PHAXIAM Therapeutics (PHXM) 9 Mar 212020 Q4 Earnings call transcript

Good morning. Good afternoon. [Foreign Language] I hope you’re all well and safe and thanks for joining us for our Full Year 2020 Earnings Call. We announced our business and financial update yesterday evening and I hope you can find the press release and our earnings presentation on the Investor Relations page of our website. With me on this call today are Dr. Medical Operating Eric Officer. Chief Financial our our Chief and El-Hariry, Officer; Soyer, and Chief Iman

remind call Before your relating financials. disclaimer to attention I to to that starting, would anticipated the on like the company’s Slide timelines, such forward-looking statements includes to operations, draw you as today’s and X

After call, I fourth months know, will you your timings for open risks the in X, results which, financial Q&A. results year-to-date. on start the differ status also to involve and over agenda He the and take quarter the short for the next to the Eric that introduction Slide XX afterwards. to before know, XXXX will will Iman be clinical and the uncertainties progress ongoing. of our key present the As and of full milestones all available as for for the questions summarize four The with will us business we year the zoom then the and expected materially. will the three they XXXX. actual could of for you Switching are and programs cause up year that highlights

an metabolism a cancer X, and – the Slide know triple-negative therapeutics leukemia. focused in breast cancer acute pancreatic before clinical cancer, in the we Moving area to programs red cell-based which really on late-stage cancer on updates on quick amino for starting the completeness, reminder blood leader have you metabolism, in acid company and lymphoblastic focused now altered as

important milestones XXXX. we expect the see them or you clinical clinical that will side, ongoing, of in hand programs right the On results all four regulatory have four

which an TRYbeCA-X, fourth positive are whether you of quarter second, XXXX results know produce ALL continue main coming the hopefully can hope able the we we weeks. We And in the and and the To months, in to United expect introduction for be early we in at data maybe this confirm for final operational pancreatic first. as ALL a ASH you two the U.S. were shortly product to patients complete year and quarter. for cancer the are our two candidates So fully on that in support sites, December X where to company as to presented and this expect know, the approval States trial, on key manufacturing and in hypersensitive in listed Euronext we’re in one report second-line Phase one Paris Princeton evaluating indeed And catalysts NASDAQ. Lyon fourth in year second Europe,

was clinical it’s first XXXX was week year, how Now the continued to the TRYbeCA-X plan was slightly second-line programs patients recent reviewing X% obviously previous well. trial the Phase almost abstract ongoing is the two as be oral randomized indeed the November of to see knowledge, recent ago COVID-XX turning the what of the the NOPHO-sponsored Starting I full and ASH year and there ASH, In call results to close the I we these patients to X week really and we that November, at XXX last this was unplanned slightly after were results. IST progress past the and our were mentioned, XXX great of months. TRYbeCA-X with in pancreatic remarkable at presented unplanned December, one enrollment above other our plus almost even over were large forward in trial the see with with positive presented four are of see to first, it’s XXX this and to completed looking again to of make call, the the COVID presentation we ongoing. well to fronts able challenges. this really that months obviously full great X, in the enrollment the related for preparing extremely November, XXXX XXX progressing And progress during I’m on all above the trial then in largest enrollment we selected and when the we now. pleased We peak this been at trial have When target trials pandemic. the patients. Slide highlights, this and to And in knew cancer proud then And month despite patients,

had and in and the year cohort escalate Just mentioning first to supply we enrolled. of highlights the our we demonstrated to is hope the just January, weeks. here in be in meantime, launched was manufacturing to robustness trial dose and our is This also the challenging new XXXX first the IST the it patients call, pleased next that we was dose the in The the but Phase to the in first-line operations. of so when say cancer, last also over pancreatic X able clearly coming key patient

and teams product, been demand an product. on able to which continue is our Our supplying have producing

without So that not especially the interruption It’s it’s notable. like levels throughout pandemic. your and record usual drug

to loan. our put of year, the in will in cash of the Rolli. the and will we other financing supporting instruments the financing a on we you continued requires detail the appointment the If state and operations executive runway facility you the that on beside form are with tell these company of extraordinary Dr. implications provide initiatives strengthens Stewart team of more And secured can up And this million that also $XX started Board is condition, dedication. progress made the Chief Eric discuss on – cash know it hire guaranteed place financial corporate and clinical progress. our have in runway. our with Launching and Officer of its ramping Melanie March last Technical last I level, Princeton important that manufacturing Craig in our front was non-dilutive different in We that Also as in year. November

all programs have getting focused this next year if is And you expecting we as key of results focused we mentioned So was to Thanks all year. ahead we teams, lot and we’re to see clinical and very great and this on the thanks to catalyst and not common these the of we on Previous are clearly I’m know, on or it, clinical year, luck, point mission updates. where the four together the and in the with progress have that I our now. tremendous have regulatory to – efforts. us XXXX the is occasion for be U.S. will a delivery now dedication of page efforts and possible. our as these execution slide. X, clearly it in key don’t thing And summarized to repeat zoom think middle time achievements all registration remained then are Slide the that thank patient only of for I really both of I’ve been of the you efforts the for results. I already, track committed in a Europe or of activity of which but one now, we may of who bit tracks to three in everybody a to in switching

pancreatic other readiness, was to cycle and obviously, to regulatory planning at TNBC other be indeed feed for for the provide readiness readiness, is sort we I the focused we and readiness this, all years now keyword of eryaspase update supply company on name on the past next the two you that and what the are trials company, will of can if of manufacturing also the you an success other the readiness, where in IT inspection have pleased ongoing, commercial tell – of the life filings, the deliver hope. teams buzz And And trials execution are earnings first-line And readiness, the you call. we over see this our it. for very readiness, the

here, up clinical on So introduction, Iman, to to provide Slide an who to will switching on the update and X the trials. for passing

afternoon, Gil. you, United Good Thank morning, States. Europe. Good

we our are development in a So I’ll program. clinical give update you quick where

So control on advanced is a start strategy, And second-line of care which X irinotecan menu gentle standard or of pivotal this secondary course, the the is rate, could This be study is a without trial, usual and design. endpoint end two with eryaspase. survival. Slide generic naturally I’ll a [indiscernible] of III with As care come the status. The all And of is in safety, Stage rate, chemotherapy, irinotecan-based survival, age chemo Stage planned or of performance IV patients which points this receive big reminder a or you was just have quality standard life. number and response primary disease suspects is including with to enrolled progression, free overall it’s the good disease gemcitabine years of either a the of cancer. a randomized to chemotherapy the over XX The pancreatic study was abraxane such

biopsies collecting liquid analysis. We are extensive also and tissues biomarker for biomarker subsequent

are Hidalgo we studies the So in Manuel States. the the for think trials. almost I I is have we recruitment development probably best seen in doing one the Europe of two component PIs Professor, I’ve study of Pascal actually, to Hammel the the X, previous clinical XX number and for primary Slide have ever years, United Switching been European for and graphs and the this

of goals we trial. week almost week – this during our So life we were on really the met in

So of to and and a of progress year XXX months patients. target huge for enrollment a We patients last XXX sure. over-enrolled made back this we’ve we the total trial few past in the was size over enrolled December we completed slightly

was then of also IDMC we’ve the they reviews and to not those, Data but is Independent So three the And the month through the no recommended raise where the analysis, trial IDMC. safety which issues regarding and as safety. the without Committee was fourth were last last by gone where four any the first views raised also an did issues of plan, this Monitoring continue pure interim

So of the patients, than the continue of on beginning this that our we quarter the expect end will rather trial of quarter patient’s the first this that the results trial provide and still probably we to is patient fourth follow-up, that the quarter. at year, the continue of final

and of so X.XXX we have almost a an This hazard unmet need XX% certainly Just the study this trial the XXX with is medical be Phase that seen have design, patients, the in survival ratio that clearly overall to signal trial. in statistical hope that replicated power we this would quick in with improvement a disease. with of in detect X we a reminder

So to final you share results also you later as this mentioned the year. we ready are with

exciting a indication, gears switching one. also So to but different

developed the who in The who as clinical almost The the end asparagine a hypersensitivity reactions, of was reactions also arm trial lymphoblastic single across the well. countries. this X a Slide is patients patients XX the trial received investigator So group but and pharmacodynamic points additional XX, leukemia hypersensitivity pegylated NOPHO these the by primary included in sites prior Nordic endpoint conducted profile given the Phase acute this trial, with to Oncaspar. it’s was to number and asparaginase Baltic trial initiated the trial Nordic safety pharmacological have of

You which in may patients very XX last and was enrollment positive study ASH study August with nice you showing at of course, with really the in was completed presentation an that last that year was oral that December, presented results. of that the recall in study study again remember a total

trial. by the XX presented gears give conclusion investigators Slide then to number to switching it So this as leading the

importantly, the So days. excellent concentration the the activity to eryaspase study administration first the at met we all almost pharmacokinetic endpoint trough activity patients, was least primary its at of an the looking asparaginase with XX asparaginase for at primary and had endpoint

need you to evidence the trial. also additional Importantly, see in supporting

courses reactions be alternative patients trial to as This X and all randomized could population, prior this patients So almost treatment with asparaginase that with Safety to in in asparaginase. believe and with intended the in leukemia an attractive the and in acute to option lymphoblastic overall of this because in has that study receive used ALL. therapy evidence truncated could were important hypersensitivity potentially is lead patients shown able patient treatment. survival great asparaginase PIs inferior certainly Phase

that Slide treated approximately to estimate XX, action. them we this of is are number while an develop patients who hypersensitivity potential Moving important asparaginase ones will with indication. Basically,

and confirmed need FDA. constant been has is have dialogue FDA this certainly, unmet and with So this with the medical we

know you the facing As this approved you know, Erwinaze as several is the in over drug years. indication only past and supply been has Erwinaze shortage

So the replacement medical that raises being need unmet also the need challenge for an therapy. and a

investigator initiated asparaginase alternative whether patients based on be Europe. that that was We are now in trial evaluating eryaspase for can asparaginase, this these performed

United at support license FDA, in So whether States. we dialogue can the this application the have started with see

prepare whether update if We And months are we pre-BLA this the that will then quarter second in discussing we we a – we’ll will and will just some for in this indication hopefully the Once the to request the XXXX. expecting potential have this in Europe And also have particular in start BLA coming submission again, approaching in confirmed we of half in advice and potential of provide process approval. for second for Europe. you ongoing, CHMP filing for for Go/No-Go the meeting, year.

least approval which in trying trial trough NOPHO activity European It initiated similar the XX, again United So so reason this pharmacological platform in is across the concentration rather you purpose know this we’re concentration that point to was even or as going is through this The in trial. not Slide or the takes is asparaginase showing safety. investigator and than at XX% comparison, a population. that’s every in based why patient two importantly, here, on we the is really better similar, outcome a is our to Erwinaze is if whole that that here eryaspase, believe, number where previous size of trough have given was States me that to of proof-of-concept weeks. the – which But profile, and trial more make not but the and again, approval trial,

it would uses life. half otherwise for burden, asparaginase three of – of to which to short a days to every of so require a particularly come indications And shorter known the Erwinaze pediatric or makes the their receive all two or infrequent asparaginase another less we with have are

reasons to for that pieces really market. have jigsaw our case different the we clear our as ensure we So the path believe going a through that we these again, we will here. are are to have – of the approval, that guide And

proof-of-concept concludes the the It’s study. me at ALL the signal so And So that and number takes looking that in negative Slide that triple and trial to XX. again study objective disease a cancer. that therefore, switch basically gears And is – component control breast response is on detection to this rate. no must be to led see trial addition. measurable study in mutation BRCA advanced by cancer of to in and Patient, Awada a have it randomized The It’s Jules a effect European Professor is triple eryaspase with enrolling is they Bordet patients Belgium. the have negative to trial. breast disease asparaginase with able

provide Dr. eryaspase. receive this PK/PD. monitoring would without again with they trial expect care of response, a especially So of patients all standard ongoing to here, additional, results safety gemcitabine/carboplatin in and of trial. Enrollment to safety first-line conducted end led interest trial course, is adding again, the be Gil Noel. or by Marcus objective biomarkers tolerability one last in first looking again, is patients the and modify this and Georgetown, for, would of And quarter. investigator initiated which our towards we and the that this the is pancreatic this study, at of this being actually gears Then switch eryaspase the FOLFIRINOX mentioned with advanced time. cancer. in is And earlier And

they in this end standard the dose is the chemotherapy. naturally, point maximum So in with combination identifying primary tolerated

next first hope weeks. that will enrolls We cohort to start the running the pleased are the really cohort, coming the in and we trial in

well-tolerated that to far, dose. So believe that is trigger the the and we treatment next the escalation certainly would

I’ll update. to provide the on clinical and you. mic Thank updates will Eric to front, So finish the with this, the financial I the pass

to switching expenses The full are in to in XXXX. full financial year in €X.X XX, highlights Showing million preclinical development plus Phase of information. that increase was increase operating million, to morning, mostly with plus in That everyone. Thank XXXX year-over-year, or starting decrease that P&L million €X.X And €X.X net obviously trial operating loss Language] million company’s million cancer. items reviewing loss was for number the attributable pancreatic key Slide the €XX.X with the year financial the was XX% you. And X Good Thank for we in related loss that’s results. the the million was we’re increase, up now the clinical the [Foreign and the clinical you, Iman. €XX.X and X% for expenses. €X.X

payments which in was consisted decrease to in income, We And to were XXXX. G&A, also recur had U.S. and a €X.X €X.X the million decrease capacity with a foreign in million impact euro related net of to with agreement million which million million to exchange SQZ €X.X million exchange IFRS in dollar incurred license million reflected million €X.X that was in decrease related that in convertible establishment the of mostly expenses swap the negative in XXXX. and €X tax of €X.X the other the that in decrease mostly financial end XXXX expense, not the notes. gains, to – June was the the the euro did foreign manufacturing and from related Biotechnologies of the accounting that finally, in decrease results R&D due upfront €X.X credits and Finishing a €X.X

a our would That’s on to I Slide minutes to we’re to slide. Before XX. moving remind financing number moving the initiatives recent the to next take cash, and month, like over few

of US$X ABO was is a issue June dilution of authorized. To finally, notes discretion we’ve in solution a the actually and First, At recalling depository Société last and regulatory the shares The provided by the XXXX, amount. a year December this two marketplace. compared American notes. U.S. This company And totaling that sell ERYTECH’s million this ATM €XX a the a pandemic. €XX.X to is To-date, We’ve and then also the is tranches And earlier which January. since zero prevailing eligible And in COVID which at-the-market the non-dilutive Slide year. that’s million. cash. beginning we in program, called or million reverse loan, and to implemented for France, XXXX. of received we fully million for response investors also same With one financing This an million, called €X the €XX made five dilution currently PGE million for XX% move further XX been limits in was approximately in that the with is Générale, in date, million. on XX XX% to in Bpifrance the US$XX.X is subject or December million shares of €X ordinary of investor allows have and potential placement the and unless to as each. that convertible can signed government that, loan banks, us tranche tranches year, cash severance of to this guarantees attached the a last granted designed state-guaranteed year financing the XXXX the context we next €XX.X a of form Blue of sixth XX% the to convertible loan, with coupon converted with that’s Ocean with form and with end an cash limits equivalents in the agreement is at French Alpha issuance maximum on inquiries of number of subject and of XX, that

made in €XX.X net period of the million million cash a XX utilization in in convertible €XX activities available the called million and loan for and result financing and current proceeds The €X.X of of first current net position together program. exchange financing euro of ATM negative expenses the tranches operating potential tranche million equity the into of against fourth and the to on cash milestone financing from over XXXX the million. has of its €XX.X currency there a a for million cash in of also sixth convertible that, and operating a XXXX million dollar the €X during million the with generated can agreements position company proceeds pre-existing the the and believes the while of into option research in ERYTECH fund investing its current decrease is the depreciation With that’s quarter led Bpifrance net million the proceeds notes, has that planned loan €X on programs payment of U.S. loan was the under that the €XX.X financing of XXXX, and activities, XXXX. PGE program XXXX, five included So quarter remaining called in beginning months the activities and €X.X placement Since generated €XX.X impact.

one Finally, dedicated few upcoming this XX. Gil we the wrap-up slide, has our execution our years of XXXX is milestones, a in important next quick news now obviously it key Slide already, flow, of year of pancreatic trial a catalyst and line Phase number X TRYbeCA-X, a but be had said Starting multiple second legal announces our cancer. to major with catalyst. with

As mentioned in already year. we by this expect the final Gil QX and study the of results Iman,

ERYTECH hypersensitive for in regulatory catalyst ALL. more the key ALL, Another is potential developments specifically

tracks for have we is of because explained to the entering XX to Gil we the items or forward already has key already goes prepare the in And to of BLA approval half year. points this mentioned, an with year, company, the this time by path this indication. we indications. In we next the these provide first second in be two half here. in confirmed, two the may regulatory in FDA potential if catalyst submission the in an months Again, on well, able if expect for update Iman, first this expect registration for everything there’s as an potential As be for two preparing

first-line we rESPECT. programs, Noel results TRYbeCA-X is in trial the in X the Georgetown, named expect Finally, before the Dr. currently study Phase by end Phase in the two the conducted news and in TNBC first of X indications clinical year in we trial also cancer, expect in flows other pancreatic in that

We’ll I your half have. already the dose thank We may you you call With the that, like expect determine to second year. open would any in attention. questions also for the this tolerated for to of maximum

As course, always, very to you Language] ask you Operator, now session. like any you’re if it’s French, over welcome of in of [Foreign so. to for question would the Q&A do to

[Operator Philippa first with Gardner question Instructions] Our comes Jefferies. from

You may question. proceed with your

to will I afternoon. Good in English, Hi. asking stick please.

couple could questions, of So if a please. I

in to assume the that recent Eric, So and other BLA comes just or monitoring if when caused cash first only, most it thinking should stop. any what would it implications in to geographies place. me perhaps and of agreements financial interim can in analysis, that think last about was review much data question My timings would the be you sort the question you’ve have that sort given were fair of sort year, inspections And used about much safety harm on potentially Thank operations wondering, indication of sort filings – sort about having or might the for of flow financing U.S. said trial risk done I’m know need sort terms there this cancer. Europe. your cancer then of in of drug that it future, would you that ALL all, the was about of in when was superiority think And perhaps the looking year the this how then I and to on those you each help and how well. spent your the you get was you that excluding for think of cash I finally how of, filing a terms just of second you ALL wondering any in obviously you on futility? have the in that you. if for been help I Does of way as pancreatic at on pancreatic to any to was also mean, in the if about able another look R&D we continuation then but current for file the that board and just just with doing of tool a side, the that spend in

Thank you, third the on indeed I’ll and take to Iman the I’ll Eric. first. the pass Philippa. second to

So, the synergy potential between filings obviously two yes, the main fact, the dose same. roughly to the related in is preclinical is

they so the doing XX% the already would been CMC part is, And I this we’ve can since as we same. – long – a time, say,

the same going into part ALL bit cetera, basically, goes bit also so needs basically history, back little a back it’s So further the same of original some, but the are further manufacturing, to the product. a et There module. data

So – to long say, it’s answer there is clear yes, synergy.

able being will worried we’ll but further not will run, for a so only be dry to have pancreatic. file be And early that also be not the to done anymore

think question… third So that’s I on

can able of review? are indication, file – that already got terms do you in at at the pancreatic mean, time is another to that I you to And or filing for Gil, to indication another ALL just that in still at does the I under I work just precise cancer? example, can that time, stage that. you plan how you – file under on I in file were follow-up does guess, review review to in ask under if in Europe. you’ve if that’s have

doesn’t It impact your own.

be the case the it think different it’s in during I mainly I different same it file as ALL indication. and INDs, can U.S., product we first it’s obviously, the ALL – other do So file in then think in and U.S. first process it’s we yes, but – this will but on will two the yes, can

that part second take I’ll question. the Philippa, So, of

So analysis assumption around your the interim is this and is correct. yes,

and obligation patients. potential was look They the that trials would the could to and have no to data there recommendation formal has the us While to sponsor, a totality futility as correct. at continued analysis detriment IDMC planned that’s trial. the The in see, if so be in a made the

for part Eric. the Then third

Indeed, we towards and last of this we’ll cash Obviously, in all this cash reduction for is year was XXXX in X the year. would our one. utilization a – down cash trials probably We our least last burn, half have the good these of that indicator would wind say of on ongoing second take half somewhat still I’ll first I start year. recurrent burn, expect the a place. Phase to at

cash guiding enhanced. We’re we with have the

runway guiding this mid-QX results catalyst ALL Phase just we as have into meantime, other discussed. year, on the final of we’ll should the the cash We’re In on the QX, coincide X. which with somehow the

also financing managing the cash using And We spend we some us Given very a during use cash as we that but to prioritizing may further we that and we you what’s on more. situation on tools the but making the we’ve side, �� bridge already, sure our been have we and our just obviously bit after are have enhanced. side. key we and are be wisely, programs results, carefully, be necessary the – expense that clinical noted, may using look financing

great. you very much. That’s Thank

Thank you, Philippa.

you. Thank

Benjamin Our next with Securities. Ren JMP question comes from

You may proceed with your question.

like. the under just more and started last Good XXX from, enrollment can of taking or about enrolled when off year, based morning, the TRYBeCA-X, patients going lockdowns – on we about March when little a with Maybe like so questions. seems of March you for bit starting talk XX guys. Thanks that and this really it curve,

detect of survival? Do impact have adequately So any I you of follow-ups. talk and treatments? guess, of the in can to a a a as patients, couple – you has in to the intended you an what had powered how terms Are some occurred those to difference patients. sort bit I have the to of And especially, about of if those been still courses then follow-up that exclude, overall little might’ve you sense

that At in of made lookdown actually follow-up measures some to critical prioritize, every eryaspase treatment have – the that to and have, up treatment, the of in of plan for of were We’ve lab the the COVID on the Hi. I patient investigator, then every the time of patient most the site course the the size. some TRYBeCA-X. on this some importantly, aspects, drug. been flight know impact but because a for and almost about, immediately is that, an some of what every and there patients question. pull road And “virtually” site call because take that as instances nice trial – this this able to the side. with not the to some we critical drug taken back the were example, manufacturer key drug heat carefully the off-shelf we and with sure March, Overall, conduct we we has on was outcome, for sure the make minimal single delays deprioritize of We where, single tests, the the staff to plan road manufactured. actually very of which make we that even

mentioned So we I agree this treatment earlier, fact done the in time. as in were think what, we have in the is Gil and and intuiting supply job

from if virtually perspective. perspective say, So I whatsoever would we impact not minimal, have, a follow-up and treatment

mentioned all however, given not plans, FDA. analysis patients We terms as FDA, and immediately the – in that COVID, the both a with our with is still potential of case in our statistical exclude guidance stated COVID report in will in we review the but of measures – from terms EMA, we lot as which measures well forms, of

that every we an that exclude patients related And we’ve is by document might risk which required latest in done actually And created impact not instance. also some this and who extensive done finally, planning the exercise there not to showed have we assessment, that And authority. with impact risk are analysis, COVID extensive to we’ve single an COVID. was an was health extensive shared of agencies. that We for

I measures that a you I ITT, final and the successful. on analysis. – we the based lot patients, this don’t as why is actually, done we’ve expect think know, is this which So are primary of is

include because is to is afford of have principal overall not will current impact, them, the treat and patients we And least our analysis. the cannot if will a there patients. the hypothetically, of intent – at we COVID to papers those even all in not will plan So also survival course this in exclude

would than, less if to going any, So want almost, non-existent. maybe a number, would not be don’t to I it’s give say be but there it’s – expect I it’s I is it

Got it.

forward that. broad. why very when you trials then second be the switching strategy, that done so for you application this It the Gil some can to were have or far. about the and pursue gears ahead I’m this Thank U.S. then me, time U.S. much path FDA just you EU they’ve told going been giving remind ALL, the already regulatory Okay. quickly seems had regulatory tenure And wink-wink with of you discussions they’re you already maybe start kind very Gil, guess this have a hearing preliminary – off go potential first be the nudge-nudge perfectly pursuing you sort if kind U.S. like to move coming first, would as a to – the with to the they and with what’s line why we’re FDA. of would can in be great. to discussions submit. just us I to the discussion Is kind the of and of before of remind with CHMP forgetting

questions. good and Ren, Thanks,

but aspects related started in you before, even it’s already, is at FDA it’s unmet we already Phase to already with a that U.S., interactions is in this trial we already pointed while – discussing you this and we the were effectively also also, had U.S., patients also, ongoing years we related dialogue unmet And we the in this told it because had was is arginase because a because with look So so there the – at CAR sort Most reason and relapse hypersensitive the least the the is knew to here. We – ALL, indication T need the is we they ago but market a ago, lot but really indeed to indeed, couple dialogue we it’s continue us arginase trial that X we the needs we probably pointed this basically The start us there what in in the And work different FDA refractory. the essentially driven to key is used. Europe. patients used may main in remember Phase of done this given the at us in best disappearing unmet lead. thought history allergic the here trial they in literally blinatumomab, randomized sort asparaginase there X/X U.S. I really an by meantime, at where was – of have need Europe in had of were why and but as is this the – in is saying done a remember small, of U.S. we yes, dialogue had is

of part second a interactions. question, it the clearly been dialogue. There have on is so your And different

with with to asked eligible told of FDA NOPHO trial example GCP. for in the to for it confirmed, last data year, but has answer and Phase asking we this have not did was It them does needs. patients. to in We different validation based consider – We as obviously make for also where yes, already approval to to on met interim for re-consenting but with the this path unmet not could And on It U.S., paper, forward they’re us do from we assays. show surprise question about medical question, trial. spring summer the has or trial at things the – an X would answer this this of different to was it no. And it guidance do basis No the trial has need do the IST U.S.? Europe in the be on

continuing pieces now of the we’re the puzzle dialogue. these so And putting together all and

sort initiate we Europe. it And – but this months really couple if go a to we re- next indeed so a first weeks, make before steps more there, then will and almost indeed hope the we And potential. take yes, of our in also can will maybe own then we conviction but U.S., of dialogue

it. Got

And tolerated first-line you have on guess, to, you of you just asparaginase now? guess final evaluating one that pancreatic, really do one that the right you’re I have well, as more data reminder. know When that also for you the the IST and or are or dose? what predict, efficacy the be then doses Do a maximum do expecting the the could sense end me is end of for you year. I that think by we XXXX would space as do you of area that’s Okay. a Thank therapeutic I are to year think event? And of by reach

question leave I’ll this for Iman.

Sure.

XX per the decided well-tolerated. very our then toxicity, a believe our with it rationale, the was and the we dose go design that a and recommended we good Gil, saying further kilogram, the we far, if reason, is recommended path that per really that with level is drug be up different on we kilogram, down. to XXX, would it dose dose to which that so level, can we’ll cleanly dose And move let is starting for could all indications a way started dose. units which go see – the If – was And if in good because we dose. trial level, with minus is our not, have the sees next that that the We some me the PI, experience which is one the units extensive indications. given that it’s clearly just with So XXX by start

for X, great So Phase achieve the that be tolerate recommended for would the we us, will all be indications. with in it be other we not phase go would which again, that, line beyond that would the recommended XXX if with because dose

I PI plan cohorts additional to in at that and is So in patients timing, think at let least to us PI dose critical we plan dose single get The at six first some difficult a generate treated efficacy, and a and terms the that or the – and accord the cohort XX/XX a a arm. really it’s we validity the extension see, of of efficacy that question patients the rationale, in with looking in small safety do cohort data. would

objectives is all to So we’ll component, secondary like the with and trial not. modify additional protocol. certainly the listed These a the data, that’s in the to part it for of maybe But randomized are keen goes maybe study PI instance do the maybe objectives. whether efficacy they would to generate good safety how see

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Frederic. afternoon, good – morning good Hi,

Okay. I’ll take that question.

sites. in of the trial. resources didn’t approximately So a one-third through we we – We have are our focus we lot the recruitment on TRYbeCA-X, since again,

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you. Thank Okay.

your [Operator you. from question. question Please next comes Instructions] Boris Thank Peaker with Our proceed with Cowen.

Cynthia Boris. on is this Hi, for

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further time. at you. And over call then any Thank I’d like this now to remarks. further back to any for the company I’m the questions turn showing not

again all. support or your participation you for Thanks interest. your your for thank So for continued

stay you you In will news know up, We call. wish progress comes our let the tuned. we’ll the to again a and keep on – great anything Thanks already always joining day. as meantime, you next we’ll and we look update for forward we’ll obviously if and