IMRA - Earnings call transcript Q2 2021 | Enliven Therapeutics, Inc.

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Operator

Good day. Thank you for standing by, and welcome to the IMARA Inc. Q2 Earnings Conference Call and Webcast. [Operator Instructions] I would now like to hand the conference over to your speaker today, Mike Gray. Thank you. ahead. go Please

Mike Gray

Officer, morning, XXXX Good IMARA’s welcome IMARA’s Chief to and Thanks, call. everyone, I’m quarter Medical our and conference Rahul by Attie. joining second CEO, Condra. Ballal; and Ken this President morning

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

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

Rahul Ballal

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

The and recent have been weeks specifically period IMR-XXX. a second productive and quarter for IMARA

ball progress have have to ongoing pleased substantial and downfield Phase moved made are our We the Xb trials. in

progress enrollment as First, disease, b study our enrollment. Ardent in sickle our trial, team this in accelerated clinical want to made world, important the ongoing U.S., from yesterday, subjects Phase for I the across trial, We’ve This a thank trial. of of even enroll in we’ve Europe, the and completed conducted Africa. seen to accomplishment and we we’ve IMARA. Ardent its East, commitment an Ardent announced has is for has patient global And cell The including in the the pandemic. which Middle most as been study been backdrop dedication COVID-XX effort and key

across countries, primary data to a the from trial we the As in now result this several enrollment from our are and XXXX. report expect guidance, quarter first of prior faster refining analysis

s As IMR-XXX, part weeks. F-cells, including PD or biomarkers, patients crisis fetal examine VOC hemoglobin vaso-occlusive effective of the on XX and that primary analysis, HbF well safety as we as in XX expect at or approximately to

of approximately analysis safety in of of a PD ahead biomarkers, in during F-cells. this We this quarter dose at weeks the and with to as We XXXX. trial readout results one-third view XXXX XX interim in on full also fourth check including focus enrolled data report of expect the QX patients an HbF from in interim the study

and the data Ardent of conduct very worked important trial coming months. to I’m the have tirelessly have in on the We readouts pleased

within We view IMR-XXX relevant our treatment. at at Phase the with sickle XX and cell its was placebo the EHA in our Xa substantially Phase in higher an patients expectations recently XXXX response webcast June final EHA Xa primary webcast Open endpoint, study a for It IMR-XXX is of both strengthens presentations placebo. results X% presented HbF with important trial XX% clinical section dose as investors held European of of and which and data the from trial, levels that these review the least in the HbF absolute on controlled defined at Extension IMR-XXX held or Phase or X% virtually versus presented and website. events Congress, in available the it’s Association, disease of an We Label outcomes EHA could Xb on that rate clinical Hematology We also Annul OLE data which presentation as achieve an increase subjects adults at June. proof-of-concept are of

outcome if the have and will secondary lower the rate, competitive seen clear VOC the in At Phase end of a Xb Phase IMR-XXX In to if studies, day, will a Xa clinical demonstrate OLE addition, approved. to Phase success, can we profile the VOCs rates the key annualized was to parent the what seen study. be of Xa similar Phase heavy X we improvements in the replicate commercial expect endpoint and of in path

groups XX% As scores, placebo a rates, all biomarker in refresher, profile, the a pooled subjects from with respect including results results, improved and mean tolerated VOC rate HbF. trial groups. the variable Xa VOC safety XX well reported VOC versus Phase pooled patient to indicate results final demonstrate the lower for lower IMR-XXX-treated enrolled the pain annualized a severity

of a days observed. was in VOC time the to XXX placebo first versus significant median addition, In groups for days XX IMR-XXX-treated increase the for groups,

patients is IMR-XXX plus hydroxyurea who approximately in XX was on from in active substantially hospitalizations, annualized groups OLE patients year, with low and HU. were annualized taking We the trial for treated to lower HU on data based Patients study. was the a in in patients rate treated separate IMR-XXX treatment clinical VOC clinical the a This set in OLE maintained rates months, see per on the encouraged continuing VOC mean data rate of parent to the interim from were Phase also hospitalizations X.XX background on rate similar group. per benefit the VOC year Xa from distinct plus trial. VOC versus patients placebo Regarding eight in X.XX compared rates. the is annualized lower IMR-XXX related the placebo And

who the study, Phase with For mean annualized previously patients further rate support XX they the Xa serving as patient in to study. the IMR-XXX own Phase patients the findings in The was parent Xa this VOC in switched there the XX% the in study when from placebo were control. benefits decrease a OLE trial in their continued VOC groups

reduced in of and white that works blood vaso believe other dilation. types, a to reduced cell and blood disease, we multimodal of inflammation of points VOC across activation potentially cell the adhesion Finally, cells action point categories, red IMR-XXX cells, sickle which improvement mechanism and several

in HU of was and the trials, monotherapy as use. IMR-XXX well Xa opening as therapy opportunity for the Phase tolerated Importantly, OLE monotherapy, in combination as clinical well alongside both a each with combination

daily, Phase weeks. IMR-XXX rate currently even to dosing have increases. up XXX positive and four to X% doses on month are at XX% response milligram more than receiving OLE XXX that on its or also had point, time Ardent of HbF increases a XX Remember, potential trial HbF the an IMR-XXX. clinical is In power of clinical data, show addition for milligram we the more in Xb at pleased XX% patients higher robust that to believe XX of the versus show trial eight of while to X% VOC absolute IMR-XXX HbF placebo We dose

and signal. milligram with rate, HbF So, already on XXX in to expect in right a are doses the XX% the higher that we OLE and response improve ballpark further

the thalassemia, enrolled we’ve in our beta in increased Forte trial having of Xb NTDT study or transfusion-dependent trial, while this enrollment in also have enrollment cohort, or the clinical half in Phase patients. also the to full non-transfusion-dependent approximately we TDT where Turning enrollment accelerated seen cohort, seeing reached

Furthermore, from burden, expect cohort quarter data analysis. to – the rates first of looking at weeks which of readout allow patients evaluate of XXXX in PD points study. XX at and similar weeks additional faster approximately quarter safety, in full data the data the XX cohort in plan points enrollment the at in now We biomarkers fourth XXXX as interim report XX transfusion interim on TDT the we to and, an TDT

expanding think with a and in work for HFpEF cardiology cardiology To as in our with this that a proof-of-concept is implicated developing some interested failure way in time heart advisory focused are board toward protocol study to with late indication to We’ve with now, indication experienced XXXX. we disease. recent help clinical clinic. for an ejection footprint and debilitating on the these hope expect this is HFpEF preserved an months medical and where in an indication been disease later to to we’re begin interact meeting target overexpression year. the PDEX our selectively We’ve unmet our data from in preclinical this that fraction end, division X that are a in treat the or Phase help may excited needs. enriched we PDEX an with We HFpEF a in medical submitted meaningful to eye serious [ph] working high also attractive coming Hence, present areas cardiorenal FDA

Real from grant impacted and XXXX, grants $XXX,XXX. in During by the program’s cell support increased program, XX XX grant year. second families organizations states second nonprofit, support initiative. Impact funding recipients disease which grant and to grant CBOs This The patients beta-thalassemia, quarter, we awarded recipients includes by community-based community to also of $XX,XXX serving funding inaugural its totaling the announced annual sickle was the

by Impact the local their of to disease year beta-thalassemia. their continued let people and ideas affected the organizations reflects cell to We on positive effects accomplish the its proud and sickle had Real communities for has patients, second local goals lives program are families, further and Expanding program of foster of innovative their date. and supporting health the community our commitment

we making addition she million which to provides of the in public key development appointment on Williams, Laura and our the to Directors. trials, commercialization, corporate an IMR-XXX front, stage multiple therapeutic capital experience also advocate fund across is of our XXXX. through addition areas. of significant XX financing, strong our a in capital important to highlights and way her of end $XX M.D., a late to brings extends products to IMARA leading experience through guiding Also mark board. continue run Board early Laura outstanding the including And community, to clinical our drug the MPH July, closed We years

formally in Council USAN States June, or a IMR-XXX. United name Adopted generic tovinontrine as for Lastly, adopted Names

Thank may IMR-XXX first encouraging communications. and to forward you in periods XXXX, You progress financial planned believe the to our we in quarter my in updating readouts presenting look our trials. data In call in second multiple Mike conclusion, IMARA and I active Xb data, significant beginning, of on referred progress, review XXXX. of VOC now as both that making and and you quarter the future part the ongoing first including to to fourth Phase to terms We back in clinical on will the of quarter of further see the tovinontrine for turn the results.

Mike Gray

Rahul. Thanks

Net SEC to million of Our you a second $XX.X in development of company. included primarily due loss the enable of requirements equivalents I’ll cash net well $XX.X to clinical XXXX. for for as the personnel-related quarter end the $X.X investigator can believe that our of up of and We increase $X.XX stock, XXXX. $X.XX per of as cash, line expenses XXXX. second $XX found offering manufacturing quarter first of quarter Thanks. the XXXX, XXXX million quarter approximately shares please our cash the was investments research million and operating details this common with million. to $XXX,XXX stockholders other oversight that and us $XX.X quarter the expenditure as More of XXXX investments were proceeds million quarter in we of was of results for or as loss That could the XXXX of for development release capital press G&A public net issued also equivalents and as compared and increased second was compared share, that our remarks. the ended and of – with per compared the result XXXX, materials, of as of morning. The $XX.X operating summarize common second of as our July attributable primarily from a quarter this June as the to the the for million, second for filed expenses now. related share, expenses The prepared increase morning, will million for are trials clinical operating clinical fund earlier to which XXXX, through quarter and IMR-XXX. or public second quarter $X.X Operator, sorry the a concludes R&D of XX-Q we XXXX. costs the to million $X.X second We $X.X of in cash, second of to related company’s were questions? open G&A fees the be XX the to million,

Operator

[Operator from from Instructions] question of comes And first lives Nochomovitz the your Citi. Yigal

Unidentified Analyst

Yigal. on trial. in completing We and that enrollment Hi, Thanks so couple for our sickle this you’ve congrats is [ph] on cell questions reported for had VOC questions on the data Carly the far. a taking

of the you primary biomarker VOCs. are year. effect Phase the And report secondly, the then you to could next Xb as mentioned data in think trial So, quarter in that on plan IMR-XXX I guess data first collecting help analysis first, VOC you of I that what part support

if So impact Or of just on enough really cohort on to see will better a weeks for anticipate should be to of your you. you on if wanted data week VOCs. Thank be sort understand larger is in XX the thoughts an XX to effect patients. VOC time the waiting we get

Rahul Ballal

Carly much, it I’m the Ken Officer, our going over cover very to questions. those responses. for Attie to turn Medical Chief you to Thank

Ken Attie

take Hi. it. weeks, it’s, subjects subject, all all so And what XX analysis, will than do it’s Yes, Maybe actually with when between and reached weeks your to going the in patients question then means of with patients a good at particular whether actually weeks, of number that be is I’ll that or treatment. more large they Morning. we’re somewhere of XX the XX XX annualize When an subjects other weeks. do XX first. we interim has VOC have subjects third That say the substantially Thanks. of the you analyses second

available. data all use will we So

months, nine annualize So if it someone nine months. the was with we on treated based

patients months be even might XX Some at already.

obviously, I question, even are at markers inflammation this we XX when same think the trials the previously, a measuring And rate. it’ll most So adhesion, of you’re reaches be correct, biomarkers reflection of of hemolysis, approximation. markers first be and accurate pretty But many of that’ll VOC year of your markers everyone we’ve the looking good one weeks, includes in cardiac of been clinical pre-clinically. that stress. To

in biomarkers study. we still So have measured all this those of being

Of blinded course, now. it’s right

that that not Those course primary hemoglobin, are are be results total yet. hemoglobin primary the those blood just F But F look at to contain at. so And cells the red will and and of available related biomarkers biomarkers, hemoglobin we we look that F-cells. or the

Unidentified Analyst

helpful. Okay, that’s very you so much. Thank

Rahul Ballal

you. Thank

Ken Attie

Thanks.

Operator

your And Morgan next Stanley. Harrison from Matthew line question from the of comes

Costa Sean

for Good questions This XXX. us is morning, everyone. Sean Matthew. on Two from Costa

for is molecules one first And HbF include currently given several competition sickle development. hemoglobin around disease molecules users cell modifiers. small in these The that progressing or the in are

follow-up? in And have your a how about Thank wondering I And what competitors? differentiate XXX versus are you. We are you competition. view then the thinking would

Rahul Ballal

you. over Ken start it then. thank I’ll to some add additional to turn commentary. Great, I just

the excited cell development all, different to companies of of in great see landscape. sickle we’re it’s this lots by approaching First

the products adaxio those the same multimodal of results end drug approved of on in XXs. our hit is mechanisms adaxio’s Our unlike the white is the the IMR-XXX at patients that that, day look inflammation in us red saw ourselves all fundamental hydroxyurea Xa in two the hydroxyurea when approximately the study products potentially in VOC type [ph], from at VOCs. the of to mid and in cells, both you view reductions other for squarely XX mid-XXs, the Phase way that And and works different works those differentiate even competitors, aggregation and on vasodilation allows it cells, a

reduction results, XX%. are of In VOC OLE. in annualized terms results of type Phase the same we’ve mean Xa changes around the rates And seen the in

mechanism advantages a taking at Anything look is think us company, just all What our makes product for readout competitive? taking for that VOCs, when of Ken? So you else the us. the profile a the by back I step ultimately differentiating target into

Ken Attie

changes. of terms and see No, maybe the I there. But being are I They not focused results that, the just case. red think results very cells VOCs. of hemoglobin think on some nice robust quite in And blood might molecules other as that

So number reduce drug are number our we focused the of of only crisis the the crises of pain the ability hospitalizations, of of to on number the now certainly with not painful well. and severity the and as

Costa Sean

that than population. very remains disease population, below up, sickle you, visits this for the total Thank inpatient patients vaccination the follow sickle cell we lower And helpful. are vaccination hearing because pre-pandemic the levels, rate significantly cell is the the mostly in physician

We to you. the Thank PK/PD cell impact sampling if disease potentially or sickle from study. on of your the any are measurements in wondering this has have patients

Rahul Ballal

Thank in as, you. patients point question. many in visits, That’s a that making could for for sure visits We’ve well well say office countries, clinic seen turning studies. that they’re a that. coming as visits good I are all

So, That’s a we’ve but averaging rate, sites part about think the board, it more this, robust also a and like last enthusiasm patients. for bringing week in few weeks. new there’s in really some I to getting been drug out like a patients XX something recruitment on trying due

for many visits. modeling, PK PK didn’t need on too we of decided we them simplified based some haven’t we So PK We’ve have to our sampling. collection stay our overnight seen missed

So that’s being in visit. a one day done

data So healthy going study We’ve I think the is robust. are also PK to of extensive middle in be in our pretty PK an volunteers.

in. and of lot have we coming So PD data PK a

Costa Sean

you very Thank much. Very helpful.

Ken Attie

you. Thank

Rahul Ballal

Thanks, Costa.

Operator

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

Joseph Swartz

very Thanks morning. Good much.

or there decreases produce Xa response exposure of good that you comments my doses of supports Phase that analyses And HbF the last basically to can are on for have increases Xb implications on are data that any PK trial, any which VOCs? higher questions, being IMR-XXX, in responses is segue where Phase some the doses the one and hypothesis Your in are evaluated? done a better is higher

Rahul Ballal

Yes. for question. Hi, that thanks

We do But have bit I’ll nice were the evaluation subjects give indeed we rate study, end profile. area way that compared a at data the the we further We’ve we studies. study. it, the annualized looked you we VOC formal the new from done And in more of for full to those hope to the for analyses, versus when an we’ve at, Xa saw under so Phase a not have the do in of able example the what these PK where curve negative correlation. PK

So want, we that’s what right.

see So the saw we didn’t was fewer R at We high That or rates, there. but And per the that VOC exposure XXX increases, as we’re a two talking low fewer year. really per have less and exposures, and higher trend only milligrams day. VOCs. about than P very value, fairly

So that approximately, we our particular. stronger milligrams and now and go in Phase going as relationship Xb That VOC the know some that patients hemoglobin curve trials, we’re up for in for milligrams to level. out low F F-cells, was AUC really XXX to again extend will to we in XXX even be doubling that

the we change a and with absolute exposure. an of So there in X.XX. F-cell of X.XX And percentage R increased increasing had P

current even that we’re go XXX. can see higher. at increase go as see that going XXX, we saying at in was that’s this even XX%,XX%, dramatically we our to So XX% then that to And dose and XXX levels, F-cells

as will turn with more XX%, up cells subjects F seeing maybe percentage. start drive red in hemoglobin and the and we’re that XX% F-cells So, even

Joseph Swartz

you explained Interesting. things? the Have factors VOCs versus at other And those also? was HbF reduction of then much in correlations how looked by

Rahul Ballal

the or particular biomarkers. some F-cells. adhesion hemoglobin explained to driving that be when to right at signals to Phase directional have as But to it’s not fully combination But any et have specific And sure now. would dose, factors no other change would it’d biomarker we be but for or we’re molecules, to in saw great Sure, and say value in on up – did down, We in there. and VOCs be cetera. we at of I’m go I going not think take get surrogate these sites, We will single improvement look the this. a we’re say, seem going stronger. data a We why it marker go get single F by that’s these the

Joseph Swartz

complex a probably it’s multi equation. factor Right,

Rahul Ballal

Yes.

Joseph Swartz

Xa any Xb and how us, Phase Phase your another Maybe results? trial? and sickle in b differ cell as you tell Phase extensively on And and the trials. the in VOCs question Phase how distributed, were ensure versus sites conduct adjudicated organized Xa quality, the highest the will Can the cleanups way Xb to the in in

Rahul Ballal

well the the would for this other done it experts, a the some own Phase committees, through that characterize refined parameters investigators CRO. have outside internal MDs over adjudicating are that and coming the study two collection in you say the acute that VOC as well to VOC look the most the in side the the as UK, include think sequestration, VOCs the FDA. priapism, the reviewing We know feedback in as how at of We’ve our data VOC. in our our a the which trial the safety review reflect analgesia, all chest MDs now two data. of as I don’t at on and as to behavior of Xa VOCs review the from I was So U.S. syndrome to They course recognize of sites need changed

the committee. adjudication VOCs think carefully an looked with not are If I at, your that’s So being independent question.

of we capture unique more We report form VOCs the if case hospitalized, event a And they’re course are adverse information capturing serious with VOCs. for information. even on

where it’s going forward to as that continue we’re as that going to standard sure a careful, and being make have we characterizing the way of conducted. far to the I study have VOCs think mostly

and XX countries sites. XX in, XX to are over We

in not queries, logistical patients, challenges making labs. a effort concertedly, missed not responding So are say the they’re them performing said, come our up. an recruit The or quite the having extremely are visits I we’re study, only when like physicians I but sites challenge. keep But would to is to rapidly it quite well, really and

noticing really So that. we’re

at our we PRA, managers and the of ICON So group own group now quite experienced it. have are that at trial

trying an send in and good done we’ve data, samples arrive you from number condition can to give of a and terms challenge we’re And the things be to a the to Africa these the so creative that’s analyzed Europe. manner. to still of make collect of biomarker sometimes transport a Just in in samples, example, sure some of timely

So these throughout carefully looked being things are the at study.

Joseph Swartz

really helpful for Thanks That’s color. insights. the all

Rahul Ballal

Thanks, Joe.

Operator

there And Mr. further Instructions] [Operator no this are Gray. at time. questions

Mike Gray

operator. Thank Again, wanted for to thank we you very you much, joining today’s call.

We’re excited about speak and forward year. our upcoming Thanks our this later safe momentum healthy fall again. going into to programs Stay the and across safe. readouts look data and

Operator

This does conclude you your today’s conference Thank for call. participation.

disconnect. may You now

Enliven Therapeutics (ELVN) 8 Aug 212021 Q2 Earnings call transcript