IMRA - Earnings call transcript Q3 2021 | Enliven Therapeutics, Inc.

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Operator

Good day, and thank you for standing by. Welcome to the IMARA Inc. Q3 Earnings Conference Call and Webcast. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be question-and-answer session. now today, hand Mike would to conference I speaker your Gray. Instructions] like the to over [Operator Please go ahead.

Mike Gray

joined IMARA’s Thank you, quarter I’m third welcome to morning Operator. Good morning, XXXX everyone, conference Rahul and CEO, President and IMARA’s this Ballal. by call.

or that I’d prospects, begin, everyone remind for Safe of constitute during statements forward-looking to we in section SEC. as not SEC views company’s future today Risk Harbor that about as Factors the the forth the of conference Act statements provisions as recent Any forward-looking with this call as make of differ results our morning on under like of events the Private set upon as including forward-looking XXXX. our statements quarterly other expectations, represent the made we date. the this may Before or various statements this only any these factors, subsequent plans result filed relied could and representing purposes Reform should call Form from by we of expressed Litigation we and a filings those various materially that important made well with most Actual those be Securities of implied XX-Q as views any our report on

quarter key return Ballal, who the call to IMARA’s of recent over accomplishments. forward-looking today. rely open questions. discussion not representing and date results. subsequent may so should any even any then do forward-looking to at will With our we review views following future, update we’ll some turn Therefore, views that, third disclaim these these to Rahul’s Rahul Rahul? overview then you the our elect our obligation quarter And CEO, any now we of statements statements if call for While to point to specifically I’ll as I’ll provide in the on an and financial change. as third our President

Rahul Ballal

everyone, thank today’s and call. morning, Mike. you, you joining Good Thank for

The IMR-XXX, and recent have been tovinontrine. in weeks specifically period on we'll a which refer game third to productive and generic quarter also for IMARA this

we We Phase by Xb expect Forte quarter, to and Ardent cell in we Beginning NrfX to beta-thalassemia steps program preserved data Fraction clinic-ready disease, Oral this are in our tovinontrine with we interim or from pipeline And trial an to cell in heart Ardent pleased work HFpEF. progress with continuing completed development and in trial failure we have our quarter. Activator. with announcing patient ongoing trial tovinontrine. have taken this both of a have reported the IMR-XXX substantial to ongoing earlier Xb and sickle as enrollment sickle Ejection expand made disease trial in report clinical new our Furthermore, concrete Phase our

approximately from an Interim report in quarter. F-cells. trial to focus We analysis data of expect of will and analysis dose patients weeks biomarkers, and interim specifically one-third at PD XX HbF safety this this during on

Europe, crises vaso-occlusive across The been weeks. we Africa. approximately XXX enrolled as VOCs or of as In of will the well on HbF the in as The we XXXX. addition this rate world, global subjects a at Ardent primary F-cells, effort, dataset study the has to have effect primary analysis including on analysis quarter and the readout, and tovinontrine focus Middle of XX the expect from East first U.S.,

and data to important worked of this trial have readouts tirelessly months. pleased the has are in the coming team on Our conduct

XX at tovinontrine sickle safety updated in to annual December In or XX Society XX disease look held adult forward cell Ardent addition months OLE to the this trial Xa reporting from meeting to quarter, trial be of the this with year. our Phase data extension VOC readout open and American we Hematology to label of

the from Annual Xa results results X-month results, HbF. As Phase The a the Congress. a Hematology and from at indicate trial, parent OLE reported as severity safety reported score, improved to parent with European biomarker June including data variable well-tolerated Association respect in as well lower rates, we VOC patient study the final refresher, profile,

enrolled VOC the Importantly, for the tovinontrine X VOC in versus annualized lower groups placebo treated a results groups. pooled XX% Phase demonstrated rate all XX subjects meaning in trial pooled the

rates. study. In demonstrated to from trial In when groups. They're tovinontrine were in placebo also as further patients pooled that rate VOC these lower addition, annualized in Xa the as XX data related continuing from reduced each benefit well X study median Phase the continued increase to encouraged to clinical for groups annualized VOC compared the trial VOC parent findings a pooled VOC, significant OLE support see hospitalizations. of believe time from the benefits OLE We patients in the the case,

Hbf of Lastly, doses at addition to study, the X that absolute more and OLE weeks. versus show at to increases. milligram in more XX% X% X-month milligram at or receiving X% boe, to XX% that XXX patients of and show positive XX robust of have Ardent currently the Phase up on the that or time in tovinontrine dosing also Xb pleased to an We rate tovinontrine VOC Remember even increases trial response is had potential HbF placebo power trial data the is than OLE XXX of point believe tovinontrine. we’re the higher in HbF XX

expect reporting signal, later higher may the We further trial quarter. we're from which improve Ardent is interim looking data this to doses forward that why on

Phase Forte and our to thalassemia. Turning beta clinical trial Xb

for in dependent reach also cohort. TDT NTDT transfusion the We continued enrollment non-transfusion dependent or seeing or in enrollment cohort. the Also

expect plan TDT plan and the quarter, patients weeks. XX burden of first in biomarkers we at XXXX. to TDT PD We to which Furthermore, weeks this approximately in quarter transfusion the safety, readouts additional XX we XX cohort cohort for data at the evaluate conduct interim from full

points analysis. interim similar at data Looking at the

ASH of updates the Meeting the we're this we coming to both at to to plan looking addition clinical December, beta days. upcoming In Annual upcoming in in data these forward preclinical thalassemia important data, present providing

are To expanded we indication our for selectively proof-of-concept preserved experienced to our PDEX high help of and Phase serious over failure internal footprint in our team expressions expanding protocol end, in areas the where with with cardiology that Fraction Ejection a implicated We developed unmet study or clinical X board. a diseases with HFpEF also heart needs. advisory

XXXX. We eye American also an later expect an FDA this of cardiology which scheduled we to nephrology oral the collectively, take substantial is division quarter, made program presentation clinic place to the interact of HFpEF in with announced Scientific Heart we've the enabling with so Association Sessions, in week. the Yesterday, towards this progress

mouse peptide data tovinontrine includes with inhibition selective reduce of abstract X shown B-type the to lower HFpEF size of with which and PDEX in in models cardiomyocytes levels. natriuretic preclinical Our atrial plasma was in median

In in vehicle markers urine blood all including nitrogen models. compared treated or lower in addition, tovinontrine and ratio albumin-to-creatinine dysfunction, with mice urea mice with renal were treated

IMARA significantly Toni research pharmaceuticals, organizations. change Kaleido, clinical Vice HFpEF our join years Novartis, with her option and at rate, Attie. HFpEF programs. Officer, research biotech to the as to area, IMARA Toni I'm President also to team to comes has have lead clinical program, regulatory a Dr. that Bransford cardiologist, did own multiple clinical oversaw pressure. clinical In not value development Prior comes we summary, responsible XX of Ken also on tovinontrine To clinical development as PARAMOUNT Kaleido, our Toni IMARA a Chief efforts, HFpEF. internally A translation HFpEF announce therapeutic and to closely including seasoned tovinontrine PDEX literature from she for to M.D. conducting she Bransford, of lead discovery where at appointed as Importantly, generated interactions. projects roles working inhibition HFpEF, a Toni with IMARA leading our within led heart deep as pleased Clinical We're programs blood data, our of and alongside Medical authority patients in global of accumulated Development. independent for was was potential experience well treatment believe development for or where expertise treatment for of the promising with and lead maybe trials the PARAGON of the delighted tovinontrine for cardiovascular

that initiated of disorders decreased own preclinical sickle regulates selected increased previously principle, was or research Independent ASH number improved In segmental progress substantial asset oxidative that is show in NrfX meeting. oral as on of Briefly, NrfX The activator. we've Pace, an ran a antioxidant X–related IMR-XXX HbF maturation. clinic-ready, addition preclinical markers a IMR-XXX of abstract. author activator factor made literature tovinontrine, was expression F-cells Dr. IMARA arterial studies work IMR-XXX with cell and announce through Complexa, are cell sickle its new a drug to red the with aspect glomerulosclerosis irrelevant manufacturing. submitted reactivates And X, hemoglobin fumarate, CXA-XX, our suggests in NrfX coordinates hemoglobin. Inc. models VOCs. X and is erythroid IMR-XXX and Since inflammation, models clinical sickle significantly is blood NrfX of factor pipeline. and excited of with in-vivo evaluated increased inhibits there's the In IMR-XXX a red fetal activation diseases disease and known proof clinic-ready known nuclear EMF sound trials for development the a beta preclinical in dimethyl toward NF-kB to blood oral in and enabled And as we’ve asset to cell IMR-XXX medical response by and PAH. or hypertension the presentation we in hemolytic was data that a in HbF. stress, as In-vitro leader NrfX. formerly cell Phase upcoming at a cell and focal Betty is pulmonary data an product hemoglobin, thalassemia a model this in pathway FSGS IMR-XXX genes

beginning We a and XXXX. potential believe for to fourth first to the As In first call look programs, quarter data at in We updating you back and XXXX. development part the developing to conclusion, of our a progress, the in ready this clinic of look turn to you. have indication and results. quarter, Mike? forward updates in the IMARA further we expected And Thank periods quarter clinical including on production we our expanding third on IMR-XXX quarter explore pipeline. I'll providing forward core financial tasks. readouts review opportunities later our Mike that

Mike Gray

Thanks, Rahul.

quarter $X.XX million believe net the as related company's or to please be release of for fees related prepared $X.XX as morning, well of $XX.X per sufficient this were December earlier XXXX. line as in found as SEC primarily the Net and cash oversight loss be other Research of our and million filed quarter can as I'll $X research are first details attributable as was operations third third for for press as of was XXXX compared personnel results equivalents clinical to clinical and open our increase million The primarily the to the related of for quarter the fund XXXX $XX.X us XX-Q costs. capital stockholders increased that with third quarter related third quarter were the of More increase for administrative loss due for included XXXX, And which provides tovinontrine, in in issued the we per of quarter investigator development summarize quarter to to this XX, this operating share to costs. of of the also and $X.X that September compared IMARA Cash, We with a third third enable operating XXXX. expenses funds $XX.X morning. of the third of to million of and General R&D to common as materials, to trials the Operator, million manufacturing now. or planned personnel XXXX. remarks. $XXX.X expenses the you XXXX. The of million, the XXXX other million share development G&A the concludes Our increased to of into XXXX compared compared $XXX,XXX questions? million XX, were could of $XXX,XXX and XXXX. development, clinical quarter investments $X.X $XX.X to was

Operator

comes first Yigal of [Operator the question from Instructions] with Your Nochomovitz Citi. line

Carly Kenselaar

Hi, Yigal. for this Thanks questions. We is Carly taking for our had on questions. two

hemoglobin. you the second And that cell, Xb indications mentioned consider you NrfX disease the kidney sensed, fetal on details some sickle disorders? are you on of the you powering focused hemoglobin on First in or will Phase study then on activator in the on

so relatedly to you of what Thanks annualized powering curious on you and Just on can the year prior the study? are about stratifying VOCs rate had say in patients much. based the patients the number VOC

Rahul Ballal

it hand question. second Thank Ken, take one and you. then the first our to the for Chief I'll Medical Officer,

in including NrfX So implicated number I renal think, as different you of is diseases. our diseases, a know, activation

blood including rare hemoglobinopathies. disorders, right now cell red is Our cell focus disorders,

our So at first really that is indication in disease sphere. shot

associated sickle actually renal at beyond sickle leverage is are mechanism, reactivate diseases strongest hemoglobin. now affiliated to right that unlike cell activators areas in We disease specifically fetal data anti-oxidant the induce indications. are data the two our those NrfX and note designed cell and NrfX’s looking and cell which PAH and I'll in before just

And specific hemoglobin. the translocation so creates nucleus ability to reactivate like around we which to mechanism NrfX actually fetal the the

powering into and to are some of primary and previously there of indications Ken cell red tried So it give over some with -- the going the this that asset to you mechanistic have the the both some advantages disorders secondary. color to turn over study certainly on kidney been

Ken Attie

is This Attie. Rahul. Thanks, Ken

for We for of which an study from have primarily primary F more increase was response the X% rate increase baseline. an endpoint, hemoglobin the powering or in

We secondary our of haven't calculations separately for endpoints. each done the

probably have We saw current to powered the in the several in in rate the difference we to study. study, the initially we VOCs of had feel the the Phase the key Xa the baseline factors, results we stratification protocol into will to number that the be to we analyzed Xb the Although previous patients year. revised study in study, VOCs prior specify the our a subjects include order get endpoint That Phase to show historical VOC it did of a was study based made Xa not VOCs Phase VOC study for year. on what from of or similar with minimum X now and rate had XX X but the rate secondary

in as looking a X analysis And which be with so to sensitivity prior we as both analysis. X will subjects well in plan VOCs year have -̄- our finalized XX the as analysis we plan fiscal at XX to

Operator

comes question from Joseph Your Schwartz next the SVB Leerink. of with line

Unidentified Analyst

dialing Joe. for I'm question. Hi, [indiscernible] you our in taking for Thank

we when study I First, could at what from you ASH. expect wondering, your guess VOC X Phase to ongoing XX-month OLE your I as was data presented see present

expect in? should expect Are Now, with study? differences from that’s you've from patients how presented data what any many we far your should OLE there so we

Rahul Ballal

Sure.

So all. I think, for thanks the of question, first

have two the kind data nuances data the XX-month OLE deny. So month I think study for our will of of X

doing As of annualized you guys VOC. know, we have been rates

for So has XX-month in days the data the have annualized going months, at XXX is is most approximately will X patient over months, out the X part been ASH example, patient looking we're have The that effort since one to minimal for patients XX XX be its to annualized nice that in study present That now that the period VOCs sense on over the the about the endpoint, on at months, will study. patients. VOCs we're of annualization X has of year. out X their

VOC patients those and understanding opposed at VOC data yearly will that as X rate shorter. those what the annualizing comfortable is look was in rates think out we for when months So to be, I

then that incremental set. and So be what going finish well that's shown we which set point. EHA, I VOCs. views we just an think of maybe to throughout as on But HbF these data is the advantage at obviously data as X-month F-cells that showing And

Mike Gray

additional September XXXX. data XX rolls year and all for Rahul XX mentioned as one data safety have we approximately then just So as a for

Unidentified Analyst

this do on where the clinic? then IMR-XXX envision, How challenges envision you getting some into is And and did next question our IMR-XXX. are decide agent ticketing factors advancing

Rahul Ballal

Yes.

pathways, bit detailed ability dimethyl Pace's may followed as quite NF-kB you from reactivate we time. is as antioxidant in Dr. Augusta at hemoglobin, activation have So quite well general. there its for University not or and of lab actually may those an literature reduce be literature know, a fumarate some on the guys NrfX And fetal to as around

indications PAH lucky clinic, that cell certainly a safe enough you as for And that That for PAH so dose. those Phase a well X trials we And have long data the perspective complete for very could regimen and vis-a-vis the as the patients a to study in in was the were up the did unique study upon sickle X-fold. we tolerated. program were handing to at not were that X future. in They company To time. that over and dose prior at and us, success ready not a showed available titrated and specific, by low be that a programs had increase mentioned, dose that we any looked dosing was had to able to FSGS a to asset stumble were

And much perspective. dose so higher we're starting from a

from extremely preclinically starting that ASH mechanism you well defined. is our are hemoglobin or the least induction a look reactivation at is fetal if robust. at We to presentation, And

induction, that As we're X-fold approximate increase an as fetal in example Furthermore, at not fetal also induction to companies alpha the the hemoglobin in at in crises cells only use dependent by data. VOC many CDXX shown which fetal near hemoglobin was as did the a in X-fold, looked models, we seeing sample. look reduction hemoglobin TNF increase [indiscernible] the we dose the a

that the a a only cell sickle ready add confirmed not is the fact as in active across the shows about you the clinic for are literature same class. excited in number And existing of pretty get cell so beta-thalassemia. models, disease. that is Then And in done we've we sickle that happening for you asset drug this DMS, XXX

point the that about notice also You challenges.

make ultimately drug clinical So is dates, one another substance drug getting terms anytime of expiry receive certainly of products. company, terms in in those to product from a you drugs asset of

had substance paths, of has are the in we side XXX. we've So the that the we've evaluating margin PAH, for a already our process product study forward. IND would it from we'll FSGS path already. the update And drug markets clinical starting of for And XXXX, number external in done started that force a right patients work clinical Since away. about an we in on and certainly

Operator

next line Harrison Your from the Morgan of with Instructions] question Matthew [Operator Stanley. comes

Costa Sean

Costa in Matthew. you test what Good fast you Congrats how translate little questions you humans the you. doses and for progress. Sean think Can could XXX. doses pathway And morning, This bit all Thank talk in in a And the these secondly, development data humans? on everyone. doses it is safety on you about the us given X May you like Complexa? from under available have these do the available have profile data? looks even potentially be how from

Rahul Ballal

it's to hear thanks from Costa, Yes, and for you good questions. the

So when the about brief, we to asset XXX the mg in made as BID to models, healthy tested prior be the did in IMR-XXX us. study study from question mg as daily. reference To doses that preclinical previous the handing total XXX clinic, volunteers high Complexa our over in they

high that as that And tested they dose dose so in models we our models. preclinical the

to doses BID. the around kg specific, is BID per if daily, that the kg XX.X dose model you talent the right for So are XXX look for mg equivalent mg human per total be at XX mg

we with clinical started to So data and downscale mice. we

the dose the So the we experiments preclinical getting hit out in the knew clinic. even could we before we of started preclinical that

in advantage this clinic-ready of So getting is that asset an case. a

overall, about the nausea, are the was the gone healthy mentioned BID, through You and mg AEs with drug safety. food. most little the that XXX headache talked a tolerated volunteer just data, well and commonly data and the at associated vomiting the doses We've we bit

And drug about efficacy clinic, drug the that a finding to us actually forward in so for and remain a good stage the models, triangulating and preclinical job the challenge of of dose obviously a for next substance of in got terms getting have, think, think I we safety, and drug. product making as course, dose, you

Costa Sean

And in BID clarification, that you will you disclosed the clinic? be just you Or testing haven't those on do yet? mean XXX milligram that

Rahul Ballal

any disclosed doses. We haven't

those, I translate efficacy? think both the data clinical and ultimately the it clinical I think I indication. as of working feel doses to of still said, we with your through the comfortable yes. answer question was, paths forward do is could But we're preclinical that

Costa Sean

scenarios can potentially Complexa? it you the data be the around available if could our accelerated pathway, the And development touch potential on given from

Rahul Ballal

X, this So again, how us. are a we'll maybe X, trials. hemoglobinopathies certainly development clinical Number do red wanted in red be the the and principles of path well. I are that clinic-ready rare cell asset not quite disorders into timelines that update a X, that And our knows we we certainly forward. to we clinical at for think put commenting company near-term. the point. But we're the stage think could Number number on you, clinical cell, X understand for I really And process detailing organizing

all evaluating patients. that But has So XXX going there's the fact on that to take there are for rapid potentially lots that they've tested we're the fact and X INDs fastest over by path drug, to higher best forward. up fact clinic. of drug The this different doses the used that and been approaches open sets be the that to us tested could path

Operator

turn At time, like now to call over management. to I the no would further are there questions. back this

Rahul Ballal

the appreciate Everyone Thank and We're stay joining Thank today. safe. angles much forward have upcoming we've speak we the from you for healthy different this and a about and talked time call. to about company momentum that data variety that the look at excited and readouts. very of safe already morning's you your

Operator

Thank participating. today's concludes This for call. you conference

You may now disconnect.

Enliven Therapeutics (ELVN) 9 Nov 212021 Q3 Earnings call transcript