PCSA Processa Pharmaceuticals

David Young Chief Executive Officer
Jim Stanker Chief Financial Officer
Mike Floyd Chief Operating Officer
Robin Garner Craig-Hallum Capital Group
Call transcript
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Greetings! And welcome to Processa Pharmaceuticals, First 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 call is being recorded. to Stanker, like Financial now would introduce Chief Jim Officer. I sir. you, Thank

may You begin.

Jim Stanker

With call our on Young, you, me Thank operator. the Executive and Officer. our Officer are Mike Operating Floyd, Chief Chief David Dr.

we will Dr. presentation I’d a accompany to everyone remind Before that begin, PowerPoint like

earnings link Young’s remarks. to the follow the and click please go PowerPoint along. prepared Release slides, on view to To Press the webcast

on safe made of XXXX. harbor within of historical the Reform the reading XXXX. like Securities forward-looking made XXXX the call safe-harbor the pursuant to to facts, statements Section statement This the Act of I’d in of the Now, forward-looking described of Act by is for XXA of considered call, Litigation this meaning Securities statements with the All begin XXE may Section statement. Securities the Private exception statements Act be and of

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

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

loss operational for reported per update, compared The increased an of share or continue rest by our Q&A. followed ended the We We or for $X.XX loss PCSXXX a for to will which $XXX,XXX March XXXX share as of of and to our the incurred a costs quarter loss net million Young clinical $X.XX net per a same of anticipate the be start relates these we net will year. $X.X trials increase for primarily in to XXXX. for period the PCSXXXX. increase costs XX,

XXXX $X.X cash Xb was XXXX, first at our CROs. million used offering for XXXX. Our proceeds preparing received operating of for proceeds million increased million closed up Xb trail net $X.X $X.X trial also incurred private common of to Phase quarter for compared gross PCSXXX in net to when February to we PCSXXXX, after advance we and to payments related costs. our the costs This of deducting by activities from Phase offering In including stock, the due first $XX.X increase we million during which our of quarter

we XX, shares million March had Following outstanding. of offering this XX.X as and common

development in trial and Phase related XXXX. Phase increase to incurred to XXXX. in $X Xb our XXXX million During quarter PCSXXX R&D our trial the of same due and we Xb primarily in the for of incurred we expenses for period costs million XXXX, first $XXX,XXX our to preparing The $X.X compared costs research was totaling for for

the compared Allocated our ended and first in compensation the R&D same non-cash $XXX,XXX $XXX,XXX of G&A totaled between XXXX. general period expenses for quarter and to administrative During costs XXXX, costs. our $XXX,XXX is

my remarks. the our cash That million CEO, concludes of $XX call over and equivalents. Dr. had we XX March of turn to I’ll As cash

go please David, Young. ahead.

David Young

Processa XXXX, clinical the today. in-depth the Jim. briefly details Since next you highlight in call the expecting slides. Thank share on then story, all I what five do what afternoon! should we to Good us far accomplished the over what to joining for be have on plan be you so drug you, I Thank knows everyone is will pipeline, not all review covering our six this months.

presented slide have what before. changed slide This development. before. is the out we We a be I the have of have drug and that in defined overall subsequent we clinical first Nothing the is quarter drugs has stated to note each updating status which drug slides. on development corporate achieved timeline for ourselves. will first the from lays you goals in It important our for we that

and goal closer specific is overall that. development to we drugs move submission Our accomplished to FDA

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goals want we Regarding investors our the potential on had right, a who to invest corporate Processa. in of number

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by conclude this. Let saying me

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We questions? as the obtain FDA over deliver remarks. value the next August. timeline now to end clearance increase invited This for please for also one and two different open been in can lines continuing deliverables as months. IND the also our a you And the some one in given pipeline, over by the probability goals, finally, to everyone in the May about FDA, thing XXXXX we have Q&A. each the poll have We has at of hope view Disease for We’ve well the Rare better drugs our concludes significantly present phone to of analysts months. increasing this anticipate few us operator six the the hope follow earnings Processa clinical while our to expect on say Conferences, to approval for that who the six ask Operator, my to will months. pipeline. Processa I for very next I’ll and of call interesting to by


coming first Garner. from Instructions].Your Robin question is [Operator Certainly.

is live. Your line

Robin Garner

have my question. may. I evening Thank so Good I and Hi! few if thanks for much. a taking you

publishing and enrollment if clinical numbers you’re have for on First, needing study you of the how clinical congratulations the on and update both for that an could XXX. XXXX I’m curious the patient us design sites achieve you so anticipate far, enrolled targeting? give number many to you total

David Young

David. Hi this is Robin,

So starting to both one which just or we referring you screening already are the you is XXX are for? to referring are studies

Robin Garner

would great both. about to it be hear Yeah,

David Young


numbers of terms now numbers. what the are already XXX. have We sites can the have You know in I of don’t be you study, for U.S. ballpark tell we five into going to I right but each terms putting exact in

will anywhere or going will We that and more and it we are five have. sites from another really whether be three adding combination that sites to be four four be will between on are, U.S. right. depend And to it a they which three, Europe,

expect we sites to at six and So for somewhere have least between XXX. XX

sites are have we we XXXX, XXXX. For couple initiating, now for of a

and or five they about U.S. will for We sites four be have XXXX expect to all

Robin Garner

you color. Thank Great! that for additional

the what of looking would you early again, maybe the considering kind and terms the and at next year end share be of to year. at but analysis In separately, point, interim both of then studies that data

David Young

Okay, should a of what to we so and the at X going in of that. want if actually well if clinical for in the confirm should studies, XXXX, work, want BPD, looks we all the to have just we expect that we fact that dosing we X. do. we the regimen at enzyme it what the All versus have it think Capecitabine, to at the cohort doing We study cohort terms that’s work we etc., chose abilities want for preclinical design confirm [inaudible], out actually of that dose metabolism, so interim in look we evidence XXXX will studies analysis as in think done is says be before, both looking to that’s

able be if We tolerated right. will are understand those well, also doses fact in to

doses X, cohort that X X, information cohort get at drugs and tolerate metabolite for we to in it’s cohort from we cohort think we’re have so MTD And happens we’ll think and X. PK information enough the and Capecitabine in we the be to the to everything ability information going cohort it the of cohort that right, time, to at we’re going right say direction, the but will doing be unless but X, not don’t X

determined, that we we what we have believe not this proves MTD think the right. but So kind of will is

Our hypothesis couple interesting With placebo is next is controlled XXXX. we XXX, a XXX trial. it’s the of correct find and cohorts, about in MTD that’s to that so just thing have the

not a So that not as one they belief group They as of the placebo response have six responding months, not well with the rate; the us, the be responding will of to occur will no KOLs because drug. over that we natural doesn’t they have have, there’s typically that been be six the months these sharing healing it people. right questions in the and ulcers will will have over is

the So that’s the is the numbers. on versus so group group, expectation kind at or placebo will and treated group placebo of our zero our looking one will randomly maybe depending part be and we’ll four, or three the confirmation, patient that of have the treated have response

So to the see we early the going in we’re make actually right between sure on, direction. expect just groups some to differences

Robin Garner

And which less tumors, cancer design Right, thank besides is actually GI the treating have other anticipate patients terms types tract that. Do XXXX, in study that you colorectal? for then of quite you broad.

David Young

going colorectal colorectal the just the be actually it the cancer. Yeah, making a when for metastatic end go will we cancer. will indication pivotal be to XXXX When study and the we is that indication. so we That go further metastatic we’re in

that’s I’ve MTD you and the MTD these is the the done patients, doesn’t had does, where in or what a all if is specific cancer determines cancer determine this for this other, drug, wider past the that determine patient I’m the studies and drug, of whether pancreatic I’ve I typically cancer, to I you really given study it tolerate what because stomach group an you However, of choose colorectal really is of really any matter, the because drug, tolerability first can had you tolerability know study, this doses. trying or can done for

concerned less cancer colorectal So getting only about patients. I’m

more Now example. there’s we terms cancer patients of know though patients numbers pancreatic cancer than that in of patients colorectal for

to all patients in cycles be is the but have the maybe to to So enough to the also projection colorectal able to the see might patients MTD results drug, have is. long there The survival clinically, be what to to there a is to goal the again the the we we able key some be finish though cancer study. and it expect that to has hope is some their that’s that get positive not tolerate

Robin Garner

great, you. Okay, question my last Perhaps Thank just for tonight.

for used that biomarker currently currently to detail XXXX, vague share In biomarker evaluate that be by it at if time, terms progress, and of to this a patient more needs is that you a can your physicians? on

David Young

I this. yeah, on So have vague be to

be monitor on that’s the one is have to patients this reason a presently used dosing are much receive to out vague. do have or vague. how or to receive. to so and not IP biomarker not drug very I be We drug I should working some It It’s determine is and they determine to what a should used, that’s presently that biomarker

Robin Garner

questions and Okay, very much understand. milestones. answering for my look Thank forward all to the we you

David Young

you. Thank


Instructions]. [Operator

question [Inaudible]. Your next coming from is

line live. Your is

David Young

evening. Good Aden. Hi

Unidentified Analyst

Hi! I a couple. Thanks have for my taking questions.

First you comment NL. the used off on label PCSXXX, to most treat drug frequently what’s could

the just is be of nothing that you is has a – us I’m kind break percentages, what given just in going approved most kind understand of what trying used and with. and obviously, drugs actually competing give down PCSXXX could So to to

David Young

Steroids, then Okay, also plus – the is being the result of steroids, with the so Topical change right. inflammation. softening The itching ulcers, and cause of skin, Steroids There also Topical multiple you that Steroids levels Topical that hardening the dermis topical, of and used. drugs of of some to but can in skin, problem for and treatment causes used there’s know of those part that like being kind are are is drugs the the

stick you itself. it a solve that do the the it not it does on for don’t could typically right. do forever, But steroids little you on, can’t ulcer but bit, the ulcerations, So people so

drug. one are XXX, of that, The of have is they the lot of patients is they really used. - can’t the used tried, drug which there nobody’s a as again, they who well other dose, non-deuterated with tolerate you higher prove need can that effects, patients But all those higher again a can’t evidence, it’s so option, the immunomodulator there’s a that those are Those pentoxifylline the ones been who, results There are dose the respond is they are we’re tolerate because and side about. those parent closed can’t the tolerate that positive they those as mixed prescribed do ulcers, label is side or there’s drug dose does, who of to used because talking effects. mixed that now. Unfortunately the take all able also different of highest the but been lower to the get the are at have drug and or patients the the that those right highest version dose anecdotal or injectables know, some and and drugs are they to good the immunomodulator but are can’t have

Unidentified Analyst

for I Right, the it’s that. any no is opinion to both, if right. a four – drug, patient weeks in weeks, to how but treatment because trial they participate to file hard recruit in that four-weeks, it because is stop excluding new going something, to would so for patients need there use there within function your order they’re these for be study to so. at [inaudible] XX I’m a the In criteria appreciate nothing its four clinical looking

David Young

many drugs That’s drug, previously ulcers, their they correct. patients, of In taking when to to therapy keep treatments too if does the don’t they because and we talked our or if experience don’t – just effects. help not the talking KOLs there’s side or

it doesn’t these seem to it taking drugs. anything, if doesn’t help, doing stop be they So

of on these drug; most on these So ulcerate patients any are drugs. are not any of patients not most

Unidentified Analyst

financial I although Alright, have understood. Understood, one question.

you obviously appears quarter active of wasn’t it this active clinical million first and that burned So the quarter $X.X in trials. terms the

Just throughout you trying accelerate the once this get sense a begins, to trial pace So purposes. the for year? to expect do modeling

David Young

be – do we rate do we higher. Yes, yes, We burn to expect do. the

to using So cash, be we there’s expect question that. no about do more

give you I quarters. until exact you know but know actually right expect amount we it to increase started, following in gets You the can’t now studies the the do

$X.X of talk up-front know the that about, CROs. to some you the that money million, included Now you money some also

of the it’s So know burning of actually that up-front CROs work requirements some on. actual the of the you to up. start some not Its or went study in terms

Unidentified Analyst

you. the thank professional for I And regarding understood, question Understood, is last have milestones. timing the

think I we have happens months, some three you to mentioned from want would months. investors six patient who So what hear but new

projections can we’re example next on by give what going chance the any that call, there hear kind enrollment trials two So those you call? of of Is in the you by to any the call, next the quarterly complete any can for of end quarter? next

David Young

that things So hear about. I a of you’ll couple there are think

progress patients that’ll know both our I studies, in hear you XXXX and enrolling you’ll both know be of about XXX. think you

possible, also you – outside is it think though I possible.

done third the XXXX second possible You or we know but it’s end not the of it get and to two something it’s treatment probability. cycles the enrolled could not the month know don’t of end quarter likely. the probably But It’s by that probability, a is or I of quarter. high the have it’s one probable, the not quickly likely,

anything occurring hear which that, serious about expect, adverse about. the think patients of and that don’t are enrollment any you hearing forward, if we in sure there’s I those the you – or but the thing of and progress you are can be on our events know the we like might some moving that things that update that rolling you are you’ll I So be really are is the only know

until for now. IND third won’t expect if think can update is It’s an XXXXX, there. preparing the up we’re you in you quarter, too XXXXX, going the The we of not know thing with other the second just go on IND which anything right on quarter, have won’t in about anything so coming is you’re because enrollment. really will I you talking end really have that June, that all But the that’s

Jim Stanker

and But would have order third you other interim is, of first you – in cohort of first ‘XX anticipate for to things would full the would ’XX. would in the – thing that quarter us quarter of you see see that half though in the XXX ‘XX, the that rather of the in results, one one be analysis

that So enrolled the in we’re we XXXX. have for we and third be first part available quarter projecting that would of the would data

Unidentified Analyst

Okay, much forward you. my Thank questions. you thank taking update. the very I’m looking for to

David Young

Thank you.


Malalie Hogan Your [ph]. next from is question coming

Your line is live.

David Young

Hi Hogan!

Unidentified Analyst

an about to Hi we’re David! Hi from see the quick on received question you question follow-up interim XXXX. going earlier Mike! Just results a

see that some us cohorts mentioned assuming as to frame for you data see and key expecting, F-Bal referring maybe you’re we if and expected – on You behaving and we’ll for metabolites? should of Can is what and see XXX you’re those investors exactly to I’m on key metabolites some X X we’re sort DPD. going

David Young


you correct. are So,

I right, be and as exists the expect of in the cohorts. the will able patients from in As that pharmacokinetics to these we body F-Bal said, we first the level two the cohorts, that determine or

be our days Our time zero, right. and F-Bal the our If is that that that’s start That’s there will initially no in over nothing, expectation that’s of first very over seven occurs, amount time there will will expectation, be the great. practically F-Bal, hypothesis. low,

days much if total alright. and to Over really you that’s for. it XXXX get after be week F-Bal, what don’t we some seven exist that, levels” looking you but that days after don’t there may the the next Not be gave be “normal XXXX, we’re may XX that expect so later,

to levels. the looking We’re compare F-Ball

that and we If bit typically hypothesis and lot, if give no XX correct. fantastic, that’s days but and you XXXX, days XXXX you occurring versus is don’t little F-Ball be there practically a our our be is you at after will maybe, there’ll not XXXX give what that, a seven expectation see give if is

Unidentified Analyst

Fantastic! that to data. Look forward seeing

David Young

Yeah, me too.


have further conclude from time. and We lines you does at event. This no ladies today’s this questions the Thank gentlemen.

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

David Young

you. Thank

Jim Stanker

you. Thank