PHAXIAM Therapeutics (PHXM) 8 Nov 202020 Q3 Earnings call transcript

Thank you, Rudy. Good morning, the people here in U.S.; good afternoon in Europe, [Foreign Language]. I hope you're all well and safe and thank you for joining us for our earnings call for the third quarter of 2020. We announced our business and financial update yesterday evening.

You should be able to access the press release and our earnings presentation on the Investors Relations page of our website. call three this Dr. locations, on me today, different from are With El-Hariry, and Operating and Officer; Chief Officer. Soyer, Iman Medical Financial Eric our our Chief Chief

timing Before such X and risks to would results you materially. that anticipated X. and attention starting, timelines, includes financials, the to remind to and forward-looking the call could draw operations, statements to Slide involve to cause relating differ uncertainties your I on disclaimer today's I'm moving as which actual like to that Slide company's

we the minimalizing two the and milestones Although trial results and in to trials present respond we in which, months the to challenges financial nine the caused have that highlights quarter the have us available be key will will the not of the and will acute of the focusing the And providing third first presentation, to agenda Phase trial, the lymphoblastic any second-line for Phase investigator-sponsored our obviously on zoom ALL, the X business XX after Eric X over updates clinical the year, NOPHO major cancer, leukemia. operations. on for and the pandemic, COVID-XX To pancreatic operational third Iman and an months. of upcoming After summarize TRYbeCA-X been year-to-date. expected standard. successful the impact continues pandemic the for three our Slide on key I at then and take in progress quarter, by X, can to exclude the the on start status the will the with trials, trial questions.

ever view completeness, and sites, company, in acute on acid in cancer have just starting the area Phase for lymphoblastic X, company metabolism, our amino on pancreatic blood and therapeutics in manufacturing which one in X. Europe, clinical patients an We metabolism and produce for Slide triple-negative to candidates leukemia, cancer, product red focused U.S. to a one in X, the breast Phase cancer Lyon Phase for now in targeting altered are operational programs cancer And another cell-based X, -- Princeton cells in the we Moving cancer know, second late-stage a leader before on we fully trial you quick two part trial result on a cancer. X death X in enabled listed And the trial, the curve clinical Phase of And is rate of be cancer, and survival the again as TRYbeCA-X to update. graph us this XX% X.X an pancreatic important go strongest NASDAQ. right risk we're in on the study Paris Euronext reduction of in seen pancreatic hazard is XX acknowledge in to large the with Phase the to which will second-line our this second-line the ratio side has which been to indeed

X, Moving is Slide TRYbeCA-X, you'll TRYbeCA-X. see but to there more there than is

trials We have clinical four of and programs. a preclinical three pipeline

into have For the again, will to not this everything. we time go update,

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ongoing year or the continued extremely to The COVID despite even tenure, picking to from this Slide starting the required enrollment for QX reached above over now NOPHO-sponsored number large months still on This programs obviously first to ago. week as expected full and proud quarter place X. the important complete plan, that again. Now, very time, analysis week, with Phase to the been challenges. plan, to progress last make are means the IST enrolment the clinical the Iman's events NOPHO, see teams pleased no I'm on And fronts on say for slide, the us, interim to also a coming of COVID-XX trial highlights remarkable the our with recently next able said the have close also take TRYbeCA-X we away we impact for have analysis trial guided it's be up to the continued and that of in as after the been next weeks first, without X COVID the the and of continues, And is previously. with how in even few taking next approved. past progress, all interim is notable

patients. available And pleased here. are been It the sponsor ASH. time Iman of the more provide presentation at interim We be the top-line December and includes of very for with oral that data XX presented. X, by yesterday final presentation trial for NOPHO detail results, will has selected data should on the first the the

Last as ready the was the would we investigator-sponsored Phase are reported by to IST in study The said time, launch. trial like before, other X for mention trial first-line an pancreatic. also programs, I progressing that I the Georgetown It's well. University.

anytime Stemcells, brings appointment chain like now gene to level, programs nearing initiated obviously potentially we in because corporate Officer. pivotal we the been the the therapies will Stewart this manufacturing affairs with XX-plus-years come to and expect cell experience Companies Craig Orchard, regulatory to quality knowledge completion, Important commercial development, Chief turning Technical in Stewart's excited deep and for Stewart supply key patients two obviously new the of complex our and technical in manufacturing, I'm operations, PCT. as biologics Then Sangamo, as scale. Inc., and to announce Now, site of be now. and and first advance has the worldwide.

cash in Eric a efforts States, and have of to was week outcome feel approximately earlier can new It the obviously the teams, We XXX,XXX tremendous very driving make rate. Europe non-dilutive state and Every same form live alone €XX which l'Etat provide make we feel other achievements helping of place a the impact put will have and Garantis patient do. -- And of patients the France, indications clear United there in this. and in think in possible, very progress lot loan, Europe -- can This number approximately the mission, we patient the And with discuss we better a progress, on details are example all we about was impact will of type implications don't is focused is extremely and and financing I'm survival, your this first-line. in the Slide COVID-XX instruments now the patients cancer in financing medicines. the guaranteed year, together thanks cancer XX%. with and our half committed to dedication patients which pleased. targeting efforts. complexities. less in run urgent million is and our we in to longer, activity patients, everything a this non-dilutive second-line time who the this secure created very just the are the I On of in front, for more announced the this for that and financial both we U.S. pancreatic target this this in plus the And X, long-term with to a this thank Prêts everybody better. than for only is Pancreatic of pandemic. we have able as as the par loan And are zooming need diagnosed a for factor the a also important of great and we of patients been of and the zoom die people releasing on context of to is real aggressive

half about population, second-line to the patients progress even the more prognosis obviously is So of dismal. in and will this

smaller the -- in but spectrum patients than this On target, and indications indication, side the on about still, focus. the the other and ALL of least at more medicate of slide, bottom of Iman much specific I it XX,XXX

many of available key for to known these to to develop since an or a patients. asparaginase contributor survival patients that continuing that The issue on up know, component XX% is and Asparaginase, treatments integral will as and has it's cure the you close to been ALL of hypersensitivities asparaginase. years is treatment-limiting

of For allergic cancer, pancreatic these done treatment believe estimate as concept can and make these X,XXX CrossMark that X,XXX a in worldwide, support will we areas is this NOPHO previous indication clinical emergency product difference. in But trial. people of shown indeed patients multiple very there -- to system needs, the importance this for these U.S. proof candidate and it about That's trials. real options. in ALL we our in little patients, the in the have of in trials advanced real We

are of category. agility cancer non-encapsulated proof the the needs important -- We to a this the XX% for triple-negative very pancreatic, patients. cancer that broad therapeutic and TNBC, asparaginase can the to is there's forward tumor dependent at we very bringing unmet negative and with one space which and be known types these asparagine X the XX% believe about tumor also breast range trial to types of solid all and which TNBC, ALL, Phase then utility is now the triple of glutamine for And be is use indeed ongoing that our needs other is in are least in which also of breast the high current this to and CrossMark next medical beyond unmet liquid and beneficial which window

the how who I'll here, needs from will trials. Iman, Iman and and progress we're more making turn now provide to the detail addressing yours. floor are is the the to up on So updates, our medical call we these business

everyone. Good afternoon, Gil. morning. you, Thank Good Okay.

on As Slide a you is the trial. quick know, TRYbeCA-X I'm X. just clinic recap starting This on

of made second-line received survival instead is improving physicians The is And far States. approximately United added to care trial over and the was sitting, comparing pancreatic the in on what launched overall you Professor XX% this and second-line recall or cancer XXXX this chemotherapy. is gemcitabine X,XXX end chemotherapy. as Hammel abraxane [indiscernible] trial in trial are and study in trial patients chemotherapy of in France including we The XX irinotecan/onivyde countries in clearly and and evaluating involved when standard So that's in by States. patient [indiscernible]. Hidalgo United for may in of as dependent as of The it

based So well this performance as investigational study trial of is agent diagnosis the the are for with additional is disease, and sciences overall as survival ratio specified status, an hazard X.XXX chemotherapy. looking backbone improvement of in and on Eryaspase we as advanced at

XX, on to number you the just quick Slide give Turning to timeline.

pleased. very We really are

trial this earlier, to accrued analysis complete this the and, end so in year enrollment XX% Gil as interim have of mentioned than interim required we the is analysis we for and we immediately. more enrollment are number before We on almost for against target our are QX. the [Indiscernible] study expect in that

evidence in data also we independent survival But only in futility You in interim of doesn't And projecting study. and there intensive quarter as this overall of one of will to accompanying is to the taking two three additional data XXXX. safety and that no time know. is this, may the challenges, to on that more interim monitoring planned our had you possible QX 'XX, the that we the analysis this would data we more where today, bit analysis. little the conducted of the -- our patients be as committee improvement given superiority [indiscernible]. reviews based There are If the COVID-related cleaning [indiscernible] we again key importantly, the to and is continue patient recall are analysis due analysis in in fourth in from first by final completion are evidence have enough was XXX last the outcomes

the good is This news have gears is us. developed to the articulated So which hypersensitivity completed by trial patients and an group, The asparaginase. asparaginase a is slide, XX, oncology -- group Oncaspar next not last two patient reactions they trial The Europe. a patients study new in only group, The and to in for Slide switching of is certain specifically trial investigator-initiated weeks is study asparaginase the NOPHO but the oncology completed is shifting study to the who of in completed treatment NOPHP XX interesting trial, hematology enrollment study that made the renowned treatment. the ago. NOPHO very patients in also which

of and to for and We that the of take you next December be on are at has XX, that will we approval. slide, in oral study the case ASH presentation been I'd Xth like a pleased this you to results ASH. the that point it you the give published was accepted this as as But -- an slide on Slide have top-line is why we [indiscernible] we that will by think an solid This and far year. based

ongoing develop given And therapy there to prior And formation show of only asparaginase the see to not the in clinical to need with therapy [indiscernible], of so, interest, United that, on are an first of results applications based reported therefore asparaginase in have patients total. Where actions what publications Erwinase are in as develop asparaginase also needs trial, the also this alternative only an we was not you XX several basis unmet because free that the hypersensitivity these patients that is them but that -- adverse and we almost in this but impact transmitted and hypersensitive was when is States believe presents in patients. overall the to the see indication a the XXXX. patients we in is to that on that shortage, tools to outcome actually today asparaginase typical applications believe is medical and for or similarities this activity And one there why all particularly in was you the that survival in patients. in event year patient this show patients XX in and survival asparaginase, would

provide providing the and further have what data would we this think we is slide ASH forward industry turn path financial are update my financial to cash that that on presented and in I potential Over and with an the FDA where in at line will to abstract, over the we this So and which And I various to results institution. determine published be of we activities by with would Eric. full you, in concludes and a whether to have quarter the think like will Eric discussion position. this

activities, -- And financial we're And had second ERYTECH totaling a $XX.X the did €X.X of million position Iman. and X% this XX, SQZ million, €XX.X was €X.X recur quarter, million approximately cash. the €XX.X months million and in of to third with decrease on that's agreements position during of comments for quarter first million deck. and million million XX XX and increase million decrease with cash in nine moving the decrease million first We're on was everyone. which was morning, mostly XXXX, is cash XXXX million in of operating of XXXX a or financing Net highlights the million million which our Biotechnologies loss depreciation a €XX.X presentation. XX% XX, quarter. XXXX. September information. while XXXX pancreatic was company's [indiscernible] on financial €X.X that We're year-over-year as of The of end for the slide the in million you, cash €XX.X The And and incurred Thank a in June first on in of for of the equivalents or at manufacturing mostly word with year starting payments operating to against loss million expenses, negative reviewing utilization, we're from first million in was on that €XX.X Also months good €XX.X dollar X million increase exchange on used increase actually, for cash vX.X XX Phase Euro recent nine consisted €XX.X the a plus million activities, of for million, now the related period of now and compared Starting the establishment P&L €X.X was license Slide in June the nine consisted decrease most XXXX. the with with of December XXXX Slide financing slide in the capacity, and activities, the the attributable investing the in €XX.X loss of €X.X net in And led on up the related to now to a€XX.X XX, €XX.X preclinical trial in which the income. was which impact. which the a €X.X of XXXX, €X not, €X.X and consisting €X the the XXXX. in cash million, million cash in And to expenses €X.X clinical in income, mostly course, upfront now result million of number G&A, related currency US cancer. clinical And initiatives. of utilization million the operating generated net to in months development comprised

proceeds per amount government year. We cash will of years end the the and bonds cash And loans. XX, upcoming the French a should loans current of of with fixed its quick few of Slide order. period. as that, of of effective the the for bottom with First, securities may net end of ATM. financing could we're was Blue F-X been program the each that's equity year ATM term, an and of company, would dedicated we of with to SEC will a of ATM called company as the execution, The XXXX The the a in the like will important that Form that the will the amounts Générale million term rate XXXX in the respectively, today, of and little ATM the the we August and the program guarantee at of one a dilutive Ocean a state-guaranteed of October start further notes in XXXX total milestones. today, in all on that defer five-year to-date, June X.XX% million an million state-guaranteed signed that in say form under non- we at each shelf over through registration finally, bear extend PGE US the to potential convertible and Also, X.XX% financing convertible €XX interest its page and the to secured tranches XX% €X have the combination And due of initial news notes And the and under we've wrap Bpifrance when the notes, with initial proceeds up not this year we you and €X of have loan in principal extended the with statement in account million XXXX. has September, with this of of loan, million announces and into or financing Générale on ERYTECH after of €X.X the horizon until option, in the with pursuant Each the taking called its be remember amount by announced the as loan. Cowen. on at Société horizon the convertible converted. so chronological loan sold by X, two QX and repayment one also cover agreements financing equivalents, in program, a a implementation any into multiple be with July week, €XX we've was Bpifrance and filed earlier a at-the-markets company I flow, declared Société provide key cash of believe And announced and to catalysts. And form the XXXX. annum the Alpha

indication, presentation at NOPHO of accepted a be who X trial Our ALL updates asparaginase. December If the presented. subject seen to study FDA that Phase few financial this next already should line data so in continuing that by may data far, ASH data patients hypersensitivity most with and and patients in to X year be on view final XX we're last what June ALL filing as mid-next go the we've the this expected been as of and topline ago, the in We've dialogue will final of we are time, and key early I've indication the results the the next right provided explained available develop minutes pegylated direction, year. the the for of was abstracts these final to have in BLA first early on in oral we have in study interim milestone mode with ongoing

page X pancreatic back and the we're TRYbeCA-X the second-line the of to cancer. Next, study Phase with in top is

patients the trial, with study in already Then than XX% end year. next TRYbeCA-X is to milestone of As the superiority this [indiscernible]. complete analysis be able no we key of to the more in enrollments mentioned, in interim expect before for the

endpoint interim the or be results outcomes, we first you met and which is case MAA able the and possible expect conclude -- as we filing to of to can of a And again if for finally, will two the the primary two-thirds analysis, final XXXX. with of second then would in this expected the already word XXXX, trials. move know, which, half of a the a towards lead either superiority continue early the events quarter we is We in then in two survival of only it BLA

over who to any do in to very Thank next that the with to cancer already Phase in would First start X you welcome continuation questions Rudy, I results Georgetown the will now remind and call year. that's your parts we also of of towards would to study you questions may also open like TRYbeCA-X, will results metastatic you're, Again, expect Lombardi in And attention. any for before where X an this IST would with is course, you. the have. trial the you study you. expect the that, to French enrollment the patient later before With the I end be XXXX. like of the I first-line end to in the like Phase [Foreign we for ask cancer. Cancer breast initiation Operator, thank of the Center so. pancreatic This of of of year the triple-negative U.S. Speech].

you, Thank Eric. [Operator Instructions].

Benjamin comes line Our from first Securities. Reni JMP from of question the

Your open. line is

this of even Hi, pancreatic second-line Justin potential or moving interest maintenance From treatment at Eryaspase with combinations. discussions Walsh well in for looking cancer, if a there's into in or is does our on Reni. KOLs, lot first-line

that know the I you would So second-line? your I'm have just succeeds trial, and in is if investigator-sponsored Georgetown plans starting. beyond Eryaspase be development potential that approved TRYbeCA-X what that's wondering

I'll Thank answer you, Justin. here. let with and an start initial Gil Iman complete it.

So it's a very indeed. good question

obviously first-line, an But it and, we the we in to that first-line, second-line is feel in for from, The is data saying, interesting. yes, also would interested, positive Georgetown we the confirmational in combination the realized [indiscernible] was ground first-line, subject example, to is there as before this study can interest very feedback gaining to safety be to with got so group go you fulfillments. FOLFIRINOX Southwest, well, important much show and

escalation advanced but, this dose this first-line, also in do And combination the same being if strong to and also a like study. Georgetown example, a in idea where hear locally is so for important. FOLFIRINOX And then feel for setting, so whole that's it interest for idea that we

complement So, you whether Iman, want on know, this? yes, don't to I

Yes.

the therapy have with niche can so based good be Also Gil we that would this there indication maintain and like a on duration the rationale time a for indications some to considering, our [indiscernible] shown is with side. for But that considering other the of have really So setting. an mentioned measure a that maintenance level and longer are really are beyond of safety, other are and we to on is physical moving including the we you we also and [indiscernible]. is, through certain second-line given that indication to indications forward Eryaspase that tolerability discussions

tested the protective If a without it's if have monotherapy you survival, also we cetera. et or physical response, and sleep, shown remember, in benefit with excess heightened overall gem trial

gem/abraxane to eligible and, only we so this and performance cancer who like gem clinical particularly second-line receive presents real for one, not to I these need Phase most that therefore, subsets in a maybe be receive indication a of of be alone the X. could therefore, three pancreatic life chemotherapy a like poor there And Phase true are patients. and patients would for perhaps in X in are This they in believe to [indiscernible] particularly trials eligible others. mean those two patients -- in eligible companies interested unmet or we performance because data, pancreatic an that are ours this are cancer, And, excluded believe

also support at can So highlights, support ask would that niche these this some a are pilot get [indiscernible] trial an discussion. trial are but looking in to sub [indiscernible] like combination to be us at that the ultra we indication we small

That's Thank very And helpful. couple a more. you. just

the allergy full specific you've results. discussions to ongoing have already to meeting an to did them just NOPHO planned you need the with a have that And patients feedback saying that regulators in if there's mentioned FDA discuss with You respect asparaginase? from ALL. unmet received was beyond I you any that's who wondering an if

question. Iman, you can also take this

Yes.

course, that give indication of that actually determine green representation, NOPHO this ASH we the we will as a share published that will [indiscernible] has I to for FDA. other the information is the planning meeting. us have internal that will trial, there's in to if will can whether So it the a need in at and, [indiscernible] confirmed been well medical unmet the trial light by data confirm But results be around proceed as we once

question Perfect. the for last us. then Thank you. And

platform is, seeing interesting any some the more dates there the course, data is specific the focus there. data if expect or out when was can more I [ph]? know but of wondering and to I we on Just work, preclinical clinical see are Erizine of still the very Erwincynaze

do doing And That's of, clinical but there more all view to continuing work Indeed cycle combinations. for we preclinical, life related we're interesting have in work good management trials unmentioned sort still -- question, have, the the it's to overshadowed Justin. study. there. in the we're of we're really additional -- now preclinical pre-clinically the done so up proof secure we for by can The [indiscernible] proxy, financially We've program in Phase concept, trials X the clinical that grasp fact created ready waiting momentum Eryaspase. to we're the of

some on supports, should [ph] combinations It's sort some, out. like it's a out, some too it there's we not erimetinase I seeing still ongoing attention. context. these also out different yes, But that, still or to now. we Of what ongoing, calls difficult -- long the have think there's from we're of So things I suggestion and our more say, a should publication one be hope good with it that to deiminase, are idea other first coming there of, Erizine, year the for And, but get what work with half -- next the been in come compounds. arginine good working not preclinical we dedicate a it in should put components

Thank you.

of from Our the comes next question line Gardner Philippa from Jefferies.

open. Your is line

a of I I've please. if questions could, couple got

all, analysis. first So interim of in was the wondering terms of I just

a you in that you such the need if question, you this at and could than quite are therapies. CMC regulators trial now accrued, all that could on the could before to could rapidly more about and see there -- that? data particularly analysis you that to of quite that that data for of And quarter, the in So have of all you CMC is the it year? have is So how complex the that? enable actually come chance What the the that actually then we've of events seen could my these the you interim, you. you proceed second the end focused you're sooner CMC, outcome terms getting need Thank in say first positive filing talking that having we ready terms

Thank leave her in to really I And you, Iman this the good it's and because also afternoon. Philippa, will fields.

she's she's been I think to trying disconnected and reconnect.

sure. yeah, Yeah,

So cleaning, on the for the limited. enrolment, that's little yeah, chance events the had the end because see impact on obviously, trial to impact on is data has the COVID we the very site events, where is and the And the access of not times, sort and be we communicate if before COVID, year, would the normal a to given inter there of, say -- accrued. of instead are

why an it's expected. around because the that's longer -- the around So that there need is uncertainty reason taking say we the than we QX,

So indeed in know it's year. to And key the therapies, on since all one it cell I'm no the before saying the therapy. in CMC question, these the have of always, that's possibility I end in

in an very have had interaction. also an we We good had meeting questions, We -- the have dialogue. with the ongoing there had the CMC with the meeting, summer

we're milestone. on November, readiness. recruitment And operational He's address nicely has sure almost Obviously, there, of been joined CMC, now, product early and experience key been years there. different points technical so making operational, now XX effectively also the settings ready in different over we're he's of with the have we Stewart view And combinations. progressing a all very a this in us but he recruited us completely year -- with indeed, been GMP, in working almost the to

for delay the us. taking in I'm the confident and the potential for sort sort we're approval of not right that steps, there so And of, become, does CMC

Gafanhão next Our from the comes of question Ingrid from Kempen. line

Your line open. is

everyone. taking Thanks my good a I questions, couple questions. Hi, may. of I if have afternoon, for

for data mention seems but we is you to with in numbers was the enzyme ASH, and activity. of at benefits give to and thresholds, do of above they XXX color at the leader, extracts of also sent of mention that patients them the the out these terms they means looking couple the should how us I and questions or for some ALL that just that clinical be coming for what data? think [indiscernible] [indiscernible] And a on asparaginase a already a we saw this of couple couple of description first all, the

demonstration start sort has like asparaginase also endpoint. also over here threshold XXX the XXX Erwinase in is was through mentioned, for been give activity other XXX approvals, XXX. the It's that, about past the and over of, Iman. like secondary approved to also, the threshold I'll this of been approvals. of has like then information for above more Oncaspar

over now well-established 'XXs, have to this XXX, that the will market that since on if this been so benefits threshold so maintained has of And been demonstrated. asparaginase. only be asparaginase since that the activity can has lead clinical It's

sort response, have for level, which And like trial the complete established for almost was that clearly So activity are Phase that it's, our this endpoint the seen clinical response X an we the was surrogate now right objective -- asparaginase. we is trials dispatcher have and benefit of, survival. randomized, in the related

data, it's be the that in clinical study is trial local clinical arm will single establish the Here comparator. the a difficult to that it's compared benefit to

don't this and to you Iman, really do yes, add and, safety completely. know. to endpoint want an it's answered answer? So endpoint a I activity it

like comment high known in assessing because that the additional asparaginases system to solid only [indiscernible] develop only Ingrid, I addressed, of are inactivation. point activities, whole the the called about what not level is the but to the is asparaginase The would pressure asparaginase

it is start or giving may so effect And means see drug, but if you're you from to that really virtually clinical that it doesn't thermodynamic you it a have the these any dropping benefits. have,

is agencies, of, if expect you is threshold, asparaginase. level or for established, it is benefits this you -- as mean, that would the -- that why we activity in why achieve clinical Now, other I to endpoint sort FDA that asparaginase have and expected

science So asparaginase Oncaspar have what with different in and clinical different trials that's particular randomized shown.

that is why. So

a On liter the it neutralizing the therefore, as [indiscernible] one but with inactivation a is per agencies. to established a in case focus that the to is levels by even silent analysis the sensitivity started sensitivity you the or that, and nothing number antibodies. to XXX, more, achieve unit of XXX critical drop, that for antibodies, is higher development show more And can XXX needs that on of threshold

second clearer for And just and a us. thank much. bit makes maybe was I if for a Eric. really may, Well, you question helpful It very

us a tranches tranches? should which this give and would are to considerations Alpha Ocean. mind draw you some in color of that guidance So when of little additional keep actually you was from trigger bit one loan? you some we next draw that to planning Blue are Can What the

would -- decision, any I yes. well, make Ingrid, not what

the to our this tranches. extended that this As know, next us is do some True selection runway. you PGE given loan has

there's see the are, conditions -- yet. we'll these no So what market decision

the line comes question next Fred of Our from Gomez Pharmium. from

is line Your open.

on you Jazz find XXX Phase [indiscernible] mostly know you that ALL. of children study -- I the and X are That studying only. currently two taking sufficient could Thank ask in confident the XX another in is be U.S.? side, could to the to patients proportion And for questions. How from of patients my a don't I more XX Erwinase. be restricted Okay. patients. of than children the the combination running new my among

especially two dose because knowing convince I'm pancreatic you can with one major to Jazz instrumentation last know to and the is French sure in project concern the a indication, the address for issue [indiscernible] you Erwinase for And Jazz could people? the the market the be at a new on these. you different cancer end Do pricing. on one potentially children issued with different regiment and you and access think second to hear same has to file supply is to curious is in a that do areas the we it this is is you make ALL. agency also because report and at to that The that approve Erwinase. Recently struggling helpful medicine how regulators guidance

see you pricing you. an you should -- pricing that should be So that how could impact indication? you about do the we on Thank to have think see, knowing do different unpredictable we we how can and think two

Eric. you, Thank

Yes, new So Erwinase. Jazz is here on I'll start. working also

trial on XXX based but patients. So there up as all may answered Erwinase the such only interim so It's be trial they that this is Jazz one shortage ongoing. but this able one patients was take the we the supply third yes that day -- there filing to the be and maybe the before, have other I I XX we in think, quarter. fact added should given with It's given and account the will that day, into that some to is experience now a

of two been a So years. it's really last painful periods

that's fact unmet -- there's the know, So but made, what also needs you what's suggest is this has I and is medical ongoing. know don't

sorry. the I -- that half medical life, a the with product half also So need Erwinase unmet mind stay in but have is day we to will think a life keep shelf product

crossed XX need out month, per injections So it month. injections per two

into So there's XX also to other account. that's these, the enough? So the And with FDA. is really these dialogue take patients aspects

of So experience, of performed the compassionate broad product Erwinase the in XX with present current ALL, will safety to ALL, patients plus have then real broad in product, is a use XXX XX to it patients, program number and, we patients Jazz life of, what's really -- program as specifically events, Erwinase but sort also experience of in pancreatic. close database XXX the

there in that that we -- depend it given the but we have. are pediatric medical basis on whole think is And Oncology. will the NOPHO, all the a is hopeful, indeed, unmet and It yes, there data dialogue So of all Pediatric the Society will that, it and XX we pediatric. needs almost and is is Oncology surgery, the essential Nordic a Hematology

of are adults continue to other U.S., countries. you it's just this -- the in but this also. young mentioned it's that And So there in the some in all in there I'll dismiss France, on the it's shortages

where unmet them. aspects, need, in look to we'll get and possibility the approvals opportunity that's the convenience above medical real we address clearly, see and So hopefully, the this

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call time, remarks. further That now I this showing to Beyen no the Mr. at will closing Gil turn over for questions I'm

the Thank support everybody updated thank your We you through the participation, remainder keeping on you. as always want to of of progress for look will and the I questions attention, the continued for the to this ERYTECH. -- great forward year. keep

One November. Thanks of in the Conference you wish great Jefferies next the day. Hope everyone. see participating there. be locations will those Thanks a to probably and you-all again at for joining