Polarityte (RGTPQ) 30 Mar 222021 Q4 Earnings call transcript

00:04 Good day. And welcome to the PolarityTE Fiscal Year 2021 Earnings Conference Call. Today’s conference is being recorded. 00:12 At this time, I would turn the conference over to Cameron Hoyler. Please go ahead, sir.

Operator. you, Thank XX:XX thank XXXX joining results. and discuss call fiscal year you morning PolarityTE’s for to Good I’m Hoyler, Cameron General Counsel.

plans but shortly reflect our conclusion the call Investor A circumstances law. replay occur that be of XX-K XX:XX the purposes President; in Chief not On in of on or the we on with for after call the that forward-looking Officer subsequent SEC. begin, Hague, the filed Harbor remind like XX:XX XX:XX from statements report about caption statements our call. our the disclaim will forward-looking to only of ended today’s those and recorded. the except annual to from the members constitute participants Wednesday, section results Private expectations are events current obligation Safe like Patterson, Form results expectations, XX:XX subject under forward-looking of I’d provisions and by recorded Factors, available the actual any statements Executive the reports statements Securities everyone Executive under differ Team, materially on which XXth, a I company’s Financial call this date, as which and to to Risk includes Before today due risks Litigation call, XXXX, We statements Officer. that is indicated. the factors, Relations and on of and the may XX, Act These Jake XXXX, are Reform discussion call March described such required update prospects year to include highlight Chief the December and variety of uncertainties to would actual Richard those following future these cause of differ to XXXX. today’s to that forward-looking may made speak website caution materially as including Any statements for limited that to being detailed based are today’s are that and will we

of now it Additionally, in is would expressed is XX:XX any call prohibited. CEO. any over to I PolarityTE’s Richard the or strictly and turn Hague, written rebroadcast PolarityTE the like the consent redistribution, call form property to of without retransmission

to study our XX:XX receiving in Jake progress today's the begin that call will and report Thank Since for related Epithelial IND, green good with you, last Cameron, sites to for treatment patients Clearly, enrollment. approval a Wagner morning Monday. several I randomized prepare to over DFUs identifying foot accomplishment am critical ulcers as or cutaneous result DFUs. everyone. financial for welcome our well the diligently our pleased XX:XX with a that clinical kick first Vascularized and to was turn our IND COVER and we IND as for working SkinTE, with X approval, week, our consistent first been very in pivotal on for And quarter the XX:XX update trial we lighted who patient of the control multi-center have ulcers from to on trial SkinTE other under I'll was as highlights Patterson, of of Closure FDA the launch Obtained entitled our to evaluating Regeneration diabetic SkinTE mid-January. share update. most for in off an SkinTE provide a chronic treatment evaluate call

have sites the we’re trials We are approximately for track targeting up May. by to operational to on end like of fully study XX the XX and

of deal aware next targeted types period. year. and that closely, a our planned have from XXX patient and are This great data standard-of-care those for at interim outcomes we followed of prior a as complete of As data was story XX-weeks includes a XX-week chronic reminder, follow-up XXX statistical QX SkinTE showed that VLU a percent treating of a many positive this is HCT knee with DFU for But well study product. XX:XX registered Both readout treat you we studies versus cutaneous a have outcome the while commenced area our marketing during XXX significance ulcers, RCT hard to reduction. studies that closure and

Patterson. XXXX, ended the very million used of XX:XX of I'd terms Additionally, this XX:XX over SkinTE. With in our application year. previously, data we solid trials. patients, a achieve call $XX.X is the months special that pivotal great the at see our vast to December one in to prior in gives to continue per offering our upcoming during raised discipline. was but want ability successfully operations for to it proceeds have direct on help Jake stockholders that fiscal or sheet we've to compared the both strength some also provide million more an expected intended turn reverse execute during balance execution $XX.X we additional $X.X discussed cash the proxy deal the majority gross in as stock from I leading million held per been split of The confidence average to As our million highlight CFO, meeting or a that us and of XXst off recently us registered on XX:XX only will million Jake? and to XX-months to detail of moment, now $X.X $X May. at That month Jake like is of we a offering. provide

completed company. into that we XX:XX Thank now stage morning, everyone. good you, Richard, development to and transition a clinical want I our emphasize have

XXst in and to sales and our for decreased balance XXXX, reductions for to in XXst physically general XXXX. effectively XX:XX expenses December and in sheet. year Operating managing cash offset million December our expenses, disciplined per used the restructuring by ways costs and cash will XX-months or XX:XX compared costs looking were ended to As by month. increases continue development $XX.X to December used costs XX% $XX.X be was extend $XX.X We XXst million The million expenses. million the attributable or and for of month, noted, and or ended year XXXX is XXXX expenses administrative an an the reduction per Richard operating ended compared operations for million and operations of the average XXst $X.X other charges XX-months to ended expenses, that December in in research of average $X.X marketing partially

equivalents believe excludes be to with finished $X costs approximately cash base $XX.X the continues million cash XXXX burn, fourth and on activities with per concluding average. goal cash Our equivalents sheet of quarter for cash related balance associated and activities We which BLA back a $XX.X will to trials clinical month Richard on working now capital. maintaining X:XX fund operational our We the XXXX. our like below of remarks. business over turn and call and of cash I’d to million into the

Jake. you, Thank XX:XX

I represent continue enormous has unyield increase to market decades, obesity and Before ulcers and ulcers approximately I'd we orderly over prevalence and is to and X% and Injury as for the increase to to like [indiscernible] of anatomy due and restore these time. an impact rise. to Accordingly, opportunity cutaneous majority hard-to-heal impact cutaneous the or ulcers revisit and the XX:XX these and wounds the presents that process wounds that patients often continue significant that that X system in increased Diabetic grow US have to through Chronic wounds effect unmet diabetes, tissue extent The morbidity close, greater to ulcers, larger patient's the function infection incidence ulcers entire PolarityTE. remain ulcers population million and chronic and chronic the is healthcare market XX:XX the the to make for depth. dollar these and Venous their to skin. that of of direct chronic some population. system failed of enormous, risk, Ulcers and cutaneous timely patients to the the anatomy repair ages of progress The of expected Pressure to briefly our on opportunity cutaneous mortality have and have vulnerability cardiovascular annually necessary estimated disease, multi-billion or and persist foot years, healthcare normal up Leg patients chronicity expect also which

cohorts. amputation there but an limb ulcers, of disability. full X recent to non-traumatic seconds. XX:XX or partial thirty And amputation of greater with For times with chronic match studies limb chronic with finally, a occurring mortality X a these patients, every XX% to associated possibility cutaneous is have associated compared estimated times very of real cutaneous ulcer limb risk patients, amputations are shown

regarding seized we everyone made significant these our IND. our our with team during the related As in initiatives, under patients third-parties of begin not team again the XXX in we to deal engaged is for marketing of conditions, incredibly efforts. completed. we've progress XX:XX latter market proud M&A XX-months, and I’m half the to the treating due Lastly, discussions since was strategic for XXXX, the reasons that volatile certain our

Q&A. we like milestones XX:XX the partners. I'd was with BLA combined expect by SkinTE this to directly the recent tangible initiated the our and positive physicians we’ll we feedback to the potential the coming was from in part highly call However, communicated regarding were confident company strategic by of am strategic the fact and potential consider commercialization that accomplishments encouraged to approval. effectively position with pursue opportunity that for order achieve that quarters, SkinTE open you. to future XX:XX to opportunities now upon Thank I

go [Operator Thank Kristen Kluska Please Fitzgerald. our you, Instructions] ahead. from question from sir. Cantor take XX:XX first We'll now

trial, and XX:XX month I to previous think right things that enrollment was this Hi, light but out questions first around DFU color to for XX of on to wanted X terms well? you to at in the Thanks also taking some that additional the you call if of a ask you sites that your work fair in laid Wagner as good my XX way with look around the enrollment, guidance for now, morning. the the plan comments if of morning. still

and feel Yes, based SkinTE think first Kristen, we're to to past -- experience, on thanks for patient Hi, excited later enrolling we timing spoke our this very our Ideally. about I being confident achievable good looking those your forward Yes. and question. timeframes that the month I month XX:XX are and morning this treated -- start

trial to before second data think update you the trial? to XX:XX a in if the from agency any could DFU running this Okay, around thanks. study is you the that something if that parallel? is Wagner Or potentially starting And see do there wants

Great XX:XX Sure. question.

that be So to we're we actually aligned make that to a requesting discussion sure communication study. FDA have on had formal with going some and informal second with we're them

design and is that to cetera. to size want with get to we definitely and end. But about et sure plan year study criteria, FDA make before communicate most the Our alignment start that we study

of As that to year most now, still and I as would timing then we'll before VLU get said, we determined. And kicked study run but likely in a be the patients, hopes that's expect to off. the be

XX:XX Okay. for the Thank you questions. taking

XX:XX you. Thank

XX:XX [Operator comes And Catamount next Advisors. question Instructions] Cobb the Sadler from from

it Hey, question. Hey, the taking going? XX:XX Richard Richard. thanks for How's

a a strategic then question it how for maybe maybe to can an that. as that you about forward acquisition, do a answer about? And there? had here? bit your an look Because thoughts going to Just your on you're do happened What what maybe follow-up maybe or acquired? talk little partnerships so initiatives, What if I'll are you relates have came might you

other non-disclosure various Well, initiated who given how on from previous that XX:XX limited on the actually But very to companies feedback very as technology positive the based our are feedback. parties. can much to I outreach have feedback call, discuss with was to I'm Sure. we mentioned the around users, have I the SkinTE related

of conditions the was didn't on of over time And fruition, as that that been quarter because fair amount to I after said, process, market initial genesis come it experiencing everyone's So the of the ultimately last the a so. outreach. extended or ultimately the

of keep order available obtaining always our as a in will to going that company be plan continue to has BLA that forward. to its look achieve to and for options to been can continue SkinTE ensure different successfully eyes and and to our Our strategy the strategy us for ears open

think XX:XX from but Okay, from look strategic -- got I Because to capital be [indiscernible] also I interest the rising Okay. trial market from good. but a opportunity, at definitely That a perspective. there's sounds perspective, your was

your or like formal And you going daily your what because came so, a just you Are would would you to up but have because process? open FDA this I mean, versus through, to definitely to a Or it more going get would at probably open right? initiatives are so -- guess, sounds need and do some great, you at mean, plan? If have you're the execute would point like are that you. I I FDA maybe you I -- right, be But that capital more -- something results the formal point, approval. to get process

something So, point, you so And you've what year? maybe the sort Just some some would of plan be what got open to toward -- of process? will see be at do up the Or what end the there? happens? would execute

to story from investment certainly, to we've methods ensure continue Well obviously, what take could executing on options Sure. the community made clinical progress before, mean, on as we to to to open and in priority working certainly as and various to story past As I one. we're a trial to to very execute absolutely the parties keep I identify tell expect and on make. running to our our we XX:XX we've very as partnerships exciting to various various going to with opportunities, parallel mentioned that's focus XX:XX exciting and to to past behind open are potential that, is with and perspective such the momentum cleared think FDA financial that strategic we also and such continue with calls, we said and in want and -- forms. that well. our a that continue build discussing to certainly And current get can work trial going continue to and to on up second number

So high keep to order aggressive we're on be properly we positioned will and be at all be very that open can to we thoughtful to clinical to we as a going development to continue execute options and level, need strategy. our in ensure

that's on you you as I mean, on Well, it I can well as which the could can really Okay. you're which -- you're as as executing control. yes, progress. I and mean, can at this possibly you based definitely XX:XX on congrats can But do well doing you control what point. you

good. So that's

Okay lot. Appreciate it. a Thanks

Thank XX:XX it. you, Cobb. Appreciate

XX:XX I'd to back Thank With any Cameron hand over this, closing the you. for to like remarks. call

like just you you today's it. for call, for joining thank appreciate and your thank We’d to everyone XX:XX We support.

XX:XX Thank you This today's your gentlemen, Thank concludes now you. call. participation you ladies for may conference and disconnect.