ONTX - Earnings call 3 2023 | Traws Pharma, Inc.

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Operator

Ladies and gentlemen, thank you for standing by. Welcome to Onconova Therapeutics Third Quarter 2023 Financial Results and Business Update Conference Call. [Operator Instructions] As a reminder, this call is being recorded today, November 14, 2023.At this time, I would like to turn the call over to Bruce Mackle of LifeSci Advisors.

Bruce Mackle

Thank you, operator, and welcome, everyone, to Onconova's Third Quarter 2023 Financial Results and Business Update Conference Call. Earlier this afternoon, Onconova issued a press release reporting its financial results and business progress.

we yet Investors press the & at my not available it company's have Onconova's www.onconova.com.Following the from in Media introduction, you seen CEO, release, this is website President If and hear Dr. will section of Medical Chief Dr. Officer, Fruchtman; Steve and Moyo; Guerin. Officer Chief Chief Operating Financial Victor Mark Officer, and conference to available Reform this statements Affairs we forward-looking session Q&A risks under following prepared remarks.Before XXXX, Onconova's during cause Medical and Meena will call a and statements VP of that Arora, during Development, I the involve remind materially. would can the include of provisions actual Private safe like begin, differ results and Research which made Act harbor uncertainties that Global will Securities to everyone also be Litigation the of

the to only by statements as these change.Except date are speak circumstances facts obligation made required to underlying future statements events as any as update and disclaims they or the Forward-looking circumstances. information, may reflect forward-looking law, Onconova of

more SEC Dr. For the the President over CEO, statements, in Onconova's disclaimer the Fruchtman. will factors risk release review company's today's to please press that, turn in the and I and now call on Steve filings.With information forward-looking

Steven Fruchtman

this open who everyone joining Bruce, thanks of progress quarter and XXXX. made Thanks, to in by Onconova excellent us call. today has is that for I'll saying the third

mission class results and outlook our to on call develop and of the importantly, presentation, finally on and -- Medical growth kinase need. CDKX/X on Chief synthesis.The update Officer, our hard-to-treat lead and program your open CDKX/X our Moyo DNA for an outline internal with scientific of know, and Victor third breast today, indications, brief our review our products with potent proprietary lead our multi-billion for novel cell so to in program, Officer by as our Narazaciclib Dr. you a call inhibitory dollar was [indiscernible] care Starting based medical proprietary a and Guerin data quarter an in with kinase, development this rigosertib of several provide our runway and particularly Mark and you face positive Financial narazaciclib, Onconova's update patients Officer, program, questions.As milestones, I changed for negative and scientist cancer our our preparations class. from Operating course, dedicated hormone remains the Chief our will recent receptor the into narazaciclib, During has and unmet as cancer. cash next-generation drugs the are well metastatic on the with drug designed entrant summarize and inhibitor financial as efforts Chief provide upcoming

be for its our tolerability to based inhibitors. activity, on target CDKX/X ability believe drug from improved of lower -- to to because the risk studies, preclinical of other inhibitors an narazaciclib differentiated CDKX/X multi-kinase based on by approved the the may addition resistance CDKX/X we the potential targets efficacy other beyond and profile improved In may well.The act as

vital additional disease helped cells. established cancer cell cancer in preclinical proteins narazaciclib's presence survival, the proliferation involved important targets ability signaling sites its and as CSFXR including of and known on well the expansive how also to studies have cancer define impact and NUAKX, Our of as metastatic BUBX.More to in ARKX, as

the on under probability than use other in including an combination our one, ready, escalation be studies data approved we These call Phase of reason the segment positive one, a the reasons. external proposed have high FDA our secondly, inhibitors and to: high success. choice Network Gynecologic probability the and initial lead endometrioid data X/X for Phase number or in the Number hormone of window support our cancer.To the success engage lack experts regulatory the of of use Gynecologic potential narazaciclib second -- that acronym has complete indication this underscore the be design indication the with this to for medical is therapeutic the selected and for clinical registrational we therapy, supports potential and ENGOT. main success.Publication trial letrozole. wide data endometrioid approved work We X and and to compendia of endometrial is plan CDKX/X narazaciclib programs inhibitors to define with with label dosing trial X trial letrozole conduct during is the safer trial of our be regulatory RPXD; combinations that key the Group, We on three, high European success.The Oncology Trials with in design registrational registration low-grade Note unmet from for a right for cancer the off-label a potential effort Oncology technical believe CDKX an ranging other construction; GOG, describe technical endometrial cancer X the -- support LGEEC this a suggest today, dose and and or pivotal need indicating the and the the dose endometrial dose, recommended with index. or may studies

collaboration of registration on few these quarters. next steps the provide to each of Our of prestigious plan these part is intend both the over as very ongoing to with trial groups.We information more conduct our

underway trials. As the you are narazaciclib including know, X there monotherapy combination program, and early-stage in studies

engagement acceptable multi-kinase we our action, dose will overall we and escalate clinical escalation evaluate these dose. and recommended X have Given based of Victor conducted the the safety one fully achieve status the optimal decided very studies the least biological the summarize to of Phase carefully.While on cohort have safety profile more studies to at narazaciclib's dosing are mechanism and narazaciclib of to dose observing, target we

underscores have therapeutic is safety index.Changing program program I and potential of continue X/X XXXX. differentiated for on a the it rigosertib. to is a may touch the program narazaciclib news for quarter would wide into because of to this gears, As We result good profile narazaciclib, second first the like Phase for briefly believe very the our a that

focus our X been with capital solid rigosertib's efficiency, of on rigosertib keeping of driven have in the we mechanisms. know, signal tumor impact series on on X a focused you of indications utility trials clinical As by through investigator-sponsored finding exploring

studies.Number and of three, a have first to, selected you Phase an seen The rare XXXX, the with our and desperate our and had date first in seen on internal-external to carcinoma. for the the with couple milestones. rest X/X the know, We an based can as including such on into as second FDA we the the registrational provide lead at dose, trial plan indication mapping we of to also develop the protocol we of cancer disease meeting we plan at our first designation to are to outlined the squamous continue year us combination XXXX, one, us that PLK-X this for Achievement a recommended escalation cell of this we with Phase with next provide call, next pathway quarters, is we readiness the rare to outlined pursuit in least X trial patient XXXX.Looking disease very are we in one with the indication, feedback an we update including in so on the and design dose will lung to have and dose B trial other to completed in quarter RDEB-associated into solid epidermolysis involved narazaciclib quarter achieving pivotal call. bring of intend intend cell cell. the following experts, on of half KRAS-mutated obtaining squamous this the definition recessive impressive to registrational once segment will out refractory the medical establish the study safety XXXX, cancer Number unmet program, our over a escalation that the clinical a focused following of we and indications quarter update and patients the FDA registrational in will as -- define enable our engagement group in this dystrophic this previously narazaciclib, population.As for foundation which readout may the on interactions protein and on ENGOT. study. milestones the June. add FDA cancer. complicating ahead non-small inhibitors.As be work agency half include these cohort call, need GOG the more us meeting first with orphan which focusing provide orphan in bring pharmacology in indication a mutated indication checkpoint disease in and registration cell the second on on Type the breast bullosa, KRAS squamous and of RDEB-associated two, from to expand We of steps clinical carcinoma, In for of Note second the RDEB-associated dosing ultra-rare ovarian program the responses the a SCC a significant Based in

strategy experience are medical wide I Meena's development their hematology Affairs, track Meena Research in development. in Arora care of and to oncology is significant as rigosertib, update and Victor taking next the of hand rare as For instrumental over the clinical provide to to on formally success Development. getting details the program.Before support Victor and we be drugs and previously the and instrumental depth most would designation and the to would of drug in on some in together extensive and provide revolutionary and and both this role Medical record impactful like half program. unique turn Vice of President more like steps in them obtain I researcher first the warmly to fields worked in the diseases where as experts some to Officer plan just I XXXX, I to on at and oncology Chief expertise Global for a welcome call, an bring accomplished drug Victor for I believe of as drug and affairs oncology.Both noted we of regulatory clinical registrational will and call to Victor? company's approval for he was orphan narazaciclib Medical I continue rigosertib.Now J&J, narazaciclib in plan of prepare the the the warmly and congratulate

Victor Moyo

meeting good you and X/X Thank afternoon, and touch and medical our provide the narazaciclib you, upcoming on with recent Today, I'd narazaciclib. briefly like on everyone. an update Steve, with Phase presentation.Starting program to

which dose combination our recall, dose may Phase escalation in X study there tumors underway Phase monotherapy in study escalation in Phase centers patients. There's and you a dose HanX As monotherapy are solid the with X X/X advanced in X study, who letrozole. the A day underway third-line the program X/X dose United escalation second gynecological China, with in U.S. centers the studies widely at partner the expansion a X Phase milligram is prescribed anti-estrogen of This at agent, narazaciclib in of other tumors is study and This and a States. evaluating fixed doses are is combination patients LGEEC and in per underway X conducted undergoing treatment. been increasing has study X.X dose

is As on Phase combination of the make X.X U.S. initial Phase at the XX, to I'd study, and on study, one, per day XX the and narazaciclib of to enroll observations. November milligrams XXX entire safe we the X-week proliferation CDK are X/X it the could dosing have X-week to points strategy X/X have is treatment. possible X day the Number program.In a with characteristics cell required per initial that cohort per have milligrams narazaciclib off prescribed the are patients without believe the following to X this most daily we marrow the This date. about dose dosing second on may like an strategy of for dosed the across starting because it next milligrams we Fist, studies, data, narazaciclib X may in cohort.Based requirement pharmacokinetic In need cohort is dosing narazaciclib for bone off week between of once and time based inhibitors.We narazaciclib. tumor about because important at we XXXX, letrozole X X the the important of XXX for seventh important safety the on, potential monotherapy patients patients on we address feature treatment Phase data during identified need recovery have dosing. in day. is safety tolerated with off observed be X/X date, weeks well who also commonly amazing for may permit

neutropenia to dose in affirming of in we've readout differentiated dose. target the an XXX the engagement X with XXXX, the included optimization event the Optimus the may are enable Steve's in seeing Project least the which of medical narazaciclib.Number is safety based cohort dose on completed at dose, first for to one the This for dosing define characteristics are supports presentation from because to like overall in and These Each to Dermatology based of narazaciclib two, from This approach prior good wide a Philadelphia. first escalate escalation Venereology, at breaker that a fully pharmacology wide Mantle three, European dose and more presentations receiving European the window the thymidine one, also Thomas safety for number recommended December, to the of be explore escalation activity Hospital suggest and of in to line data meeting profile and RDEB-associated we clinical a given dose our presented grade rigosertib XXX would to observing, our the these of dosing observation kinase study. the and Lymphoma difficult data that be ibrutinib of once believe by optimal quarter, by expect Academy the it safety cell underscore Number above.As combination will decision approval.Also additional ahead target and was to from half therapeutic it diarrhea. preclinical programs. based -- University Cell at results therapeutic the of at the X to narazaciclib X have lymphoma index preclinical X cell we of Austria potential our will that adverse the good as day. underscores presentation guidance squamous least us made into program of a Phase the dosing help of and order able the enable mantle distinctive quarter.I Secondly, news related resistant patients initial for the and treatment very we dose sensitive for these that in was to comment narazaciclib to and per data X FDA for X/X biology X X recommended in a our engagement or narazaciclib safety the achieve index.We presentations there in third late provide We the add Phase narazaciclib we carcinoma, reasonable echo avoid that excellent X engagement of potential present This target studies colleagues study is that to believe seeing Phase may data dosing in promising keeping extend on a the Salzburg, to believe MCL rigosertib.Looking and for program milligrams cell cohort on on with abstracts. it optimal or meeting. and we we were were at annual of with to least indicated plan to Jefferson narazaciclib biological assay and profile milligrams Steve, in doses second the are more EADV.The would combination in

Symposium Cancer often at one Breast called is San the first at Antonio The SABCS.

CDKX/X American and in a kinase collaborators BTKI the the ASH or mantle resistant and Narazaciclib, model.We inhibition One Narazaciclib ibrutinib a cell poster presentation cycle cell a of antagonist, restoration tumor will where a reprogramming, inhibitory for our have in arrest to of our present second of poster differentiated prolongs sensitivity enhanced enabling differentiated Society present lymphoma. will titled: preclinical contribute titled: targets metabolic activity Hematology at growth collaborators a

We programs the will am weeks.In narazaciclib rigosertib our and and share coming I XXXX. for in more closing, of progress our the this about in outlook abstract -- optimistic

and cell is anticancer cancer agent. unique interesting For activity data This a that this RDEB-associated condition. rigosertib could make squamous pathways promising critical and plus rigosertib, PLK-X ultra-rare KRAS a on have observed medical very activity address need distinct its in the for we

have targets cancer the based action to changed narazaciclib, the the where mechanism the we that more on its and CDKX/X we'll cancers defined where Now inhibitors be engaged endometrial can have There of we for be likely successful these better. rigosertib.For face by be positive believe better studying on in class indications consistent substantially cancer. data is of clinical

safety, to on features -- that broader expansive is and potential that, unique are addition narazaciclib enthusiasm profile a in which my narazaciclib.With hand In will of could the portion differentiated for Based could program These and that profile. I showing engagement, target acceptable for optimism of Mark. a conclude initial the have preclinical large clinical studies, to result it off utilities. our enables our defined we multi-kinase my the and activity cornerstone give call

Mark Guerin

and XXXX XXXX $X.X third of in of development the administrative expenses to was the the XXXX. on same General and loss million Victor, and good and we fund December with cash sufficient ongoing Based $XX.X position XXXX.Research of $X.X quarter of third this million projections, XXXX. the and for XXXX.Net compares be third our $X.XX the the million $X.X third period as on in $XX.X period to continue million $X.X of to to and of average partially closed million loss XXXX quarter equivalents believe my per financial were quarter now offset expenses third the Thanks quarter for XX, per shares into AGM loss our net by of XXXX operations compared for clinical for with hand very same cash $X.X on compared for batch Steve development weighted in million of the engage quarter or average share costs or remarks. weighted of in the timing much, with of opportunities were I'll of related same the corporate a $X.X afternoon, third to perspective, trials quarter primarily of cash XX From current we result million, our outstanding. million concluding The clinical related the higher of back XXXX business XXXX Onconova progression XXXX compared review and support partnering everyone. quarter the to period. expenses, will our complete, current to share manufacturing a for $X.XX third [ general outstanding. a XX.X our in XXXX, trial with discussions to in his change million million production was period the shares range This call administrative net of for ] and the a actively for compares programs.With

Steven Fruchtman

and Thank are We you, closing, been forward in we up Mark. and as we excellent XXXX has the to the look that third on In new wrap the both about rigosertib progress for begin progress quarter. narazaciclib year. enthusiastic made that building

Looking ahead, we following milestones. the focused are on achieving

Group, recommended X clinical quarters, work readiness to dose, Network Trials, including couple over the dose XXXX; the GOG, trial the the in which first our inhibitor to first on we segment Phase for European X Gynecologic medical three, including Gynecological the the and design into quarter multi-kinase with Oncology X/X safety of update narazaciclib's to; an work Phase bring continue external escalation present of provide on XXXX; plans our may meetings; of our pivotal important half differentiated intend provide experts, the four, one, and two, narazaciclib, program, ENGOT. read-out the us X Our FDA abstracts Phase of continued pharmacology engagement with December Oncology the definition of on at and next a our

foundation of with and provide narazaciclib Our solid part mantle underway. groups. breast LGEEC next ongoing indications several collaboration a including lymphoma.For trial ovarian strong rigosertib, potential plan our strategy with our milestones an utilized for and the is these both conduct trial for as indications, a added steps with investigator-sponsored has to These program will cancer, cell of registration cancer

of a to focused cell squamous dedicated drug effort steps recognize to provide next designation XXXX.In the management RDEB-associated in registrational here and program first half the update plan we to orphan diligent an to is closing, remain I on and work the continue main our to carcinoma, want Our investigators, the very you is, Operator? dedicated of our team, obtain on and to who work. investment important the progress.With and support and participate investment and today's the patients question-and-answer important updating trials of well as community and We clinical brave our the that, forward as most session. on -- for look of and our continued we'll partners in begin Onconova employees,

Operator

of Instructions] comes question first from Zhu line the Our [Operator Partners. Guggenheim from Charles

Edouard Mullarky

on pivotal tracking? when question narazaciclib Maybe off Edouard past at is your the at start think for how in a letrozole we And data -- on update the talked about This efficacy is just that how plus see data, with to XXXX. Charles combination, maybe could a how for Guggenheim. a trial XQ Zhu I you've initial

I'm wondering just you're now? how that So about thinking

Steven Fruchtman

Victor, you Sure. like would to that? take

Victor Moyo

we still of the now, process Yes. in Right are dose escalation.

As requiring we both us mentioned, a therapeutic are mode. going to Steve go to before wider to index I and higher seeing expansion we're doses

XXXX as well will So study. study into extend with along monotherapy the a result this as

Steven Fruchtman

just And proliferation, overall don't the want progression-free survival trial. response. seeing CDKX/X I They plus add what prevent cytotoxic were that improvement to CDKX/X our overall said, everybody our approved that, not prolongation PFS on inhibitors cause but are in reason and of and tumor survival, survival. in drugs. not remind The for response we Victor approved anticipate hopefully to inhibitors They registration which to

Edouard Mullarky

can. maybe And just if a I question, follow-up

to efficacy have to think at On further gain room that? dose on the characterization, both how are how about based you it escalation, escalating least the I neutropenia by you much the you do like have you you keep Do thinking the assay. sounds monotherapy kinase still you -- or have sufficient escalating? thymidine think and guess room PK/PD on

Steven Fruchtman

Victor?

Victor Moyo

well whether the look optimal to as X, ultimately Phase study. a would dose the for of reached pharmacodynamic Yes, an of combination we've we decision make the characteristics and PK as at safety a the

of not do see we other and and same of [ might some a diarrhea the neutropenia point do the ] -- inhibitors. You you degree out that since CDK raise good

coming of as pharmacodynamics. focusing on be PK but including the will as the We data from well gout tolerability

you to optimal We And of dose or dose. be might see had that to reaching close cohorts. maximum it tolerated suggest when the that, would have expand really usually, we the the are couple last what

Operator

Ladenburg Our next from line from Demir question Thalmann. comes the of Ahu

Ahu Demir

on ask have X My if more RDEB time, narazaciclib, questions and I'll first one I X have I portions. on program. has question

any one of patients First we expect And you would to PFS the to of the when the data we given the any your on the how part would see versus efficacy safety is following the many on expecting see rates, PFS? question data? response mature second is, comments the do when clinical are data study? from portion up show envision And on Edouard's to question, activity

Steven Fruchtman

I'll a first, the rest Ahu. and give your may, if of I part Victor question take second

-- So in we the and let's PFS, a without control is say can X.X arm, letrozole palbo breast cancer months.

our ultimately very control it to clearly hard our what of not a be, months or interpret we're be. this X as arm be part may of that PFS what XX the should X And registration dose Phase population. for wait dose if the and the just X or purpose months, whatever The to is going XX the will patient months X X.X Phase thus, to study. establish is months it's will what recommended in trial in So be Phase the without PFS

in some of And to tumor again, both have and narazaciclib a us overall to these trial survival, PFS and plus you registration letrozole the clearly the are if it? dose will not compare arm data. trial, what likely which FDA that and if in I registration I drugs, don't the will arm you there really control likely, than will see to it, efficacy repeat will PFS your So for more by question, of know a data control be is the be just response PFS watch overall we but -- be combination would determined I sometimes tell answered they part response And like will response. may the overall combination cytotoxic don't rather accept.So see determine that thus more goal letrozole able with remember first our narazaciclib shrinkage the is to survival Ahu. really not

Ahu Demir

part as safety the see? first going to many any engagement target are well? of study. What the see The was we How patients? we Are analysis going and portion to other

Victor Moyo

had so could a Okay. you please? that, take think Victor, rest I you've enough of

Victor Moyo

escalation the portion be Yes. The by, phase, of the ultimately -- is number cohorts that course, driven of we will dose enroll.

is we variable an X XX we to that to of enroll So is a where XA that Phase give in approximation and up. patients portion portion. number, Phase The up end slated might

Ahu Demir

the question next My on is safety profile.

are with you much So are to in with off the that like having not new How move also forward the that going are steps diarrhea taking What the information. And mentioned you to week the the off? portion information is new. need setting or to the take agency? remove you not high-impact that or is neutropenia What X discussions part? X clinical portion week

Victor Moyo

that in and as continuously. now, hold agency. our first our X the basis that we safety with we continuous for discussions discussion dose Phase Right our recommended is still Well, dosing, that dosing, are continuous agency as is include dosing long supported off, what that the observed would have we are And to provide we subsequently. with the assessing of will the

doing X CDKX/X do. the X that So -- we the we're of have to week now, that are weeks on, inhibitors holding right not some on not

are dosing continuously. We

Operator

comes with Joe next Wainwright. H.C. Our from Pantginis question

Joshua Korsen

cancer? and the cell I lung how Joe. looking on X the in KRAS question number enrollment that's the for the about had for a Josh is Phase TKI-resistant non-small study of patients This for in rigosertib

Steven Fruchtman

Victor?

Victor Moyo

last Yes. study. update, enrolled that X in on the we Since patients more

an have report from subsequently looking the update are to outcomes once terms a we We in investigator. obtain of

Joshua Korsen

across or for trial? in kind tumor tumors indications uniform pretty solid specific more monotherapy it the a the you any And solid solid seeing the trial like has certain are tumor, of for narazaciclib been

Victor Moyo

We have enrolled patients with truly a divert set of solid tumors.

so And as patent monotherapy out. that I in can describe particular a the isn't standing there

anything of isn't gastrointestinal to stands on are being are unique Our terms the that tumors, in tended of we more initial GI patients population patient really there seeing. type the be out as but

Operator

line question of Markets. comes Capital the from Our Robert NOBLE next LeBoyer from

Robert LeBoyer

Since is for X narazaciclib your additional the you're going start Phase to cohort be doing date at projected solid an tumors, point? in what this

Steven Fruchtman

Again, to a I'll give Victor that. take rest,

at to the a into establish additional the with would safety the XXX want may we dose. trial of cohort, we until they see then DLTs that registration can't meet may We If the in Robert. recommended not, be it's great go Phase to the [indiscernible]. dose we agency the quarter X because dose. XXXX know first of we milligram So question, the If see

So if the in dose into in the registration estimate X to recommended low-grade meet we of to first cancer. XXXX have 'XX of that We trial with quarter endometrial the half will first go agency. begin and the Phase establish

Robert LeBoyer

And are would in DLTs in be the if XXXX? no added, add cohort another to second you cohort there

Steven Fruchtman

hard dose we We marker, always dose we're we're it's on depends more It know what thymidine escalate, these PK a really maximum maxing pharmacodynamic level. So involved escalate kinase kinase up staying depends we we proliferation, depends. also It PK or engaging is we regarding Victor a see as engagement. mild to and It predict or have cell is a we see as explained, of some Robert. the we stem things, seeing neutropenia. out going engagements on market, as already the at

to no there's need So dose escalate.

means claim be with enough of XXX XXX dose XXX XXX evidence So, go with the into a maximum the the that Are have all done X we Phase is recommended which engagement milligram target do we milligram meaning or Phase DLTs milligram, to diluted recommended milligram, dose. things see would be safe will XXX PK decision. to at we those at get X milligram

in question that So ability. answer best it but it's data to I the hypothetically, to with of answered my easy

Operator

from from Our the of comes Alliance James Molloy question line next Global Partners.

James Molloy

clinical the the to on challenges to walk is sort have some of question the know My that. discussed you take the should designation. how designation orphan rigosertib that get steps that? we the through of look get and sort orphan I plan of rigosertib getting the before trial Can might you on you

Steven Fruchtman

we the how right? like the I'll squamous squamous may. that clearly This introduced of develops, as I RDEB FDA? the if in an calling to is Meena, this connection the year so our Meena? concept lost, in would perhaps orphan cell develop diseases, to an from cell is question XX patients to Once RDEB Group U.S. the that of at patients take within the die And disease, X.X squamous and was is XX% Sure. take There of RDEB in per expert disease. cell clearly, that XXX U.K., Orphan rare years.So Meena orphan you is expert

sun call is cell to cell cell is cell, removed good which prognosis FDA, are required. from instance, RDEB because, spontaneous disease, cell this squamous and squamous the different damaged cell. squamous Sun very late it cell cell RDEB I squamous cell Our surgically, usually years, a squamous fact orphan goal very for our COLXAX squamous develops I of squamous damaged just And different in is what doesn't XXs, explain aggressive differentiates sun in end squamous one, and of spontaneous And have. teenage at is damaged as therapy that [ complicating to the early squamous the mutation ] the will squamous the [indiscernible] gene elderly. group why spontaneous developed RDEB mentioned. is that that's cell RDEB in

our squamous orphan being squamous in by to in goal in the explain the which, this not cell, is clearly, detail an fact, is explain and orphan is greater agency why group to said. at to So just I disease But our cell goal interact the is squamous RDEB different cell definition disease. what RDEB with common

Meena Arora

no Apologies, into last we abstract, taking and late-breaking then learnings we'll month add experience -- a at and initial my meeting as also line patient dropped. moving the from registrational to from EADV presented the we have into be that development the things apart further and discussions. I've as well got program clinical

discussion that. the to the we'll addition about line in drug there. So be also Apologies, my designation, dropped orphan mentioned doing we

Steven Fruchtman

much But I Meena view. in did so my than on sound [indiscernible] informed only did based

James Molloy

of does it work? is a be, you a I it or to mechanically and on out? fill of various of boxes go form to guess question the sort is that disease just presentation of How have check pitch sort do or more follow-up will sort kind them one make

Steven Fruchtman

We call. hopefully, make to. Orphan them. will that way orphan any there much interaction wants the chance will us with more it group do for designation an a think basically be the We'll Group And FDA And that's valuable.

meeting. book that written they respond and these We briefing we them. will a most request to face-to-face virtually, understanding is just deserve we to up believe doing My a of may on why designation. orphan It's

Operator

participation today's concludes call. I'm in conference thank today's for queue. and event. for showing This gentlemen, no Ladies the questions further your you

disconnect. now may You

Steven Fruchtman

you. Thank

Traws Pharma (TRAW) 14 Nov 232023 Q3 Earnings call transcript