DCTH - Earnings call transcript Q3 2021

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Operator

Good day ladies and gentlemen, and welcome to the Delcath third quarter 2021 earnings call. At this time, all participants have been placed on listen-only mode and the floor will be open for questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, James Carbonara. Sir, the floor is yours.

James Carbonara

Thank you, and once again welcome to Delcath Systems’ third quarter 2021 earnings call. call Mitchell, the Dr. Executive on me are Chief Gerard Officer; With Operating Padula, John, Affairs Commercial VP Chief Medical VP Operations, and Clinical Purpura, Johnny of Muir, and Senior Officer. Principal interim Accounting Development, Kevin John Officer, Christine of the I’d the Safe by Harbor like call reading statement. to begin for Litigation This of Reform Harbor the XXXX. statement in described to pursuant statements is Act the made Safe forward-looking Private Securities the meaning exception forward-looking statements Section of XXXX. facts, Exchange All call, made Securities considered the this Act may and of the statements of with within XXXX Section of on XX(a) be of of the historical Act XX(e) Securities

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

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

Mitchell. call proceed. the Gerard, please Now I would like turn over to to Gerard

Gerard Mitchell

its the Phase trial end of Eight point everyone on made announced we analysis Hepzato patients metastatic an patients. based had ocular III for joining in months XX% ago, Thank liver-dominant with of you pre-specified FOCUS melanoma of today. a

interval XX% XX.X% XX%. lower rate Specifically, trial had an response objective a Hepzato the with in with competence of bound patients treated of

teams’ achievement primary bound threshold by point the the been the not enable of who yet key NDA been could the on Given submission. of the had not of the time, the just At X.X% lower of which the XX% pre-specified Since the database focused end the that have entered XX% electronic to outcome monitored magnitude patients XX regardless exceeded data successful for of over has required this success, tasks have efforts evaluated. point, and clinical into change, the the data. we been all

in non-essential COVID-related due the team, data, clinical slip. has and December the by X. the planned efforts Given trial despite for efficacy we it difficulties said, restrictions we the creative final would the where I approximately resulted and monitoring XXXX on one-year timelines this to progress. both to monitors plan financial year the CRL be staff day extraordinary delay internal and This had I started to not is access sharing of now site and pleased and the the company in unexpected am year, have pause release investor that entry second which at we With in caused pandemic, in data very with when projected ongoing

guidance We to NDA from quarter late our the the the are of resubmission first on also altering midyear. in

the medical disappointed first the allows monitoring and be delay, will rolling to If adequate FDA earlier control. and in XXX% investors maintain need want start will the know non-clinical I writing our for related submission, While quarter. a we for plan in this modules quality submitted we time

when complete. Hepzato filing the makes only they fully responses fast a accepts submission, generally rolling for status While the eligible CRLs track the FDA to are

time. it Class which XXXX. early a This will viewed will FDA rolling to positively more one by CRL, anticipate might be submission six-month timeline resubmission that the our meeting, review in pre-NDA questions a PDUFA addressed the response during for be the in we Given X give of a them

or EAP the sites to Cancer August University, September. intention access to Center, sites State participate participating University. indicated and expanded University and their single have Johnny ensure publications Our increase last to trained number of Tennessee, broad in the include John was launch. call, date, FDA I steadily EAP by submitted the protocol, Duke To Johnny? a in our the five published. number in there Stanford base the and center FDA throughout We presentations. and intend summary XXXX retrospective results a Moffitt give have been of University, investigator-initiated approved and of to Since would upon these of to ask prospective commercial of to Dr. a and centers dual from trials is like Ohio

Dr. Johnny John

patients all these, disease for a duration months. one the median response, Thank patients, eight XX.X%. of - of from presented hepatitis adverse - first which febrile is with of included Leiden treated likely included cases and cases, the the ipilimumab with and Medical observed Immune-related and of patients of response were two The from abstract of or - of four related two Netherlands you rate phase trial X events most investigators to two each completed nature. deaths limiting was eight cases X and in toxicities were Center thyroiditis, responses XX.X%. the an grade September, patient control in observed of overall neutropenia, dose in these disease seven ocular cases, The in patient the Stable a included Gerard. in dose of response or which neutropenia, of The conference. X Grade treatment response phase Radiological Society and cholecystitis the Europe, one and inflammatory investigating was myositis combination nivolumab has one events escalation trial, a trial after rate and PHP and months, University occurred. the no the CHOPIN in of adverse response hypertension. for fever, from X case two No XXXX partial in seven data investigator-initiated melanoma. during follow-up PHP and data patients complete In metastatic median Interventional the CIRSE at Cardiovascular

treated Particularly trial very are this of agents. the intriguing immuno both second Combination immunotherapy months. developed also of a mortality Hematological investigate common a CIRSE XX the in logical given other XX% and use than greatly was with to and in or on the with the the of was was total event intend excited combination being with published reported X presented was metastases. most is is first South Hampton from efficacy area investigating University PHP X survival in patient become oncology adverse with conference presence patients U.K. to A support We agents use the publication which therapy A most was one agents those procedure-related CIRSE PHP. conference with grade sponsor trials toxicity and by a XXX we that cases. of the third response less overall in combination the overall survival, that load There diminished the X.XX. number investigating age, of Barmbek based subsequently analysis and was of Hanover, was XX P-value in at Hospital seen treatment Medical ocular at patients in was included XX.X%. succumbed in a sepsis multi-variable five results disease Germany. Medical abstract months the median the X.X tumor patients a to XX number partial correlated PHP School and XX.X%. retrospective Stable Hamburg, Asklepios rate Complete The median and treatments. which in seen Median median of metastatic patient response of months. XXX patients and XX with was melanoma overall infection. in of The at were Center with primary of survival patient A treated a Netherlands, tumor, was XX.X% PHP Hanover per after an a progression-free Klinik procedures that showed was of XX.X Germany, type objective disease performed procedure the in of significantly for which PHP the study patients of the survival and with rate treatments for self-limiting Leiden in three. control response rate multi-center University overall response liver

such treatment-related X a patients. approximately occurred X.XX versus of X.XX a per XXXX patient of events of and deaths. and patient, was noteworthy treatment-related the adverse XXXX, between XXXX in in is difference XXXX between performed that P-value Forty-three X reduction XX% no per events versus grade there a to significant X.XXX. or were It procedures There

supports RCTs these of high were previous that publications and totality the of perspective patients the the are can multiple be supporting PHP clinical benefit, given evidence, the rates. majority from administered of none a data, only the thus safely disease data with together control and and FOCUS trial While consistently times receive treated regulatory from the taken Europe

number a to evidence PHP the patient to now response call are that the across I’ll of a numbers the while can addition, tumor In back Gerard. date hand produce supports types. small,

Gerard Mitchell

to launch forward support increasing look efforts more as investigator-initiated studies other tumor additional We sponsored types. Johnny. in our trials to you as Thank well

announced, multiple both launch will previously We day. liver decided metastases. and cholangiocarcinoma for therapy in standalone that we on is liver for cancer, absence in further types in in As both and a role for have patients and high Hepzato setting tumor intrahepatic metastases upcoming risk the give investor treatments at trials evident radiologically colorectal at in sponsor a both combination that believe and our to details as other there with

prelaunch our preparation, commercial planning continue fronts. we to Moving several along

for discussions are development of dossier, with believe with value will given into we that are our we are that tool we of we treatment the melanoma. While payors the payors, an guidelines already metastatic into incorporated starting NCCN important global for ocular be an well advantageous position from confident we

isolation the isolated to the Being morbidity is melanoma. percutaneous related that IHP, minimally of in treatment payor adoption as metastatic a data profusion, or liver number institutions strong both level same - the enable Specifically, over by use should perfusion clinical accelerate a perfusion regional to the to perfusion is mortality associated than designed consistent the IHP. guidelines This but without with and decades efficacy greatly of ocular two with support. more the IHP procedure hepatic guidelines generated and Recall the surgical invasive treatment of include existing PHP of of hepatic liver. due

We patient better to understand are to patient access referral patterns. de-identified starting longitudinal data

XXXX. be able referring physicians seeks will about informs availability We Hepzato in group out EAP sites medical of as utility to this and the affairs our data of the test

force, sales data away longitudinal While a we year start hiring are we from are about to this using also mapping likely territories. a

make appropriate the it withdraw U.S. but Europe, public additional disputed disclosures that beyond in sale Since have given is We prevented contract, to agreement. of year, the indications is indications. pleased previously led and am could our be FOCUS for license will resource issued Delcath, trial point the as interim, to When the steadily the both been into XX running In start new trial the that value recruiting and of medical with believe new launch and where limited. October small FOCUS medac dedicated company of the a its the medical fit XX, Delcath. may XX%. extraordinarily and headcount to at to explored. the an do to efforts to of will termination company’s matter, trial, filing, the the BTG of companies the patients well developed my start complete multi-national from the new very right material have taking highlight joined experienced just the steps on is disrupted. tight job NDA terminate that and by product, the building in should not development ability commercial executive disclosed started our producing from the the on professional launch Years the for to notice quarter, affairs of the despite an have growth fail we that company a is Latin one resubmission, On number differences company I oncology team and threatened in expanding to Chemosat Hepzato despite period. of license we I six-month His a from supporting affairs product we Ujhelyi. North was of issue. grown it Michael notice professionals, to this past of of TheraSphere, damages team Michael perfect have America III this interventional nature have interventional a comprised this oncology’s XX field with past time ensure a availability to notified When we who To of for notice Dr. the this X-K in our just the a initial for developments comment small talent team team Phase delays plan the high prepare October we medac both hire and an the medical need termination limitations claim Turning arbitrate agreement to market, year in occur, America. company experience material of we XXXX, expand Europe. I the

operations, We sheet up drug made and TVT with Venture clinical Opportunities strengthened at director-level significant In regulatory facility all $XX and balance initial an our by August, development Avenue have Fund, entering also funded oncology oncology million in with regulatory experience we debt providing and close. in a submissions. with million to $XX hires

the patients Hepzato role hepatic X, members hepatic-dominant to updated for the a and discussing physicians be we event data will accomplish which On provide ocular treatment metastatic KOL regulatory together, a and will melanoma. of commercialization resources perfusion, Taken the overall trial added our FOCUS with team potential percutaneous including required and survival, senior as December capital feature new major hosting goals. development,

discuss the of in in and cholangiocarcinoma, colorectal Additionally, unmet need treating metastases clinical as general utility liver intrahepatic related cancer potential large physicians in the development will strategies. well Hepzato as and

commercialization and investors. expansion have our Delcath. useful on summary, The the we’ve this commercialization steps obvious, at and KOLs expansion taken six In to hear commercialization quarter value important KOLs to Hepzato and our should To for various the expect are PHP Hepzato initial new be expansion ability topics. presenting critical from prospects in enormously indication least of into drivers state system past on for areas. towards of these the to We

and Christine? forward be questions, the in supported as of and Interventional to of personnel, first data, financials. by publication at turn review a papers but we’ll funding, key three to Christine to continue Journal look over by the in to body brought have growing the CIRSE We taking the demonstrated and Radiology. Cardiovascular call I the

Christine Padula

Thank you Gerard.

of option to period option XX, The expense included net no the $X.X a XXXX, quarter in million as million prior loss cash, $XX restricted expenses in of ended for million $XXX,XXX Our which sales $X Chemosat for September approximately three the The of to the year in months year expenses and administrative September same months expenses Europe. XXXX. total three compared compared XX, quarter approximately to compared to the equivalents, XX, $X.X for product and general prior of XX, million was procedures cash revenue our were XXXX recorded for had of the end of the total $X Selling, $X of the $XXX,XXX of period current the $X million total to approximately to million $X.X the compared research expenses quarter. compared in cash in cash, million the quarter. stock our the prior the company prior to million XXXX. operating stock and for On and compared Overall, expense we $XX.X year for the at prior for cash, September development ended for year net million $X.X XXXX compared loss were the year were our million $X September year million quarter. quarter, quarter includes

has phone I achievement September During million funded Ventures been operating additional for XX, including XXXX XXXX, venture a Fund. and between the will the initial is with million million ask X, of million, we and Venture On a of and X, $XX.X of be Fund’s XX, December the debt milestones. August open Q&A. Opportunities and Avenue XXXX transaction The will the and in $X ended loan three September certain cash for $XX questions? which concludes may you proceeds financing $XX XXXX into to which lines closed of activities. Can we request discretion. months please upon restricted our now $XX.X million tranche respectively financial used company remarks, Operator at check account million gross $X Avenue released my an be That October The XX, funded

Operator

question. instructions] is Please question from pose announce your affiliation, today Marie first [Operator for Your coming then Thibault. your

Marie Thibault

be on reviewed the some considering me Thank be that in will today, to BTIG. repeat FDA data of FDA submission, be there you we’re to the Marie or you that to the accept could secondly first some just there? Thank Gerard, hear my update is to they I included be submission? confirm, that choosing waiting rolling taking Thibault to full FOCUS process, questions. on data that for the submission here what Then [indiscernible] still that on rolling not in will on was the the data the you’re FDA, submit will wanted expecting question December can this a FDA that whether and will Hi, X. from ask you. for versus wanted European will accept some we’ll of

Gerard Mitchell

efficacy day into but some is final data. that will present the small Sure. parameters will What still, we the nor be of to impact we need to none that amounts impact have present the be we will to monitored, data There essentially any show, some consistent will will to that KOL FDA. see--what the data of needs that on present which upcoming at All what data be the parameters. put still database should material you a any safety of the of with be you intend to we efficacy

complete. to it be In part of I under submitted my do not ago, rolling of fast are CRLs we the in however, status, from to they a track rolling until which responses that have terms submission; we the mentioned many in remarks, says as years are submission, regulations, allowed another should

the to I whole case, unique interested but whole just new them they’d we’re Now rolling PDUFA it’s a without which What going would similar so NDA, our new is so that to essentially essentially a a be do think FDA more kind submission, do to talk of in that clock the situation. we’re give in we’ll submitting would it’s this trial them propose time a at to pre-NDA see. we starting, and meeting -

will or data, part it Now part analysis, but efficacy the of in simply The the NDA, FDA of consider doesn’t it’s the publications European supportive. those as referenced terms that important. be of all but

out With certainly is but of be the supportive. it there, as publications number going to categorized helpful, it’s

Marie Thibault

EAP? helpful. sites know Gerard. if you to that? clearance on that’s they Thank I’ll use allowed know you said the access. on follow-up Okay, I the you I Where FDA front. Thank join. Have from start my five really again. been operating under agreed are expanded that that you don’t have the here that gotten we’ve to with

Gerard Mitchell

Yes, gotten bit more a we’ve John ask with in are that those about I’ll to the little process we clearance. Johnny where give sites. color

Dr. Johnny John

Sure Gerard.

As Gerard just we we documents and EAP protocol FDA full our the submitted the clearance said, from for have received for study.

various of to at these to through. for - just some stages expecting with come we’re IRB them the quickly, We’re waiting very five approval we’re sites open

we’re of site are past have with up site Some IRB, month. the negotiating the been at it’s and various to so hurdles to the them but come scientific certain coming language review cases, we we’re and certain in submitted budget gone stages for so we’re first the and ready through site, the final approval but running hoping at In still have committee waiting and contract it’s to to patients the through. enrol

Marie Thibault

again. you Thank

Operator

announce Scott your question is next affiliation, Your Please then coming Henry. question. pose from your

Scott Henry

you Thank good Capital. Roth morning. and

Just couple a questions.

Do is look on December to estimate have of think statistical any for on the the data, information you of but the in in I a you’ve with forward at X. full don’t or the data this past, perhaps optimism in I point, hearing still we’re of least benefit. at the un-blinded? significance expressed First, survival survival looking treatment. some data point XX% the that new more favor

Gerard Mitchell

level remained the from tried had say I’ve simply the away just confidence before I’ll I has Yes, unchanged. precise number. to stay

rather it in the well achieved terms again, to that as could comparative knows, so of PFS as studies show it’s a I as significance I’m climb. but that size significant--I given strong very Given we strong, at which that but that But show benefit would I’m terminated, show significant, - turned quite should small in I of confident just advantage. as a was confident in be be it’s arm like before even we a as a arm the advantage. statistical, comparator came the doubt will into was hill saw meaningful trial, shouldn’t in least strong single we statistical everyone arm a say the OS, recently that

Scott Henry

that you of data you of the Then helpful. or timeline great. Just color. think get of the the is when for Okay, That’s of whether a reasonable your XXXX, aggressive? rolling some FDA target to lot we figure it to sense. trying that Is about get approval, submission. variables including to in Thank obviously end out, can

Gerard Mitchell

to clinical it’s We before to CMC PDUFA most their not a and we if want there, like FDA the wall - and don’t requirements, blunt, them a this back’s ready. primary rolling give human look they like of the feel To XXXX. another squeezed, is we’re going at meet help submission, rolling find something to submission, all out meets their module It’s the we’d hinting PDUFA reason because its to that’s timeline, PDUFA and offer them can gets meet No, get the nature we CRL if whether FDA will a succumb do. to meet the like or put to against to in else, be I’m their something them requirements, anything. we to easier lot

of I and it to both interest think interest in would clock it the early. our pieces giving their be by essentially them PDUFA extend

Scott Henry

for you steps combination next trial be that? thank to Then for color. what with evaluate the would CHOPIN therapy, Okay, that the the

Gerard Mitchell

Johnny, on you comment please? want to that,

Dr. Johnny John

Sure.

talking about the escalation their abstract I As phase, mentioned, the Phase of dose the trial. was

that Phase continuing full time. go but to we They presenting patients be data as on we so ongoing the some Phase which a have basis II, this in the the randomized we complete the which that. future portion. being is from look conference, data second have next II, at this the to II, is may would an some ongoing and at The treated is getting We step moved portion is be set Phase of into through trial, forward randomized which phase

Scott Henry

model. question, think we line Okay, going on just nuances there’s the quarterly Sometimes How forward interest basis? a great. there. should expense some Final accounting on about the

any Just think should we sort target that? about of on

Gerard Mitchell

broke expenses? interest say you on me. Did up It

Scott Henry

Yes, interest expense, correct.

Gerard Mitchell

confirm it but be should I fairly think do that? to Chris, consistent, want you

Christine Padula

be so the it interest-only based have and months Avenue very will consistent interest Venture, and we on start Gerard, Yes doing XX of we principal. then

So yes, it flat relatively quarterly be should line. a

Scott Henry

Thank great. Okay, the for taking you questions.

Gerard Mitchell

you. Thank

Operator

coming Your announce question Jen. affiliation, then pose your Yale Please question. next your is from

Yale Jen

Thanks for taking the to question what first might presenting you X, from Laidlaw question. & Company. to the My factors first in my question time need the still December to--yes, be is data gating that before be you’re now that that complete would the

Gerard Mitchell

gating the In plenty any data is CRO actual them to the to meets have I because their of factors. buffer. they work see I will be I which done, and assuming we QC analysis think through terms our itself, fiscal timelines, primarily There’s but done think process, their by of don’t has then run

we not how gating solid think of had will But but present tick thing as is the really from didn’t that’s want the design final on. data I FOCUS, hold more, day trial the CRC terms in for I having investor etc, is so off, a itself no weeks for when ICC. when discussions. there design gating item. the signed along we number to up that’s the we now, think Right clinical question I mature and more of item ongoing outlines have the we’re and be maturing

Yale Jen

helpful. Okay, very great. That’s

[indiscernible] rolling that able that any is a talking CMC comment you on the be that module, that? color the on potential you about As more is what and submission status of would to were

Gerard Mitchell

that. Yes, Purpura, to respond why don’t COO our John have I

John Purpura

been rolling Sure the along ongoing it with would be rolling that Gerard, two say, the data first would the non-clinical submit FDA, of from, up agree could subject if X. and Yale. thank our modules module FDA the has Yes, be Hello of to targets will Those module a submission. work you. CMC to one we ongoing,

Gerard Mitchell

in the we I those get so pre-NDA away we of on work later, for submit CMC if end think a I done by the have be little everything the meeting, of year, have done is modules, think time Then two. ongoing to of think right FDA in basically--I terms we’ll position should we this to by now, right get have the a we will but that, maybe okay the submitting with moving be two the

Yale Jen

So the should meeting, consider quarter year--next we consider--the we I last of that with be pre-NDA say? could FDA first is should year, question meeting this should

Gerard Mitchell

Yes, sometime of the first within two months XXXX.

Yale Jen

Okay, milestones, great, congrats. and finish congrats to these and

Gerard Mitchell

you much. Thank very

Operator

are queue. more questions no There in

Gerard Mitchell

day both thank We another of a time well Okay, into at need. for you month thank your less you your clinical actually and Again, development all for sharing forward than in FOCUS the update to plans a unmet attention. areas data look our further for investor on participation high the trial and additional and have great day.

Operator

conclude does you. today’s and this call. gentlemen, Ladies Thank conference

and have for you disconnect this a your Thank participation. lines phone wonderful at day. time your may You

Delcath Systems (DCTH) 9 Nov 212021 Q3 Earnings call transcript