Earnings call transcript Q3 2022

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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 Third Quarter 2022 Financial Results and Business Update. My name is Michelle, and I'll 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 separate and are Web the to data update press everyone. our you, releases announced available quarter earlier MARIO-X good site in this we to Both a third results our call release at discuss Welcome financial XXXX that Michelle, and press on today's infi.com. morning, morning.

Chief open with Executive President; following call On call me Larry Jr., Adelene Perkins, for and today Bloch, Officer the and Chief are Chair; Medical up Q&A Ilaria, Robert remarks. Officer. our We'll the

potential call, and our note and development plans, projections. during this forward-looking therapeutic candidates, make clinical future our strategic our we of Please financial product plans, expectations about statements including that the may objectives,

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

Now, I'd like to turn the call over to Adelene.

Adelene Perkins

breast front-line to in negative review thank metastatic Thanks, with combination pleased for updated quarter encouraging and third Infinity's cancer nab-paclitaxel to trial business or from to evaluating XXXX Phase Jayne, in Today, our us with X eganelisib you are provide and joining single-arm TNBC. triple data update. we everyone patients atezolizumab MARIO-X

continue for which the review we patients, clinical durable by long-term show encouraged to are updated will shortly. results, which We benefit

future priority. advance place partnership earnings development top disclosed call, we to eventual we plan that we to and studies of putting pave development. into entering have a aligned to in second our after partner a eganelisib approval additional and the strategic eganelisib's are partnership We to initiate are quarter made way eganelisib's our on As ensure on

bring date you our Let progress. up on me to

provide Our neck, and our partnership development focused potential has benefit broad breast, seen in an future initial studied ovarian, and the business tumors the melanoma prioritized goal which urothelial, of eganelisib plan cancers quarter It for to-date, randomized-controlled the development clinical multiple a discussions are plan focus announce head array including in directed of is setting. in a development been tests. towards solid of The and the third to eganelisib XXXX. across development

at year our MARIO-X data with encouraging additional Turning a there Breast is of IMpassionXXX XXXX, since to the study. last benchmark maturity Antonio the of Cancer an patients for in relative evidence to benefit data, update the Symposium long-term San December

both for eganelisib with PD-LX status. long-term are survival other report and now promising studied. which progression-free patients long-term negative benefit one-year to rates with patient indications, tumors, has patients We positive seen in the is of benefit consentient were PD-LX This TNBC been with in all in PD-LX which, for able regardless

of treatment. period Additionally, there extended signals during safety were new the no

MARIO-XXX urothelial metastatic clinical pleased updated cancer positive X eganelisib with are randomized-controlled in quarter. study also We from second-line during to versus the nivolumab third report the results platinum-resistant plus evaluating patients nivolumab Phase

of two-year eganelisib patient's the the we combination compared as a analysis survival monotherapy. As landmark care previously reported, nivolumab approximately doubling standard of overall showed to

potential eganelisib has five across our date. transformative the key promising clinical to results oncology of indications and a immuno-oncology provide solid continued be settings evidence demonstrated treatment therapy indications reasons. three that strength across has to in multiple Eganelisib data The for

with that anti-cancer the activity suppression, tumor-like and reduces and reprogrammed potent data translational activates a have inhibition an target immune environment, and we specific in First, with eganelisib target showing first-in-class macrophages therapy immune on response.

demonstrated distinct have a prolonged of see eganelisib survival the clinical indications the trial us eganelisib care over randomized-controlled of in progression-free in allowed extended with multiple contribution drug current that survival Second, overall over standards and data combination partners. its

importantly, acceptable manageable in combination drug regimens. in two- profile and an to three-drug and and eganelisib been other with have shown safety Third very combination including has

this At our now just encouraging call turn Rob? would I data. eganelisib time, Ilaria over Dr. to like to the review to recent

Robert Ilaria

TNBC Thank to X efficacy were and of patients. you, to atezolizumab or IMpassionXXX in either TNBC PD-LX enrolled front-line the of Adelene. eligibility positive mirror Phase the addition and for designed to PD-LX our the was MARIO-X negative to study were Good nab-paclitaxel morning. MARIO-X criteria eganelisib cohorts. the safety The objective of study in evaluate metastatic benchmarking. tumor The Patients facilitate

the that of front-line are tumors limited regimens for in There of been checkpoint metastatic tumors. to with TNBC note with no important immune in two-thirds TNBC metastatic have inhibitor positive approved checkpoint negative PD-LX immune approximately which combination inhibitors patients It's PD-LX represent approval chemotherapy patients.

and As patients with MARIO-X in months. duration XX TNBC a of follow-up for valuable X, were October XXXX, enrolled valuable of of patients XX were safety a in for efficacy median XX

In patients had the and had dataset, tumors positive patients XX efficacy tumors, PD-LX undetermined PD-LX of patients negative XX tumors, X had PD-LX status.

we MARIO-X share improvement. to improvement PFS in evidence median IMpassionXXX X.X with of PFS we and to continue that very see of encouraging XX% a compared a study. see in patients progression-free months in an PD-LX months negative benefit to durable with median pleased are In continue as this in X.X tumors, survival We relative

benefit a we importantly, rate seeing PFS XX.X%. of long-term of with are more one-year Even also potential evidence

a inferior the exceeds negative patients with PFS checkpoint it XX.X for inhibitor one-year PFS negative ITT, one-year of which immune subgroup for included therapy, course and was MARIO-X positive IMpassionXXX PFS population, with that disclosed the be the PD-LX Although should rate negative noted not IMpassionXXX outcomes PD-LX one-year in PD-LX with the the rate tumors, rate tumors.

potential we relative PD-LX XX.X% a In IMpassionXXX, long-term positive in observed of PFS benefit compared improvement. patients with XX.X% of a with one-year evidence tumors, rate also to XX%

response compared activity to of PD-LX of of the eganelisib rate XX.X% in the in rate In PD-LX addition evidence IMpassionXXX positive with tumors, patients IMpassionXXX. is anti-tumor objective PFS XX.X% to with in a higher by tumors. rate, the further we was patients XX.X% The MARIO-X XX.X% response largely patients in versus encouraging driven one-year triplet complete observed positive

median XX.X a in with the to see was duration in median IMpassionXXX, median PFS Lastly, of continue the X.X a X.X to compared relative months IMpassionXXX. improvement not PFS XX% PD-LX We on population a months response months months did improvement. positive MARIO-X of to X.X compared

PD-LX proved pembrolizumab in to With PFS with enroll, with which patient cohort. characterize the plus the chemotherapy approval robust to a our less size patient us PD-LX be population median tumors, sample challenging compared positive of this provided to patients a negative to

The of These each were one-year updated indicator XX.X%; was very safety skin consistent extended of in rate safety rate, over The consistent XX.X%, PFS the analysis the of rate adverse in for PFS one-year potential PFS in AEs triplet or long-term a events, tumors in X signals neuropathy had XX.X%. entire no treatment-related treatment. the expectations XX.X hepatic component higher reported and XX% time ITT, negative an on remains one-year Grade TNBC were tumors. And the in neutropenia relative improvement at drugs. AEs and peripheral most adverse XX.X% new regimen with status three positive IMpassionXXX at benefit, PD-LX population. observed XX% across events common MARIO-X in PD-LX a for during the combined XX.X% the PD-LX a and tumor Nonetheless, MARIO-X, MARIO-X

AEs, treatment patients in for which and favorably of IMpassionXXX doublet. discontinued triplet a the for to atezolizumab XX.X% for XX.X% compares treatment-related regimen the reported nab-paclitaxel

an amount combined adverse relatively hepatic with often when saw higher short or without the immune was checkpoint be most and to time, a Law. continue of no treatment-related common AEs eganelisib corticosteroids. events reversible While elevation remain Hy's infrequent, is Grade Bilirubin inhibitor, they of X we evidence within

These second-line progress-free TNBC provided the one-year survival gain in data build insight regimen combined benefit on consistent us trial urothelial and of upon PD-LX Xb cancer the types atezolizumab patients a one-year maturity where across platinum-resistant cancer. data potential in are eganelisib almost randomized our survival important inhibitors, the with new tumor benefit from eganelisib such in as into to encouraging MARIO-X next with rates MARIO-XXX squamous a has in of of status. with summary, our steps studies overall The of and with data randomized landmark tumor checkpoint are to X robust, the build two-year multiple demonstrated refractory the immune MARIO-X In head Adelene Phase described we greater our long-term eganelisib across patients' findings triplet from promising nab-paclitaxel study findings totality for neck. potential and Data Phase clinical to cell setting. trial opportunity

Now, I'll turn call results. financial Larry Larry? third our quarter to over to review the

Larry Bloch

Rob. Thank you,

During capital allocation. the we disciplined, to continued a prudent third pursue to quarter, approach

related Research increase in were XXXX. of cash of to expense $X.X million compared primarily compared million So, staff additional and eganelisib. December XXXX million, quarter compensation to Infinity compared at XX, of at this the same to third General development million third development for total the quarter administrative expense $XX.X of of future And XXXX, XXXX. the end period same XXXX is as $X.X to for due $XX.X quarter million at XXXX. was expenses in higher for of third million the the the had period to $X.X $X.X and

per million primarily diluted to $XX.X of share share of common third for $X.XX, and same was of compared $X.XX services. loss the guidance due or XXXX and diluted quarter common to financial in increase basic a per or unchanged. for XXXX. the loss was period loss decrease remains loss basic Net Infinity's a And $XX.X XXXX million in of special in net

million, was $XX net announced million. financing on million We from the for guidance does goal million of range $XX finance from be quarter activities first to year-end and development and XXXX continue business range our to additional expect include to not between cash execute XXXX strategic $XX as to XXXX. eganelisib between in even or to loss partnership Infinity's $XX and

questions. we open for the At call this time, can up

Operator

first from Sandler. Edward you. [Operator Tenthoff with question our Instructions] And the of Piper line Thank comes

open, Your go please line ahead. is

Edward Tenthoff

you be And update this on of Antonio that and other Thank presenting there and the year? for update the very comments San Breast, sort much, you or at will Thanks. the we presentation data be is appreciate all Great. Should MARIO a today. expecting thanks the for too. this

Adelene Perkins

for MARIO-X. you, This the question. for is the Thank Ed, data update

As could you for so on years, presented quickly. so that and last Breast two the have recent data the to data this get Antonio data we know, year call Symposium San cut chose more this have the out most we to present the Cancer we as

longer toward meeting. medical you the know, As a there's time lead

Edward Tenthoff

the makes Yes, And appreciate sense. data, it. lot on great. I looks it of congrats a

Adelene Perkins

Thank you.

Operator

Instructions] [Operator And Jones comes the you. Thank our with line Roy Research. from of Soumit question next

is line open, please Your go ahead.

Soumit Roy

for everyone. Hi, the Thank you update.

would color pervious PFS go median number pulled the appreciated. trying particular or about these more patients the the than expected? back up understand update, Any expression that is anything the XX did be new levels Just versus to PD-LX patients

Adelene Perkins

in and Thanks, Soumit. Rob, update so it's was the that on one-year and the what that pleased see rate, meaningful of But we a The further most we more important median benefit. focused on mature, elaborate data this which bit PFS think most little perhaps, to is are can a really is you reflection PFS? long-term were

Robert Ilaria

year, in that of the the whatever challenging population middle proved Last research the were those to lot community Sure. approved, patients the got challenging in in a we year PD-LX lot chemo] of that not one provided more And challenges patient almost were number of seen Once when things enroll. ago. is a median that value the the of from bit have. one [pembro of date centers. and of is had updating we positive of PFS, you think the we list of patients I data, [Ph] a the And a course,

to PD-LX And we negative. as result, positive that can weren't able a fluctuate result, group as midpoint as the lot. get patients really as in So, a a many

there And so, yet. their year, scan who patients had hadn't were last first even some

when can variable twice I think to, have set sample smaller what compared a you the median negative was for were. challenges example, PFS set the So, of PD-LX really almost our positives be

Soumit Roy

That's it. much. you Thank so

Operator

line Instructions] with of last Riley. the comes Kalpit [Operator question Patel Thank B. our from And you.

line please ahead. go Your is open,

Mayank Mamtani

congrats and Mayank on Kalpit. team. morning, project. on This Thanks is for the taking questions Good our for

then maybe discussions UC have So, you next has for that first advance which relatively ongoing the focusing And do any to been partnership the TNBC, higher are in and stage? to follow-up. there indication being your interest one versus anticipate quick a other, on maybe I versus the

Adelene Perkins

future of partnership a the question. the a position until you describe in for we're you in We eganelisib's specifics you that thank not might to we've a the Okay, place. future few today the to in plan development. things Well, expect can development on see tell put

of encouraging a the more one First eganelisib its it clearly standard leveraging in some The is unmet focus in of the of in be be contribution will that the of can regimen be three, a will setting eganelisib it randomized-controlled contribution very a setting we data will high care. today where development a we that so show that there's over need. generated over And with indication. patient

So, breast, broad tumors. we've ovarian a urothelial, across array seen neck, mentioned, the of benefit development melanoma. us of many It eganelisib gives you paths, and as potential head solid

we're to so, going we're we trials potential XXXX. first to and with the next and partner, And a that in -- announcing trial of the the the forward subsequent prioritizing and of look first details prospective next partnership quarter

Mayank Mamtani

any the [Ph] the a of then, kind on own that Could study kind these positive and for KOLs, over thoughts to together also also would your PD-LX the away in status, on And you them [SABC] weekend, there negative, comment and is from like you related design. discussions a color. opportunity novel registration just helpful? with Thank in look as of a or and context Conference an that, if what lump could follow-up, trial and coming of be

Adelene Perkins

PD-LX over it Rob, patients in that of eganelisib highlight seen we have status. turn I'll tumor types multiple across just with benefit different Sure. and regardless

Of will approved can is of different care And patient standard Rob, those populations. course, depend elaborate on a registrational what you further? in trial maybe, the

Robert Ilaria

story, They're PD-LX question in is mean be positive there's -- populations, complex TNBC, going the a Sure. arms. are and that negative of there. PD-LX for a consistent encouraging. for thinking regarding for successful now And great of could certainly which rates haven't PFS one-year it certainly it's also, is true about our certainly two and large pretty trial although inhibitors checkpoint different two care we it populations, seeing lead different I standard both because a does those very tumors, path patient probably The the make TNBC specifically, the one been across control negative

certainly, greatest PD-LX unmet could argue that that negative So, you is the in need group.

attractive And data. totality mentioned, path. So, as we adds that's very data also of TNBC the a of the the Adelene certainly kind to believe

So, within influenced I well. decide think our which much tumor, tumor, which be I which to you and indication preferences who as go, a will partner by think their way is, very

Mayank Mamtani

additional updates. Thanks forward our for taking question, look team, and to

Operator

Adelene to back at conference And And you. I'd remarks. I'm this for showing questions further any no Thank time. the further like turn over to

Adelene Perkins

all for joining you, today. us Thank thank Michelle, you and

cancers We the dire for about generated, are therapy. that really the data treatment enthusiastic improved have potential need patients we the and eganelisib in are with progress of of of who advancing

So, on coming focus continued your we in the the efforts next eganelisib updating Thank for you our look months. the and development forward study for you support. business to of

Operator

Thank conference. does you. This today's conclude

a You may great all have day. Everyone, disconnect.

Infinity Pharmaceuticals (INFIQ) 14 Nov 222022 Q3 Earnings call transcript