INFI - Earnings call transcript Q4 2020 | Infinity Pharmaceuticals, Inc.

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Infinity Pharmaceuticals Conference Call to Discuss the Company's Operations and Full-Year 2020 Financial Results. My name is Victor, and I'll be your operator for today's call. At this time, all participant lines are in a listen-only mode. There will be a question-and-answer session to follow. Please be advised that this call is being recorded at Infinity's request.

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

Jayne Kauffman

and everyone. review good call Victor, you, Thank afternoon, our XXXX results. business full to Welcome recent progress our and of financial discuss today's to

is release are our our for infi.com. forward-looking this about plans, at on On product call, Perkins, Officer; strategic and we remarks. Q&A the Brian our and candidates, Consulting following during available Chief note that our and results plans objectives, strategies open We'll website press Adelene Please expectations potential development Chief may the statements our including President; and of me Physician. Bloch, our issued up Executive therapeutic financial make details with clinical Schwartz, future call and projections. this today afternoon Larry the The call

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

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

Adelene Perkins

study at potential breast diverse last REIT our San together, in I'd TNBC for Chief Cancer most and Cancer months through discovering solid our MARIO-X upon improve therapeutic our with broad by unique second-line you eganelisib, cancer and Breast presentation eganelisib's in cancer ASCO summarize first-in-class of Brian our to recent now Immunotherapy tumors, programs. urothelial programs, in been macrophage which conducted foundational candidate by triple-negative two Consultanting and across repair Schwartz, modulating thank and this demonstrates regimens. the thrilled ARC-X next has our of immune in joining our Society eganelisib Symposium and today's month at to data cancer MARIO-X briefly two clinical review treatment to today. presentations encouraging listed that work Meeting at discuss past Thanks, a front-line in for Infinity and that, data the of to of data above data study programming from Arcus collaborator and GU, the November, from the and our Physician, have again We're Jayne, the will of eganelisib developing Biosciences December, standard benefit and and driven Antonio to us On ovarian The transformative second-line data for from everyone our MARIO-XXX call, set four fundamental like mechanism. data. translational recent clinical presentation before But Dr. translated presentations

from in tumors MARIO-X, First, evaluating this study in melanoma inhibitor solid at data study data week. this checkpoint reinforced in Squibb Phase from on our with to combination their the head in Bristol-Myers advanced cell presented with collaboration and checkpoint prior with and Opdivo as eganelisib was to potential immediate of progressed a with who neck inhibition The resistance X/Xb patients therapy. overcome had squamous of the cancer patients eganelisib

TNBC and high and our in the Tecentriq with evaluating X Phase the combination doublet patients. patients with of of Second, therapy in clear The data as a approved from treatment data MARIO-X, would increase Roche/Genentech study the was TNBC with in collaboration front-line cohort and of Abraxene treatment PD-LX eganelisib at frontline and rate response the SABC. versus showed the Tecentriq an overall disease rate for CNBC presented control Abraxane

irrespective of and volume, this in patients response there in in high a XXX% was study a PD-LX Additionally, rate patients. of status, XXX% achieved tumor PD-X reduction

ovarian showed rate an data cancer also inhibitor indications. Arcus cancer the evaluating in addition from in patients at eganelisib's our Phase from presented checkpoint dual with a novel breast that study collaboration, Doxil antagonist data data SABCS. eganelisib doublet the was therapy relapsed/refractory includes Xb regimen identity with novel and finally, This triple-negative a free response And in in receptor Third, of and both to increase a Trimode, MARIO-XXX. their

are improving up-regulation unmet activated forward in an and the in are combination Our low expression studies, in across with to that diverse to which study to combinations include and greatest including a path beyond modulating first, advanced patients improvements clear Across inpatients. priming in focusing the for The rapid checkpoint multiple cancer out and mechanistic at control not to providing on approval immune levels data tumors, to path ability lines with need progression-free GU results who particularly therapy unmet these as by the and clear disease the BMS of enabled potentially ASCO second, of patients mapping addition cancer we needs low turn with triple response evaluating begin eganelisib and eganelisib activity, for oncology. well in data to third for has randomized X with collaboration inhibitors. responses in settings placebo-controlled care PD-LX PD-LX, of clear urothelial urothelial some rationale in efficacy translation by PD-LX was Opdivo of data of month. Phase of rate, double-blind double presented eganelisib, a tumors address advanced significant thought regimens which are and us known and with rates of immune signal consistent inhibition indications. bolstered upon our highly survival, in thus These signs showed in eganelisib response. treatment cold in emerging last standard with This the and respond checkpoint improves is robust which solid This of in show patients population

we generated locations. provide for and data suggest may benefit PX eganelisib PD-LX that the high have While both

patient of urothelial a number in Focusing provides cancer low advantages. on population PL-X distinct the

bringing trial, the XX% experience the of enabling the this First, showed a that's to inhibitors PD-LX evidenced in the population, Furthermore, disease to PD-X benefit response there's the limited cancer are patients the with cancer, the see In a XXX, entire control urothelial low low need is adding equivalent a intent-to-treat difference in the Checkmate achieved in a which we measure there's progression low have progression-free benefit a patients PD-LX population, in able overall immuno-oncology such eganelisib PD-LX patients controlled Opdivo patients the patients. the no the Opdivo less the group. rate that addition for as high above the XXX. approved benefit rate response we same were we seen to analyses from in the frontline in the demonstrated in little to combination Tecentriq high rate PD-LX cancer PD-X Checkmate had patients monotherapy with by MARIO-XXX, success level unmet fact that, level was disease were achieve PD-LX patients, in to eganelisib. X to PD-LX increased checkpoint retrospective that in We eganelisib even of cases where PD-X similar likely Opdivo, second-line providing to patients by of what as low low the approval monotherapy only. with and low in checkpoint urothelial that tremendous for many between to approvals as high for level inhibitors in Keytruda and patients are arm PD-LX therapy And in that survival not

X.XX, of magnitude the less patients, trial with the this ratio to trial of given be Importantly, with faster demonstrate with benefit to and eganelisib possible number a such can in should a smaller, few in its registration benefit it MARIO-XXX be a conduct. relatively a and expensive hazard seen of focused

be including eganelisib. drugs regardless the strategic eganelisib benefit Our patient largest the whether a goal have From just expression, are Xthose QX unmet reach suggests broadly perspective, patients the expression are or is the reasons the mechanism increased the all starting This PD-LX broader low data more of population high immuno-oncology PD-X beyond on PD-LX the could of of because patients while is with we immune who levels. initially activating of to low levels for greatest I with represents extend of utilize focusing patients. to and is need. PD-LX the patient low populations, eganelisib highlighted, to

effectively So long but broad types, data ultimately the provide we're starting low will cost eganelisib PD-LX can in the patients. believe in and term, patients most suggests and benefit rapidly tumor we be approved where across

value only leaves us facilitated I the therapeutics also extensions, clinical owned the that our rights eganelisib promise to for potential and to these targeted data unique XXXX, our well the data, recap in and to aggressive and development is to we're million positioned on provide development want patent even our creation retained steps programs, execution eganelisib and Before macrophage a $XX commercial for that shareholders. turn over our highlight clinical with of that which tumors. our strong patents given Brian that through I prior It's development next offering the incredible public strategy. recent across have thrilled solid of to therapeutic And continue really for patients full we've matter very composition to any call note term focused candidate important wholly of holds

and patients employees, and very are to and have enabled who And commitment that, this dedication We our collaborators, grateful Brian. with the for I'll partners investigators of progress. our call over especially turn the

Dr. Brian Schwartz

insights eganelisib of the care, the eganelisib with in I'd nivolumab of patients and designed evaluating was Opdivo study Adelene. safety eganelisib urothelial of naive cancer. benefit the MARIO-XXX, evaluate action, cancer The the patients. nivolumab our advanced of for to approval in X in efficacy platinum adding refractory to urothelial Phase nivolumab, second-line placebo-controlled standard start combination with IO and by you, naive IO leveraging study or to Thank CheckMate-XXX accelerated of with second-line mechanism study like randomized

ASCO results highly encouraging. at Our GU were presented

nivolumab nivolumab patients in PD-LX standard was With we saw benefit. demonstrating monotherapy. And rate combination low with and the disease of line it in as improved second care greatest versus the control survival where the Adelene eganelisib overall response progression-free of rate, really the described,

MARIO-XXX disease in we is nivolumab rate DCR XXX. the Our XX% of is achieved monotherapy the same in which with at the exactly PD-LX of CheckMate patients XX% patients that overall which low, PD-LX BMS reported XX%, ORR high the just with in above these PD-LX looking the receive to low results from the the rates, control the PD-LX strongly When in same response rate that BMS Together, nivolumab standard achieved which that of of monotherapy in potential the IO as for the the patients the PD-LX PD-LX suggest level of received to currently eganelisib has care. in patients benefit from level benefit therapy study. the high patients high as raise

ratio for that of patients less was evaluating of hazard likely the are Moving an XX% plus nivolumab benefits. MARIO-XXX, to PFS X.XX, important hazard progress emphasize on combination I'd treatment on patient PFS. relative In to placebo receiving immuno-oncology treatments. in indication how like the to such patients to ratios significant the arm,

controlled in there ratios tail reflected significant curve median would the number in over enhancing in the only raising arms, cannot to the thus that the single-arm there's one in decade arm I where be past the long-term the that immuno-oncology in the along the program. by of Kaplan-Meier are Furthermore, be hazard We benefit statistics. measure small hopefully about hazard and that of to weeks. a PFS between the First, by only leading The see study to benefit remind which MARIO-XXX, of XXXX, the by drugs immuno-oncology evaluated we time-to-event trials OS of entire you be of registration for tail with activity controlled additional X.XX curve. checkpoint and results, Based a demonstration or particularly or expect increase of trends between the to proposed the benefit, The PFS, regular differs is but PFS period. hazard stages are relevant to a differences control capture a raised the OS patients, referred the position over study measured the few the been on rounds effect given in expect study, or difference ratios which can This qualify in term and the is in drugs two the curve compelling arm which decade therefore, what the sale arms endpoint ratio. the we study. a that not will with of will are of soliciting we plots. past process these a long-term experimental of is more patients precisely a is consistent design, fails PFS in OS, be effect goal has hazard the our the the input exact of a In who the early to longer this between to the been this of over in trial research long-term expect on feedback, see percentage QX This regulatory of difference may thus and the initial tail in median planning two inhibitor, April. end contrast, receive with entail well trial information feedback present ratios

the Abraxane for inhibitors benefit of our Tecentriq and and MARIO-XXX, regimen, data TMBC on Breast approved high, quarterly checkpoint only where low cancer at will, as PD-LX to regimen approval San for limited of of the the in both study out an is We all to positive the Triple-negative frontline in regulatory breast Like Keytruda is Also, cohort we customary the this the a which since leverage call, breast setting. front Tecentriq will approved in focus MARIO-XXX time-to-event for such is another Roche/Genentech MARIO-X, presented MARIO-X strong the for PD-LX cancer the course, findings in dose line XX-milligram of TNBC, Symposium. example eganelisib Antonio triple-negative is Cancer case, and coming patients. of and adding last PD-LX use patients, approval.

high XXX% criteria addition the data benchmark to to At of leads standard patient Roche/Genentech IMpassionXXX clear we of benefit current population to MARIO-X, a to Given conference, may enable study to up-regulation were care early data of eganelisib from the at assess that first regimens their of eganelisib and had volume breast with patients patients eganelisib's efficacy comparison. To patients patients, were response patients the but the endpoints fidelity response enrolled reduction the of received contribution tumor report had Abraxane, mechanism exclusion a We evaluable over and and scan. patients the the PD-LX in again a XXX% trial extremely had low the expansion and designed Tecentriq PD-LX approval the high safety XX respect for not well. responding encouraged XX% and the that action, had PD-LX which partial an included low first and to MARIO-X PD-LX the the and to who additional time XX presented a or complete either XX% with was for the with in responding. provide cancer inclusion seven set of an of data who as that

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and is opportunity and approved ORR currently given a monotherapy, for against have to So of regimen what most the for the approval. in checkpoint the this PD-LX not population, with where were patient range up eganelisib, XX% the expected. And PD-LX next Abraxane is is that in going care, an which of three Tecentriq in XX% this in see not in expect wins which approval be is potential we immediate vaccine including trial population. low standard The approved inhibitors TNBC, path is to of an approved the in combination, yet not we been terms which group,

been responses these on monotherapy Abraxane not durable. Importantly, have

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it demonstrated the doublets same Abraxane the demonstrated doublet think triple-negative arm the the both data eganelisib. addition advanced ARC-X doublet. frontline a cancer, up broad the Arcus, also rate our patients, etrumadenant addition Doxil triplet. is triple-negative Tecentriq potential. plus had second-line clear the dose and was collaborator, are specific the we evaluated both beyond, for exact I remember settings. to cancer XX% that cancer TNBC ovarian to and upon by XX%, part important triplet The see presented improve in addition rate patients to ovarian escalation and eganelisib eganelisib to CR regimens the response eganelisib that the benefit. and and one went and of in Doxil in in in conference, potential X% of In which the doublet the with for doublet etrumadenant at in The of doublet CRs In setting breast ARC-X plus plus of portion, no compared that with a of went the with to XX% up and patients of to breast which eganelisib a response the beyond

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MARIO-X, the Tecentriq a are with in reminder, Abraxane we renal cell in in this cohort eganelisib Moving cell as frontline cohort, the carcinoma. to combining and renal the

cell have In there's again, doublet completed inhibitors XXXX. in patients checkpoint combining a we are in to to We To of is approved with not first is are in XX enrollment thus expect data MARIO-X cohort, contrast context, breast study. eganelisib a cohort cancer some the more this adding to approved doublet, to VEGF triple-negative of we and and adding which potential the around renal excitement provide of of concept lot eganelisib cohort proof-of-concept an and antibodies. half where report

with study, study, trials data moving from this registration determine be we to to best with MARIO-X and with now of combine evaluating forward. data and we eganelisib eganelisib we recent we'll of combination from Avastin. move Tecentriq hypothesis VEGF whether with to what along forward the inhibitor to improve test frontline the type outcomes adding regimen checkpoint seeing the So, are are above can approved eganelisib that If proof-of-concept

inhibitor prior ORR melanoma a data after XX% presented immediate we two SABC, At than who therapy cell in of on MARIO-X. progressed to having have less and past therapies. XX% on squamous patients checkpoint or equal their greater as disease received touching control, and a showing Finally,

this we data. opportunities multiple forward, Moving leverage see to

to mechanism window we're who nivolumab head so evaluated at for progressed opportunity cancer be opportunity the checkpoint RO with the window combined this in tumor responsive study, and can of and next in treatment neck further data best of our Cohen, the head of presentation and head patients In an cancer. Ezra as with on changes with to who steps investigator, neck in showed immediately at surgical MARIO-X resection presented from presented the the that data is eganelisib SITC, neck study, prior in in First, of the delineating study tissue which Data the subsequently administered interested inhibitor a have eganelisib. prior cancer SITC. will this receptor tumor plus therapy eganelisib of inform follow us

and in with inhibitor terms a inhibitor, our PD-X Wolchok with leverage potential triplets, are CTLAX. active addition in nature investigators to CTLA-X PD-X number the including a a PD-X where Jedd the melanoma, of from our of we doublet discussions in understand and synergies data a eganelisib eganelisib, melanoma, of to of from In to MARIO-X publication blockade the

is registration PD-LX low eganelisib beyond that modulating a metastatic And efficacy past if melanoma indication consistent a PD-X regimens, setting, we forward eganelisib a planning through there's opportunity the mechanism. In few We We and profile are of meaningfully demonstrating increase activity increases in unique patients eganelisib. months, in the have opportunity diverse patients an immediate excited refractory or urothelial a broadly broad really looking to believe to compelling see and to the activity across urothelial this an for in consistently that again, have cancer, the are revealed addition benefit PD-LX we subset. immune the cancer success trial for and seen indication.

in on patients on needs what a and solid the and needs is focused well the data unmet the also really eganelisib that opportunity TNBC is suggests making RCC We, and opportunity, vast patients extend and promise. of continued PD-X commercial as the the of have largest the tumors of of is with tumors. We of evaluating a indications PD-LX potential one enormous, in as majority of in low believe levels therefore, terms we're oncology. both it as focus on focused of medical The on truly expression, execution delivering unmet eganelisib patients, addressing that are the majority potential PD-LX and other for ability these solid given for low beyond MARIO-X to with the the are low

Roche/Genentech continued has Larry, over our BMS, Arcus, the to thank Larry. our collaborators enabled I turn especially eganelisib. whose have over call -- I'd like investigators, patients, our who at to the to with now continued Before I'll dedication dedication call and turn progress

Larry Bloch

you, Brian. Thank

I to for collaborators ladder, the financial in Professor been have true MARIO like intellectual and studies, preclinical our Regards our from our what reprogramming emphasize to regard patients just for foundation inspiration said which in from our our been turn to Jedd Kettering Varner their our to our was who've stands with true out for Before and collaborators, Wolchok Professor who with thought Brian I'd appreciation Memorial results, Sloan clinicians immuno-oncology laid including collaboration macrophage our and Judy partners. Cancer UCSD. Center

have gave and through the panel at will on X, answers small release which approach. entitled the moderated microphages to XXXX to delineated progress, presentation the through It And into will gamma be entitled April has methods as also tumor-associated truly symposium Dr. for there Friday, question Chairman gamma. were in and by of on pleased Infiniti made increasing Annual we're articles, give of action we're then member appreciation more and inhibition potential elective years The therapy Kutok's the a broadly. major now date We two back is back kids a published microenvironments. that gratified for American Sands Advisory normalization April lead next month. a invited Research Association upcoming the molecule offers X XX-minute the targeting the Meeting, annual meeting pharmacological therefore Varner four p.m. XXXX since Judy last of ACR which a the improving Dr. we be at Cancer Jeff And Kutok, which targeting for presentation reprogramming Board, of Time. X:XX the to Dr. very of talk Eastern of from k therapies session our similar well by major course as presentation fundamental two XX, Thursday, macrophage been AACR presentation a And PSP

$XX.X available our compared to XXXX, to equivalents had year turning million December of XXXX. at cash facilities results. XX, total million and XXXX $XX.X financial Infinity December cash, Now XX, full

revenue net this HealthCare offering to common general XXXX. royalties reduction sales include the common loss XX% of was to and that from million loss investments, was mostly Net share a completed related HCR the we or for $X.XX Decrease $XX XXXX the to terms $XX.X public million and proceeds, $XX net decrease stock to $XX administrative The relates by common XXXX. royalty Research in share compensation compared million was to driven services. in million, proceeds been loss primarily the loss equivalents in the to $X.XX on from duvelisib and representing $XX of million. XXXX X primarily and $X.X compared for the XXXX of royalty $XX.X basic million in diluted million of the loss February XXXX study per And Importantly, Verastem compensation, year-end in syndrome. proceeds royalties to between early sale achievement first to between sale million to ranging professional XXXX. was for for development XXXX was balance I of monetization, million PellePharm, paid its over $X.X due royalty expense does well net as financial $XX.X net follows. royalties and expense a as a loss as Takeda was XXXX. XXXX. patidegib expect Copiktra of XXXX initiation in in as of quarter $XX relates approximately $XX.X in of per closing Bio. the to In which public in Takeda, G&A securities rights the and million XXXX or net for with presented as in IN was in expects decrease $XX.X cash is million due the this XXXX compared end of $X.X during $XXX,XXX from agreed expense $XX.X primarily an XXXX stock million to $X during in Affinity's not Royalty XXXX. recognized from of million, Revenue basic net million cash to and Partners we this from to million diluted exchange, for we of compared Secura range $X expense share offering decrease in And equal $XX XXXX, expense of Copiktra decrease for of Infinity's to of available which which forgo a for guidance, for million in from the Bio. then milestone cash, Gorlin of XXXX and and Phase If in a from Secura to gross million

for potential positive equal the stock PellePharm of continued from between development PellePharm So the plans, Indy's at development equivalents can Company's look with PellePharm conducting activities. in we XX appreciate of securities, the existing -- guidance adequate royalty based offering value or in until of sales $X This At questions. is cash, termination a X for additional we has million XXXX today. does the up or and your of January interest interest, eganelisib. Syndrome, needs XX, the Operator? from the up Infinity's call next or right to or the not milestone price the expects will operating a Phase to February these the for earlier agreement. the months as payment share days be of the for its this on our the proceeds repurchase We equity A XX funding capital once support to view business the greater BVF, time, $XX current forward from it's satisfy public XXXX sale now from until potential be of from $X X that Company's Infinity net Phase potential closed including least include BVF or million available cash Gorlin data

Operator

Our from first Instructions] [Operator come line Nick Fargo. question Wells of Abbott will the from

You may begin.

Nick Abbott

Good afternoon and my the quite thanks months. over of set for Congratulations there question. few last data readouts on taking impressive

does a had What Just some trials? a be entail? other next in of terms plus that going exploratory or is eganelisib? phase registration the to sufficient that for trial registration single cash of guidance, the Is trial

Larry Bloch

question. This is take Larry. I'll that

of with said, initiation which study. as potential obviously, the our So our interactions plans, that current Brian the be by, is informed FDA. guidance have on the we upcoming registration-enabling the operating currently based But includes will

confidence that TNBC later for look example, like. on thereafter. half interval initiations for this additional as of year additional -- based might second in this ongoing some year scale It updates include of And data, So not the this that the scope the of what providing as providing year. does the clinical that initiate updates in well first we look half to might might there's initiate studies and or forward we MARIO-X balance of investigations some around upon, trial we

Operator

Our next line come from Rama of the will JPMorgan. Anupam question from

Matt Bannon

our evening guys. Good taking question. is for This for Thanks Matt on Anupam.

If we cancer much. and were for know so including side. helpful. super logistical you financial from will the into urothelial details the if of with us forthcoming, So existing Thanks actually, we the trial are would the design more that but of be focused eganelisib over earlier in that studies, the collaboration on of clinical And the MARIO-XXX, the wondering remind could agreement, carry on the Bristol terms registration trial?

Adelene Perkins

for Sure, question. Matt. Thanks the

the arm's an we is existing refer as relationship. what to BMS length So relationship the with MARIO-XXX on

arms to arm adding And their of lot of is been so, again, of a BMS a study. involved Opdivo providing on treatment sharing study as CheckMate-XXX MARIO-XXX Opdivo and well arm actively combination both the insight in the in included being design -- our the as and has comparing on from free two has because Opdivo it given been that study, we're which supportive important of extraordinarily the was charge,

So, it's terrific a collaboration. been

not will decisions study. the for have when registration who made yet with make partnerships We and about partnerships

this to at that's point. be So, determined

Operator

[Operator Sandler. from Piper Tenthoff line from Instructions] will the come next Ted Our of question

may begin. You

Ted Tenthoff

the the all on on progress. Congrats update Great.

sense, to the cancer detail provide with a more get urothelial But conversations trying in additional do be large following think you that FDA. Phase appreciate phase? X study might Just how you

Adelene Perkins

what on start PD-LX So ranges when might which, that on And a X.XX, target minus some of exactly a relatively patients. something Again, having conversations, -- or we might to of of really low little Brian, an patients hazard conversations is elaborate. XX have. it XXX-patient depend result, at I'll trial, as on ratio the you the focus those and a range, with can look pursuing the strong premature we'll hazard achieve the It use we're that that we in for the small plus that. we've a ratio prior right you does But endpoints registration that depends -- believe we now of because number. reason we approvable in

it does what on depend right really now. So, we're thinking conversations, the but that's of ballpark about

Operator

to closing actually Adelene to the any over for And like call any questions. I'm not you. remarks. Thank showing turn further I'd

Adelene Perkins

to We're as months. MARIO-X forward urothelial additional opportunity well Victor. data sharing in in for you, plans frontline the as this registration really advancing we from the locations in PD-LX for the plans in more TNBC and specific cancer, -- trial be coming to tremendous eganelisib Thank excited our look

your all on a joining continued and us thank evening. So for support nice today's and you have call for

Operator

the call. Ladies this conference participating. for and gentlemen, concludes you Thank

disconnect. now may You

Infinity Pharmaceuticals (INFIQ) 17 Mar 212020 Q4 Earnings call transcript