Polarityte (RGTPQ) 13 Aug 212021 Q2 Earnings call transcript

Good day, and welcome to the PolarityTE Second Quarter 2021 Earnings Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Rich Haerle, Vice President of Investor Relations. Please go ahead, sir.

Thank you, operator. you results. PolarityTE's thank second to and XXXX quarter afternoon, for call joining discuss Good Haerle, President Rich I'm Vice of Investor Relations.

today Seaburg, President On which Patterson, call are the of the executive Interim includes CFO. David COO; CEO; and Hague, Richard and Jake members team,

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

is PolarityTE and like rebroadcast turn any in would without of the call the form is it prohibited. Seaburg. any the of to consent or now redistribution, property David Additionally, strictly retransmission I written over expressed call to PolarityTE's

and quarter by highlights like turn over who welcome, then some Jake off the kick and our by to development update from corporate followed with everyone. will Rich, you, Patterson. updates and Richard plan Thank call to our today's our review for SkinTE, I'd financial Hague, call

economic need of chronic indication cutaneous many aware, chronic this are July submitted IND proposed represent ulcers. you we an cutaneous As estimated because burden. context, To on countries for SkinTE X% this put in has will X% lifetime. We their large a significant unmet a medical ulcers XX, an and adults it during market cutaneous been developed to into chronic with of experience ulcer that in roughly

chronic costs substantial. associated the with are Additionally, wounds treating

began indication an as injury reported that ulcers has pressure foot share market based per it par over For experience to average our commitment guided HCT/P, this was treatment sometime and been near to be and $XX,XXX, example, the establish team a to that pathway working hospital entire wounds on announced from to roughly their hard limited we is opportunity half submitted announcement, XXX and we prior In pivot FDA most XXXX, cost-intensive clinical of treating pricing a our and this a investors because second Immediately at beginning presents believe to and and to expect optimized cost to billion July. from with Furthermore, the with capture range. to of the submit our per the is and the $XX want direct our pursue informed We to included of that patients XXX SkinTE our work plan strategy X,XXX year. learnings our that ensure the XXX IND of the reimbursement. on it entire great cancer a dedication during XXXX. charge in to diabetic SkinTE chose that pathway I congratulate IND allowed April submit HCT/P challenging alternatives. we us team could of our following with

acceptance made to side, on in target second would remarks average. our BLA towards been commencing PolarityTE, to on and two capital IND his a Furthermore, quarter and advance burn prepared we than progress IND cash through to-date. million efficiency. in was are the operational This per than second, has submission; lower that the the we've on XX% top the details follows: cash exciting operation continued at quarter. going used submitted, that we proud will less forward first, and continue a base are highlight company study like as month of work I pivotal as but clinically very of first the regulatory our an an process Now eventual our activities as priorities staged time $X to additional our focus during provide is Jake SkinTE prior securing of we

believe successful valuable outcome. to remain we accomplish make closely We to committed a will and that working BLA continue the that with asset, to more SkinTE FDA a

SkinTE. who will for Now development detail additional the over like turn Richard to the provide I'd to call Richard? surrounding plan Hague,

everyone. you, David, good afternoon, Thank and

those received SkinTE and response cutaneous had IND we and additional chronic FDA's we and submitted information, responses clinical for we CMC helpful to responses in our to have wound required for proposed approval. submission, July what pursuing in feel trials categorize pivotal we with two well and generally week. feedback requests achieve of from on this further our with industry received support FDA's that regards With that David provided to recently with to line We plan that and described, align are proceed questions ulcers wound we has clinical we ulcers types closure. indication revised XX. a for and felt defines position our very chronic timely FDA's allow were As reviewers have initial anticipated. functional I that very would our an cosmetic and to and pleased earlier is requests to our different that proposed series the as feedback indication orderly trials FDA BLA key to would in of on clear our chronic mind, guidance produce indication, IND. our events of elements as an guidance cutaneous failed two the structural, a broader With potentially ulcers. durable a In cutaneous through

X trial be as first is proposed for with thickness Our wounds which described DFU, structures. full exposed critical can Wagner

from ultimately positive hard-to-treat wound this real-world treatment in have population that differentiate and for this other alternatives very itself We patient believe type. outcomes SkinTE seen can

trial yet Our is to be second FDA. proposed to

with would may we begin enrollment a SkinTE. months. and expect XX we expect experience, we the with great approximately complex look type, play FDA accepted on FDA, take of a promotional patients deal It react and settings $X plan will the IND working important management XX However, have SkinTE, Pending We hospital estimate where of to requests cases, positive how cutaneous our cost we single wound as to care follow-up soon highly stay. and seek in three of in to will of chronic to interaction can too to the complex in is have we fully any, this population. applied each our due the important speculate with responses IND prior to target care, our are trial a that million. be initiation multiple ulcers we seen possible. to soon quickly that the approximately enrolling committed will in application and accepted, theme patient but of agency if with which the role comorbidities begin receive, first additional to common Based confidence after as is Once of effective second also An as our we have on patient or is overall within an length what, would additional most difficult-to-heal of months study another we cost information study to to enrolling first. to results have

call to to Jake for Now update. turn the Jake? financial like I'd Patterson over a

Thank you, afternoon, and good Richard, everyone.

$X.X the million on XX% comparable stock of from XX% effectuated million by million June million to revenues or Total for substantial million month in is for receivable. in of common $X.X and decreased the lower driven operating the sales $XX.XX accounts million. of decreased which XX, XXXX. contract average XX, $X.XX The the three XXXX, April on $X.XX month costs the For periods. for million is from loan XXXX of per SkinTE This in we in in quarter salary second million and personnel XXXX, includes June period due quarter-over-quarter million the the period in on the in million net three-month for and May Net the quarter to average month, $X.X $X.XX from million the activities three fair approximately cessation $X.X in change $XX.X revenues XXXX. lower for service expenses the period month cash May expenses for to XXXX, reduced million June, per approximately loss period product company's largely from of second primarily million for of reduction of XX reported the quarter period forgiveness in costs in of across for average, in operating in the in a and an of comparable loss XXXX decreased XXXX, of per and XXXX. of decrease operating June XX, spend to decrease total burn by the PPP decrease period the $XX.XX $X.X an $XX.XX decreased liability to second Cash SkinTE The Operating loss comparable XX% XXXX, $XX.X $X.XX from in XX% the XX% and million million the operating headcount-related month decreased warrant subsequent company that from was on $X.X in in decrease first of in driven XXXX. quarter. to value quarter a revenues, used was

our operational continue to now base on activities XXXX excludes million daily quarter cash business with per call believe for the cash the balance burn, million below some equivalents average. target like We the and finished into cash equivalents and sheet second approximately million capital. of XXXX. working of the to back remarks. $XX.X our associated XXXX and $X over of which third activities quarter $XX.X through with to month cash We Seaburg We cash clinical fund and trials end the related costs David will of of turn and will I'd on concluding

the The talent, SkinTE we our development confidence approval. we've on Jake. Thank execute a to have and for months past with that required dedication made in plan a team several BLA my progress you, successful during experience place the achieve to reinforces

recent regulatory joining IND step was you remains a efficiency to capital commitment the through and us I'd the SkinTE our open and for Q&A, like priorities. process, for Our which on our call submission now highest with first critical to today. up advance thank focus along

will go first ahead Instructions] go with [Operator We you. our you ahead. Color, Thank may question.

open. line Your is

This Thanks Cantor is Kluska my from Fitzgerald. question. taking Kristen for

The question. a clarification was one just first

the So submitted has your earlier you seems week. dialogue the terms it response of in quite like this been with rapid FDA since the IND

were point? to wanted the of the what round Or any FDA step your regarding to you responses at next further there from from this essentially the next if Just team required feedback submitted? ask receive is

because love I you you'll Thanks, Richard, Kristen, pleasure. address and that? a that always Kristen first on ask to questions. you would the it's like go best always

area of Kristen. group, Sure. them to receive did and early to the we an in week, we and should responding and that we're back response we've from a clinical them. Actually, It's made that progress response particular in in great our feel response like process the question. good sometime next Hi, have additional with

setting of And that. last estimate brain were course, over under cutaneous been wanted then others that and I have to rough fall the for I you SkinTE. one-off some having on of the pick quarter, of a X,XXX treated trial commented you see patients Thanks them percent Okay. you experiences. your a have with of shared and that in the would were, know chronic that those definition ulcer? if

can I would clearly. XX% number – rough patient. I under it's but with capture fall significant very easily that certainly But additional higher do and always I number. team with every say category, research on us share not probably patients and wound some that. But it's shared that have some do information it's than the a you, we to type, single XX% those probably Yes. would would is don't say, of this a The because

Okay, with patients position specifically then trial up figure you could which to of the discuss I that perhaps But this what trials? a number? went the design Is with us help into million understand know great. that other not with today And the off you $X us. Or the number? cited, you you're proposed per study factors coming helped were it factors like based this for come number of up in

Yes. patients. with It proposed starts number certainly of the

experience the we terms us needed of our our that power proposed study. informed in given with So for where DFU previous to statistical be this RCT,

that was aspect the wound great of CRO, And a So has care deal cost space. of with experience of the the in we're guiding structure. who working course, the

the of plan with do based And to through to trial, support them our discussions so also that work the part they our that and equation. was on

how set FDA of communicate to specifically think is you around experience then a we on Is the Thanks. it. I like accepted? trials, question once IND to The clearly common everything catalysts about field share what with have Or thinking is with Street? IND and Got to be should Okay. this the already that? this. that the are position that acceptance, have items and you in feel you be terms some do you'll in a going you once timing And something

our able that and And from the very mean to a to study an proposal. appropriate ultimate for we're shortly a is be studies. line, I then completion from going perspective out regarding the interaction second and in the clarity to that address absolutely. very, going the study follow is a Yes, get we're weeks on the first clear first over – cost goal Certainly, to after our to coming time proposal. both lay

So the some most of plan have additional certainly terms that's when insight things. we'll various get clarity, of soon the in to but timing we

Okay. Last question.

you that IND results accepted, you for again get first Or the before with each the from to would that Assuming the questions. waiting trials my with second the other? gets Thanks be are taking simultaneously trial would expect these running on moving to second?

Sure. Thank you, Kristen.

process the to FDA want So with accelerate they what timing allow. we have will as of certainly in of that's We as part that the have the and we much discussion terms to can. study clinical

the So to going to we of from FDA. be can, aggressive we're as have guidance as follow but course, we

to bit a is getting here unknown right in So as second now. up the be we But thought aggressive as that's and – study that can it's an of underlying we're going running.

Thank you.

Kristen. Thanks,

And appear questions for do disconnect. Instructions] to this like would now may [Operator call. does We you our it participation, further you that at time. thank conclude we and have no now We your