INFI - Earnings call transcript Q2 2020 | 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 company’s Operations and Financial Results for the Second Quarter 2020. My name is Shannon, and I’ll be your operator for today’s call. At this time all participants are in 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 our second to XXXX financial everyone. our you, business quarter good to recent review call discuss Welcome and progress results. Shannon, and today’s afternoon,

press Chief our the Brian website issued the Chief Schwartz, available release On Perkins, Physician. with remarks. call Larry our and We’ll is today me Officer; call up for at Consulting following Q&A Bloch, The Adelene open details and afternoon are Executive President; this infi.com. and results our on

We note resolution about and the of candidates, our due to during that have and projections. that SEC, pending development expectations forward-looking we plans, issues technical and make filing us strategies, clinical product potential at EDGAR this is our also to submitted call, and objectives, are financial Please but companies. may XX-Q impacting therapeutic the plans our future the strategic statements our other including

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

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

Adelene Perkins

everyone for thank you us joining Jayne, to today. and Thanks,

a has development been clinical also for Our goal known plan robust as Infinity execute eganelisib, to on IPI-XXX. in

our on re-programming quarter its regarding antitumor provided we settings to in stated and across COVID-XX and more macrophages our a approach impact that cancer call. eganelisib potential on the function. by updated patients different the evaluate we would an Last evaluating are improve update micro clinical tumor from outcomes programs second provide We environment for to of to guidance indications treatment quarter,

are While We’ll to of during project our COVID-XX evolving more our situation, I’ll across first but timeline. briefly review urothelial controlled the and cancer. specific much trials. with updated BMS, peers magnitude randomized, we which in still call, the start we MARIO-XXX, and updates managing we’re impact trials with better provide a X in patients on position our the in Opdivo are collaboration eganelisib our I’ll study evaluating guidance in with Phase in with combination the advanced

reduced are XX we of milligrams dose milligrams the daily, enrolled XX from milligram patients efficacy safety XX of May, in dose the announced the eganelisib for we May. to and As now through evaluating and

milligram of are benefit step. end dose the pleased to this is well to tolerated the which dose form of report We continue patient will year, the evaluate that we the through combination will and XX next

And frontline is in or patients of update MARIO-X, in next negative with Tecentriq as cancer, RCC. TNBC. frontline a renal in cancer, breast study with are Phase our patients treatment eganelisib X collaboration Tecentriq Abraxane combination cell on treatment triple Abraxane the combination which with as with for and with Our and we or a evaluating in Roche/Genentech

preliminary to data MARIO-X We end at from this of present track the are on year.

the the the advanced Opdivo this to year. data in quarter X/Xb of eganelisib We collaboration cancer the our enrollment in that patients may combination in present intend of trial XXXX. TNBC path of enrollment end with tumors. evaluating solid by first inform by the additional in year of complete to end Phase Squibb of Bristol-Myers study and with development with by end the expect From also of MARIO-X, We renal the cell the cohort cohort

Xb to Phase with forward future eganelisib patients in TNBC. these in Arcus novel receptor running checkpoint-inhibitor-free updates is is Biosciences, Doxil our ABXXX with trials, well, patients to study addition a adenosine and we their another in includes inhibitor, relapsed/refractory regimen to that evaluating look study markets. dual collaborator, study The TNBC. a Infinity-sponsored and proceeding In This is

situation monitoring with it are COVID-XX have of access compliance carefully on any protocol continues our treatment, minimal with ensuring ultimate enrollment, address to or disruption. to evolve, patient to initiations, the of the While goal and we impacts proactively continued site treatment patients no

a to consulting Before Dr. we clinical I’d joined Infinity across generation data updates, more and oncology who role interpretation experience in detailed been the April. development drug Schwartz, Brian’s in in trials. our introduce the deep of Chief like move to Physician has invaluable Brian in

his him of as Chief are Merck Officer an record successful over team have its to now to until Medical at Brian, that, December to up XXXX. served drug Prior who guidance. acquisition ArQule delighted provide of having by on transition in I’ll insight and Infinity, call the clinical the our updates. With recently, most impressive developments, track have We’re and has fortunate to Brian will

Brian Schwartz

I’m at be Adelene. with the Infinity. excited you, Starting to on team update an with Thank out collaborating MARIO-X.

of ongoing you as evaluating in study; Tecentriq frontline there patients As a at are study Tecentriq combination in eganelisib currently multi X therapy cohorts triple breast TNBC eganelisib XX negative in MARIO-X frontline combination cancer. another RCC renal in two with patients; cohort conducted the with and Phase recall, and as cell in this cancer one sites with Avastin for XX and evaluating XX a Abraxane and U.S. is patients approximately patients therapy The

trial, safety moved completed the running and expansion have in of of the they’ve of portion into We both cohorts formal phase RCC. trial the TNBC this and both

news exciting some for Now MARIO-X. from

generation quarter this of progress activity cohort. highly signals TNBC clinical the of early, important made with in clinical but encouraging a have We

an triple of forward abstract meeting particularly breast activity are and medical to the with from is we year options. inhibitor preliminary data deadliest to the TNBC bolts form the activity seen combination in these generating the collaboration an of with limited line free at are in a this treatment TNBC cancer in setting submitted in and late present MARIO-X therapy. with given the combination data in looking eganelisib seeing have setting, data on setting the frontline we complements We nivolumab first are Arcus second line providing the in the with TNBC The MARIO-X expansion in checkpoint from

Moving shared call, trial. experiencing observing uptick up today can status an now that that we the update the and of update study activities. site related in last running majority onto I the our in we we’re in an were On for for sites the delays identified and trial. are initiation enrollment provide the

clinical delays, CRO enrollment to with cohort, with progress. TNBC are delays of terms encouraged and proactively initial well enrollment In by in disruptions. despite we partners In and the cohort address minimal the working now closely our progressing enrollment, is RCC the are

in complete said, expect the Adelene cohort As to TNBC we in cohort XXXX. this early by year the and RCC enrollment

in MARIO-XXX, urothelial patients next I/O is Moving cancer, controlled this randomized with to with in with Phase study X naïve evaluating our advanced eganelisib BMS. in platinum-refractory, Opdivo collaboration combination

enzyme we milligrams dose we data to last of QD quarter treated In with or the XX liver elevations the were information five sequela, a these In X committee, – these X. had implemented Our from reviewed without were address elevations. initial higher these IDMC, and data and reduction or elevation these to meeting the XX Grade from first Grade patients, once call, from patients seen milligrams shared Grade liver seven liver safety patients, scheduled two with the independent MARIO-XXX enzyme while XX monitoring resolved a in X XX reversible day study.

once of sustained the As there’s inhibition and reminder, daily pharmacokinetics the near a of doses comfortable and milligrams presented, with as previously milligram compete eganelisib pharmacodynamics at with XX PIX-K we’re and monotherapy dose, XX above. because of gamma

of enrolled these it Our in enabling the of study. reduction elevations goal ultimate have to previously was successful, dose reduce been appears patients treatment continued the and we

end for we been from able continue be these that the pleased of inform enrolled MARIO-X for use MARIO-X and mature, MARIO-XXX challenges this in have to patients steps with these visits waiting by limited are data data disruptions. the We Overall, year. and associated with treatment despite COVID-XX to next MARIO-XXX, patients study are to continued to able and we’ll the

protocol continued in MDSC situation expand to unique have of times access treat work with that exciting treatment to we with continue maintain safe, of ensuring are to and prognosis treatment. often the Infinity, remember reach and committed indications and the that and are in to to trial these sites a With early that look to the meaningful monitor data to providing as our closely highly closely cancers, to from It important it’s MARIO-X, to immunotherapy we benefits to access eganelisib continue patients as well poor compliance. our forward patients will settings. encouraging targeted across advance hopes treatment patients as challenging treatment We ensure is

clinical and to investigators Larry, I the would dedication to over progress. Before I’ll continued Roche/Genentech thank enabled over patients, has Larry. at turn whose and With I to call the transition like our that, our BMS, call Arcus, collaborators

Larry Bloch

Brian. you, Thank

are pleased the a We discussed. this data sharing at forward early, later elicit rejoining year but we Infinity to really exciting encouraging that time you’re just and that at clinical look

Research consulting in financial million cash of The million and well and second our primarily XXXX. $X.X the $X.XX, $XX.X expense related XXXX. available-for-sale to had stock XXXX. or same results. at per loss as XX, June equivalents to XX, loss or for development the quarter and At Turning diluted basic Infinity compared basic cash, a XXXX March $X.XX total per $XX.X compensation. a compared of period the million administrative loss XXXX, and securities the period same decrease to XXXX same million, of XXXX. for of as common $X.X was second share share an was loss of common in second net a for in of second the quarter $X.X in decrease period quarter million, for $XX.X and of for the million amount $X.X Net to million, for General XXXX expense compared equivalent was quarter to is diluted

which and satisfy be cash PellePharm’s potential including our patidegib balance business-development million. not the needs based $XX Gorlin continued cash expect sale activities, guidance the as to current development BVF the your trial our gel available-for-sale appreciate funding We ongoing million Phase or exclude questions. and based activities, into and anticipate PellePharm. the to with or the X we end time, support company’s XXXX in ranging additional the the $X from, XXXX. business-development of interest milestones adequate And of milestone well plans, include call from between existing upon Syndrome we Operator? any second Infinity’s or funding of $XX equity this clinical open of up up potential topical operating on million in or We financial additional will securities forward equivalents does cash, move eganelisib. can company’s half And the for payment investment

Operator

Anupam comes first JPMorgan. from with Instructions] Rama question Our [Operator

Your line is open.

Anupam Rama

year. taking the for updates much so the Thanks half looking the and to forward my of in second question

is later question first on – the press about that talked release, MARIO-X my update encouraging with year, So you in activity you’re the seeing this and activity this early TNBC.

the you wondering of scope the quick just how guys given of later getting IPI-XXX? translational kind data So we of MARIO-X, defining terms and activity? encouraging size what And looking on things to of And nature data, be a think on here. activity be expecting are of biomarkers much. then we’ll that one underscored the we’re sort in you competitive for year, Thanks the just this so landscape, of should early and antitumor the

Adelene Perkins

inclusion you Brian it what is and Abraxane. approval double in And trial can to designed tell on TNBC Anupam. criteria the to in the thanks, with So combination Front-Line as MARIO-X, Tecentriq I’ll was Roche/Genentech same deliberately done what passion we’ve for of elaborate, trial exclusion very I and to over which have the turn XXX, but the is

and was that a just as overall rate matching eval And XX% have to it’s patient by of of that a rate response – not CR we’re less I received of you the randomized the using data high of new approval expression PD-LX enrolment in while they levels can So, XX%. benchmark. decelerated an tell than the criteria, and that

adding So X.X% contributing double is to that’s is be combination. the benchmark that to need to to that that – show we

his in really disclosing please yet have, site we’ll hard We place. said can initiation as not at dataset really We’re we’re enrolled. because to working remarks, the get that’s patient taking that the Brain

over end of So, working the hard but I’d turn by year. it to that to we’re as to you. it’s too And dataset Brian, early make robust on the that. comment as possible

Brian Schwartz

Yes.

think I summarized it Adelene well. really

dataset, looks duration safety of a and relatively even and partial combination, think at numbers when of efficacy as look one the triple though are we’re number I early complete the therapy, parameters, small. relatively response, of still encouraged we the the even though a different very well small, at with as response

to the uncontrolled end this trial. expanding is year. forward look the datasets the that by So, and we share to we’re Obviously, able of

with been it. the quite nuances far, has the data all encouraging. But so go So,

Anupam Rama

taking for much so Thanks Great. questions. our

Operator

you. Thank

question next from Our comes Riley B with D’Silva Andrew FBR.

line is Your open.

Andrew D’Silva

for Hey, my good questions. taking and thanks afternoon

of couple questions a Just from me.

give If MARIO-XXX you have [Technical to could data utilize of and been color could to existing expect a Difficulty] – thus [ph]. bit the from amendment halfway enrolled be just far able doses that patients little be tubing for

Adelene Perkins

Yes.

So in data-driven. will to be by just again, lead Brian the address I’ll any trial can this. amendments saying,

that. And so where we’re we’re encouraged the safety data that’s can Brian we’ll elaborate that why carefully evolving always by go watching efficacy on with the data, and

Brian Schwartz

Yes.

looking out terms tail setting quickly XX sort dosed XX studied which datasets XX lastly, heavily will will of define – will the safety patients checkpoint out at how how And the both opportunity the patients We’ll very the have to you the of that started who define stringently, and doing, as help patient have the at inhibitors in bit and all in milligrams. So, or three in doing of long-term being the curve, adjuvant the additional urothelial have milligrams. important a urothelial maintenance have are know, little path started we’ll milligrams, at more we’ll of have the efficacy, who now cancer. this data to the are are us cancer. we be group forward.

receiving front or a patients the is first So checkpoint the line population. setting inhibitors – not changing prior

terms make what data is those all decision that in best into forward of to taking able account, the get be So of path a once the for things we set trial. we’ll

Andrew D’Silva

have and the a Okay, just great. just sheet. balance then on couple I And questions guidance

As a far bit. you let of please your as us burden know? a me was sense whether coming guidance goes, R&D give little reduced spending you out Could of assuming just just could

Larry Bloch

absolutely some the out Larry. Yes, this addressing the R&D right. as epidemic. half of coming of with challenges COVID Yes, the you’re Thanks. of year predominantly It’s we’re from first is the

Andrew D’Silva

as financing sheet, – then that’s balance action it year, took perfect. non-recourse the Okay, It’s you then the that actions And make to on active? to able and the the this be royalty relates place earlier essentially to on right?

Larry Bloch

and It’s upon forced the be repurchase completely instantly. cannot non-recourse

Andrew D’Silva

Okay.

Adelene Perkins

a we Of that’s no completely did HCR but liability, just would for to both I there the royalty year both reasons true. Those as are And by the with elaborate, recorded and stream. of is repay with obligation this BVF, secured that earlier accounting and monetizations royalty they’re those. totally

Andrew D’Silva

sense. makes that’s very That And have. luck Thank going Okay. I all you of much. Best forward.

Operator

Roy Thank you. [Operator JonesTrading. Instructions] Our next question comes from with Soumit

Your line is open.

Soumit Roy

Congratulations at using side? My didn’t Hello, is milligram, XX, QD already. XX question. dose a behind up want question You on been everyone. this the see – milligram efficacy you at the what on taking saturation per MARIO-XXX, Thank I’m to every XX trying is know it don’t it to some for XX what for forward the reason off, pushing and compromising why? to moved – has reason and behind you understand the when dropped could XX using on call target use I was is if reasoning the the front. it in asked so

Adelene Perkins

Yes.

Larry Bloch

Yes.

the function that trying much we that time. to think patients you long what to a period often drug – know, dose So, bunch trial, adding that going and agents We there a milligram. is push at MARIO-X the oncology a milligram I it’s single don’t a of was a we milligram this I much, XX milligram sure good clearly we cuts. make had both the target sometimes. on oncology, safer so of types on dose data, XX for clearly But data versus in the we it’s just randomized have tumor in little tend to bit just the in realized are of good But is anyone. for reviewing a in And soon drug the between is the be under the far the inhibition, from case, other of where sort delta PD, nivolumab, XX think in the XX as the

Soumit Roy

apologies if And answered, that. been question this already Okay. I for has again,

we plus MARIO-XXX; this think you Opdivo synergistic through else? something is you in you’re that seeing effect further is this some you this? it looking are or paradoxically How are have seeing, XXX color? Is any the We’re do from

Adelene Perkins

So know single hypotheses, a hepatotoxicity. there is combination each own is its has agent on we a multiple that different some degree of of then degree the drug has hepatotoxicity. And

may a primarily that’s controlled in elicit And a immune top response. We hypotheses have is reasonably combination of it together steroids. that number in A the a in another terms well seen hepatitis with of Hip of transient stronger

each but the all drugs to out. with it’s time that, many could be That’s we There sure cover factors out different bases. it tease could taking contribution. reasons and of be we difficult it one MARIO-XXX make So are to why

stopped, drug So the to if event able you for one example, reoccur reintroduce second drug, the I and you’re or see not. does

better in the get we’ll each So what much terms contribution of is. drug a of idea

Soumit Roy

Okay.

see even XX data [indiscernible]? through would XX ratio levels in the we patients year-end, CDX/CDX some patients translational these obvious versus like and the MDSC So milligram milligram

Adelene Perkins

continued Correct. that collect the able as I on evaluate have mean, to as all all to we be and biomarkers we’ll ready. it’s soon patients,

Adelene Perkins

is We the worked enable I’ll data, controlled as said Soumit, retain may you addition, Brian may that while and blind. that, our because ensure a learn in us that hard to something not will that optimize able to so we study, be very next we’ve steps. to And it remind share we

Soumit Roy

question, congratulations you taking Thank so again. understandable. the Perfectly and for much

Adelene Perkins

Thanks.

Operator

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

Adelene Perkins

you, Shannon. Thank

forward and months evolving and nivolumab end updates you continued I providing data, with the excited and we’re tell, year. hope the through very can our coming additional of look we you again, to progress As in about

all I you for call, today’s a thanks have nice and joining evening. on us hope So

Operator

this Ladies for and today’s you call. gentlemen, participating. concludes Thank conference

You may now disconnect.

Infinity Pharmaceuticals (INFIQ) 31 Jul 202020 Q2 Earnings call transcript