INFI - Earnings call transcript Q2 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 Second Quarter 2018. My name is Skyler 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

Thank today of President Kutok, our to quarter XXXX Larry everyone. our you, Bloch, With and business Perkins, second good our me Chief results. Officer. to Officer; here recent review Jeff call Adelene Chief discuss Welcome and progress financial Skyler. And are Dr. today's Scientific afternoon, Executive

our this about Q&A development following strategic and our We strategies call, remarks. up our and will call for including statements potential afternoon that clinical results forward-looking open release objectives, press our plans, website may we note this is future the expectations candidates, our of plans financial issued make Please the The and projections. and on during at details therapeutic infi.com. product our available

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

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

Adelene Perkins

joining everyone Jayne. Thanks, And to us today. for thanks

the quarter. positive second We are of since and developments pleased the quarter with progress end recent our with very additional

Medical Vice over us in has led Agios leukemia Agresta two approval Head of First, the Clinical last President resulted targeted the the Dr. Development. the year. At which treatment Agios, where drugs to clinical of he we Officer. for the oncology first-in-class of are our program company's development Sam Samuel welcome the Chief from to and of was Infinity, joins Sam delighted as

within the X both of and were compelling IDHIFA was approved last TIBSOVO which first The data. Phase on monotherapy month single-arm

we Sam Pharmaceuticals as in first-in-class development oncology half enable inhibitor. Agios, the the of on Sam XX academic important and that clinical the making been to three Merrimack eight clinical previously addition involved Genentech us inform development PIX-kinase-gamma joins and these now having us at for decade, data across practiced the to time has over In companies are drugs to was paths years. me future at oral a prioritize medicine last expect program. in the selective different development IPI-XXX the second in and advancements will for that, we our IPI-XXX, of let turn with With year critically

pro-tumor macrophages a and play effects to or either know, As withstanding remains recent plays in myeloid-derived activation. there is or an a not patients them reprogramming resist many people treatment. for the limiting role suppression macrophages immunotherapies in you MDSCs and The significant immunotherapies. better do cancer, majority important therapy, within growing of function. for to suppressor and immune and the evidence role need respond initially an they a There these increasing IPI-XXX respond not targets unique relapse. progress cells reducing from with interim anti-tumor subsequently Thus, immune that MDSCs and of

was showed increased presented immune solid that in and data IPI-XXX Oncology or immune year's American IPI-XXX well with with ASCO on-mechanism expected on Clinical of are and with a robust of combination Annual nivolumab, Meeting, We reduced currently in we the Xb advanced inhibitor immune Phase clinically which evaluating active activation. patients promising tolerated markers a in suppression tumors. in approximately IPI-XXX XXX this checkpoint At with study nivolumab, combination PD-X clinical Society

in seen they excited we data IPI-XXX these patients are reinforce what already monotherapy. have by treated as We with

findings these combination detail trial. will XXXX, in Kutok Jeff portion mature data expansion Dr. from anticipate development the These more able of shortly. Officer second guiding evidence future and contribute therapy. share data IPI-XXX half combination we of will the to of In the medical Scientific scientific clinical the being Chief Our to

of respond rigorously rate Our checkpoint the been likely inhibitor. combination studying than designed patients the expansion to patients to to we likely have difficult to show cohorts nivolumab. in the be to lead the over IPI-XXX combination which are inhibitor, checkpoint respond to highest a a contribution in not combination interpret, to Rather studying response might but

are any clinical and benefit responses over checkpoint indication activity a IPI-XXX So of the strong inhibitor.

ratio development this decisions guiding success signal-to-noise in IPI-XXX, a the it and interpreting sets high is ensures a with for important IPI-XXX. of which probability trials increasing future bar activity high critically in While very future our of

For three with patients cell expansion of cohorts in CT the our cell the and lung neck, as patient's non-small scan in melanoma cancer, example, in checkpoint a and combination must on inhibitor a documents of squamous carcinoma the patients Any have of progression of indicative of to activity of patients resistance these area study. need pave high checkpoint our an in would would enrolling and path development. for to future overcome prior in immediately ability inhibitors, to extremely clear IPI-XXX therapy be head

been with we is And clinically also and blood in activity baseline in lastly, ability with inhibitors. evidence triple-negative activity, to being cancer of tested IPI-XXX’s MDSCs and patients poor with patients IPI-XXX correlated have which responses mesothelioma confirm initial where to with patients levels of inhibitor to with who seeking checkpoint IPI-XXX’s high -- are limited response have verify exposed we to turning to checkpoint are are tumors effectively reported adrenocortical carcinoma, checkpoint inhibitors previously have cold preclinical hot, breast in We work not taking where which patients therapy.

expansion ongoing and this pleased presenting later the in from cohort and forward to data trial combination by this component enrollment of the this look year. momentum We are

cancer enter collaboration and breast IPI-XXX negative in adenosine quarter, This antagonist, antibody therapies also receptor anti-PD-X chemotherapy in ABXXX ABXXX, cancer. into Arcus' two ovarian Arcus with a we pleased to to were Biosciences investigate triple with clinical and Arcus' triple combination a dual

the an been enhanced and second will to data on data will We triplets mechanism which rigorously result allow these of will designed in has to tumor these patient we given include suppression with therapy do reduction combination from of evaluate to which unique these central top-line triple IPI-XXX of activation, pro-tumor the XXXX. Arcus' in not us trials able immune also ABXXX The identify in include IPI-XXX’s compare benefit. increased triplets update and combination triplets to providing studies potential therapeutic combining look the in IPI-XXX populations of the believe to to and action that We IPI-XXX’s contribution which chemotherapy. trials forward ABXXX One immune to doublet IPI-XXX. and combination in anti study agents same combination be with is ABXXX from evaluate IPI-XXX and may that these

half the of a tell, has us XXXX can one all you busy of been for at Infinity. As first

the We opportunities are I’ll significant before with excited turn and about the And the progress have over Jeff. made us. that, we to call to-date

Jeff Kutok

Thanks, Adelene.

especially that monotherapy. escalation in we a these that at here three to have We features by in outline we we patients, we combination been today. which quarter, ASCO see were focused dose IPI-XXX our all data combination nivolumab. therapy for as reinforced are presented encouraged ASCO happy that were with on discussed features And we data the Last shared at I’ll key of

both very with profile. safety favorable a showing we First, pleased tolerability the with of as a IPI-XXX monotherapy, were nivolumab, and combined

Data Monotherapy IPI-XXX responses two one anti to providing in with a clinically from is show decreased IPI-XXX action benefit extensive one blood tumor cancer adrenocortical biopsies not microsatellite is demonstrating in IPI-XXX as active, treatment. preclinical the studies macrophages well these IPI-XXX the immune rapid cells with with in data in MX And as consistent to greater IPI-XXX with deep treated the biopsies nivolumab typically blood perform combined effects suggesting was durable shrinkage cancer. increase peripheral demonstrated increase and from IPI-XXX paired and and and and that with increases patients; Second, patients. stimulation time respond with targeting This IPI-XXX patients suggests inhibitor stable suppressive myeloid previously Who in nivolumab, MDSCs immune mechanism Peripheral both tumor indicate alone, immune receiving after that to with be patients study. blood, top combination as PD-X alone cytotoxic studies. third, demonstrated the the fixed-dose reductions indicating longer of tumor expected on exhausted the both nivolumab on-mechanism. an reduces nivolumab proliferation gallbladder translational activation, dose immune correlated continues to in in the and objective that nivolumab. of beyond on contributing of is of would statistically related and to suppression of T-cells IPI-XXX

strong a overcoming existing combination the Importantly, active is with on-mechanism of immunotherapy. IPI-XXX. this both that means foundation role development an nivolumab for clinically important and of limitations in data in These the continued and provides may play IPI-XXX

portion we the we we second be regulatory it the mature Larry. on over will reporting combination inform potentially XXXX, As more towards that, expansion further to first-in-class this trial, data strategy expect product of and will our development look With candidate. for I'll which turn of half the

Larry Bloch

Jeff. you, Thank

the the for we ensures progress we have and As discipline execute are made this our in pleased the We quarter development which progress fiscal on have second strong key plan Adelene Jeff with we that described, with in to place IPI-XXX. resources XXXX. made

due compared a in for XXXX. for for to diluted XX, the $XX by decrease cash, stock to in -- was IPI-XXX of We and million of General XXXX. common million, largely was diluted March second not in the to was $X.XX, compared for administrative in development loss XXXX. expense G&A $X.XX in to a loss a a in due million for related and expense R&D XXXX and reduction available-for-sale at $X securities of any for in quarter Net to a period compensation. cash bonus compensation. loss XXXX. $XX.X R&D for and XXXX period decrease year. quarter revenue of share total equivalents $X.X expense in to decrease this the same primarily at million, bonus same million, the second a of XXXX, $X.X $X.X clinical or The time or second expense net the the quarter and increase compared second compensation common compared and was As we had The in to million, stock million basic XX, quarter per or period share per $XX.X expense XXXX reduction record was same $X.X XXXX, did June and basic in million loss last offset

them objectives of key first the at finish IPI-XXX our year XXXX for the objectives against me half by and the the set from Let now ourselves for dose reviewing summarized expansion essentially of execution with this report escalation June previously. disease-specific XXXX. these and data We’ve goals goals combination these half of beginning at reporting by expansion, our cohorts year, from monotherapy we data nivolumab. Jeff from data nivolumab as second would for data met with in the ASCO initial

mature ASCO. for on of to in enrollment expansion trial showed build the Having meet year the IPI-XXX that data the second track objective. objectives Our represent to we completed portion on half the of be mesothelioma initial we on data more will already combination at continue this cohort,

range Our that year to are XXXX for we million from $XX million. objectives $XX the financial to expect net loss

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

to Verastem from by payment data the first important potential the October deliver milestone approval date our This $X duvelisib we for you through initiation year. be until questions. current hedgehog appointed earlier Agresta, of potential prior include XXXX, expanded regulatory of recent study company, in in able or this clinical Phase FDA Medical PellePharm, to to With With Phase through on leadership XXXX. to this extend including Bristol-Myers expect X include our does being does Marie-Louise which financial area them with duvelisib, on today resources Xb resources can Development not rigorous Chief our inhibitor upon to our clinical execute additions financial time, Squibb in we runway class cash and potential to a We was a management and X, the runway also IPI-XXX. the Fjällskog, Agios include announced open collaborators XXXX. a IPI-XXX from the Novartis licensed expect study Arcus, private Operator? from robust These the And from and we Officer XXX-patient newly have not clinical cash a distinct clinical upon This million runway XXXX. program, we which plan within X importantly, PDUFA to Vice cash call our we continuing for recruited $XX for development QX of Sam milestone, evaluated President, world several balance of key approximately hypotheses from forward and the the key cash that updating the review look We of approval Clinical XXXX. at million we earlier payment runway. progress given our

Operator

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

Your now line open. is

Unidentified Analyst

do is, second Hi, Katherine. And loss expect potential million is does you've that loss guidance know guys. for guided from Thanks you loss the my come first year, from of This question. net where the I million, include given of PellePharm Roland a it’s in question to half on mainly? Verastem? taking or to bigger for payments the $XX My $XX

Larry Bloch

Yes.

the our of most additional the X in expenditures program none clinical as Adelene’s the nor initiation program. XXXX. potential for milestone hedgehog tell costs the second duvelisib, approval inhibitor discussion licensed guidance we you So, recent potential from can including of focused we the includes the for potential of of Verastem expanding them PellePharm collaboration, of of data, milestone in And year development that the our Arcus on either Phase our IPI-XXX the half our

Operator

[Operator Instructions].

from Our comes next Birchenough Wells question Jim Fargo. with

open. Your line is now

Nicholas Abbott

to CMO he’s timing Thank clinical Agresta what for regulatory It’s you might potential it not guess know himself there the when a Dr. strategy in have you I with tell to the us surprised as little I but the opposed can in update. clearer Nick was speak now data maybe Jim. maybe I the just a for for motivation you joining. to be? recruit was when and the what on later of year becomes

Adelene Perkins

Adelene. Nick. Sure. Thanks, It’s

getting at time. of we on approval and recently you that’s can really medicines first-in-class important most I what are development So Sam recruit to thrilled tell that is he focused this been to has really what's and us.

to development will data where that -- else this year using path. So of about results later think in translational expand as the that also this the to future the we but together we be development our interpreting map findings and getting of data our with IPI-XXX

generating leverage XXXX. a it’s for perfect data into we really to development So and move us time the him expanded come to in are help

Nicholas Abbott

an with you are combination interested combinations now for one then the can in and PIXK-gamma the and the already inhibiting look stage there new other drop collaboration, under to in And adenosine. Jeff and at a at combination which there like have address so and that potential of Arcus is, Are other are of that whether partners adds looking Arcus efficacy definitively you clinical ongoing the you allow PIXK-gamma to cohort program study? early will

Jeff Kutok

Yes, Nick.

other those with studies ongoing our other clinical and we decisions in We our ones are will partnership modalities team. that possible position are think evaluating MDSC. That well with tumor-associated at really in now certainly in interested preclinical discuss with don’t we would combination part certainly informed but be macrophages to combining like that right targeting we're multiple other Arcus. the partners I pair looking make we're development and a are with

Larry Bloch

of FDA complement next is IPI-XXX. much Marie-Louise development able recruit is translational very to were along the the Sam models. on someone this It that's and preclinical clinical question recent we actually very your with to is successful strategizing that Agresta's experience Nick, and be with the Adelene Larry. is of stature He reasons builds for the Fjällskog have Jeff's one excited to first partnership that to of phase really

Operator

Rama next Anupam question with comes JPMorgan. Our from

open. Your line is now

Tessa Romero

this you one then beyond how us. for evening. Anupam us were can additional in Can and on also And for progressing? quickly Tessa the quickly expansion enrollment is provide the from recap I solid to update cohorts combination is couple And types cohorts selected recruitment an a Maybe have on additional tumor maybe is those follow-up. this how maybe mesothelioma? progressing how other for Hi, the tumor you

Adelene Perkins

Sure. Thanks, Tessa.

we cohorts mentioned -- of that enrolled. that ASCO and types at XX on is time an tumor what our we provided completely we patients the as expansion cohort was mesothelioma the that fact combination the So as for with patients’ you had the enrollment overview presented at together enrolled

We well on cohorts of see interim going really of presenting are We is have year it earlier we include as to selection it other criteria enrollment effect say that and certainly are of the updates may to expect hope mentioned that I not those nivolumab. include The we and enrollment providing IPI-XXX those will meet where be could later cohorts other this than ensuring cohorts data. well. what on was really mature the mesothelioma over designed to we

of resistance a the key one hypothesis we inhibitor. IPI-XXX so, ability was the published to presented in that checkpoint -- and Nature Jeff paper of Kutok was And overcome to a

our melanoma directly And cell and are that enrolling. prior inhibitor hypothesis progressed so, lung progression checkpoint a to head cohort patients had designed and test three have squamous will being in to cell the on neck cancer and immediately documented of cancer non-small enrolled and

So we do to breast triple-negative checkpoint that was three. inhibitor. respond selected the with because reason triple-negative cancer typically We patients well cancer breast not those selected

activity IPI-XXX. a contribution indicative And of would be so, again, of there

MX. macrophages across from responses the disease-specific following all reprograms we that in seen in a showing cancer are do that lastly, respond is and data and and then the cohort IPI-XXX the fact And types study we study. two MX the prospectively being monotherapy we up it’s believe prognosis. MDSC patients very of on those reduction mesothelioma in high screened have reflective a first tumor adrenocortical work are and our patients already escalation and typically cohorts our level, high combination MDSCs lot about we a in excited done that with our we have other signals see Our MDSC levels directly for the to we for which well not mechanistically ever The saw that of and clinically have poor dose

checkpoint again well to activity. activity prognosis IPI-XXX don’t and So signal encouraging of that patients a very inhibitors in respond that have be poor would

So data informative our to is Phase get Phase our that to development. X that ensure very we we the very X worked have hard from

Tessa Romero

should what Thank know all on additional I definitely cohorts? maybe second helpful to color. call. that, that guess, to provide be And combination a for our Great. we want you Very half for end. some you any Adelene, tidbits here follow-up expecting you, the data we gave in should on additional I the here? But the expect kind what of on color

Adelene Perkins

important that what’s be have about Sure, the in most cohort of we well, those for data is activity any to enough conclusive cohorts.

So be the the totality of looking will at data. we

looking the drug will is we expected what at to. We be doing mechanistically it

increase MDSCs, will We treatment, reduction response rate, of T-cells. of time at be of reinvigoration in looking evidence on

be our populations the So we totality looking will forward. paths in those help map to against at data which of relative need the the will us patient

Operator

no to remarks. I’m questions. over At the for showing closing this to Adelene like time, back turn further call I’d

Adelene Perkins

Skyler. you, Thank

end thank very excited a the later opportunity Have great about and this on everyone us us forward updating IPI-XXX we and are joining a you for We good of today's we summer for day call. and to you with have look year.

Operator

Ladies the thank This participation does for and you program. today's your conclude gentlemen, conference. in

great a have Everyone disconnect. now may You day.

Infinity Pharmaceuticals (INFIQ) 7 Aug 182018 Q2 Earnings call transcript