Processa Pharmaceuticals (PCSA)

Jim Stanker Chief Financial Officer
David Young Chief Executive Officer
Robin Garner Craig-Hallum
Naz Rahman Maxim Group
Call transcript
Due to licensing restrictions, you must log in to view earnings call transcripts.

Greetings, and welcome to Processa Pharmaceuticals First Quarter 2022 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 and welcome quarter you, Processa’s to development update results drug XXXX conference Thank first call.

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

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

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

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

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

manage allow to we XX, ongoing trials continue complete into will balance had We this us And operations of and March We fund as three of to XXXX. third cash $XX.X a believe clinical the our quarter our XXXX, our million. cash efficiently. of

and our three During and non-cash March in XX, to of the million. months operations GAAP due loss amortization effect is we clinical our of our on compensation. XXXX, significantly less cash the spent stock-based ended This than $X.X net like items trials

ended of of period clinical ongoing David trial of three incurred activities these rest clinical anticipate share increase in or the We to reported XX, months for continue the trial trials million $X.XX net net XXXX. trials. we in loss as a pipeline primarily costs $X.X have the in and net increase $X.XX drugs The development as discuss. our we we we loss three XXXX, a or relates will continue of fund that our loss for our the a will a March compared other For in increase $X.X share, million costs our to to same year

$X.X ended in compared months the during million, Our three XXXX. activities million XXXX in was cash March XX, period $X.X operating net the same to used for

continued of utilize team prepaid related trials. were to executive our costs some outflow in reduce experienced to able trials incentives equity cash use our our certain GAAP other our to we increased this we While quarter in our clinical expenses to of employees, clinical make and and operations, and compensating

related primarily for to our due increase expenses active totaling XXXX. costs incurred incurred same R&D we clinical The to $X million, ended in the $X.X million months three we in research trials. During our March the are development compared XXXX, period to XX, costs and

During year. and compared last other primarily million, costs R&D same activities. increase to the March We non-cash allocated for to period related $XXX,XXX three consulting our ended our costs. of the $X.X and salary XXXX, The operating costs totaled compensation $XXX,XXX XX, expenses and increases between G&A months G&A in non-cash

As XX, shares million XXXX, outstanding. of March XX.X we had common

this a David, CEO, we purchase. As late go will turn an call of March, ahead. please we over in licensees. announced previously had common We opportunist shares one remarks. our my I concludes stock to David That our purchased Young. of our XXX,XXX from be the considered to

David Young

XXXX pipeline the you you, you Good us. and our joining Thank to we’ve quarter should will I be what drug Today, I which Slides of Slides briefly in to summarizing to expecting over development Jim. background months. Thank have are programs plan first XX slides, XX content in presented. for afternoon. the be previously share next the what X accomplished I XX. highlight nine

website stated, our you more. on Jim As slides posted the study if are want to them

or development Let’s X. have improving Processa and/or our patients opportunities includes within drugs of condition. survival life of medical have This Processa independent is need company, treatment to are focused our goal our staff to first either a Slide that of on the different blockbusters. have the medical shots or we on each state option a potential thing who to drug. better unmet five or which Processa who an each a Each investors, five drug five patients unmet for market go option. no drug a means our There’s potential with quality is pipeline a of one addresses need being have slide, billion These treatment giving blockbuster size more. need $X that

simultaneously developing the the questions. process. importantly, XX science to best started develop development a is FDA process are approach provide number that we all when and our ago contracts two worked More answer to This through scientific but we FDA going the way determining all are stages, now answer regulatory various and years of on at five to drugs regulatory we clinical

review expect March to of guidances. I development at the multiple each milestones and I these the briefly of of end to discuss will our to a drug number that from have now led within pipeline. We contracts the year. milestones achieve Our August FDA we as near-term

Next remind describes the the on of would used we pipeline. to I I like slide. slide. have point everyone, out the covered X the To Since five slide, to have our other some item only criteria in drugs already select Slide key one that

of The efficacy similar This evidence second drugs drug for criteria evidence. red five pharmacology. targeted for some a is the population in in with stating efficacy that clinical the box very means each of or there the

Next slide.

Now let’s look pipeline. our of a at summary

in drugs development. four have clinical We

XXXX. are what capecitabine, generation next of we rebranding have We which previously we called

And And have are in drug Three stage. them. XXXXX is of gastroparesis, XXX we unmet the one treatment disease. medical the necrobiosis lipoidica of cancer. treatment adverse a an the for XXX, events fourth of need where the associated rare drugs serious pre-IND of have fifth for the ulcerative have XXXX. the is options We and with treatment for present XXXXX orphan treatment The

Next slide. This we the slide highlights provides achieved quarter what the XXXX. you of of have first with in

have obtaining our with the key to assist in and moved our closer submission. NDA design We data FDA, of us to trials the pivotal our discussions

generation de in and which Phase XXXX novo XB generation we the next amended capecitabine patients next program, protocol. the to began associated amended have with capecitabine, understand better formation protocol as enrolling we of the DPD defined previously For

manner. For in final and patients for timely enrollment XXX, order our analysis to potential interim a complete we’ve expanded our NL more outreach in to ulcerative identify

five For trial versus developing our we XXXX XXXXX, And assays identify that gastroparesis to we’ve enrolled XXXX, to for response if patients potential gemcitabine. we far. for predict biomarkers so determine began could would

of evaluation development the continue our potential which will In addition, we increase will regulatory FDA paths, for approval. and probability

you give next to our first generation like an would I update cancer slide. program. capecitabine Next on

we previously have about billion in the As generation is $X for colorectal market stated, market. capecitabine next cancer

capecitabine with and be potentially less dose capecitabine existing efficacy better next to greater the effects limiting higher than potency. expect We generation given side

non-cancer have Next slide. Xb and increase limiting to-date, killing hours. effects we trial decrease From a XX metabolites have caused side for Phase we an seen dose in the to XX the that our potency seen in

protocol and However, for will days increased The seven one, last next and all chemotherapy, generation for seven the potency dose not chemotherapy PCSXXXX capecitabine. all days for maximum these treatment. of that tolerated did metabolism inhibit two effects regimens amended of determines,

in Next the from generation quarter we’ve next months, next Processa first the over slide. nine accomplished to what XXXX and This slide expect capecitabine. summarize the of what

regimen for trial. identified the next an we next personalized First, chemotherapy. killing the to QX? seven initial potency achieve what the Two, amended we’ve to we be the the expedite inhibit the PCSXXXX in days our do that regimens completed dose next used generation formation we to Xb dose increase limiting during And year? sites PCSXXXX amended for the the end in in defining enrolling our and to have One, be individualized approach of capecitabine in we’ve we the What achieve hope capecitabine. capecitabine of expect the Xb regimen protocol. generation dosage begun mid-XXXX, the of study already will using will the have non-cancer of side should Phase to Phase Well, and add we By preliminarily generation enrollment. Phase dosage patients hope cancer rest the a to of tolerated clinical maximum of three, that of protocol, metabolites identify and the cause or all we year, effects metabolites treatment killing X evaluation

Next slide.

Let of me NL. now review treatment PCSXXX for the ulcerative

natural is one healing a of in first rare the less billion this recall, may X% than two which of NL you probably open ulcers after $X patients. to the in disease years market onset occurs during As ulcerative

same the efficacy dose use limiting limit care, ulcers PTX, of the of FDA of call Next can because as slide. treatments amounts a resulting no better of PTX. no PCSXXX profile. use metabolite the are administered. There closing treatments works pentoxifylline different some The analog PTX. of their limited and PTX safety safety quantitatively given I a side in the PCSXXX patients, it, qualitatively often as but standard off-label has drugs all dose in metabolite include be deuterated the has profile. metabolites effects have is but that or approved of the off-label

XXXX nine first to what what months. slide This the slide. in quarter with PCSXXX and over Next expect next summarizes we’ve accomplished the of

to in identification our now, five enrolled in eight bringing top in Well, we hope requirements evaluating in to Also, have evaluation to are next what such sites. hope one impact again, been expect have we the to patients analysis. that XXXX? trial data expanded enrollment the XXXX. mid-XXXX, has What a the the of we basic used additional the major reading interim of QX, and screening patients plan on pre-screening screening the in in the XX to the identified months we have seven patient do prior require and We trial. have we determine Xb we have had initiate So we end over interim remedial to meet the pre-screening to sites have into year, At meet be COVID X Phase efforts expect of in enrollment a if end more the five to out, XXXX the Although, with they the in of achieve moving analysis patient from on Phase FDA and at have our and depending that for one patient we enrollment, results our achieved meeting procedure. to our completed on the line FDA to QX? the trial with hope do

off-label reviewing of use potent to X-HTX and other This is Quickly PCSXXXXX slide. Next selective and agonist a treatment treat gastroparesis. X-HTX more agonist gastroparesis. the drugs for

preclinical agonist, has X-HTX studies serious the for to black PCSXXXXX requires only gastroparesis and greater and selectivity Because with lower limited potency much dose higher side much, metoclopramide Other dose of slide. drug warnings use. Next and side than other receptor, drugs. has and X-HTX effects box effects limiting the the in and clinical these treat PCSXXXXX a less approved of

slide. Next

and again, to for months? So, what next five out nine this over enrolled achieve trial have total patients far. we the expect XX achieved we what We’ve of plan the so do

the of top the in study with line rate of We the empty expect of complete the October in the timeframe September, a change year. by readout gastric end enrollment

that rate drug will cancers today sales of for IND, various similar XX% treatment we which I with to for billion number slide. have which is a used This the maximum last cancers across But failure as XX% approximately or for. The be gemcitabine, drug Next fourth second cancer PCSXXXX. used a therapy. a is of an the and line drug drug, a is $X of to first reviewing

Next for have pancreatic an slide. treatment of the PCSXXXX clinical IND presently and been cancer has studies completed. preliminary

cancer efficacy has demonstrated Some populations different been of already in pancreatic patients.

evaluating be assays for we slide. we potential as that Next molecules began specific developing QX, biological biomarkers In will PCSXXXX. for

Thus, hypothesis patients that to PCSXXXX gemcitabine. treated The evaluation will for should response molecules select giving preliminary away initial over patient’s is preferentially some to to gemcitabine. PCSXXXX these Our and a mid-XXXX. completed be with to able assay of us be predict be

We we for can of study the PCSXXXX developed of PCSXXXX. roadmaps have at for the that to number populations, the clinical end expect of for such this to FDA year cancers and next the different our meet development a discuss targeted with

that Next slide. and In can have for PCSXXX a with PCSXXXXX moved effect you generation successfully we enrollment forward, serious see having conclusion, even PCSXXX. on next COVID capecitabine,

the the midyear data to that trials. larger efficacy on us by trials expect the will key We and these year have end design of at help three

deck expect profile. ask provide lastly, the with each pipeline you background concludes that the for remarks. FDA We various along slides, the the all in roadmap highest which are they also last operator in with has of some will our more demonstrating probability to slides have targeted now insight interactions a risk for lines the and more are collaboration us we anticipate pull to but Operator, And the populations path open The slides that discuss will into questions? programs This drug have Q&A. paths information. provide development FDA presented for these please the can phone the for with approvable I’ll an potential not form. approval. that my benefit to I been before will


now open you. Instructions] questions. gentlemen, the [Operator Thank Certainly. Ladies and is floor for

Garner Robin from Your Craig-Hallum. is from coming first question

live. is line Your

Robin Garner

that different a and Hi pathway you across my ask that for begin just an is and thank so regulatory question. could wanted broadly indication there you approach shorter a cancers. given start to approval? that about I to taking gemcitabine to of PCSXXXX treated there, for types create could Is smaller

David Young

is This Robin. question, the for Thanks David.

you depends are lot what It in of It’s correct. by mean a used You different shorter. cancers.

are not line talking the you’re also if and the roadmaps go time, something to in That’s a be subpopulations, get there cancer, and time the what different the to in developing shortest the the example, everything, [Technical line work terms the shorter for So it timeframe, about third cost shortest then of takes timeframe, the and can evaluating. pancreatic Difficulty] of evaluate that’s and first we’ll there type we’re are, therapy each cancer for we’re regarding develop that approved. so that and most would take program plan approved FDA out PCSXXXX, get we to hopefully, likely time, just likely just most

Robin Garner

capecitabine, Thank distinction. Phase you gen might preview believe dose? Wanted and of about give you what to a close us that understand Fully you. to some Okay. whether ask also interim kind we’re entail expecting mid you’re Can X as if to by recommended that data year. next that not or this

David Young

looking We’ll next – yet, to at, at question. days looking good what capecitabine. we’ll the but results I has across you a day will and be can increased I That’s all the be potency be all dosing for if tell capecitabine, Sure. the potency at. the know what don’t of generation if you I tell looking we can again, see

So at. be that’s the we’ll looking first thing

be The not second thing These two things. looking at, any this just in and we’ll order. different are is

effects. second to be that cause dose those because the The at non-cancer they’re dose thing side metabolites are metabolism cell limiting, to killing we’ll look is – limit looking at

metabolites. is side be regimen will we we’ll be in will the on What predict the forward pattern, that dependent we’ll those So dosage low to looking with And that’s be expect we’ll effect regimen of a what able at at pattern high PCSXXXX. result which we things. pattern expect both see potency, to see go to

Robin Garner

increasing that. question, the a And much for fruitful. PCSXXX update third that proven very wanted give us ask you see you I if to may if towards if Thank have you’ve an efforts could Okay. on and enrollment made

David Young


these because So years patients with some terms we is COVID. in had a years. of these these we for and of reason PCSXXX and problems problems ulcers had had years lot have the of And

So XX% of choice the are over diabetic. they a had patients and

basis they home, study on And and be or they’ve for COVID, out go the been see which stay vine also issues living had they’ve with and less wait COVID got till the have years. exposed regular So and go a a us COVID for then physician out. their choice, to been

a patients I think the what’s waited – happened thing. is of and one that’s lot that that was

contact The patients, think the contact second done things we’ve helped the remedial that only thing we’re efforts, our in started the fourth we we that’s physicians, is starting cetera. I And more a all gave groups, remedial – other some – like we actually and of contact I expanded see et to when of talk, quarter. some – as said, – I in

We’re patients to it I I then potential sure is study. saying, in an of through starting we’re through an the a versus think make to now them a ulcer now only that’s then us place ulcer. come course, really have starting to in, helped, and to think contact starting see and have I to And process an into patients going get better pre-screening the patients And identify pre-screen the we erosion.

Robin Garner

you on much congrats quarter. and the Thank Okay. very

David Young

Thank you.


coming Maxim Instructions] question Thank Naz Rahman Your from Group. [Operator is you. next from

Your live. line is

Naz Rahman

Hi. Thanks my taking question. for

screening on you Could comment mentioned me just of process? there. a pass patients Let screening. actually percent Just what fail on you couple start PCSXXX, the versus

David Young

it’s the initially have I percentage of initially, small Yes. top my pass. – not did the the the and we a at reason know And the is head, don’t pre-screen. number but reason off a

come would in ulcer. say, been okay, and you to would NL, then have an study. in have told wanted I I call and I and NL don’t be have they say, well, I’ve So patients And in, the we’d

ulcer. an really It’s not abrasion. an only You or an have erosion

the And so study. can’t you be in

ulcer like had patients in screened. those give those see have where we’ve of an ulcer, who yes, number. Because to of on of hard quarter, weed at think those pre-screening their procedure a – then – of say, third place, we a why out it’s really why come to an it, patients. their That’s with early and able ulcers. actually to been me in picture we end that’s is could what put you look the ulcer. some of And kind so patients And that And that don’t does this be in they we where the take now

changed kind process it’s is, take the middle patients for screening So because we process. percentage the this to in better say, of the to what hard me into actual

Naz Rahman

All right.

find the does you or guess, process screening digital improves rate? – did So initial that, the I more the digital screening

David Young

have pictures improves of number We the improves initial – yes, patients found the Yes, does. screening being screened. it the that rate

Naz Rahman


data have additional to enrolled any So have I at this both guess, And patients what well, on by data of a by bit, the confidence you applies sort this – point, XXXXX. and why gives guess that question you’ll year-end? have or year-end? that delays Like point little definitely XXX the to like you’ll amount but I definitely would at now necessary expect do you touched you’re you don’t think of you

David Young


Naz Rahman

I XXX guess both and XXXXX.

David Young

I’m sorry for and what – what? XXX

Naz Rahman

And XXXXX both trials. for

David Young

that And XXXXX. said? Is what you

Naz Rahman

yes. XXXXX,

David Young



Naz Rahman

yep. For both trials,

David Young


and we’re mean, got already. patients So I of be it’s come XXXXX those lot We’ve patients patients the the some going come it’s in there. had that’s everyone they we’ve really a had in most patients to the – enrolled. confident They paresis, has because a lot all other had of fail of we’ve comorbidities. a we’ve reasons, five be lot had could But in other study. of had one because And

in treated they’re September XX completing that only expect sometime and to be days. We And for right? October, enrollment

at within we that XX And the results end year. therefore, would the some be So of the days. to expect get

confident about one. that We’re pretty very we’re –

XXXXX will and hundreds what with in it In How many so U.S. on will because And I hundreds of of it. hurt those COVID comes hurt XXX, still studies happens will terms be be much mean less I again, there’s the there’s question patients no depends more I of hurt the XXX of of for gastroparesis think us. think up, I patients. both There’s about if hurt. COVID think issue thousands be back around

a why a bit. a that’s little I So think little COVID to it’s little enroll. if to going be But back delayed comes we’re heavy, easier then

Naz Rahman

Do development, on a when after the the scheduled it. you already you you Got anything XXXX, or And the do have have biomarker would complete you expect regarding meeting when to plan assays? assay with FDA?

David Young

meet the planning sometime the of year, we’re So to in end with FDA December.

preparing cat our right roadmaps now. – We’re our

will preparing different the which be We’re we with options depending designs are of now road on take. studies the right

the expectation so is meeting. for actual And of in an end that’s year the

reword let In we’re how at terms of assays, this. looking the me

we We which test to if are measuring are macromolecules, they will see biomarkers.

biomarkers they just and they’re used So – seeing can them but biomarkers, they’re if be be we know because they’re we that don’t potentially measuring will as call biomarkers. if macromolecules then

got people and I’ve some been we These true. as to they can they be biomarkers, used identified it’s biomarkers. will say be So not that’s already biomarker think because I if as which when careful see a macromolecules, are

Naz Rahman

Got Thanks my it. questions. taking for

David Young

Thanks, Naz.


you. Thank

Your Brisebois from Oppenheimer. from next Frank question coming is

live. is line Your

Unidentified Analyst

Dan is taking for this for Hi, the question. Frank. Thanks on

David Young

Dan. Hi

Unidentified Analyst

any one the me. lower seeing future – On Just in trial a the you are FDA a number estimated, prevalence possibility XXX, for to the given reduce of trial? lower patients? number given you’re planning of the than with interactions potentially originally considering Are you a end in the completing the lower that quick Hi.

David Young

doing We’ve us enrolling are Yes, to problem. and drugs understand with have mind. for more ultra about previously this very, been drugs They’ve involved other that. issues safety a to people. other rare but problem. given reading of with flexibility an given the We’ve they the statistically, little You’re in patients us efficacy very rare prove and FDA They rare bit We still those before. drugs, our type we And drugs, with talked difficult. super are. the

response low low to it’s zero sample size. sample group smaller is smaller a the response, say to then is, size. So the close have it that response fact it is what And decrease in KOL if the – a placebo Hopefully, possible number very if response. have that low hopefully, we may a going and is is it the to

that that zero. until group know interim I analysis could be be So but good it’s nice. would won’t because right we blinded. the just close that now We know chance final the and think yet, placebo don’t the there’s and a But to

what that’s we’re it So occur. hoping does

Unidentified Analyst

Thank Great. me. for helpful. you. it That’s That’s very

David Young

Dan. Thanks,


Instructions] our Thank Please Q&A closing That you. I you. conference concludes now for [Operator session. will Dr. Young ahead. back go the Thank remarks. to hand David

David Young

have Thank that you everybody see you, year. will months, the Phase the think but I of really thank coming for doing call. impact also you. the be and a out we attending major where that this understand near-term should on in thank reported operator. into better these and be in just to can you wanted coming both Thank wish the for what few us some now, multiple for milestones the us X from well major, we’re programs programs. best. earnings we very there Hopefully, you next key this guide Again, will We some as and milestones end much being very joining as through that


you, and This event. today’s concludes ladies Thank gentlemen.

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