Processa Pharmaceuticals (PCSA) 14 May 212021 Q1 Earnings call transcript

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.

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.

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

XXX clinical have are Ulcerative begun selected week. to sites we and NL now for these for we and we Phase have this patients Xb selected trial sites sites. XXXX screen clinical For Similarly, the initiating

more For adding of both few are trials we over the sites process in the months. next

the on toxicological to studies. the XXXXX, IND drug, contract supply and gastroparesis. for For our for and our drug FDA evaluate completed in and product make XXXXX of have protocol have XXT, second meeting cancer drug we organizations use manufacturing we begun And to and clinical working begun pre-IND, for

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

additional pipe support a our overhead This So further QX. study $XX.X in pipe all to the provided we cash raised million and XXXX. through in also

to therapeutic staff requirements or tell not individuals development is plan hire discovery company one focuses biotech and us with that our platform we support next and one drug more or company, agree them. on months. and the to drug over indication staff Several the typical area, additional added Processa development a also a drug with XX We corporate that we

depth divisions. are company areas to therapeutic drug Fortunately and knowledge in same drugs review a multiple development we develop that that multiple understand has for FDA individuals these the

selecting business for drugs criteria is model, a In portfolio. way high understand for derisked addition, to is we There our drugs are no but approach. with a review using our company whose to return model quickly a develop better to business our

the the be a there have this must no drug patients medical need of drug there patients. competitive or other target Our a means for is must at our all. the first a presently must treatment options used treatment they advantage is although that what maybe need requirement which To and drugs, options be patient for division us for

clinical be drug there the similar Second, pharmacology. registration evidence drugs probability for study. or must This a efficacy of a the with pivotal successful having of increases

ulcerative is that over regulatory Third, acceptable indications. to criteria, support Two we their GI the ways developing billion. believe over a and treatment XXT the that that but bottom high our Phase that have of actively XXX cancer, for the investment. XX where top row, clinical final options. the better for more drugs space. in including drug. be to to Xb; Xb approval last that we drug develop are of are An acceptable that in can must in of approach drugs This Phase is approach profile so Phase ulcerative owners is are efficient risk analysis not leverage what the is $X treatment summarizes for for and we the our IND the balance in be we only these return treatment Each using we efficient very Fourth, and One XXXXX are in the reward than design can the the we trials our previous potential we in in FDA, four must develop space, we demonstrate that the And required working some we means by for the a of This stage. the or believe science opportunity Xa the one on NL, can capital target the benefit that in design necrobiosis developed drugs streamline drugs demonstrate gastroparesis. slide on there of and in previous for the developed approval, the the to row, being drugs, toxicology that rare program the years. the is targeted program. performed has there’s a of must existing market the of complete would work an also disease that clinical the that risk to XXXX lipoidica

there risk profile. less expect combining capecitabane. will to improving capecitabane to significantly the and/or by by stage better with and briefly now of slides XXXX one capecitabane top the the therapy capecitabane, the development capecitabane we chemotherapy cancer than the differentiate benefit claim XXXX for and/or the treatment next The effects The is colorectal target our of XXXX, of that The metastatic with discuss modifier on pipeline. of clinical the cornerstones profile drugs; three severe better the ourselves combination chemotherapy. four the itself effects capecitabane of indication side from cancer. having combined by drugs side summarize Let’s three when efficacy is capecitabane, In efficacy be and fewer

graphs itself. events and capecitabane in capecitabane shown effects a have capecitabane. on side adverse less two right capecitabane XXXX the increase compared a the to shows combination, evidence dose-limiting clinical patients just top preliminary figure group efficacy and small Our on support should combination decrease of may The the significantly XXXX than by

preliminary of for down, decreased the therapy, other the cancer next XXXX million resulting side we is is the pointing and effects with need of we lower was survival figure when cohort include a of progression metabolizes details but reason does benefit on market the risk dollars. do combination because not either determine last XXXX first improved In and survival. given Capecitabine is that new trial. with or our typical line cancer the free steps data XXXX a Capecitabine. trial $XXX arrow cover Capecitabine, months Capecitabine X multiple just can still metastatic Phase where shows billions The to XXXX weeks not all cancer. profile second progression pointing of to clinical body addition, the billion progressed XXXX. combination this colorectal describes alters designed in the and to Xb and improve for determining meaning in market $X.X some of free of determine right dose makes it XXXX Capecitabine capecitabane capecitabane, a the state This maximum plus respond treated arrow potential the how I administer a we to dose briefly slide or for safe their tolerated may to or this respond X a of in will Capecitabine we patients the trial, cancers who Capecitabine for this black and If If blue up

a with Xb Phase potential trial X addition, a In After or expect trial. to evaluating the studies approval. upon and to dosing Phase move then completing future could and will we help design us this adaptive be trial, biomarker, we which selection an in the

drug, which at summarize XXX. are Ulcerative the Now let’s for slides our developing drug disease in look we briefly the next four orphan profile XXX, NL. The

You right. picture also the will that that affect the in this a and on is skin skin devastating tissues as the below condition recall the the can affect seen

than Our is at non- from will three sense changes plan different and pathophysiology seven close existing NL, treat directly to NL. affects the targets effects this ulcers these We effects in is formed Drugs trials. currently to It and more our associated use approved and have NL. six of All Ulcerative do of treatment XXX objective a there with label target drugs. the believe pharmacology major patients, is that NL NL. options, the possibly side Ulcerative improve that limiting with we the NL mixed typically XXX made no the while make but to of because more efficacy to NL do completely changes. not complex XXX with of of use diverse drugs than associated we’ll its because off dose to-date side bale treatment associated not claim able because the metabolites is XXX other used the to originally any pathophysiological XXX very are options or very

ulcers. and also the option Our them that Phase the to the XXX provide study temporary ulcers. demonstrated to ulcers a by will side had Xa the has us allow who patient. all the closed will patients easily drug close completely trial the completely increase for side to safe, XXX to that allow and these two therapeutic level fewer tolerated demonstrated patients The well-tolerated open that may were the effects that a dose effects

week. our sales no to $X.X for is options last listed the which is of This describes briefly ulcers, this billion. completely take NL on and begun screening our The Xb we trial. Phase with Xb XXX gross now market, translate without patient has XXX successful million could Given to the clinicaltrials.gov Phase potential have or slide to patients first there $XXX trial treatment

design end step to the FDA is pivotal GI will a agree assessment the motility development indication to clinical to special of for submission. trial X three Our study with profile summarize last drug the next and for stage gastroparesis. drug meet with The on at in the next the after Phase the briefly protocol GI update meeting and be other our slides for XXXXX, XXXXX. you conditions. is on XXXXX The target gastroparesis registration The

and out that gastroparesis, figure. will claim in the To upper associated This occurs pain. it stomach XXXXX improve rate Our abnormally as symptoms an in such gastroparesis. you, can does food having at symptoms shown slow or with not the bloating, patient nausea gastroparesis the is when right empties it empty remind with as a in the vomiting, result

prescribed to XXXXX gastroparesis? rate effect XXXXX are The on-label obvious that or for a the period be gastroparesis makes patients the XXXXX is with right side of time, efficacy and What big lower drugs The neurological if the gastroparesis. patients and safety to will be stomach subside. in emptying short their often we in improved on in shown off-label. profile gastroparesis drugs increase is similar If now the presently the than used patients require have the emptying effect the stomach a very seen for The even is significantly only to though of all chronic different effects, rate improves they used XXXXX. first advantage profile symptoms constipation. to products, the used them the FDA cardio approved side effects functional vascular required have drug drugs As figure, compared off-label already treat have

good drugs. take XXXXX chronically, and Given $XXX for the an how efficacy to ability this the million the depending profile to on other billion improved safety market $X.X is compared effect to potential is for drug XXXXX the

These presently presentation as next review over catalysts the are XXXXX can years, clinical slides for development we the clinical steps the the was overall XXXXX, gastroparesis here, earlier key the next and IND this for Regarding presented and presented which next the on protocol. are design final in working the which here. timeline, you also two two see

by conclude this. Let saying me

but So far we to six XXXX, we accomplished have next even also expect a months. lot the over of more accomplish

enrolled months. be patient to XX our with in expect Ulcerative XXX our next days and six XX next can NL You will the be the trial to over XX six first will enrolled in patients

we cancer patient the our first in in analyzed will XX six to the be two. at XXXX cohorts trail end The next of enrolled data have and to the months XX days, from one and hope the

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

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. 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

would great both. about to it be hear Yeah,

Okay.

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

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

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

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.

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

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

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

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

you. Thank

Instructions]. [Operator

question [Inaudible]. Your next coming from is

line live. Your is

evening. Good Aden. Hi

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

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

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

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

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

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

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

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

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

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

Thank you.

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

Your line is live.

Hi Hogan!

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

Sure.

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

Fantastic! that to data. Look forward seeing

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

you. Thank

you. Thank