PTE - Earnings call transcript Q3 2021

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Operator

Good day. And welcome to the PolarityTE Third Quarter 2021 Earnings Conference Call. Today’s conference is being recorded. At this time, I would turn the conference over to Mr. Cameron Hoyler. sir. ahead, go Please

Cameron Hoyler

Good discuss thank I’m third General Operator. PolarityTE’s Cameron for call Counsel. to quarter afternoon. you, you And joining Hoyler, Thank XXXX results.

President; Hague, call Executive are the Patterson, Richard On Officer Financial today and and Officer. Jake Chief Chief

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

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

Richard Hague

Thank kick update. off an other who call IND well the the Patterson progress as quarter, you, I our related financial update Cameron, welcome, a SkinTE, everyone. for with call our then highlights over to good share and and will as will morning, today’s from on provide turn Jake

you company an submitted manufacturing on items. September aware, hold IND of ulcers SkinTE on control primary address chemistry, As are identified plan it indication to FDA issues are we defined ultimately, the a clinical CMC and for chronic The issues XXrd, And with for from or proposed what and received believes notice cutaneous certain all July a the FDA. XXth. the is is by implementing hold well

information response, diligently year hold feel end. required the the and working we are the to addressable. are to submit assemble which We finalize issues confident all generate complete our to expect We to agency by that

we the concerns any be IND not has SkinTE process. throughout specific believe approach we’re However, very new potency feedback, assay regarding FDA the IND. It’s of remind to on key Based the acceptance that a supporting we to request to-date assay. additional a to that FDA to and input pursuing from could we did are important proposed to this expressed of safety receive the strategy pleased everyone our review

if proposed been the occurred. Trademark begin design, can engage sites key or On have unit multiple came FDA and of regarding to shortly additional we August covers our that on Patent we after now would MPFU a polarized Philippines able approval. accepted October we on also and have patent parallel enrolling is cover patients trial allowance U.S. Notification XXth, functional believe agreement that an accomplishments like other issued is our third received to I clinical technology. recently July in to Xrd, and clinical Prior each of to work in because Additionally, which XXth, the Chinese PolarityTE’s trial to with IND Allowance, which Acceptance were States. This Office granted United September PolarityTE’s patent for Notice using a We MPFU methods discuss patent XXth technology. application minimally patent an on our Israeli

three XX comparable September additional reduction technologies, for loss operating average of months $X.X in And We the in million XX% used was per of CFO, to loss representing Jake? period for including ending comparable operating XXXX. to a I’d the on the the the operations million regenerative continue ending XX% $XX.X to XXXX. related applications $X.X our million, to from patent in like the SkinTE. abroad September months U.S. Cash and million an pursue was over for of call our nine in XX turn now period Patterson. Jake from a decrease month, $XX.X

Jake Patterson

everyone. Richard, you, good Thank morning, and

have and changes the cease SkinTE cessation to of business in there disclosed, in of the we Net that results testing ended revenues Accordingly, ended September compared and infrastructure previously revenues SkinTE and revenues effort. were expenses, by commercial support that and corresponding offset period service months to include our compared decreased development our sales the the period September general sales and months $X.X same and increases XXXX, and of periods XX%, compared ended compared decreased costs three-month to QX in months months in partially in decreased reductions for XX% three-month to XXXX, nine-month due the and three other administrative in or expenses and XXXX. workforce, commercial XXXX, charges. decline have marketing needed XX, affecting to COVID XX, we operations were September and restructuring The operations September the research and reduction COVID of significant for reduction the and and expenses in periods cessation COVID expenses XXXX, or XX, three the operating sales of ended three three by ended our There attributable -- XX% XX, nine-month this to for product significant changes we $X.X XXXX. been the XXXX. XX, business. Operating to and million the As QX. no year, September and services costs quarter million testing in is which in the reduced were completely These testing the expenses

$X.X XX earlier, a month, $X.X ended mentioned the comparable Richard was XX% per average As XXXX. representing reduction million months period for from cash in or three used operations million of an the September in

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

Richard Hague

you, Jake. Thank

for achieving by into pleased XXXX company. progress future has We transformation very and program to ourselves our are toward late-stage substantial PolarityTE with orient a expenses in included This the to SkinTE. milestones and a reduce development management undertaking we’ve to development clinical made transform

designation XXX catalysts expect of chronic our is open of include year. our important the IND, prior result, cost an the indication, throughout next the which as plan wound a the IND pursue to a strategy second pivotal is SkinTE well to Those our on fast-track action as from for a to cutaneous in HCT/P. note under engage as experience occur indications. Furthermore, to our challenging acceptance critical that intensive of based of initial pivotal plan includes study. learning most subsequent complex pursue cutaneous study a and number future with patients of FDA discussions SkinTE over first we It enrollment of and could first the launch X,XXX chronic treating As ulcers, to XXXX half our clinical we finalize of for our and ulcer a

of have limited efficiently opportunity. multiple management market utilized like play care to application and can role great a of in -- of great settings patient which now be a continue today. that a Q&A. open the joining We a have call the for penetrate SkinTE, of I’d us effectively single to with to in it deal significant for treatment confidence population you multi-billion alternatives, allow Thank a will ultimately,

Operator

you. Thank Kristen ahead. first question Our comes Kluska from [Operator Please Fitzgerald. Instructions] from go Cantor

Kristen Kluska

This morning. is questions. Kluska Good taking Hi. Cantor. for Thanks my Kristen at

quarter had last The wanted the FDA. to call, you initial responses submitted I ask on that was, one the first to know I some

you’re guiding helpful the end? of does Have the would potentially understand clarity that by this scope submit So you additional to these into responses be response on any this full that received you full just sent how and initial tie year to process.

Richard Hague

your Kristen. Hi, question. Yeah. for Thanks

is then unfolded So we the with to process on And the point, come they had XX at that, that days did which IND various FDA submitted do. XXrd us back way to questions, our of this July.

that So that they entire part sufficiently FDA. us issues the detail, their the And utilized ultimately, were that other to of provide XX-day were not to had addressed, ultimately issues they to these responded of those information the our requests, At those clarity of end we to in as responses IND review package. they still they addressed. that period, had many felt while, presented were of informed key us

with clinical identified the regards We September letter, were that, was And of and the that clinical that then, in to what needed so we that hold XXth. final to was hold a to And list hold specific communicated verbally issues address. to ultimately, communication. received on letter led they

process feedback now assay was that and It’s that confidence The that we some them quite approach were address straightforward the receive we items now. our are did potency to can confident reasonable feel seemed were So that the right process. additional the in black were some planning and pursue a that identified and area The gave we was around that one to that’s we And and all. there. FDA. did we’re pursuing additional very pursue we us feedback are white

way assembly six the weeks the the information of we’re letter. and this process complete stage unfolded has or the final that’s basically that for response now new complete the So to over so in next

Kristen Kluska

Thank had trial of looking Okay. detail. at potential then you mentioned regarding you final And second in the for catalysts, remarks your next year. the that simultaneous

to needed as two these whether trials still or had be So off not that could had previously this I left run you of you simultaneously. terms in discussions think

then? the that you is potentially to terms any update there in So, year fact looking explore there of next are

Richard Hague

to as Well, discussions of with I have second think, the do We been it’s our mean, quickly the type trial, to wound our we our additional trial kick but need possible. rephrasing around pursue, a is has And that possible the always to that off the as only goal as accelerate as itself. not that be I fast second design goal also underway. after just that matter would agency trial earlier thoughts. first trial

with IND that is submit is to get So for our conversations first that plan underway study request shortly the a additional agency, and the the after hopefully, is study, we once can one. open second

wait it ends, the not after until or as few goal quickly first couple a to Our to seen. started possible. is months is one it months remains can off we after our plan to more get as kick whether be But a

Kristen Kluska

and hit Wound a and And are correlate like But DFU, do need you of there’s this Registry, do that what how U.S. physicians I the for think to you is product endpoints. Okay. trials, potential cetera? for standard-of-care, the that mean, so the looking users clinical Wagner does X then this a et you think like obviously, bar, the

Richard Hague

and and the Yeah. has wounds these in quite world that these in is wounds, we’ve filling reason have where before seen we the real performed after mean, because, exposed over that well I those volume purposely, structures. of wounds for going described we’ve That’s great a structures SkinTE deep the question. critical cases as closing

experience, on And don’t wound a only do the study to having past perfect initial see, on envision standard-of-care, we closure difficult. these types, in our but Wagner our so, not meaningful rate based expect extremely X. DFU But versus it’s we differences

more physicians, our that reduction, basically area coverage they’re easily exposed a that So to managed. to percent of see and X, based that structures X a and on that wound looking with experience much our those is from moves is

reduction. that to percent very being believe to payers physicians, to primary, value going population. the a the as those secondary, area one very only be one important of patient being we think but show of closure will both very to rate, the SkinTE we well see So, we’re meaningful in endpoints that as And meaningful also not

Kristen Kluska

the talk the looking about internal the patents hoping runway at like? that potential to extension could you And look expiration And for, Thank you. that submit then or in with then across what all were could totality your you’re patents? patents your what’s granted, recent these

Richard Hague

good Yeah. That’s question. a

XX terms timing, XX months. In to of been in patents have of last granted our months the all

significant. build different a will So technology support to the to patents ways. runway a and product going for of we that these pursue believe And continue is to other quite around continue nice of use we’re the can variety that the portfolio our in

So, this nice long MPFU other the technology have SkinTE. runway patents additional these support we and at of continue excited for that pursue patents point, with to develop components and we pursuing a about and the the ones are technology and as

Kristen Kluska

Great. Thanks question. so much for taking my

Richard Hague

it. you, Thank Appreciate Kristen. Yeah.

Operator

Instructions] [Operator

Cameron Hoyler

cash The one. in your about the is, you Hoyler the to capital asking do Thanks, speak you webcast. This through perhaps, need you And long speaking. is Cameron how raise runway? Operator. additional can that that? to Could question can sustain a sort this came Jake, you before We question feel of have

Jake Patterson

Sure.

we’re sufficient we expenses during target. announced as targets the the that cash mentioned during we our will $X.X into capital. we quarter $X was on in to that current based interim, hand, In I As my opportunistic million. below capital on And third believe previously our the the XXXX. raising operations of be monthly million pleased per we cash and estimates for fund cash our quarter, our that approximately for fourth month to average remarks, our approach That’s have report burn to or burn

Cameron Hoyler

Jake. Thanks,

Operator

participation. concludes today’s you Thank for this call. So

now disconnect. may You

Richard Hague

Operator. everyone. you, Thank Thank you,

Polarityte (RGTPQ) 10 Nov 212021 Q3 Earnings call transcript