DCTH - Earnings call transcript Q4 2020

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Operator

Greetings and welcome to the Delcath’s Business Update Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Relations. Investor Carbonara, James ahead. go Please

James Carbonara

of statement you. Private And quarter begin Delcath fourth statements statement. welcome call Safe the to Harbor for Reform once of business update again XXXX. forward-looking forward-looking This Harbor call XXXX Act of Safe exception the maybe to and Act in of All considered reading to this made call. pursuant Section by of the Litigation the the Act historical Systems within statements Section described of XXXX meaning Securities the the Thank is with Securities I’d Securities of statements the like made XXA facts XXE on XXXX. Exchange

statements will statements it such various from are assurances uncertainties. that Although differ to results implied prove no in reasonable, forward-looking due assumptions company the that forward-looking expectations makes expectations believes been expressed or materially and may to correct. have those Actual and these reflected risks in

files subsequent We call. to statements to earnings are this forward-looking made call undertake or with of Form For that see risk knowledge, which expressed company’s the of forward-looking the this as quarterly contained please in statements, date such in differ XX-K, or could events circumstances. forward-looking Form other or detailed well Securities not from on of update implied time company subsequently a in those on to time results to any any risks Any only the reports included and annual reflect factors the from discussion XX-Q those actual Exchange supplement as in cause uncertainties statements report Commission. in do the obligation as filed and reports

website call. that Presentations deck the to release want please Gerard, click Delcath Gerard the Please press following and presentation of the there the can today’s Michel, accompanying section handing listeners at Investor be I Before link & proceed. be the the webcast a call. will in slide remind the call to over accessed

Gerard Michel

FOCUS those you ocular global efficacy Thank clinical we investigating morning, the to the will discuss trial quarter melanoma for importance this trial, were a today. fourth the also not metastatic data call detail in the from on to and of Due patients. data, joining morning results for registration and in financial quarter, treat safety focus everyone This of HEPZATO results released preliminary this earnings the we which those released release. our

Medical release today. later and Regional about Of and Senior John, Vice today available who experience at Cancer Dr. and on to of Affairs; Chief Dr. anything course, the financial of Center, FOCUS questions was their or results. Senior Moffitt treating be Purpura, our President Director filed our Clinical to HEPZATO Lead about the later the earnings with Operating Member us questions his Officer; on Jonathan XX-K our I and study, perspective preliminary team kindly of has and joined patients Investigator and answer Zager, Therapies to else John results Johnny the are any XXXX in are call the answer me covered With

to Before over perspective call I handing content, preliminary the on who the Johnny and context. it want share the to in put review will data my

system trial a the trial hepatic metastatic second know, percutaneous melanoma Delcath to is FOCUS listeners most pivotal patients. perfusion treat As the setting Melphalan ocular with

of up on An to somewhat the to earlier a system was outweigh single efficacies success. with Therefore, CRL, portion A the supporting in a metastatic that assessment treatment voted trial. meta to analysis treatment-related used with an of we was the based version the overall the of Oncology trial the complete of of amount accomplished to of benefits FDA’s melanoma different of to the objective selection and clinical CRL. estimate a the risks, an improve analysis risks focused against the deaths letter, Leading response an peer the response as to no with earlier higher submission ODAC for of trial pivotal power ocular led dramatically rate FOCUS The on melanoma from is data as checkpoint inhibitors, minimum, arm a at generation the achieve overall trial safety I categories presentation of chose Advisory NDA a or including Committee, device or trial a procedure. of believe Drug from approval based a critical maintain treatment-related few the enabled the or criteria. publications, too, while which panel FDA’s first There the significant patient response trial, well during this. versus an we on an rate care not profile. a the that procedure metastatic have ocular reviewed significant occurred ODAC associated improving and earlier did for which panel one assessment as threshold treatment standard

single As present preliminary which a arm shortly, does single being as randomized study with care controlled exceeds threshold. response trial. was an best overall the and well Dr. before arm rate, alternative data a conducted John The to trial arm comparator will the amended yield initially a designed

a superiority in powered based treatment this HEPZATO included It comparative is of patients analysis. may including TACE ocular arm the metastatic inhibitors best number with arm While a statistically analyses the to available care, exciting the in DCR. significant trial the in over not PFS and most patients in the important BAC, over on were versus statistical improvements HEPZATO alternative patients. provides on were melanoma treated back revised amended had data advantages BAC both of against checkpoint that trial have ORR, background signal very the of the and endpoints, strong Since was or test TACE, that the

results The committee, common course, to-date somewhat is range few analysis response that the most of released use study, Nevertheless are as data an from than was trial account the lower and that of designed importantly, and patient efficacy recognize initially past years. Europe in variety all therefore over a XX-week overall us. available rates to which frequency encouraging. most the non-sponsor of which must an scan FOCUS RCT used may all recognize subject The of used are scan, review the I very was results reported we independent FOCUS differences. today Of the change. for studies are results selection, most designed not preliminary likely these of the the RCTs, originally for

in showing patients the X would incredibly keep have target or XX%, in most X compared we per the sequential evaluable a response the duration more XX-week which shorter mind likely are the scan schedule. really likely and that response, X-week of as to of more All to frequently Since European resist a comparison. easily the even is based be a some data to schedule that weeks. arm, confirmed requires on more But analysis as pre-specified two scan pertinent short studies meta intervals response must with capture cleared strong inhibitor compelling, the the we BAC checkpoint is when which criteria

enough provide is analyses any all since meaningful not be mature yet not data sharing each to for We pre-specified analysis the information. will

and sharing shown too efficacy need of is the very because patients question many preliminary results short, date have on In hepatic over still earlier seen of X,XXX are consistent of the latter, of study. studies are we four there and publications updated the what have of compared we in releasing and were the treatment-related the adverse improved combined been system. former have overall by be in which, profile for will from significant EDC or and deaths the well the using meaningfully review occurred reported patients the commercial The both in filter for or were overall the treatments risk device, significantly the IRC, the in safety and or limiting has not we many a the hematologic most there percentages to are death confirmation scans with response, seen too benefit utilize with in survival Europe. living no toxicity are the generation whether the profile we points study the the early safety later not there self arms, The Europe that over Specifically, which the duration for was yet are manageable of what primarily confident were improves but data which events today. different been with lower XXXX

these that review FOCUS to risk basis significantly forming to now Dr. preliminary profile turn available resubmission the warrants FDA. still results to will improved the is NDA data. our of the in demonstrate ongoing and trial that strongly final a the believe we later While year, complete suggest not data will the will data the the trial over call FOCUS and until I John be benefit

Johnny John

like operator. Are you to that you, morning. able for Thank first joining have this thank start would the with if slide Gerard first everyone and the we I could slide? get to we

Gerard Michel

I have advanced it.

Johnny John

thank of slide the and patients This XX PHP patients patients Of in PHP arm. patients care patients enrollment the treated BAC patients, total were arm in the that or arm and in best you. in trial arm XX the the XX XXX Yes, shows first in these arm. the were XXX BAC alternative enrolled,

time by March have in XX, XXXX for evaluable were at the time progressive required be analysis the and the at this analysis, no was included time cutoff none March evaluated criteria the meet first subject data and committee by disease evaluable this scans in received to point unless points the radiological first after two had or independent to to had And had Our response XXXX. imaging point. XX, expected order patients least

criteria, application BAC in patients analysis. patients the and PHP With had of XX we this this XX

please. slide Next

ipilimumab, the were arm, number the Investigators X and to For randomization. patients shown dacarbazine. received TACE. Out the pembrolizumab going treatment each of X the these to patients choose to that that that treated received patient X received BAC there enrolled they no patients treated patients the treatments, were dacarbazine, randomized prior here. in The XX from in XX X choose ipilimumab were could pembrolizumab, is BAC arm, of TACE, received and investigators of subgroups to were and required give of BAC

Next groups. the was was in slide slide XX XX. population, the The it both trial the please. median group on group in demographic was This BAC and in data some age XX provides the PHP mean

the in male a XX% In split PHP had XX% arm. BAC arm even fairly terms gender, the and was it of female and in we

we of X.XX With arm. arm months PHP X.XX of both the median diagnosis a the in BAC and in the liver time since metastases, months had

right population slide intent-to-treat the and Next for on slide, preliminary population see we that for analysis the please. the slide, the the rate population. reviewed In the objective we we response of this this analysis have

it arm, in XX rate those XX.X% responders. arm in BAC that evaluated, PHP were with XX.X% and X far with the response responders was patients was So XX the our

If those the the BAC we given the arm, the best partial population of you progressive and arm. is point confidence the was population, PHP based the stable add response, slide, that’s response population disease, Under X.XXXX. and the both and analysis At and this response for PHP the have the the in and bottom BAC the the rate overall had breakdown values patient in XX% disease intent-to-treat X.XXXX responders, have divided one XX.X% Chi-square the non-evaluable interval was given into for arm, ITT the seen it is treated for in that, we arm of in we the on for the and p value in XX.X%. complete

please. slide Next

analysis rate, population, was control BAC, disease PHP was XX.XX%. for it again of and preliminary the XX.XX% the terms the for In percentage

then in based add value p arm intent-to-treat was population and the on BAC Chi-square for intent-to-treat XX.XX% for was population, and X.XXXX. Disease the arm. PHP was it you the the X.XXX control If XX.XX%

values Next for analysis progression have In displayed the survival both slide, we for PHP slide arm arm. please. BAC the free the the for the and

this PFS p in at the of were be of this that the status that months the analysis point observed occurred survival So, There time. in to breakdown the was the value to X.XX in X.XX certain confidence we PFS the and had And gave this interval, in that, were was have quartiles events X.XXXX. was arm analysis the we and able and for certain BAC there median be establish patients censored the arm months. table the events to there. provided progression-free Below the PHP

and XX patients and events and this XX XX arm, were BAC were censored. was at estimate that X.XX. X time point ratio hazard the PHP patients the arm, was it events in had patients censored patients For had The

patients manageable. no treatment-emergent experienced patients, Moving profile on all XX safety to-date, in patients XX.X% leukopenia deaths events the adverse and in adverse and ongoing of were trial events. The experienced were XX.X% safety to seen and class There with that of XX event the X% we cases, complications. serious population cardiac and patients the events, In that at of trial treatment-emergent were transient the well the slide in the result system safety of of treatment-related at or safety neutropenia reported the of serious treatment no events. treatment-emergent of the experience. patients. have literature XX.X% most the serious patient adverse serious in consistent of European the trial population most the These the X.X% patients, of patients, at PHP from commonly organ the was profile adverse commonly here provides with thrombocytopenia of described nature observed

up Member added and Jonathan this disorders and that the You to time, that the I thrombocytopenia, preliminary Regional Senior Investigator ask Lead suppression, data impressions thoughts Dr. our the releasing a are questions the Zager, like thoracic At to FOCUS at X.X%. includes results shown Moffitt we on respiratory now Center, and X.X%, were today. Therapies introduce study, Zager, would what XX.X%, of leukopenia, on and today? can of were bone Dr. your of marrow cardiac see Director disorders are and which neutropenia, him being few Cancer his

Jonathan Zager

calculations group is my the So, favor this rates beats way, and the step survival with population, the of PHP last toxicity, X response rates I Obviously, preliminary in I, progression-free of rough all in data fantastic. there as tripling survival, in on in and Phase of preliminary is population our response trial even analysis IPT think the if a in the each the well. progression-free

procedure. from and very this So it’s encouraging these are benefit patients to going

Johnny John

shown safety your Thank what you. with with trial, And and the and is the treatment the the treatment profile opinion conversations of your your experience of of on own here results your investigators the with based experience? other

Jonathan Zager

bone So, the however the event. show shown results marrow that’s obviously suppression is adverse that some common and there most

it’s they outpatient all I hospital see to patients bad me following are treat by the problem less manageable Tuesday, patients really on and the and a for they are who work. the Monday as Friday these However, hours. the a discharged an in usually excellent. And is after of quality have after life than the XX they procedure back from

with adverse they and/or quality life treated any and overwhelmingly an observation. events as of these the are So, outpatient of just recover

extremely So, very well and manageable managing any think it’s patients terms in do I toxicities. the of

Johnny John

from you, Thank up Dr. now Operator? the will Zager. open audience. I the call for questions

Operator

the Thank your you. from Please [Operator line Instructions] question with with of Marie Your proceed first Thibault BTIG. comes question.

Marie Thibault

Good my are of the that as use sort appreciate matters on today. Zager. I them? first and arm kind criteria. or for is most your BAC thoughts time appreciate well Gerard comparator one of whether the is Dr. whether checkpoint as thank kind you curious for about inhibitors for they the the on then XX% comparison and one BAC morning I the questions. and view the to hurdle how what the we the taking likely more this predefined Gerard, detail am of with the FDA to Maybe will

Gerard Michel

with amending over. correspondence we data. that the you said, be trial, of is the of the their although you the get was trial, needed that totality benefit analysis us hey, to did response course in will FDA object to as if thought of they the up a) risk standard you show know, use amendment it on hit not evaluation they leading approved the Well, the a never The to hurdle meta them we the that FDA we to are

superiority not as the going checkpoint is that fact in big when it Again, data will, improvement likely know, to TACE over this I because sure like BAC. totality, the you has is am I mostly this the label heavily of or BAC the quite it for question in all or whether not an inhibitors. this will up, is arm the beating comes meta if or FDA holds think include over whether analysis weigh as the but in it TACE, well looks

whether to this not not label it not, would point. only at or So, or it help rather gets guess I can the

Marie Thibault

you should know a little we Okay, And that? timeline in that of later that full that any the expect cases this you sense. mentioned hesitate year, results I here? makes idea on to lot a for I see to timelines give know some

Gerard Michel

driven And up a for us was again, double so the broken when Yes. the And I monitoring big, got EDC whammy. again, the was up, showed big times, and COVID at when for the difficulties that know I the and period shutdown that a of hurdle sound like financial of record by XXXX. is running company

are that audience end release – meeting all do third by data sometime the of third have We I am but the end the around that, whether for and or it. of not before year. will very by probably definitely the we’d sure the the scientific hopeful it release quarter, year late we a

Marie Thibault

if I for Okay, could that’s you Dr. time very you, to Zager, please ask thank helpful. want today. your

center? as thoughts PHP if events, am On showed seriousness And it events cardiac so those treatment approved, well how marrow of for during to curious you thanks get were to mentioned the as be the on suppression. how of safety the much within on bone up I trial, the might of the the your your adopt your the maybe any own that you of question. sort thoughts some

Jonathan Zager

the all second can question first. I will take comment So, that. on I

compassionate trial, have We trial between last and already in PHPs – have this between I trials. already XXX both the done use about

offer it to at and adopting to are already patients. we center, it have the it ready we So, adopted

it you disease lives for saw the the extremely better, it’s and seen so or firsthand last well-tolerated. no-brainer. the of So control we XX% over decade that’s changes I as patient’s plus get this how over the a time have

patient SAEs even As the any a placing events. the under having double-balloon actually to be there that be far related bypass on seen in going procedures cardiac were did catheter my kind not of They balloons actually or easily events I as the chemoembolization a could filters. don’t patients events that catheterization appendectomy for of on the or patients, to any few inflation trial seem two those have in whatnot. be know variant pump were or those could are concerned, explained cardiac the and the

So, I once come not well mentioned an perform you it’s of is, board, on centers. is and that teaching the be procedure new for in before, to It procedure, think that those to have received which as understanding going will well again the extremely tolerated. is I how very perform be there centers obviously than more to adequate hard very

Marie Thibault

Thank you.

Jonathan Zager

the comment I the in immunotherapy extremely for as pre-defined immunotherapy response a comment, comparator. plus is XX% immunotherapy responds or patients, nowhere In by ourselves comment a Gerard made so against looking are percentages the melanoma, life, of a generous. And and these oncologist sense, high feel XX%. at treated near has I quickly that wanted ocular bar real just meta-analyses almost know as is setting as response the an I about overall and throw the that systemic one to and in rate we I to can

a a margin. it’s So, we that against good I and outperform number still comparing managed that a that significant by number to by think margin, are generous

Operator

your the of Capital. next Your comes with line question. with Henry Please Scott proceed from question ROTH

Scott Henry

congratulations morning data. and the Thank you. on Good

a of couple questions. Just

get of a patients, First, care close up but see how I to been the that on that’s to and XX would you available XX expected you in expect to assume for you data best I are the XX analysis. done XX? treated while. for number XX I believe you of final that get with have ended to what

Gerard Michel

mean, In terms see… I analysis, of we full will

Scott Henry

be you final to of In to sense patients terms some analysis? in the just in data of expect could full a or added analysis, the just how trying lose ultimately would many process get

Gerard Michel

Johnny, end losing detail? you maybe be up you all normal can will a are center they that’s follow-up point, then there that Well, I some them. at more you spend added. little the and mean, patients

Johnny John

currently, patients forward. in expect remaining to the Yes, get go all the as we we analysis

and and With as the be upcoming expect is time included is forth BAC those the did all additional X XX put they that didn’t then that plan the point, in obtain the this time, patients, we at on analysis. But patients not criteria in there analysis. are the this there meet preliminary We awaiting patients pointed out, data that we to our have analysis for to you treatment. but at data them patients we we for

Scott Henry

trials make I understood great. trials versus prepared little how this a just in remarks, will you and correctly, making? trial my discussion easier to I a be scanning rate And about of in correct get be this ORR. Okay, the that row understanding lower the the Is may response have a there sure two want the prior were was was to it that in interpretation point had what and prior more thus

Gerard Michel

correct. is that Yes,

the team for arm, with this just So, scan typical which started change understand was shorter overall and XX-week survival change you be amend treating an FDA trial when able to appropriate when A to many they with lot for BAC the the periodicity. have do do it’s trials of reasonable compare are the to I to to to the which you if been also patients. it wanting to was amended, a are able done this tip is when want not not overall have periodicity. asking traditional ability periodicity wouldn’t periodicity, out response are the did things of It to as you endpoints use it they because was an RCT and change the to too a

yes, responses. every versus perhaps are kept as the every an able will are long you scanning X same. weeks will you responses weeks that X XX you example, be duration you if weeks, So, catch shorter scanning are those it if was But to lose

Scott Henry

there a ask but preliminary, trial of I this differences then not Thank timing that the have at that in and not consistent throughout want trial curve that or the to take you is of you may you for this know learning Perfect. the is towards did of end data perhaps the any it and results or the procedure the is are the beginning over from the obviously some stratification, data I trial And specificity? the among may but can centers? have pretty clarity.

Gerard Michel

Johnny, we correct? the don’t have specificity

Johnny John

Yes, correct, Gerard.

We haven’t centers, we done that a specificity have that doing this to time deep at evaluate centers into at at on be centers this also experienced dive were those don’t earlier and later new versus enrolled time. but point patients we experience, but will after this that, subsequent

Scott Henry

Okay, the in consistent survival or pretty overall great. waiting to And past trials pretty is with and any trials, on Based for across overall final was question, heavily that reason correlated progression similar think wouldn’t data there medium data survival to has the other everything, ORR still free endpoint prior correlate survival. points?

Gerard Michel

don’t to make try that non-evaluable have offer play the that I put could this not at certainly they Johnny than this questions that favor want if of patients will at are I I can’t trends reason wouldn’t our I are offer Zager Dr. it I in on the this more to many it too so to but probably to just point. a am sense point, will lot that, – I data to mixed look at the numbers, many we think And trials, believe don’t you probably that would correlate, I a bag. intelligently across and speak going it’s any can. say oncology point

Scott Henry

there Congratulations. for you color thank for the questions. and Okay, taking you thank the

Gerard Michel

Yes.

Operator

next question. line Your from Arlinda Lee with Please with comes the proceed of question your Canaccord.

Arlinda Lee

guys. for my Hi, a have taking I Thanks questions. couple.

BAC? is? by ITT? then – the they maybe HEPZATO you treatments on were can of rate can question they patients more how And a duration Gerard, And talk you was a that missed the additional cardiovascular then comparison aberrant many provide And Dr. the the think events information are that mentioned I for it, any Thank talked about have had? I the number the maybe response were Dr. pretreatment Zager, IT ongoing Zager, little clinic? then was you these What third if follow-up long in you and about? you the relevant about what How versus the is might and how that of for patients bit needed can talk you.

Gerard Michel

Sure.

So, The actually that about about picking we the powered XX% beat had to a was confidence was meta-analysis roughly upper beat point interval. up What of roughly X% first on estimate patients. for And was that to the question, to at that bound immunotherapy. trial do immunooncology a was beat to of of are I know that an texts a bound beat a about or XX% the point do so some bound, lower alright, estimate that, agents. a XX% not point estimate upper bound at to confidence getting people needed would We be for upper here meta-analysis of the immunooncology to intervals.

exploratory SAP. they bar. technically in that we – analyses but are be, it the The or secondary might sailed over were were well have So, BAC predefined

was those show. what that think – to the we So, trial not are was powered

it’s Now, of in in think very, are supportive, in and very it’s the community. obviously great terms regulatory moment, at we update beating it the published when literature also scientific much uptake is purposes and of with I very the terms which for both oncology

to it question. – Now think next had the think I can cardiovascular over about will answer Zager you events, I Dr. a pass was question I the those.

Arlinda Lee

you. thank Yes,

Jonathan Zager

Yes.

if pretreated were pretreatment, trial, had, per I weren’t of your the was going washout counted were se. I sure centers pretreated. to question make that one, again, patients of on you therapy chemotherapy them none period or them by first, immunotherapy meaning If and prior the that win be say patients were none that the to to patient which pretreated. of am enrolling the enrolling So effects can’t they had to a of certain prior None trial, is there towards that these going a second take were

which came were like and we anybody those the but think I me were if to treatments did – treatments come and they immunotherapy going period, not working. to appropriate if They So are purposefully centers with other or for YXX they X had previous other for obviously washout the X chemoembolization. therapies weeks weeks me obviously, because pre-treat was to that failing,

question drug, Second, anesthesia done about that after considering event first had a to there or before who had obviously was was patient well, PHP on she was the a tolerated was right ongoing an were there SAEs. she cardiac the patient One given drug drug were very cause events, upon procedure immediately excavation. two the given drug response, cardiac cardiac and her had severe extremely on sixth a the events hypotension. and is [indiscernible] getting PHPs the sixth an well, known drug called that a to PHP, after is And that was

after the was the out, removed. was procedure already already the was patient done, So catheter catheter was after – double-balloon

So, an the was counts still Obviously, administration that a happens. event the of drug. to for but it trial, as there the explanation why that is cardiac related timing was that of

an related catheter catheter was is event second An which the the is The for which introducer. obturator, this introducer an plastic to introducer sorry. inserted double-balloon through is

you other introduce guidewires vein. rigidity there catheters. or some This, that the So, can’t is without in

a allowing the the skin. is the usually patient’s part backflow And channel. So, procedure, can which the in introducer blood the you and which faulty introducer, to groin. the of the the against of guess this was shelf right valve I that introducer, need cap faulty kit, create during or of The it’s up in had in the valve hole be off patient’s

related procedures could this procedure and that and so hard these use you trickles in to like down, there where radiology happen it’s placement, filter any on IVC an in because of hundreds is chemoembolization introducers, YXX event, interventional faulty given. trauma So, and significant some hypotension a blood see, double-balloon is drug to catheter and so this in the filters not The caused and even the bypass cardiac forth. amount blood that the to was to patient never valve again due

So the that’s are saying need double-balloon the what to meaning these device, and we we again, the I are the make filters we events perfusing the was necessarily why the of Does catheter, chemotherapy and put before where that giving finger on can sense? exactly our related liver. caused feel these not that explainable, procedure, events or

Arlinda Lee

much. you Thank does. it Yes, very

Jonathan Zager

Sure.

Arlinda Lee

of the patient number – treatments, had HEPZATO also sorry, got? another patients treatments I the Sorry, HEPZATO about that question each

Gerard Michel

to… spoke Johnny

Jonathan Zager

person be to that. Johnny best answer might the

Sorry, Gerard.

Gerard Michel

Okay.

Johnny John

a trial PHP of could Yes, so treatments X maximum in a the in patient of the the get arm.

current XXX an the to-date, overall had average is treatments. we took the moment. you and The at X between treatments have average X If

Arlinda Lee

Great. Thanks.

Operator

Yale Your from Please of proceed your the question. with line next Laidlaw Company. Jen & comes with question

Yale Jen

the guys Good of the mainly most is is it, versus the first morning current question do number data. congrats safety? previous ago, you aspects and on reported data in compare important the how data the a terms in of And which of my safety years that

Gerard Michel

Johnny?

Johnny John

events adverse as of hematological In that a the few leukopenia times seeing, primary neutropenia level. we mentioned are XX% So, here and around have toxicities. course, previous and we thrombocytopenia we the had is trial, the

a seeing in decrease in percentages are those We trial. this

Besides he not electrolyte detailed any will safety in patients, So feel the toxicities, what that the spoke do of to-date. suppression, by the terms that results without with have did cardiac imbalances, that trial profile experience those terms arrhythmias had We have nature. clinical treatment. the and very events we Zager. cardiology liver, bone did was we a all of line this have elevations, has need for European in Dr. we in all mentioned of some shown we outside a marrow enzyme patients This was that’s further in fields of sequelae seen But of, trial. in them have were better much those in of two and transient other the the and have in events evidence few

we are of quite has safety profile areas the so shown And not concern. confident that any

Gerard Michel

we the a the dramatic safety can profile simply in improvement was seen trial? first has say been in versus that Well, what Johnny, there just

Johnny John

that, Yes, say we could Gerard.

Yale Jen

very That’s great. helpful. Okay,

Johnny John

Zager on the like Dr. Zager, has to to like ask just with and trial number of would if filter he trial. Dr. large an previous investigator on treated was had comment. He this profile? a first the you the now would experience with I as safety agree the would and patients

Jonathan Zager

submitted procedure. one like the would to agree of have what presentation cardiac a after And sequelae data conference hopefully piece consequences And add and we definitely I at soon other conference – looking for the Yes, said. data what to our information I published be with specifically you any at to cardiac was and Moffitt are there some think the elevation, no it that found enzyme and with was at sequelaes we data on. treated we I Center any actually found EKG never that patients were or from even just that long-term short-term over changes that we that – echo on XXX gather correlated we to or Cancer able

meeting improved last the issues they weren’t soon these at compassionate X removing that And melphalan. found trials, marrow we two thereafter. those published X unpublished soon the accepted includes much bone feel adverse the hopefully trial, significantly again complications efficient be as filters, looking between severity the and the events, as which the these as potential which and these last in used shorter And in as patients Phase is this especially specifically were filters, the for far Phase patients cardiac and just of So, are than I they definitely none. filters have in new of but and to a the data, presentation duration with that

Yale Jen

Okay, helpful. great. That’s maybe very quick ones. And two

versus is progression-free I months, first the it significantly comments last that versus this time was the versus noticed last X.X one think aspect? that X.X the was time X quite this any it’s X.X improved the I The on versus survival study, particular months –

Gerard Michel

Johnny?

Johnny John

But Well, it some in this this We yes, measures hope this last safety over since again, trial. procedural see place that evolve We we and the and right to, taken patients. to time. sensor had you improved noticed current have been have the the that trial. of course, goes are trial to

trial doing patients the lessons the in measures the procedures We of the procedure. safety and from and other learned after treating terms the have the incorporated

these in are these we that see. all reflected results So,

European the into we also there trial patients experience market We protocol. are treating European from learnings the that follow and our treated take of then are investigators our in incorporate consultation and outside do cases that those doctors those with and provide and

and and have for patients are measures did another these So we incorporate put those were measure to-date that treatment. treatment the related we when far of the so that that is in deaths results no the to attributed was place, amendments the protocol written so we see do

hope survival evaluate comes that as the these at end we will we more data in we overall have that improvements. And also will so the reflect

Yale Jen

that centers, of to last how going Thanks. the the for Maybe Dr. forward procedures – you about tremendous the procedures? PHP the are them get which you or amount to centers great. is familiar you guys Okay so not easy question process, experienced using has with for have more new you think done procedures Zager how said but do for this adapt process difficult procedure, that approved what

Jonathan Zager

Understood.

will we proctoring beginning with teaching board there like just come there the expert at of and some So, Phase procedure. be a the ahead was the taught trial, of the centers of proctored and centers centers how they this new on X program procedure went to as do

it’s will So, some like technology, type And like that were procedure, technique. peer-to-peer new if of continue. needs any there a to new it a program or surgery be just proctoring just robotic other new

for the adaptation, technical easy has during interventional things you to is a like of want during team As and surgical aspects any the radiologists. some detailed that but to procedure performing obviously along that of understand putting want new with The procedure to the done few be very coming board, procedure kind – in of just procedure and sure other procedure. in you on and checkpoints the just way couple are process make steps a the far as and to follow that the easy need or the extremely catheters interventional the that

metastatic in provides today’s to is easy very my It’s to obviously I So, mean, that be And that in it’s it’s extremely teach. won’t well-tolerated procedure extremely adopted presentation cannot opinion, I it perform. on an easy have easily, historically on this very something survival centers. with quickly imagine chance based a patients dataset. overall survival melanoma that poor to benefit preliminary now to gives who them ocular our it deliver and and well-tolerated prolonged to have some gives them extremely a that’s progression-free extremely based

Yale Jen

a Okay, congrats. and lot great. Thanks again

Jonathan Zager

Thanks.

Operator

the with question. H.C. line question next comes Ramakanth Your with Wainwright. from your Swayampakula Please of proceed

Swayampakula Ramakanth

Thank patients patients from were that at from TACE this. have This background, Wainwright. treated is questions. To H.C. of Johnny on patients couple of inhibitors. those immune from least Thanks, doing I with Gerard it RK with the X actually the checkpoint for John remember and most numbers me least in like you. seems back I quick at treated most the

it chance you see to would So, what only compare had or that you just haven’t is against it how something… if a TACE be if

Gerard Michel

start but numbers to think obviously, getting we thin just Yes, say. haven’t rather done and it’s I important that the

published do haven’t I than trial, TACE why we Zager way I the but much BAC better it Dr. arm checkpoint inhibitors. And previous of sliced the And probably the in be think but it, data in better saw think I works there is might that control probably think it in you important. bit not than is all. at TACE the

we Zager, even are least comment about the this very one to say but do this of looks first you to it know encouraged something TACE So, you doing its TACE best to you alternative again, what’s like tested trials probably I again the at encouraged else. be of TACE. But TACE Dr. don’t extent better that of can about that the in could are what we think is seemed versus care, part that that you speak signal group are actually we to get maybe the literature point? a this than can at and there

Jonathan Zager

Yes.

last bag best in the group. a the were trial, a to trial alternative best was care XX% the crossover, was it alternative treatments, just So, TACE alternative the best to since patients compare hard care care obviously so possible TACE. it’s I think of of This something mixed

for inferior of the can one hepatic out with again, favor you the versus these numbers there overall up survival the to significantly progression-free, far do maybe gives as retrospective these favor comparison look but progression-free outperforms all it. for So, favor the progression-free and interventional PHP PHP melanoma and that the representative the I outcomes as see the reports numbers were some patient can a comparison, PHP. that, improved for than smattering hepatic are very patients. ocular from very my at terms that patients. can of direct overall that robust not think other but overall a There versus patients, patients TACE looking survival, is but of compares and the paper in paper is other radiology And there, you And But were literature of numbers, in directly what still the specifically PHP TACE. options here PHP, in numbers in small of were and definitely is chemoembolization TACE and institution based

Swayampakula Ramakanth

study these started, all for has patients of since the the standard all that Thanks gets trial? it when what of what the initiated, start been and for was from the time at changing the starting care color. And is

Jonathan Zager

standard melanoma patients changing care for The ocular all? at of

Swayampakula Ramakanth

group, the for particular metastatic this melanoma. ocular Yes,

Jonathan Zager

Right.

this now centers are hit in the think I again, this I on patients. is that to is the it some say of put at, the beneficial and depends to center bag, because So that would the the data what countries busy and they a in Europe thought mixed U.S. patients this they very you on looks are trial shows that across first,

busy So, would most choice probably a I on first of currently clinical trial would say that is the centers. be that, placement

will they ocular I literature don’t on is imagine efficacious which that putting melanoma immunotherapy support combination no very agent care. go-to-standard not commented of previous and deliver, the patients immunotherapy, TACE can or are is I the documented single that on or are versus really call YXX. feel There you seeing If the that have metastatic the it and occasional I

medical they on immunotherapy. a see you you If oncologist, might put

towards If or best telling you everybody if pushing start you see is this interventional will the start radiologist, treatment chemoembolization. PHP the patients they that choice. approved, first might Hopefully YXX is

Swayampakula Ramakanth

through hurdle question why be last to PHP? is the than reason that procedure any there learning other go could new other ineligible of one patients for me a And

Jonathan Zager

and my maybe answer So, I as I can can comment well. Johnny give mean

metastasizes and liver. the on melanoma It’s with predominantly melanoma, some to PHP you metastasizes a limited solely hepatic predilection than different and do disease to metastasize Ocular melanoma will has liver. patients of which probably ocular everywhere. as to sometimes We cutaneous sort know, extra

of are we not patient nodules for the control best of of surgical disease hepatic then disease predominant that sense. supports or treatment If further combining probably sole or with the site your at types makes these concentrating the subcutaneous at excision here metastatic So, evidence can’t the candidate has radiation liver PHP PHP or certain the there, until But extra wouldn’t Patients other candidates procedure. therapies. they not the stereotactic systemic treatment who are best patients near with their underlying to outside with best be there yet. a to even disease procedures, for type the it start liver. not also this just have obviously, the we burden therapy dysfunction liver, And concentrating liver are

So, issues. known make sticking or patients liver, the if to procedure. B percutaneous leak there to to what usually that common extremely procedure, contraindications allergies any obviously, these but perfusion. that is you aren’t dye, point with one in use we the allergies no the make C, are extra place Child-Pugh are the to these performing because have cirrhotic aren’t sure sure patients makes right hepatic the in eligible class the these best latex that’s these And All contrast underlying candidates the catheters for them not that a to products. disease hepatic Obviously, is for are chemotherapy,

Johnny John

that out of selection in those the of the criteria in safety number previous in seen just in patients the Zager. trial. majority did cycles the as and the score mentioned And this that have has and we Dr. points you, think the the of burden, spoke have those he we thank seen tumor that on. most borne increase stress, I profile trial Child-Pugh So I incorporate inclusion-exclusion would of so we And trial. versus liver and the he has

previous there and among but it’s currently and was ended the of about So, up patients, cycles. asking I that question the getting cycle average majority think X, those X between a treated were X

we was patients the large it tumor trial, the it that And for of mean previous these the in burden X in one. part So, place was safety being is below the average. and put requirements or

that subsequent the recover the at experience treatment patient bit for have we little But this We it taken a undergo liver at parenchyma that has higher. that in XX%. to European functioning know to have they treatment. capped the up the We some trial and do require

the liver requirements returned prior of patient levels the of trial baseline enzymes was in One the receive able the to in hematological and being to treatments. terms subsequent that to

fact treatment. able I recover I treatments the for were question X that the receive answers hope in the were X X, events and that patients your that transient criteria adverse these So, on the shows patients and But could to think nature. our that

Jonathan Zager

perfusing because procedure add will if liver. go the in of and/or to obviously, I with we the their not right, progression X liver working, outside and then are X, progression on X liver to continue the Johnny, they going evidence treatments, And is

that’s are procedure the at X So, obviously, XX if X weeks of a of X, up candidate. it’s identification every treatments patient in works a testament that weeks if from as you the X that, you to X, extrapolate the getting start to

Swayampakula Ramakanth

Yes. Good very much. for color. Thank you giving and luck, Thanks this additional me soon. talk Gerard all to you

Gerard Michel

that’s in, getting to the failed data. And I a this another make incorrect. with on have Alright. out up XXX% there clear. is interval there the kind etcetera a guess because and there sure the caution I confidence trial. that website that, I something or want the running on am release ORR to tweets theme few quite fell I chime really the I texts population, because investors ITT will that the a And who of out we that are necessary, put any to is if on And

for upper the was it X.XXX. what was arm, bound looked when amended As the trial, bound we was a on when I at calculation said upper power meta-analysis based the before, was and a single to done the

the beat So, the of a lower if that what would have bound occurred. then of point X.XXX, that than we the is arm estimate, met response XX% indeed okay, HEPZATO calculation that that’s The greater limit determined and overall endpoint. upper

publicly So bound, a for X.XXX this put call, when you beyond I which – out had that. the XX% misconception And done the continue for amended just to see I hand might was something had we on the focused the will bound, people of there, of we was those lower out some that catch side that and calculation this left trial this the flatfooted. pass lower to power is did if

So, of same facts. the you playing with I just the that side are to sure want regardless set investors want is what of on, to everyone make of fence to I just clear make

So with questions. with that, done I think we are

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on this complete the is the select plans portfolio development follow consulting and and for for a Our value indications initiated of we a design execution engagement additional Earlier indications to fourth the strategic priority work and to indications. higher subsequent mid-summer. HEPZATO by of this of year, track prioritization

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Dr. join an of special your I of to to busy thank Finally, closing, for for are the to submit we forward are again to could in In morning Zager taking towards much to time out all work I schedule who preparing making This of time today. you and is very an Thank exciting to and as on his use. thanks commercialization. updating questions for you time ask from available first we track benefit listen of for its NDA to HEPZATO and want XXXX a taking quarter us. this your and all time you look Delcath for all patients you

Operator

conference. This concludes today’s

at lines time. participation. this for you your disconnect Thank may You your

Delcath Systems (DCTH) 31 Mar 212020 Q4 Earnings call transcript