Moleculin Biotech (MBRX) 13 Nov 232023 Q3 Earnings call transcript

Greetings, and welcome to the Moleculin Biotech Third Quarter 2023 Conference Call and Webcast. [Operator Instructions] As a reminder, this conference is being recorded.

At this time, I'd like to turn the call over to Jenene Thomas, Investor Relations. Thank you.

begin. may You

expectations Good I Daryl. remarks welcome, At risks intentions, everyone. during forward-looking These Thank and statements like morning, to time, involve beliefs, management's state would webcast uncertainties. that future remind this projections. this are you, and may and or our made listeners

differ federal are expectations, are and based Moleculin's current this Forward-looking to safe laws statements call on harbor securities the actual materially. results could and pursuant made provisions of the on

place undue not on As any a should result, statements. reliance forward-looking you

factors of the section to Commission. in Exchange with Some the of and statements such cause differ files materially that and and Investors website. Commission's Exchange discussed the could form These you company's website actual documents carefully. from We the are Securities by Moleculin documents encourage Securities results periodic are reports these on these to available contemplated the the looking review in

contained studies, company's or and in and to the this own relates and Additionally, from sources obtained surveys certain data research. publications, information third-party webcast on estimates based is other

subject sources or company that independent independently be trials no from obtained these source data regarding as progress makes Any verified verify discussed third-party adequacy, does date to presentation, clinical or change. and the While the and reliable as considered not the to any information representation completeness to of this and of, believes accuracy of it of preliminary any third-party source. are

Jonathan Vice team and Executive Walter Dr. Senior Officer; Officer. Chief Officer; joining Waymack, today's So Moleculin's Foster, President Chairman Klemp, John us on Executive Chief and Financial from and are Chief call Paul leadership Medical

Chairman please Walter call proceed. over now would turn like CEO. Wally, I Klemp, and to to the

of Klemp, hello, Founder, everyone. Moleculin I'm Chairman Thanks, Jenene, and Biotech. and CEO Wally

we've the of been call. finally data saying on be able to year We've We to deliver excited some QX that now would welcome you for our Phase and been this we data, time to earnings hoping this II for. are really are

clear, come this a preliminary And to subject share is going this start, but to data there's good and the to change, few in a be quarters, with and on more call. you it's we're have To next and one. a lot it we

through of both been the in for approvals the advanced the had and STS core is outcome you that beliefs. fact there we more ask years, and most indications been new to an last tool AML the walk keep anthracycline. these over first-line today, that therapy dozen indications to in mind for data for the I'd continues anthracycline. Despite so our As the the of be a important therapeutic one remains both and best has drug X use or with hope positive than a That

deep sharing those patients to prevent this high-value tool today's from potential limitations and from have most days a their Unfortunately, Moleculin annamycin, list major available that drug is of about both that And this program do targeted patients anthracyclines those our in But intend this pipeline broad, to course, of we excluded have, use. the been are lead until indications. additional on be indispensable who is a with to with now, making long over. benefit. in intends

of this you efficient with by preeminent many network a know, exploiting structure As global doing collaborators. of we're a highly capital

trial our and acute trials between are to myeloid sarcoma. about capture and running U.S. focus that in our Now completed, XX After European are our one trials our we'll X advanced trial pipeline to begin, Today, is robust for the all, just on soft them: we've and in clinical slide. we're leukemia too just technologies. complicated approved in talking currently of tissue

annamycin we have we in have a and status of and track range designation position indications, both for fast reminder, and indications. potential patent orphan drug a a As strong

For been is terminate anthracyclines to critical current long. anthracycline patients either for the understand of or can't the why the is Far are treatment have so new receive use cardiotoxicity. has you desired This reason of to it's greatest before benefit. those limited anthracyclines limitation primary story, the and to who receiving away, the to

there limitations organ are also well, tissue and resulting multidrug mechanisms. As from resistance distribution

As to who today's patients a result, get from there don't are simply many benefit anthracyclines.

cardiotoxicity, lifetime cardiotoxic, when are the in to quite it comes data Anthracyclines a dose so FDA XXX meter. has milligrams of fact, per maximum are Now that surprising. allowable the square established

your a negligible. there's milligrams see As XXX And you to of can you if chart certain XXX you is square cardiac go experience the meter, up risk impairment from milligrams, if XX% to you the per you of But on only accumulate maximum, you left, if will some of impairment. XXX% go some will have form kind impairment. chance it's that cardiac up

chance more the even XXX there's this X% make shows chart on milligrams you'll graphic, treatment. during heart full-on to have meter, Now failure an the per square right that

only translate indications, all Likewise, you When you or of their dose, those maximum doxorubicin, is they're they're cannot a currently at poor range of soft allowable to always though of relegated advanced nothing in little cocktails an anthracyclines that and tissue diagnosed relapse. they're AML anchored therapy more XX% lives. prescribed half standard around once extend to respond, will than deemed care reality lead anthracycline, see receive to drug because that due or of unfit about all will health. this of And sarcoma, do with age our even the lifetime the usually patients to patients

patients, a is there a XX%. used very among be needs generates there But AML, combination combination on is too ven-aza to often $X.X this that This a patients a tolerate, azacitidine. strong better it's complete clear ven-aza simply and are is most difficult of drug hard with answers consensus in to in that a patients. capable not AbbVie. of billion generating response for which in drug clinicians revenue XX% best In just year The It's currently for answer. is enough. good for that venetoclax, called is available And

best In around advanced be a no STS, can best but patients There survival. be half is overall appear improvement the trabectedine, to simply And they the answer. offer there now and a treatments PFS is. about the appreciable must with fallback to X-month better in dacarbazine

is We've And STS. Annamycin both I pivotal strong not indications are we Phase anthracycline and to completed call have patent drug protection a outcomes orphan importantly, next-generation Phase appears completed II what AML, status that's Phase completed our and STS, both improving designed preparing and be study we've in are fast we've enrollment testing to XXXX. now II. track in noncardiotoxic AML be and, trial. through in Annamycin Phase only approval in In a does I. in for also and and

we cardiotoxic they anthracycline knowledge, annamycin of there Cleveland the no But making we our every we're only then our claim say data make So stress testing of Clinic. one is less technologies and mean is expert to noncardiotoxic. to capable cardiotoxicity submitting we are important XXX% are an to ones with It's the this as aspect that at the claim cardiology because when independent than noncardiotoxic, players out other there doxorubicin.

be easier in being we appear patients on approved to anthracyclines. addition And noncardiotoxic, to currently than completely

on many the we're having tumor multidrug with patients means, potent it is concentrating of annamycin. models, will XX% in doxorubicin patients. any expanded or many But lose the loss despite that actually able to annamycin We're patients, small easier even be of that less fact most with than though it's the hair. their once and avoid doxorubicin patients efficacy that limit than hair as seeing on to treated more additional should is a annamycin relevant STS, AML XXx example, And mechanism patients indications. As XX% resistance in to doxorubicin more and

by it institutional for we pipeline, to are utilizing very relates the effectively As expanding development. our funding clinical way, nondilutive

and both UTMB, trials MD sponsored funding benefit Curie our this clinical and benefited Institute clinical outside And Emory to several Poland. we've year development coming at we're Anderson, from addition funding this from year. expecting research Madame to from yet In the Anderson -- University in MD

some paid thus big dividends And far. research our sponsored has

the fact of advanced annamycin the annamycin XXx that's an the is metastasis it ideal our making better which to playing in than AML lungs in what ongoing the accumulating most is trial, point at addition now this STS, and lungs. between that candidate for In Phase II doxorubicin, is research the to eliminated is synergy demonstrating cytarabine out also commonly

So you with that to as data. Chief invite on our Senior background, to I'd Waymack, Medical like new the the specifics Paul Officer, give

before of the to get standpoint combining single a finally time annamycin the for long the for point was of the a agent as cytarabine Phase data and a to we safety are taken AML, AML II has patients. regulatory demonstrate challenge from but efficacy of there. clinical generating Part it to It with needing Wally. Thanks,

anthracycline could had we that to safely and receiving difficult this well treat the patients be dosed any maximum with line patients Given at also are allowable work to or fifth also above third, had worst dose, were to patients who we which therapies, fourth, the meant most that demonstrate FDA's expect impact.

all therapies. cytarabine, preclinical finally with patients. for treating X now that we II first Now patients case. challenges, a a AML study who incidentally this the the data be appears AML these X notwithstanding patients, more are of combination And trial combination effective in our now have testing in even would our prior be from with suggested to We annamycin entered with median a Phase

be very are a would have rate, not responses. pretreated report pleased We annamycin patients. completed to something This dosing, their we X XX% who such response among complete patients have heavily represents and in expected that

recall rate. a approval may the you response XX% Wally ven-aza comparison, based For complete was that mentioned on of

we So whereas approval a pretreated And of believe ven-aza was marketing we that trial, therapy are the level for heavily annamycin. support are doing at patients, approval, will this in what's performing we first-line more, patients. already in

our at there to insights look specifics the apparent. you relating now are that valuable When some are responders, complete

refractory of First, ven-aza, no to but ven-aza prior was the to ven-aza. One then to had and other them one exposure responded relapsed.

now with other confirmed treatment marrow simply their months after time passed declare remission. first transplant not climbing, with the X as We durability bone since of X third having and X received enough remission just can't has annamycin. at for durable, months because The treatment responders a X patient yet and and the are

allowable meter anthracycline to It's that of activity, milligrams were a also of pathway. be in establishing And treated X if all to level worth AML. good Again, marketing dose to XXX lifetime were we position what per the maximum see very this of we'll a this square. think well pointing we is hoping in patients above continue we these out see approval

a of and are lot trial approval to from now clinical sarcoma. believe in But bodes present our There's the trial's soft have ultimate we to preliminary an as advanced Turning U.S. sarcoma. the this well our here. able soft complete tissue Phase total, data process enrollment We a arm tissue to data in of trial II whole. some for

approvals therapies. while is been that out zero to dose the improvements When us a survival here is of higher in for or that optimum we with survival XX% of be in need shows in not had have most which XXX so on turns months XX% most X the unmet The had the regimen, dosing prior you we regimen the optimal trial to productive very dose, or great based highest X among modest around and progression-free on PFS. tested. patients took square, isolate it It received recent progression-free patients meter this rate, far X on a dosing who the milligrams the or the turned this right reaching column response per the out that

but That indication, the other for only favorably with it's the compares half story. approvals

survival. is overall second-line extended of One shortfalls of therapies the delivering

and Although II survival, receiving had Phase for patients to still XX, overall we medium to for II survival survival at until basis elapsed of are was for be we since the all survival the XX and the that numbers X, the cohorts the appear number overall the XX overall the of haven't Phase Considering data the median way still be trial the marketing annamycin XX reached headed Phase stronger won't look our alive portion months fall we could from to where that climbing. to entering alive in median a overall the can approval. group be see of diagnosis an down months enough I even time reach patients we

tissue that's We these sarcoma had enthusiasm and Oncology CTOS, of of opinion Connected at the a the soft Conference leaders with Tissue Society sharing in data pleasure group Dublin, was recent key high. the

which own their to result, approval different a expect now we a As trial, X pivotal year. run we groups off next versions to have of kicking proposing be

Foster, call. to Chief Financial to Jon? Jon I'll wrap now the hand it and President Officer, up Vice off Executive our

with with roughly and raise XXXX, burn our ended Thanks, us equity debt our Paul. this we've sheet million quarter and get little discussion balance in with hand, major XXXX. been the in of our cash We current warrants. quarter cash $XX a will clean last With no third that into our runway rate, consistent remains since on the overhang in

of believe, in delivering This XXXX. to allows just table shares short XXXX, we outstanding. and the have million XX milestones the early XXXX, later We milestones deliver runway set these us, for into

recruitment presentations. clinical other Regarding With picked of an recruitment to being AML, XXXX, FDA expect II events our treatment that, expect XXXX. and the be annamycin the has EMA the we with also as fulfilled conferences for Phase engaging meeting. efficacy we steps second we trial continue in us and discussed, in updates earliest, open concurrently with MBXXX such half the scientific for next of and will public trial, or the sooner, with quarterly clinical the of From the to with label delivering other up, early trial that, identify if the and at begin next the pivotal end not and

partly investigators investigator-funded Regarding investigators discussions that in expect first-line of half. treatment believe just for that's second in response possible first and advanced subjects to the initiated EU we treatment CTOS meetings in us and second either as tissue we monitor trial, a OS or discussed. continue to either be U.S. in the But that identified program with of with The the the quarter to Paul final stopping PFS, forward XXXX STS, at the soft will or XXXX next in our readout. of leads not of fully, report advanced us moving with to for the and half could sarcoma, in

upon just are of building the efficacy we All data that milestones these discussed.

Wally?

Jon. Thanks,

time exhibited quite now We've and of data. not nature single any lifetime the no touting now, for treated patients, a allowable noncardiotoxic been XX whom one some taken above we've cardiotoxicity. there signs just but is the has maximum of were For annamycin, most well dose, substitute of

But enough the marketing now approval? are and II substantiate big of those is and drug. we to be question Yes, needs actually is shown a worthy the until activity being more in the efficacy. will cardiotoxicity data everything in a what what it Phase mind, has question. absence we've without now, is preliminary, to delivering, And annamycin that's setting a up in with that deliver unanswered caveats be answered. of believe meaningless few order need with become we been Could you it patients. annamycin multibillion-dollar But Well, to

to our of advanced anthracyclines core And anthracycline. important back host to it have improvement in AML denied a all belief. represents finally Annamycin and a been comes for to available now, Those anthracyclines. decades. cancers, as make haven't most an opportunity. who, is real those And tool as other The tool patients well in hard-to-treat until STS, improved this been this we're going

quarter, our for So presentation that happy folks up wraps any We'd Jenene. prepared to handle questions be have. the

[Operator first come question with the of Our from Jonathan Instructions] ROTH MKM. line has Aschoff

the AML, you Congrats that percent what Shouldn't the be But XX to on CR rate well [indiscernible]? as really analysis ask patient? as data. cytarabine I about can stroke is, exclude would in in the from the wanted denominator SAE

probably statistical Paul, for I CR basis think address to you're best establishing the rates.

one? this to want tackle you So

with have alone a monotherapy things in trial Because we XX%. we would Yes. in differently II a treating them around pivotal of CR would since cytarabine, getting you do Phase include just trial. XXX Certainly, in as we the annamycin the pivotal continued to study, intent-to-treat with the And person analysis, reaction a allergic trial, similar an results were had a all. rate

we patients to had here finished. wanted So present just who

finished therapy. their out point would this patient in trial we've who I got another

a we from the put until the have that in confirmation We the had documentation. have that written CR, we deck verbal they slide site don't but

patients So intent-to-treat documented II it and in be III followed very be have whereas in the the broadly Phase in we protocol, the specific analysis. would trial, who with are data trying study pivotal who Phase a to exactly more

Okay. to it in data press that to STSLM the data it for week set the today's update Is fair compared ago? is new that release say no a

Yes.

familiar Jon, you're most with what's publicly been shared.

want do you in? to So dial that

No, I disagree, Jonathan. would

the right-hand when trial. the If start you Q, and press took to the waterfall look at that at look on at line the presented chart, look chart all believe also you're we second add up XX of comers and data. a getting and better where get into that in that this release, people therapies, therapies. you prior Slide remember, substantially you I'd at and data. looking to you side -- we We with on, took zeroed in if And we're down that XX up also third we dose

the it's of on, data, correct? greater that it's duration same was But reported just prior patients n

the we reported II was Ib now Phase then We and XX% Ib, we're Phase -- the data. presenting on, and No. Phase moved

we And we XX was waterfall chart. and did so added data, goes across you what it see how patients, can that the

XXX much, we we [indiscernible]. to worse trabectedine, And XXX and just we milligrams found was XXX got below and so at dacarbazine start and up, out comparative better too and with we prior We people therapies, looking that results. and once patients, got end the less results

dose be II at the of Phase recommended recommended [indiscernible] I've patients past And II must the Phase all mean though, notes X up dose. whom I that of II the Phase and to Phase taking patients, written in Ib up XX. adds XX

Yes.

have Jonathan, that data just OS, is we as hadn't well updated since that been updated here, now point segment elucidated. PFS, the I think as report, last

for think point, that time sharing in first information there's new I the but So this I release. important we're take your

All right.

So for do many lastly, have to you trial enroll how a both pivotal AML to expect patients STSLM? and in

than proposed focusing statisticians. the lengthy pivotal trial you've protocols. And discussions with both know spent you So had Paul, and on investigators more anybody time I

you tackle to one? that So want

is demands. the answer whatever FDA ultimate The

finalized coming but overall like. efficacy in exact you for the For soft the in. and plans not the few patients the yet as tissue anticipate not that an still hundreds, we because can't on, trial, because are sarcoma, are have median we number give would the mentioned, the reached have be it We going trial and still will I survival we yet data pivotal

through have as similar, doing to AML, trial would than we're The what going we the FDA propose based approval first-line before, to XXX. to first-line we approval do that mentioned subsequent to documents, the like accelerated patients. single Based accelerated For a now trial. for we sure we're trial on are a If with therapy XXX patients date. for if not better, single-arm therapy. have approval we that process. enrolling We a results the therapy a a we would about go and single is with XXX to would single-arm about are trial, make required be guidance getting data on take FDA would get pathway propose trial would through the to confirmatory randomized trial now, There seen that

me add on And Paul, let that. to

first line, elderly mean and unfit correct? You

Yes.

For elderly.

elderly trial, of then randomized where indication, traditional more you versus was arm. approval study we approval, And patients, go need doing far ven-aza an you we For a what and therapy off a broader is control do from on our first-line approval. and trial, would that get again, accelerated confirmatory a do would single-arm single-arm randomized if study, which active unfit not in accelerated

Okay.

it's it an trial the funding have Just per XXXX? getting made you what patients with you trial have somewhere the Can kind X finding and or XXXX to triple progress answer, in is clear of you going helpful. investigator-sponsored in -- other that of products, lower make lastly digits

nuance let to start this. that So there, may some add but want me Jon, have you to you

that pediatric most one ongoing moved quick recap. And then our University tumors. brain with has prolific was investigator. a areas sponsored in of a outside the investigator in the with been And funding been just Emory -- at then And MD trial One Anderson to MD of the that STATX probably University. XXXX. inhibitor Anderson Northwestern we've of there, discussions

to that they they externally brain from They've are that through for investigator some awaiting come It's in already off funded want very another tumors adult likely another the And before brain come off. with will progress know Emory pediatric folks additional XXXX. the indicated to that, kick trial. we kick at trial data tumor

There's and the information. to tumors comparing especially of clearly They're essentially have when in there. pediatrics. there's of some that for comes U.S. symbiotic recognized potential XXXX folks it they're now activity brain consortium a So across

IV that formulation And we then it -- formulation, intend IV just that to that for on we finally, recognize characteristics grind away are we we clear an an have be And going investigators the all with XXXX. drug. because that I've of to the the to probably are better switch PK IV continue delivery have described made incident they all an to

it's call it's On government highly right virology stuff what and side, focus now the -- it, funding I relates U.S. XXXX, that so continue speculative, as be primary of face I slow-moving. highly XXXX at moving basis we of our that's But -- it to on is there. the grant let's speed to grant research just

slowest have I program is XXXX. we the say So that in the right would portfolio now

and... All right,

would And the trial -- then is add on Northwestern against add I with XXXX clinicaltrials.gov. combination would GBM. that in listed It's that I already to radiation,

the And today. come later out will Q Okay.

filed. been already have should Q The

the questions Group. Jason from next come Our of McCarthy with Maxim line

squared. for In the looks like meter median it's STS per less data, months patients PFS, XXX are with who it the than mgs X.X

before OS in the so did have must needle yes. You -- -- the know survival was the That's Ib. but OS. overall move months median it Phase was mentioned from patients didn't the much in has What far I reached approved? OS, first it in had that it XX trabectedine XX it

Okay.

don't I OS data. excited the go so that They on they because there we're into median That's in jump mean, why really OS to PFS we're data. referencing, receiving. PF about I I'll the really focus we're looked paper -- that

do XXX in Okay. squared you're the meter you what for from but trial? in you're where having annamycin, trial per -- And the are go AML STS think higher differences the mg to going mechanistically, or less

Let maybe I there here dynamics it Paul, fill in there that -- adequately. think work. me haven't at start think off, wherever X But covered and I you are

of is One patients. of in the thrombocytopenia specter them

we so even can against though that -- XXX, the But a of know And establish issue become the that an was bumped a trial. in never hurdle we we to on keep cross fact, MTD the in up and handwriting to with wall DLT we was that thrombocytopenia as did reaching technically not it was patients going -- ongoing the barrier treatment.

felt push seeing similar envelope not so activity so dose at lower And like, let's here. levels, we okay, the we're

work the of window, will. center you in therapeutic the if Let's

More understand get question, any with of is we that higher why more do dosing? specifically I -- might think better not your anthracycline. because classically benefit to out an speaking, your we Because higher

can potential of the you start counter-effective get dosage. any some a benefit diminishing that a where out the to there the can't has returns to gone point actually know, of level, sort But go some mechanistic when to X There's whereby through, have cell you scientific are more of analysis topoisomerase poison, is you inventor a increasing certain be the appears there reasons get maximum. to You kill for simply results. as you this,

a poison too additional But is go theory where a theory. get any can far point that there's with we -- of but benefit not and out that's there have the argument, to you a don't support specific it. And the says it's out there topo data mechanism X that

Paul, to do you that? to But anything want add

Yes.

Let me indications. just add just the

sarcoma AML because and which XXX straight for XXX. a actually than XXX XXX the the for is correct, are point, the tissue soft X for doing good that's days, doing we're You we're lower is becomes

where to tissue blood up If times by and it bone at event is. far, counts in the XXX, we hitting cells you enforces marrow. of adverse DLT, hit. AML, marrow. because #X, is you're bone the because low especially counts, was look It therapy stop. delay We our that have to to with is go us didn't the cancer but platelets, got sarcoma, low the we blood could That's that's platelet to Well, where a the soft at had the

So a out of you've blast wipe them while. hell and the for essentially to got them

issue the toxicity hold we and safety in an that's with AML location. the the dosing location if in delay forcing So efficacy that is AML, too soft to us is here, go sarcoma because high, not also tissue

So it's just an efficacy. one adverse for the other, with event for indication that's

So I difference you. that's in reason than for the little tissue a the it sense that makes we're if soft primary AML, keeping think than lower sarcoma to why and

question. Got it. Last

kind where set look had indication Can therapy detail PFS, You of thinking another what the mentioned go-to in along of potentially OS anthracycline an be to might you more selecting the a little as whatever may next like therapy, be bit what year. indication? you lines perhaps provide may a key or a

can't of human on speculating data number Yes. we a implications but be, of indications. I PFS, we've to the in mean got very OS would compelling what this speak

gets specifically, And liver. the one cancer the patients carcinoma as to For the But most pancreatic out mets probably is mets. lungs. as -- Jason, example, I'm triple-negative breast there liver sure present and pancreatic to cancer, cancer renal mets that cancer with the the pancreatic lungs. excitement you to Also you mets most know, cell

so most side And common metastasis. of the it's

doxorubicin. a long to fact the now about lungs, in liver that it hyper-accumulate as for can the talked compared time we've hyper-accumulate the we turns in out also And we

to than think like Xx X more is I doxorubicin. ratio the

be might actually the anthracycline the first to in to it table opportunity bring pancreatic So an cancer.

what would So we be it's say if who most we were to that probably investigator-funded one. -- kind and of study enthusiastic choose and pick about,

Okay.

the that weak already liver potential the for the there? and to is does used are healthy has then. either because talks because lot liver follow-up the not that because liver, just or liver accumulating chemotherapies a liver the tumors Just Because in a you're it tissue reduce of mets in in primary

even Well, though disproportionate level. the we data animal in we at know liver in is to Xx increase don't see we vis-à-vis accumulate mean, that the what -- toxicity doxorubicin, I we any from animals appear

Paul, monitoring What's patients. human liver in there? perspective you've your toxicities been

no date, To of have liver seen indication we toxicity.

-- physician with liver called criteria. a look bilirubin for up. have seen what's famous ], in That's You [ Hyez go H-Y-E-Z disease. liver based not [ on seen toxicity -- ] and we We've

enzymes We go clinically never a a up little, to significant have liver but degree. they seen fluctuate

So our toxicity. approaching We we're of evidence patients guess, as in XX of of treated being liver have now, all don't I studies.

questions from Oppenheimer. of Jeff next Our line come Jones with the

of forward on path from A approval. endpoint Congrats a data. PFS similar on the is correct? that Is what's the updated at, in couple looking questions, following of been trabectedine, STS to you're for lung My your that quarter already. understanding mets and discussed

Well, I materially we modify we've needle at really think to think that that OS. got would the shot on we a moving say

correct if I'm that PFS both time our PFS wrong, actually of opportunity to combination the the me and, ever, I here of translated but So think into be window OS. increased Paul, of for first

-- since impressive quicker Again, for any from We clinical it obviously, OS. PFS trial, are we the a be would prefer measuring becoming to regulatory would in be would as variables, data standpoint, and said, but we'd approval PFS OS. both Wally very have

into PFS II OS Phase for labeling propose initial approval opportunities. we at better and end just meeting, of add the would to on product So probably, FDA marketing the an then

And meter state of X on the squared your mg while at of X.X XXX range PFS sense. in OS prior the makes you the X.X more the therapy, data the when months. the intent-to-treat Phase as that populations subgroups to X In order both look That trabectedine, for it's Ib the the in somewhere X.X look Okay. less was across II. guess, and with -- lines you've I than per provided, then, I the PFS at or it's

even X X.X to months PFS. months, X.X month, the So you're taking adding

the And of know, company And question to months. a goes X.X the so there or program the you just with PFS trial it probably of meaningfulness. dropped the clinical was as dropped that

PFS. with abandoned So the they just the product X.X-month

[indiscernible] that important. So overall critically

we chose it's a the subset thing inclusion-exclusion prior here. of to that is difficult X would note first-line in fewer not of or most I point that It's therapies it's one therapy. of first Jeff, column. right-hand point that our than I a think all, criteria is, But in important patients greater out difference

is was lung So sarcoma. trial. mets. This not only taking all tissue This not advanced. we're an all-comers advanced not soft all was This

will, every subgroup while of text, mets, in most seen for those the the trial subgroup trials published, specific overall And actually one in of gives that somewhere ever lung population. no lung acknowledge vis-à-vis mets their the we've data underperformed

way we do, So worst the criteria. we possible chose we this in lungs we selection -- the accumulate because deliberately

will that, trial, likely having be trial approval the it's very be first-line Now more said an think likely and design we all-comers to patients.

talking about we're the that realized gets that we but as likely not is the design we trial, today structure. setting for we trial target everything So for precisely this a approval we're approval think, data us, easier

That's Okay. helpful.

study, the your -- sort you're II you're costs the talking XXX of end a And second and pivotal as first look what in implying? ven-aza side, at half or pivotal 'XX depending patients, for Phase about otherwise of frankly, AML in like an or just XXX were both and you on lung the to STS AML single year. the mets, STS were you On potential do time start lines, arm talking study as randomized and half a about in of a

in ballpark. that's Jon, clearly your

handle to that want one? You

Sure.

Phase about talking Drug full a talking II/III you're We're [indiscernible]. study, think roughly I pivotal million. $XX included, study? So

indication? In which

about not the for enough there's looks very There's trial this. AML. Paul's looks might And that STS. not likely side it a Jeff, enough STS been It this. like in among we on external it, to institutions pivotal articulate we're going we -- mentioned he but specializing that funding were segment, in enthusiasm -- on are that have have

total Okay. required study? the funding pivotal What would STS the for be

we funded -- much talking that you Are Well, from the trial. really well, a depends from get how externally say about... on I would

funding. external of Exclusive

and all-in investment funding external your So then would reduce obviously requirement?

Yes. ground, A IIb, fairly a million. include Phase get That cheap. We'd be than to pivotal off would estimate the less not $X it does -- pivotal the not population. would just

terms think than of I But lot practically cost. trial, a in different it's AML the speaking, not pivotal

for the of our reached over like Mr. closing I the floor remarks. to question-and-answer end to turn have session. would We now Klemp back

Look, something it for talk first data, this real Thanks, clearly about excited about. we're Daryl. having to the time,

our might stop what in where finally -- the able about think been point we're supporters time. and we talking loyal now. patient is start that we're talking Look, very I right happen long at a future happening about to what have for

delivering data. to happier couldn't this of kind we be finally So be

who timing And your frankly, for are story, new those better. of you the be to couldn't

in few more expect next building. updates data should the You positive is quarters because this

so is been going all waiting as and we're we quickly communicate for. we'll And that pathway what can to to we've This as establish marketplace. a annamycin, pivotal the for

have and lot, a week. you great a thank So

does you. your today's We conclude teleconference. participation. appreciate Thank This

rest time. lines You this day. your may at the disconnect of your Enjoy