerated Second, not a IPI-XXX tolerated as having reached with a very been

IPI-XXX the on at monotherapy IPI-XXX’s dose combination data the particularly share of of in translational mechanism, pretreatment evaluation foundation on-treatment the This suppression will is monotherapy changes patients the to given evaluate all-comer activation. patient data portion we expansion monotherapy our portion will treated tumor SITC biopsies solid Third, valuable in immune the trial, activities This changes and this escalation from in population heterogeneous we in and At antitumor of and in nature for induced induced meaningful tumor ASCO, microenvironment. of pre-treated showed expansion the that the a IPI-XXX the decreases initial which provide data trial. cohorts. includes increases heavily IPI-XXX pro-tumor immune

builds on escalation poster upon and monotherapy. At and Our on a portion three will therapies. poster checkpoint ASCO, data combination focus that combination which of remainder demonstrated features in associated the we XXXX, forward of to presented be the novel showing will primary ASCO as the dose key throughout session the at IPI-XXX be combination immune of the look trial, discussion

population particularly is combination, benefit in of benefit rates from important immuno-oncology patient that Durability of And cannot measure where treatment with active the First, the benefit is that dose-escalation an for meaningfully IPI-XXX response in durable. therapies who this therapy. is an combination assessed. all-comer patients

cohorts second more a in of comprehensive combination of assessment more XXXX. homogeneous patient the with benefit enable Our half will population patient a

that continues effective important administered IPI-XXX will to expectation particularly that be drugs nivolumab. tolerated be Second, therapies. immuno-oncology when well This as in combination combination most the given with is

to have enrolled a PD-X data mechanistic patient forward we At cohorts this XXXX these early from expect that six of of in in mechanisms are will from initiated predefined of in which we combination well reporting initial the data complementary the patients blood population. disease of specific ASCO, MDSCs, we Third, levels the of perspective, from for first These the we cohort end expansion data myeloid-derived Furthermore, of suppressor enrolling second share mature the baseline data which prescreened cells nature look to the IPI-XXX at XX sharing from forward translational look and the and of were cohort, support inhibition. enrollment to year, in half half for year. also patients or patients open the in a second quarter. high

which mandatory now cohorts combination biopsies, will will allow clinical Finally, and to across insights all require distinct and expansion detail. several pretreatment seven hypotheses, Jeff us translational on-treatment correlate develop which and

Jeff Kutok

you, Adelene. Thank

head combination data progression half melanoma particularly with resistance ability Taking In to and that data the being to cancer cohorts several exciting is inhibitor to PD-LX on these MDSC preclinical are year. PD-X the cohorts expansion of reporting on lung next in we is their in this and patients hypothesis the data demonstrated evaluates we to addition together this combination cohort distinct recent in to prior a three therapy. looking also Adelene's at documented the or non-small on studies neck hypotheses nivolumab. in have When ASCO tested overcome of distinct with most our month, second more IPI-XXX's high blockade, cohorts and in summary IPI-XXX expect cancer, checkpoint share and forward of that based the cell from

activity. This being been previously with cancer, checkpoint checkpoint exposed is limited have ability had enhance inhibition being to patients IPI-XXX's breast Another who inhibitors. and response tested inhibition that is to checkpoint in hypotheses where not evaluated has the indications is triple-negative to

In in baseline adrenocortical expanding MDSC high patients escalation addition, cohort to responses. in clinical blood seeking immune and for The mesothelioma, which levels for of activity high have we from our seen are MDSCs, of studies screened three being signals, significant is patients with confirm suppress by IPI-XXX are we to known dose carcinoma reasons.

First, levels inhibitor core high pretreatment of correlated are response checkpoint to with MDSCs therapy.

effects Second, IPI-XXX vitro can and overcome MDSCs patients IPI-XXX MDSCs T-cells. the in can shows on reduce than in data that suppressive

nivolumab. escalation dose data suggesting from IPI-XXX baseline IPI-XXX and high alone with an translational response both Third, the MDSCs combination between association in and to cohorts

this is that have we this cohorts approximately MDSCs patient patients XXX the data MDSC disease such expect specific in In year. levels the to addition enrollment cohort, on also evaluating criteria benefit to high an MDSCs to with we in and correlate later are

be able tumor the will we and relationship to MDSCs in the between blood types. in tumor associated Importantly, evaluate across multiple biopsies macrophages

and the opportunity IPI-XXX, development selective development. I'll within novel advancing a sense that, our to the With Larry. investigators a the team immuno-oncology is significant with turn over bring call inhibitor a represents PIXK-gamma to of of in IPI-XXX clinical with patients. for clinical transformative treatment are approach forward potentially great which have We only The Infinity and this urgency

Larry Bloch

Thank you, Jeff.

of the plan trial sites, and as patients year at in well Made extraordinary that shareholders. can be investigators possible thereby first have Infinity you at families, the have cash have for a by to a development Infinity the are we enabling continued and IPI-XXX. Infinity As of who enrolled From the by team XXXX the we ensuring our of our financial our progress to their dedicated extent of XXXX and and runway important pleased commitment will see XXXX, into perspective, to as resources from for place quarter support key in the IPI-XXX. quarter staff third execute

$X due compared for period quarter in compensation. $X.X and total a million XXXX. March period loss the primarily per was was $XX.X XXXX. in to million, for was million first R&D diluted loss diluted the quarter XXXX, The IPI-XXX. share at $X.X net available-for-sale bonus XXXX, same a expenses the and in common of administrative a $X.XX to XXXX. common higher the had XXXX or was loss due R&D we or to first million and $X.X million, expense compared and basic in for $X.XX, stock General $X.X G&A loss for compared same December development primarily of same to to expense share to for for in of per basic cash expense of was $XX.X XX, cash, The quarter a equivalents million, clinical million, and for compared Net the securities in first XX, the period increase XXXX expense As $XX.X XXXX. million of decrease reduction of

guidance unchanged. financial remains XXXX Our

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

several cash deliver being study hypotheses XXX-patient our clinical our expect runway. within of to We from important distinct approximately in Phase current data clinical evaluated IPI-XXX Xb

potential runway from runway rigorous October the This was runway milestone, them we priority million Importantly upon company to potential not by duvelisib the payment extend and regulatory X also inhibitor of the a of our for which approval licensed FDA study to XXXX. which include payment approval review PellePharm, the into not private With Phase financial date in from with cash first management cash include $X XXXX. hedgehog the $XX of given initiation does this potential the does million upon expect program, XXXX. we the recently Verastem, duvelisib, cash PDUFA X, continued

far the we with and throughout updating report for open made and We progress time, we this program. questions. the look we've Operator? are At to activity year very call you as data forward from so the safety we the pleased can IPI-XXX,

Operator

Blair. Thank Our comes from William first you. Katherine Instructions] question Xu with [Operator

Your now line is open.

Audrey Le

much many will see see from a guys, about Katherine. what we quick might which Thanks like, just at is there? And Hi, taking at of combination let Could like to us then just cohort? expect disease this know I on question. how and had six couple for dose the you levels we might my the combination for dose Audrey how ASCO. in patients specific cohort see follow-ups expansion for escalation

Adelene Perkins

Audrey. Sure,

XX is, So a of of actively on what combination enrollment expansion are enrollment be we is, we sharing total one cohorts the the enrolled on. six reporting the will dose that of because disease will key who were is those the the be specific things of specific cohorts, have status enrolling. what And combination patients, escalation, which

point. those study assessment their how we’ll of patients are provide patients by first were But on data many cohort. Now have on not reached yet many

Audrey Le

guys you started know Great. I enrolling… just the Thanks. And for MDSC high,

Adelene Perkins

we We We – baseline began won't Yes. data began we tell screening you of through on process. have that have and their for high those have enrollment. continuing just have screening have provided the MDS can't matriculating guidance MDSCs because will we now patients several satisfied are circulating we who though of who We not the levels criteria rest having patients.

Audrey Le

I can might. of of what like those don't what share if types like types cancers, know, you patients

Adelene Perkins

Not that cohort, high for MDSC that very early. still

Audrey Le

much. so Thanks

Adelene Perkins

Audrey. you, Thank

Operator

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

Adelene Perkins

Thank you, Jimmy.

excited are a the for you call we and throughout joining the with the today. look have IPI-XXX updating about thanks everyone, day, good to and we forward We Have year. opportunity

Operator

a you program. have may Ladies day. and all great disconnect. does gentlemen, And Everyone, this your conclude

Infinity Pharmaceuticals (INFIQ) 8 May 182018 Q1 Earnings call transcript