PCSA - Earnings call transcript Q3 2021 | Processa Pharmaceuticals, Inc.

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Operator

Greetings, and welcome to Processa Pharmaceuticals Third Quarter 2021 Earnings Conference Call and Corporate Update. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce Jim Stanker, Chief Financial Officer. sir. you, Thank

begin. You may

Jim Stanker

And results welcome quarter you. Processa’s to drug development quarterly and XXXX update Thank third conference call.

the Officer; PowerPoint accompany our I want Joining our presentation filed our before will on call remind Form Dr. we are me XX-Q. quarter David this Chief call, Executive Operating everyone and Dr. Chief Floyd, to third Mike Officer. Shortly today Young, that a

PowerPoint the on be Young’s release XXE slides, link To prepared the with facts Securities please the press I on this described view of the XXXX. Safe Harbor historical along. call in and XXA forward-looking to of follow XXXX considered is statement. exception and call, click Section of our of This Private Safe the the forward-looking by Litigation made webcast Reform the Harbor may to Securities the within go Act of to statements of Act earnings Section start the the statements statement Securities meaning of statements remarks. will pursuant XXXX. for made Act All reading

expectations materially we prove Actual implied and assumptions reflected such reasonable, we due and be in to Although, in from differ to can those make statements believe expressed results assurances forward-looking that forward-looking may statements correct. no risks uncertainties. these expectations are will or various

briefly this forward-looking At do other reports events then and file statements undertake only financial XX-Q, could published in implied any will subsequently actual update well to on and cause touch included reflect detailed from Securities on quarterly risks time, results, are that We date XX-K, Dr. any the report with results from obligation uncertainties risk of over we in forward-looking subsequent statements this the the earnings as contained Commission. turn in or Form or made Exchange or time-to-time not circumstances. such of statements, those annual on this Form in as to call. differ our it For knowledge, forward-looking expressed a call please filed reports discussion Any our I those of to factors to supplement as in see

drug Q&A. to will on which our an update followed by activities, be development Young provide

continue cash of a we balance efficiently. We our manage XX, to XXXX, as $XX.X September And of had million.

ended $X.X in nine $X.X to million million by XXXX, December the million this During XXXX. accomplished other our trials balance months and and placement We September cash private when spending costs. operating increased compared for related XX, raising XX, by we $X.X a clinical

for $X.X as flow September the define only months nine XXXX as $X.X expenses salaries employees, administrative cash operating our all Overhead for as development on well XX, and team. our including our was we spent ending includes While million overhead. general million. what We

for million and research $X the in to the an drugs continue we included our continue pipeline. in loss We PCSXXXXX of in The PCSXXXX and the our we development with increased for compared or these and to in Corporation. acquisition gastroparesis. XXXX, $X.X or the share net other continue to acquisition increase as increased our quarter development share anticipate we PCSXXX $X.XX $X of reported costs XXXX. for to ulcerative by XXXX. the XXXX, to ended $X.XX lipoidica licensing XXXXX comparable necrobiosis in our in in-process our third for of activities X of For advanced loss loss of costs to XX, per of refractory compared gastrointestinal third million the tumors. for And million trial net relates patients of trials XXXX in as same rest Phase September a for period will The our the the year clinical quarter increase loss enroll a we Adjusting progress for trials quarter from expense incurred tract related adjusted our period costs, begin we million the Yuhan of $X.X net net

for gross offering and In also payment $XXX,XXX and licensing related February $X nine PCSXXXXX, million ended proceeds operating clinical PCSXXXX. including period XXXX, increased a to net $XX.X advanced offering the September payments months million we Our common of in to we the a received stock XX, incurred to in PCSXXX, PCSXXXX XXXX The of $X.X costs. of to million net from after to increase cash million by our when deducting for our for proceeds we related in private closed $XXX,XXX XXXX. which costs CROs trials was used due activities same $X.X compared our

offering common that million we outstanding. of issued today, XX.X have shares and as and Following

of clinical third active $XXX,XXX we compared the quarter related The of our the to totaling we research million, incurred primarily During incurred R&D expenses $X.X cost for and in due trials. XXXX XXXX, in development to was our million in costs period increase same to $X.X XXXX.

During the stock-based allocated between CEO, the David $XXX,XXX R&D please and costs. general administrative consulting to call David, to in over The go compensation, it’s fees, and compensation related non-cash non-cash G&A concludes remarks. That million totaled my the period $X.X of as increase Young. compared XXXX, to million I’ll is increases well $X.X third of ahead. turn expenses our XXXX. primarily professional in as quarter same other our for and

David Young

evening. Good Jim. Thank you, you for joining us. Thank

posted be previously. will will what next During you my expecting website the time on Jim the the details be pipeline with on on over you be you said covering I slide, and our discuss months. should our all today, each XX not slide as briefly updating be I’ll but

with highlights. snapshot our slide, you This slide Slide X. of provides Let’s a the go first Processa to

and most about. five more depth are major in months will in our you only major are slides. be highlights I’m discussing subsequent recent already or of the the I last has three something six, stages beginning four bullets bullets first discussions. more the some quarter that sure bullet third in highlights, The of last read happened over and key next expect the the bullets represents or and in have milestones heard The to The accomplishments our we recently, XX that

the describes select to of Again, X our criteria many this have heard that Slide slide. we is have pipeline. already that about. used drugs you seen a in slide Next or

slide. Next

we of have XXXXX, instead next-generation a let’s at into of to Now rebranding our the in capecitabine. XXXX. going point each drugs slide, summary XXXX like XXXX pipeline, the we I’d look details development, as using clinical out of that drug and which are XXX, four

four patients these be of markets. to being and XXXX the approved which be drugs We of $X Phase four capecitabine X four drugs and be XXXXX, commercialized different in all billion expect you XXXX FDA clinically XXXX and same status in the briefing to XXXX to only and to will on expect and in I XXXX. XXX, half be in evaluated next-generation we first are in which now between

look off the are hot results since press. first next-generation capecitabine interim Let’s the at

Next slide.

as modifier Next-generation chemotherapy in oral administered cornerstone and capecitabine, we previously treatment. with a chemotherapy prodrug which of capecitabine, drugs XXXX currently XXXX, the used a X-FU. designated of is chemotherapy one That includes cancer form the

shifting greater left novo cells normal right of irreversibly to We new effects DPD cause metabolite diagram, metabolism X-FU, also XXXX expect Capecitabine could because metabolic per through time. de As as as This side being the as X-FU DPD And The X-FU right not but does looking the shift to capecitabine over side of metabolized shutdown to neutrophils. body long Generation therapeutic would called the synthesize FBAL kills current a is inhibits which is inhibits as more FBAL, you DPD X-FU for can X-FU the side no than X-FU cancer XXXX from right at side the metabolism in if less And to in present, by in shutting of effects. is no X-FU Next DPD and the Next FBAL. the has forms systemic however results formed to exposure determined can that last dose. potent metabolize currently existing body, scheme is Generation DPD forever down of side milligram nucleotide, that such capecitabine. side. Capecitabine The is cells, which enzyme FBAL. a the see the the the

than And reporter So approved with capecitabine. after a XXXX to capecitabine less administered a for to potency patients, the interim Capecitabine greater Phase FBAL hours than to administering of for FDA X-FU tell determined least of it us was milligram XX% by of XX compared what the dose approved of even XX% as per current XX Next in systemic days times one times seven and was FDA XXXX dose only of XX single XXX greater. was of metabolized Xb some did And reporter capecitabine. at our X-FU Generation capecitabine exposure

after metabolism improved did the of interim last transient We single a not also increased seven for that from determined potency this and XXXX. days is and analysis dose profile

Next metabolism of slide. the occurs, XX a hours the seven after because existing dose We XX for believe DPD is over to inhibited XXXX. X-FU in that change days

then are the and Phase understand we inhibition the to timeline formation. modifying is the protocol DPD XXXX Therefore, DPD no formed to New DPD. exists irreversibly new and de better inhibit Xb of novo

other we result types would capecitabine to better evaluating By to as X-FU over precision likely as select we some taking for the is in data, more audible expect timeline multiple information benefit well patients. would cancer. I that long can to interim of us potent and to inhibit that the Generation Next to And Next the important development for but medicine or the point changed. as not protocol will we and administered. Next market Generation has not to are we we’ve Capecitabine. regimens regulatory Capecitabine Generation though, personalized than expedite treat a can X, existing XXXX and capecitabine after of be a of also to approval submissions out all extremely can call a patients like which using valuable would provide approach, achieving So Capecitabine the the expect cancer current that initiate as product market, had only also capecitabine, for risk DPD even the timeline allow Phase of seeing be that this, an may profile, to modified The FDA have

slide. Next

the of condition the to limb me of conclusive designation. initially a an unmet skin. and skin that in about and quickly Let XX% to presentation below is medical as but no its skin be XX,XXX NL is Xb orphan to All sort months And infections, as condition have accomplished diagnosis ulcers. as review And dermatological from histological which diabetic such can the where clinical lesion, NL affects the Also potential approximately approved years occur U.S., different can a and can cancer. biopsy last only Phase billion. ulcer such a condition now with prevalence drug of U.S. NL now contact with is The $X drugs. of our condition, The tissues course as the complications be the patients becomes over FDA serious we for because or appears trauma other to the market amputation can need the XXX, with to naturally ulcers, the in that the XX,XXX occur through of ulcers fragile from more patients and brittle. than occur they a

importantly, to one during of of the after X% severe first More complete years natural two in healing to moderate these less patients. onset than the encourage ulcers

achieved be includes side PTX FDA given a closing before, limiting often file. to contract also presented month. two the limit complete ulcers trial all patients, Xa effects, a side the patients drug can used and only drugs drugs patient while standard as XXX care. to is trauma wound the was is enough one Phase of off-label the in prevent but ulcers administered. significant formal closed at no a in ulcers – And approved are see the the I I metabolite And NL. said analog of In there work treatment which those pentoxifylline deuterated in This within on inadequate, call PTX. also closure PTX. or had of that contact called be some of does with in because a efficacy for who each our No effects dose drug. high is it As dose NL dose

well placebo-controlled randomized in trial, enrolled. Next in as are screening. total analysis patient XX be One patients failed and treated A patients expected patient is our in one submissions us to is to enrolled. our and critical as approval Xb development guiding to slide, have The mid-XXXX of ulcerative are interim Phase both regulatory and XXX patients NL. three screening the development program, placebo in in future expedite

and XXXX initiate Xb expect We Phase our study our complete X XXXX. Phase in to in trial

agonist. I’ll Next potent update that specific XXXXX, and XHTX slide. very The a drug last in this cover is

You developed medical the use. one There’s are off-label. limit side treatment used drugs that effects may drug for for while these drug gastroparesis. unsuccessfully this recall of have is drugs other significantly being gastroparesis only UltraMind that approved All their

XXXX effect analysis specificity our patient make To patients. second for the a Given and at trial, randomized choice this side $X gastroparesis, rate is XXXX. from high The to XXXX the study drugs of the in of evaluating or and profile of placebo-controlled to at than would emptying study for a to trial. which and of XXXXX response used FDA Phase XXXXX in for the billion is is potency half letter first all with beginning dose better half have the appears XHTX be trial final gastroparesis for drug Xa The market. roll receptor, the significantly of in first the the received proceed the expected symptoms date, we gastric the

trial protocol, the submissions analysis. enrollment And modify evaluating, drugs nine slide, regulatory next months, to we protocol to and DPD for nine order since months regulatory we development Also, our Phase over the Xb on the we expedite to example, restart breakthrough XXXXX, Phase and six possibly Capecitabine the for complete the Generation have timeline de least expect first with we if months one of Xb enrolling the the inhibition pipeline to To formation. to of to modification the we enrollment Next expect we now within for for next DPD Xb analysis XXX, trial. FDA begin inhibition for and Phase of expect our complete the for for approval, and regarding FastTrack To novo interim evaluate additional and for to one to the to an patients half complete timeline in interact at DPD interim expect analysis interim to Next of XXXX. submission mid therapy, Xa are patients months. six Phase qualify of

to where This I over concludes next XX we for slide. we’ve of the repeat we to a beyond. to three better the accomplish months, to table remind has over now poll Next XXXX call well is expect phone achieve and this open expect my are what given hope table we now please pass first for accomplished just as what understanding in I’ll remarks. everyone you last a the operator earnings to what it to and months Q&A. you as the questions? the X months. This lines Operator, can of

Operator

Absolutely.

begin question with question-and-answer Please now Garner from session. The first will Instructions] Craig-Hallum. We Robin [Operator comes go ahead. the

Robin Garner

from as came you first XXXX. the thanks evening, I’m hint preclinical Hi, the the see my any My XXx for to and that question questions. cohorts. to if good something data curious data first is on that and that clinical expected being you answering concentration gave before two

David Young

hint be think is there – a be to more It we it good but more of be this That’s a would Robin, gave us did question. would it that potent. not David. potent, Hi this

we is this So than thought. greater

Robin Garner

Okay. Great. information XXX, then learn data from And the interim for what Thank of you. at coming to kind for how what you that see expect many will doses on patients data? question and can up, we we interim

David Young

Sure.

something to split, it eight – of the supposed be won’t be what be grams then XX that this it’s The is analysis The between to dose has all. group. patients. FDA split PCSXXX X.X And at and treated is, the the patients. will interim the it response placebo placebo – handle is I say, the but data day. key real That’s dose interim will the of on So no also will anywhere how per be to patients from treated maximum

group, If rate better patients. so is there’s different Then placebo group handle on placebo they even of about out key. the some four patient responding wanted that of or responded. as of example, to the a for one response But really And group if zero, than us treatment five a get FDA looks course, that get to placebo nobody information the on has that well, group.

to everything drive placebo a for or go whatever will regulatory we response how If is really do breakthrough we of a therapy FDA. So our that or presented fast submission. driving and in track we else terms

Robin Garner

Okay. you Thank very much.

David Young

Thank you, Robin.

Operator

The Brisebois next question comes François from Please ahead. with go Oppenheimer.

François Brisebois

taking in the for you Thanks background. I if questions. barking apologize hear some the

first have data you be set – in half just from mid-XXXX, or So the here PCSXXX, interim clear, and full to trial then that? for to and mentioned, data XXXX to of to feel just data double-check we still comfortable the still complete it’s

David Young

Yes, we’re of we’re the U.S., going to example, our of recruiting some to enrollment a looking expanding – at Right that’s national now, efforts we’re a and patients. good question. be for in going

travel We’re travel. going need if to adding patients funds be

So we’re again, the is this doing a rare enrollment everything increase disease. we can to rate, but

to we’ll say at have the patients. The talking June, And see So May, get August we how will that just expectation, that something something I I’m don’t if mid-XXXX, sometime in when depend or know really it in least I when, analysis, analysis. mid that the when have range. interim range eight July, about sometime, goes. just we’ll

of very a things to complicated is here. talking remember we’re not you One analysis about the that, have

patients did many how ulcers about not ulcers completely completely closed how patients talking We’re the have had and many closed. the

that, take the patients just, it’s not you analysis It’s so So the not real getting itself in. much time. like complicated should said,

We the right the in still think of we’re because and in completion can think still complete of can happening the on the get terms all of push the we do terms XXXX. putting the before in that and patients by we at Now June study end, analysis, what’s now. that, – the of enrolled we of

that. But all all endpoints all line hopefully, the we’ll by won’t that, the enrolled, able and won’t by We – patients to, again, we’ll – year. have patients of results as at all with the And we’ll the – be able least done get year. the end year. So be we of secondary the the and the those to least line by all the do get the top be at the the end the full exploratory as have top long end analysis, a treated at

François Brisebois

mentioned, on of like even exposure just you Okay, the have going it’s then activity. you can the to expected talked And see we the XX understand you’re capecitabine. higher of Would fresh exposure, potency to terms times a higher more trying the then necessarily maybe this of in of here tumor great. use question instead pretty maybe yet are Robin doses I’m Hand-Foot some towards the comfortable that the safety if that is or maybe you data, dose side that just PCSXXXX, about counter was the not disclosing are you effects other And is, if FBAL, neutropenia. trigger wouldn’t PCSXXXX – that side, Syndrome? going wouldn’t and How

David Young

Okay.

if see questions. remember the can I me all let So

the do me last one Let first.

that. have Okay, to we Franc, evaluate

We things those why we when doses the evaluated. in dose, are things you capecitabine distress that’s Those increasing when – shut diarrhea as we’re to neutropenia is we or have result things. fact, something the to tolerated GI maximum give, dose of get we be that. have the actually And if in determined to like or in evaluate, and going DPD down

DLT side the is I the the that effects, that That’s be that are tolerated maximum what my will those feel. feeling think related be side to dose effects nucleotides. I gut will

There’s will don’t to I GI be you neutropenia. diarrhea, it tell being because But Are where yet? be they’re they nothing capecitabine therapeutic, that They’re therapeutic X-FU the per generation compare related going those levels, the highest the dose, but we we while the remember, now, and occurs. only XX% can the nucleotides, anything levels. It I about given two. It AUC, for other itself, at dose know. levels of right X-FU good the quite of capecitabine, are other will FBAL the They’re the milligrams way. our side through the the will the be not the XXX was goes exposure present So effects. things that the XX% on is nucleotide eliminated day, given here, next that the really the which through and therapeutic that in group for And the are side, levels. was you high have AUC by AUC can’t X-FU that talk urine. to X-FU

a to going you can’t we’re AUC. – the getting next So view, next pretty of PK/PD dose one would into going higher the expect dose or that, compare the really but exactly That’s after that from appropriate levels you nucleotides. not levels we’re in to be significant point

safety? I have that that efficacy? in do HFS, – Again, but What will of to see we’re think what do terms nucleotides, side any think. terms see will will effects Now, know. going will we I don’t from that Don’t in some the of

François Brisebois

Okay.

David Young

know don’t if… I

François Brisebois

ahead. Go

David Young

I don’t know if I answered everything, right?

François Brisebois

if No, in I’m you dose, safer terms And the to sure just PCSXXXX, give that potentially give because hypothesis it a be smaller safer would you absolutely you a the just of it at with combo, it capecitabine? give make dose old if of that it. capecitabine is or did here, would trying you more is

David Young

would know this past question. think past That’s what And I from a well data, you we happens, preclinical studies. tell both good happen. as what I can as

dose gave capecitabine, completely gave shutdown right now, get. you of the DPD you PCSXXXX normal what’s normally If and

would You would GI There’s no neutropenia, have definitely have definitely effects. you question. no question,

nucleotide side. some have the would effects from serious you side So

Hand-Foot have not the would You Syndrome.

have neutropenia You would on, will some definitely but not other going things have the you problems.

François Brisebois

then, I sorry fresh just this is to – pretty Okay, data. And great.

more here. learn I DPD personalize just then finished this. you’ve talked this? biomarker we and reason for Would about bio the try was you help novo to So not with you’re about PCSXXXX trying on approach there now Any PCSXXXX formation. I treatment, as did just wondering about biomarkers personalize the that lastly, to the And talk de – you to

David Young

Okay.

should ways. what used or a you enrich in population certain in the two way terms of So I’m biomarkers receive One of to population therapy. used decide – using that kind to to biomarkers

approach, right. one that’s So

to The much other in other these guide approach biomarkers you efficacy dosing. drugs. with digoxin pretty terms therapeutic a we like, to tell your of drug going is did direction to Gentamicin you choose [indiscernible] like It’s what lot your monitoring, of

approach. that’s so And a different

from more approach biomarker Our the latter. the is

general regimen, kind So to in, should this you to that coming help of have this there’s biomarkers it’s or so change not stop stick of regimen. going dose now something either believe get population of to working therapeutically. capecitabine us there’s tell got that we’ve I a PCSXXXX the guide say, to is and DPD us, will more do PCSXXXX or the

it’s think I way way, another that to it. than what that. already should you to biomarker be biomarker a the So rather do receive developed There’s we more patients been Europe. is That’s going in tell can general

approach. taking may we so be that And

because PCSXXXX, present still not In terms out of assays in we’re trying the figure biomarkers. did PCSXXXX, XXXX we anything for to for the

an assay get that clinical – assays, quickly. it be some – can taking run. bit turned something weeks little take these develop around thought, not are to actually time And we new we when weeks fast. to into because that study, assays these and than so that more of It’s to It’s that’s and has they’re develop have to weeks a we weeks

to So them that actually nitty-gritty time planning the the bit to to those be. the doing have get that’s beginning you to taking more stage a we want in work little all them do out,

nothing stuff. the doing really still beginning we’re There’s doing about. the except talked we’re nitty-gritty haven’t all we why new, that’s planning, so still And

François Brisebois

much. you very Understood. Thank

David Young

Franc. Thanks,

Operator

from question comes Huseynov Benchmark. go next Aydin with ahead. Please The

Aydin Huseynov

for question. much taking very Thanks Hi. my

one So I XXX. have on

it interim enrollment Just XXXX. than the wanting was Also, to and understand why analysis for do slower mentioned you expected? process the think you

by that end be the will the would that this year? enrollment So completed mean of

David Young

Okay.

first analysis will It this might interim an the don’t chance. of there’s be be, to think answer a me let enrollment. it year. we’re for enrollment The or end So complete extra the be. will that months But one giving the not two by completed question. We

because the we of being will is be year. will The the in The reason next – So taking we’re in more of is it all the study the aggressive of we around enrollment group recruiting. be for June. – think interim completed That’s push completed the can our be this think and enrollment will we quarter expectation. that taking patients analysis reason – the first we’re our completion

We’re doing national the recruiting.

We’re not And national to you first patients, of only the you look saying and then, your after around. sites, thing approach they out have But all when going their as talked sites, talk clinical getting recruiting, they to to to patients. know, patients PR a type you do that you’re go all and then that’s and do. they don’t

do know group hiring all then actually types dermatologists, a all are a of to pay people there to of hard, go general hit site and because of we’ve hopefully more So us going physicians, really of – to let to then help to some more interested, direct it about them diabetologists, site, a transportation, for different it. the national, their sites. to sites. types We all all patient get somebody it’s them we’re we’ll go direct easier to them this And

So we’re really pushing it hard.

Aydin Huseynov

so do the some phases, the be kind completed XXXX, there of pass when XXXX shorter the approval perspective, for just drug the be all modeling Phase would from in for given And the Phase and for should think potency Understood. approved? time right. and be when thinking the could you that X you Right, about increased X potential, when

David Young

so. hope But one to FDA. until little sure can’t that’s bit I the we answer so. hope that more a I sure hard now, I talk a right

effects decrease We those with the side neurotoxin effects side side and should well with the believe increased a the least effects stand potency pushing We FDA. at that. are decrease cardiotoxicity be to that the HFS, in of going with a

we that and the this and Yes, data future So the data we hope by so. the drug. hope for we approval that development presenting process can expedite

Aydin Huseynov

medical possibility did who the capecitabine, you survey formal have oncologists and kind Yes. of informal? any any about feedback and of And having general use capecitabine, feedback next-generation from just

David Young

Yes.

there approach. we’ve there the capecitabine to can capecitabine the those side to. effects. liked we’re That’s of the doesn’t liked and have may And idea. doing. what of that’s the about likes types consultants we are that are That’s to of that who cause idea. studies next-generation that’s that of we earlier, a talked – the in to the if oncologists said the HFS have XXX% neurotoxicity, talked – which cardiotoxicity effects like balance is us of who that them side get more They’ve studies But you talked advisors you the neutropenia, and have all a to find MTV that the the study. balance. great. purpose So purpose we that Everybody in oncologists and there’s the has type They realize you that

have cetera, the now, who said addition, in yes, interact we’re a one about be us, these et our fine. That’s – these I on on who a approvals, drug modifying some which a study, They study, bit, oncologists have were requires who hold to make patients on changes, and put told in the little my that of for of enthused to to what very to us IRB we said Every this to as right? all the are very, them dose kinds we when yes, physicians are them going have study that’s well study, In new though, patient us, said, that fallible. had not as keep for And right the we FDA. drug get patients things with to go can doing.

no do you we as that. ethically problems have it’s long and appropriate As doing think to

in them not it’s whether they would’ve something there’s they they on keep patients it. our with kind thought patients have it, they all keeping efficacy, side if And fine. the of didn’t, okay, said, effects was we’re are on can said, would or it. if no interested potential But So they of bad there

Aydin Huseynov

you much. very All Understood. right. Thank Okay.

David Young

Aydin. Thanks

Operator

[Operator Instructions] Please from question The Harrison Julian BTIG. go next with comes ahead.

Julian Harrison

thank assume XXXX, Thanks. On the it question. my what all for if better will reason these And wondering sense you progress. give on And you to like fair Congrats us that in will regimens could the have [indiscernible] to regimens continue taking a new dosing cohorts. look probably upcoming I’m is for favorable

David Young

Julian. Okay. Thanks,

increasing be tell But again, – interacting So because regimens, going doing. are going dose I amount tell FDA you on those. the be of specific I we’re can to the we we’re you doses. can’t the with to what

interval So the would decreased. dosing be

a seven the dosed more – for that was to and dosing repeated have we we’re What adding remind days of capecitabine until of we one is no day of more going of then to Right was everybody, be doses was dosing just the to there So to XXXX be there seven no in was the two start doing often of And capecitabine. administered. regimen days between and waited day we’re XXXX. within day on capecitabine. XXXX XXXX we’ll more cycle. and next going And now, dose single gave one,

So there dosing XXXX will – doses the of capecitabine. after also during of be

discuss So with that’s can’t the first thing. – And the that and negotiate to again, into we’re still FDA. because get have I we’ll specifics

before? asked you point done second than is what anything So to ratio GSK. the lower with much that was how The about done by we’re compare is, that about ratio does the talking ratio

so much all much, is – much less work lower It’s XXXX. ratio, that So completely a ratio. much, it’s different

done paper by work – done given the rev was of days. multiple dose that terms example done by for in the publications Now lower was Riviera that and

be on higher. still day, given our a will same lower or ratio of but terms given the about In not little the dose

Julian Harrison

Got it. Very helpful. Thanks, again.

Operator

to back question-and-answer like David This the for closing remarks. over Dr. would turn to any session. Young conference the concludes I

David Young

We the interaction with we’re ride. and and very doing, you all you enjoy operator. some to five products you all the the more with We us support. wanted months, attendees. believe the the stay things it. hope appreciate all questions are in the blockbusters Thank much. really appreciate you’ll about Back you. And your Thank things I and We to these trying we’re everybody the do thank really few we hopefully and just on of call, next be the to hearing all FDA.

Operator

Thank concludes conference call. you. today’s This

lines. your have You for may disconnect a you Thank participating and day. pleasant

Processa Pharmaceuticals (PCSA) 12 Nov 212021 Q3 Earnings call transcript