ABEO - Earnings call transcript Q3 2024 | Abeona Therapeutics Inc.

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Operator

Good morning, and welcome to the Abeona Therapeutics Third Quarter 2024 Conference Call.Â [Operator Instructions]Â Please note, this conference is being recorded.Â I will now turn the conference over to your host, Greg Gin, VP of Investor Relations. Greg, the floor is yours.

Gregory Gin

Thank you, Jenny. Good morning, everyone, and thank you for joining us on our third-quarter 2024 conference call.

During this call, we'll refer to the press release issued this morning announcing the third quarter results, which is available on our corporate website at www.abeonathapeutics.com.Â I would like to note that remarks made during today's call may contain projections and forward-looking statements.

pursuant laws. safe made the provisions are securities federal statements to harbor the of Forward-looking statements based differ forward-looking statements. change, expressed These are implied and subject and or actual to are results the may in materially those on from forward-looking current expectations factors in results differ our with and reports are cause Form include under the the actual those filed limited XX-K to, identified could SEC. Risk that but Various to not Factors sections periodic today call prepared our website at Dr. These remarks documents are the are available on www.abeonathapeutics.com.Â On with VishÂ Sesadri, Officer; Executive Dr. Chief Madhav Joe Vasanthavada, Chief Development; Commercial Officer and Head Vazzano, of Business Officer. and Chief Financial us will the joining Also for Q&A be Dr. session Brian call with over Kevany, us that, the Sesadri Vish now to lead turn Officer.Â And Chief to off. I Technical will Vish?

Vishwas Seshadri

Thank you, Greg. appreciate joining We everybody this morning. this call

options to have or productive patients call zamikeracel toward be seek response letter, start for multiple application fronts or it last the our recessive durable complete closely made April, bullosa ourÂ pz-celÂ biologics have treatment we preparing RDEB. with resubmission our patients on receiving in with process. of back with dystrophic continued progress worked lead candidate, and first.Â Since getting the their review bringing license since epidermolysis pz-cel These the FDA CRL, We the in product regulatory and wounds. prademagene to the in I'll progress have continue to

deficiencies trials any the to content the with on BLA did clinical any we identify August, validation meeting the noted for BLA to at Type As that in in manufacturing a not A the not reminder, I'm pz-cel or FDA or the related and The to clinical the the CRL CRL. to clinical including report where of of we the did request for we clinical resubmission, of end additional the of efficacy pleased aligned resubmission certain the CRL support the data all testing October. highlighted information data pertaining completed to our the and additional data new a the address approval had CMC FDA of safety need pz-cel.Â In release the methods. deficiencies

accepted components, guidance thank support week, date Just Meeting our the of previously identified their acceptance data observations indicates milestone that FDA an as especially not for regulatory the of package of QX tireless updated to technical the made per I of XXXX. FDA's meeting. team, host quality, dedication.Â The that them and in CRL our and by AdCom review from they or resubmission in possible advisory committee the The including the review includes dossier. FDA items intend determination this and and last to do a was inspection resubmission regulatory the our April pre-license all the us PDUFA efforts and has those necessary set XX, the clinical, our operations, for informed

need medical unmet observation, RDEB collaborative interactions our In all the the additional to addition, year. this sites review. Therefore, our of inspections review continue we anticipate part their data, to the date chronic in and pre-license were our FDA clinical feedback CRL and the We earlier work given timely not facilitate inspections for as wounds, clinical site in will from to completed every strong with approval manufacturing PLI for comprehensiveness process.Â We do resubmission with facility and treat prospects our addressing in item to confident and remain large FDA. our

Therapy building entered year, space agreement facility our elaborate we beyond footprint. U.S. expansion activities patent mention potential for next and of XXXX adjacent through Dystrophic patent I the entitled which capacity existing Using into an a for Genetically pz-cel. So a cover for the of Corrected a before Gene Ohio, drive X, that Bullosa moment.Â But in to Cleveland, manufacturing recently of lease The into obviously Recessive the commercial Autologous continue expiration Keratinocytes readiness The up our to enable is focus new to for to additional as of regulatory Madhav that, also recent process treatment in on for this to for want pz-cel issuance briefly any to the launch will ramp Epidermolysis the XXXX, date patent our excited year has patent is extension. now share RDEB. rest of claims includes I'm and a the we Jan applicable that subject current use to have term

that allows a Chief for July will functional human and position treat wounds these acknowledges underlyingÂ pz-cel. uniquely system in makingÂ pz-celÂ and Madhav turn this the pz-cel by this XX, each stable November Officer, experience, XXXX, issue technology in which any of own the cells single reduction the using insertion technology into skin that Commercial healing following pain the to adjustment patents to the Dr. forÂ pz-celÂ sheets. of trial the VII on gene call transport to highlight patent extension, Vasanthavada, now use preparations. to achieve it of relating Another could treat patent in approved,Â pz-celÂ will keratinocyte be commercial product XXXX.Â The administration.Â I'll the USPTO patient's RDEB. packaging the we to gene-corrected over and launch our expire issuance is RDEB collagen Based genome sheets U.S. that patent, clinical wound would term or Madhav? Absent to optimistic underlying our patient groundbreaking claimed If a are nature onÂ pz-cel's patent first to of

Madhav Vasanthavada

everyone. hello, and Vish, Thanks,

potential about we we in U.S. pz-cel continue are for We to making the the as next progress year. prepare are excited launch of the

to high on treatment the carcinoma. application.Â Pz-cel, heal covered including RDEB heal rarely we of the in a have multiple game-changing years approved, a pz-cel story, XX chronic, that we today launch.Â Before market approval, only at team deliver is and pain and squamous let into with Let going and its disease and debilitating me that live chronic, for treatment aspects patient no in you wound and durably At be optimistic form follow-up expertise off significant benefits those have developed market launch have our cancer with preparations, called cell with and successful epidermolysis supply single team, site chronic can gene start of members and of in the be and wounds on in the can a for access, new clinical that families. X/X are cell are feel of the can autologous if are by application over the There their single progress passionate beyond which reduction a first-in-class infections, team RDEB do These confident onboarding, recessive XX treatments body building safety medical In we therapy the years this gene nearly cell operations, after of launch with is experience the that patient patients approximately people on attracted and group trials, of marketing, clean and patient's strong and commercialization Patients in become wounds therapy, can launch, be large and chain, shown of surgical clinical theÂ pz-celÂ commercialization pz-cel a to wounds. access, very expect space deep severe other pz-cel shown will we a affairs. to to will several pz-cel not a they age. bullosa. remind with genetic healing a wounds RDEB, being and dystrophic condition of me RDEB risk for has say themselves, profile. therapy

with. We spoken are, payers, on continue caregivers patients, we have hear excited and we about the pz-cel RDEB pz-cel physicians, about have positive therefore, impact patients, and will feedback to from

trained XX% our terms in and at we between distances out points the other to RDEB the the potential centers, Roughly we by to catchment to learned is additional treatment all QTCs, of in includes center of interdisciplinary in possibleÂ pz-celÂ patient COEs and therapy toward RDEB data also for to pz-cel and the and that across treatment other strategy.Â With the the commercialization dystrophic or an approval. centers are strengthen Based far-off to managers. treated with miles on This to XXX at cell bring from begin connection lead and onboarding patient launch.Â We've time, group from onboarded FDA will have about confident site inÂ pz-celÂ demand are found expect patients, continue treated our launch. and targeting we of us these there driving centers in of analysis, cycle working U.S. in-person teams members turning meetings recently can functions pre-approval with will potential may are medical at path sites patients a in Now on EB patients are X settings. go-to-market time average high These patients specialized with each with multidisciplinary coordinators, commitment our commercialization pharmacy claims to estimate that directors, physicians revenue are expecting contracting, we These referral U.S. XXX to be that X,XXX travel centers executing we very launch, handful meetings strategy, into patients the a patients confirm members treatment QTCs with treatment pz-cel market our there XXX progress helping to regard continue is are access. X centers from approach us that we excellence about the resources multiple value at at treating the completed concentrated simple. experience.Â Over the formal focus a to to surgeons, gives our would patients EB the come sites, teams about nearly execution U.S. coming pending EB and are referrals be approval. create at of onboarding launches, Abeona start claims we align months, from and cell Patients hospitals, patients, COEs Similar XXXÂ pz-cel-eligible confidence significant being pz-cel well the geographically spanning recognized from X large miles. these of if that EB meetings educated of Upon confidence to centers being to distance are XXX EB often Of treating these meetings and currently we of testimony These hospitals. of senior centers to care conducted to community that processes the are training different an onboard and aspects site areas ensure to are qualified while have intend XXX we on from to XX% in treatment including best dispersed onboarding, and demand treatment EB travel are and post-approval.Â Now leadership most have with patients ready including therapy right sessions state. of and of data centers with COEs. The into the and steps months these approved.Â In of a

patient are We focused approval. timely ensuring appropriate access on and upon

patients payer covered believe plans, by the on XX% reminder, Medicaid, are approximately mix, a As of about remaining we by XX% XX% Medicare. by RDEB and commercial

all between reimbursement and a commercial support commercial engage for regional the XX% coming now ensure access with CMS, and appropriate to healthcare more billing is procedure RDEB with reimbursement for accurate programs market product-specific Centers key of to we months, hospital granted state and and team for request which patient and goal forÂ pz-celÂ procedures barriers payers effect Our and forÂ pz-cel. Earlier that the Services, government. with broaden will ICD-XX-PCS, this the and facilities a to Medicaid also access In the access insurance represent code, lives national providers, continues to in commercial than remove Medicaid timely August, engage our of types forÂ pz-cel. reimbursement Medicare

and out highest hospital patients recognizing may from the patient previously like breakthrough in X Medicare of by back addition, smaller trials a therapies, treatment pz-cel pz-cel the The pz-cel on far patient X received as our a have patients. square are like patients discuss application. treated their potential on assignment, wounds increasing for XXX cell so reimbursement returning a reimbursement for Chief RDEB received review thrilled Medicare also relatively the we willingness including the favorable are XXX these and treating now pz-cel Financial all providing is in also untreated levels spanning would wounds. patients have X we durability in need received RDEB our the of and testament supporting of they and twice, cover part call patient wound are has pz-cel MS-DRG inpatient of points to patients over single technology application, the among clinical confidence to for in to upon has study could ofÂ pz-cel's pediatric is Officer, the CMS' These clinical patients role following value least data come RDEB In results. us MS-DRG the Joe? mappedÂ pz-celÂ to based trials.Â One nature treatment consideration.Â Commercial study, and clinical that, XXX participate the to on Xb coverage XX exciting trials a pool pz-cel additional ongoingÂ pz-celÂ Phase X at gene a about our play Phase favorable treatments financial their our access back to available pz-cel centimeters substantial in that recognize impact for Joe They sheets its of I payers approval.Â With Vazzano, areas to where times. hand the give recognizing Xb one-time to

Joseph Vazzano

can equivalents, million and of details as XXXX. most September XXXX, financial assumptions, short-term that sheet, September would in resources on estimate cash June cash with XX-Q, balance which fund Based Thanks, Form Madhav. recent XX, to X everyone million for our you XX, into financial of results our operations website.Â Starting on with remind sufficient as restricted operating months the additional on $XXX cash investments, find to ended our our we current our XXXX. compares is we our available like existing the of have cash, plan we This I had on resources, to financial $XXX XXXX. resources and XX,

revenue sale granted account a of or if disease by been for priority runway voucher, potential from of cash pz-cel the remind the review assumption awarded Our FDA.Â I'll pz-cel pediatric the do PRV, that by from has sales you proceeds or FDA. commercial not any designation rare

in September that the $XXX to the X are for compared for The the believe So receive could value average $X.X upon ended million, were X at value a million PRVs that completed and be months a XX, of XX, PRV $XXX reported steady we long-time to relative development PRV. September indicating above its approval, expenses of about ended increasing to million $X.X we each XXXX. million.Â Research were eligible potential months sales X XXXX, last

liabilities. of the liabilities.Â With Q&A. fair $X.X was million third remeasurement XX, for on open September a resulting in administrative $X.X primarily warrant months open the quarterly loss derivative X to remeasurement expenses months XXXX the required Our for The ended general remeasured are be XXXX, value period. was the the million is XX, million, a to warrant fair the Net The market X increase general as million in spend a and quarter ended will reporting from the compared fair of administrative including XXXX. activities note quarter quarterly is September warrants each of $X.X was classified loss quarter please It commercial loss for the and third the loss call preparation value $XX.X included $XX.X that at of in launch loss net and value the for to and can due of liability you XXXX the of million the XXXX. that, resulting Q&A costs.Â Net a $XX.X third of I session? important to million Operator, from and

Operator

coming [Operator Stifel. Instructions]Â Your first question Dae from Ha Gon is of

Dae Gon Ha

Congrats progress. from remarkable. me. is for on the It's questions all Vish. One Two

strategizing How you of a think As thinking is your available. point guys which which the rollout we at to the you review about think as that's on we respective the CRL night? CMC for as as the this back or what's thanks most Filsuvez be related, discussions? Or aspect about rollout, Madhav, how you've strategy since keeps and of of are around was question-bearing you there. at do going your think are more market that about given already we kind guess, the do should think Polypharmacy-wise, been getting And kind you And that well about aspect from the the I as how payer it for patients think the centers? we commercial Vyjuvek into research insights resubmission primarily issue, second, find of forward? up comment received kind you acceptance,

Vishwas Seshadri

have and talk about question, I'll first Vyjuvek the and Madhav your Filsuvez. I'll CMC then address

in all discussing had terms pretty CRL we -- as only meetings reported, were PLI. informal quite Type A we in because the got of the identity during didn't the as those leading meeting, A we of outstanding validation, conversations the kind protocol of much we let's are discuss as And results to and the the were probably the the ones pre-reviewed, in the the on a topics. So you agreed on, Type we a CMC issues if in had already were right? testing up may, quite meeting, well the previously we ones of X noted that FDA for Those And has there.Â So seen are there, tests sense only say, right yet the in what exactly got expectation even not and but or direction Stargardt, terms outstanding is. deep comprehensive

A had of post And together. package on we discussion a have our identity based we that that confidence meeting testing, need put and we the and bit so an informal meeting the to data, actually that what shared have Type little for we preliminary

I good do using the terms Chief how These is I organisms our going things about going are Brian is that had think strong comfortable that is data which Kevany, I'm agreement our all considerations, our all why of But about, have online. and to we in of Officer, is.Â What Technical they're a we feel what pretty would package expect, is actually the Stargardt see. types that statistical the to they new to new method. demonstrate

please aspects, So do on more to you like would X so. if any Brian, color those add

Brian Kevany

question. covered on much Thanks, Yes, are pretty think internally. that everything we for aligning you Yes. the Vish, I thanks and

the was stargardt part the think of as biggest I CRL. topic

that one they as to. highly in the agency at Stargardt has attention be having put interested think to resubmission. mentioned, the particularly area collected we're more team of like I the our the that's especially I close Vish considering and that But together that topic additional is paying data, a speak them that that look can't the package data seems for So

around So the into I agency. would echo put confidence our the we Vish's package that in sentiments

Vishwas Seshadri

play addressed Dae therapies how to about I it Filsuvez's talk question. hope to Madhav little bit options a you, turn how Vyjuvek Thank will and treatment Gon, I'll over that existing Brian. first there. your our

Madhav Vasanthavada

for the Yes. Gon, No, Dae Yes. thanks, question.

patients So wounds pz-cel motivated a come them, period were for look at and pz-cel this of be extent option burden get are like when offered like given just they clinical And shown. and setting. moving we treatment options are present to just and And When market they that home that with our to also patients options. And certainly, caregivers, of the they treatment a not like their the show hearing how emotionally market there in X-month the patients, testimonies many to to and effects really research been a yes, based of we time research profile existing images. approved on will the consider the the that our but market after they have fact to receiving are are treatment treatment trials you're of respondents consider wound that these least moving look in the have.Â So existing options. especially pz-cel, treatment -- treatment able at finite has of have on wound are before given physicians with we done, that the

as through other treatment begin the to patients, we advocacy to clinical their these awareness that And engagement, as groups will patients the have are these talk beginning patient but to treatments, raising that patient as discussions. fact targeting least as are this also conversations centers onboarding just to are and EB we from we get and as preliminary referral seeing multiple and strategy in kick those are come other are well in centers, at channels. that we're about centers high-volume there patient we rollout, centers, not know because EB Now researchers our we

large it, treatment that strongly goes we it's With I feel there.Â So also product body the can other but areas so of with conversations, regards about to application options. -- pz-cel speak again And the part had benefit keeping firstly, to that's that the again, how with engagement single and the of pushback clinical fact goes rare and regards disease with of going regard multiple to of far have healing, resonates a very demand payers a when with that we going. the to think surgical the them. vis-a-vis to this years you no the is cover payer data with to

you But posted. so keep certainly all confident very far, we'll the we So about uptake. feel

Operator

Your RaycroftÂ of next fromÂ Maurice question is coming Jefferies.

Maurice Raycroft

Maybe treatments Medicare sheets? talk me with treatment be a plans. could was the payer Congrats about what will wondering first can a if more favorable like? price strategy impacts also you that conversations would variable number I Or about price how that? subsequent commercial on progress. reimbursement designation, if related and look be the how per pricing reimbursement are flat to remind conversations the and then or price of you flat payers thinking And

Madhav Vasanthavada

Thanks, Maury. Yes.

Medicare I reimbursement. on think question the the

So payer commercially expect a often spill reflected the the a insured we'll sophisticated the MS-DRG of and be is of going going XXX a arrangement recognize side cost. to technology XXX not actual other between that that fact commercial because have not patients a a kind burn right? the side. commercial the is procedure only the the the by reimbursement Medicare into rate the we because they is positively applied is of case But to or to So we have this DRG pool single nature any patients, and side provider graft-related reimbursement, payers

established has it value been with assignment. So genetic the nature technology, the this of of the

miscellaneous is patients for ICD-XX-PCS the will code, procedure don't procedure they hospital now insured codes. because on that commercially is to code that a what really because which code, is have even billing is make multiple one.Â The seamless positive rely product-specific So

it regards thinking with patients. we a pricing the strategy, the for way flat is think commercially to So code insured the patients.Â With is our per I about treatment to are going that help price pricing, even ICD-XX-PCS

We and expect that all per available that kit. have, the be for will will NDC sheets supplied price flat all pz-cel we have

XX price. that be own will to separate patient to a say, later let's price. in down If So sheets, price up line point, the their come the lifetime, flat stand-alone its were back, flat

regards there still any subsequent any payers WAC we won't any and treatment -- with regards first treatment And follow-up? had with be price pushback payers. discussing between Does We any to or changes from cycles. cycles second any have the are the also with to not the that answer, Maury,

Maurice Raycroft

really Yes, question. that's helpful. And one other maybe

can Just of have you the X you potentially a wondering treat the line assuming sight into commercially and more as many of operational you after then and done X to make patients months by leasing to well? needs launching that approval? facility that could you're if approval when end the And XXXX, to the how be new then happen about could what talk

Madhav Vasanthavada

Yes.

get is the part to something centers of in our get treatment the can qualified insurance it all continue of probably because depend alongside What and funnel think get strategy treat them that the patients location to a to we of a get I get to and and going a as will activated which to can many make start payer that how have is process approval. of benefit coverage we soon we will quickly queued up we to bring centralized centers after going we from to be we centers approval right? treatment excellence, able terms So to certainly qualified expect In treat, standpoint be them monitor we patient-ready and we make on after them patient and closer. patients guide the that's how ready, is will

is, one.Â And second is the going then we side, of the ramp are course, on capacity. to that that So manufacturing up

our launch believe have certainly exceed continue the the We the and at to to said of we focus. time supply, is that going demand that and is

go that. on As we call, have how where are about started expanding footprint Vish building and already about in alluded to our thinking the manufacturing the we

So if have on to Vish, else that? anything you add

Vishwas Seshadri

Madhav, thanks Thanks, Yes. that question, Maury. and for

us people. runs a remind that launch, will XX footprint certain I patient manufacturing but we're to but take per The se, not think can personnel. already We're the at preapproval or XX a ramp-up good of people that to it's training a capacity. probably month, even of manufacturing idea have going to speed, to because about space in train because of current hiring manufacturing doing have runs manufacturing that and some more up

capacity. a flux, is should capacity of the by that little additional bit bit think in least However, that full the ramp-up operating And post-approval the XXXX, at early. of kind we out talked where I think the of our that to be continue which to to right?Â So just will focus well end a we timing kind at we close will up but launch, as space leading by balance we efforts XX-a-month the of achieving be we about, kind it's that

We the have leased space.

who to to for with experience suites. trying have We we're of these best for manufacturing optimize that. see design such types engaging designing And are of autologous types spaces processing in GMP engineers how

to there closer we which you you right is can't closer that factors do the color And more more are how add give are without and scenarios at space there because compromise can additional multiple One multiple other that. we the how as we that to are considering can we as existing will optimizing disturbing the we for. quickly on we'll manufacturing is suites. approval time, we can do because how like, look think are I get now.Â So ramp-up speed

do equation little as need of as these we will our well clearer the into balancing do think additional how space to are parts as that think bit. we all much get I clearer bring and really X these GMP homework manufacturing, a I

we're Maury, how clarity hopefully, it we mentioned, going approval. have on should bit at demand time supply than a at So of clearly, gives an as at Madhav you the be next idea that. I little is hope looking by because least conceptually, more the capacity call, the more of our lot to a

Operator

Global James Molloy is question of coming next Alliance Your Partners. from

James Molloy

the or answer XX% eligible get you be XXX the a of little And expand could that the that into are target from should say that through potentially patient before. that when XX year per going runs forward? more on the XXX from potentially or actually the the you of month, in of sort that that thinking does to be what looking translate you guys When patients outside able the on question before per XXX supply and you even walked should approval? about we, the How

Madhav Vasanthavada

Jim. Yes. Thanks,

to agreements right? like XX quickly about as well.Â I types anywhere will the on we've How yes, XXX space multiple just think regulatory do in months. additional about year, have beyond are think to translates designs, engineering runs, little to submit review that, need XX therapies. involved we which is a So because to that additional these approximately, in to go going come that, I between the and based month, be that's it's to is and patients created is there because why review it once going at and XX of for those the past space to So are effect? we looking there's a and a start lease regulatory to is goal also we seen speak That a analogs the there is lead be time and premature that. things components to our from

get we step. and the new more designs these that ensue even crystallized will can will FDA be So little space as is later? I building sooner or a have something with our clarity that think it dialogue for that bit

on ballpark clarity. made is years So I get the more clear a But to a X.X after X we'll years good design we've print think paper.

a estimation. of very that's kind high-level So

James Molloy

demand Probably you of point, giving you be good pricing and of facing course. at are as going the see you can ideas power supply, on guys you're pricing expanding do sort pricing. Vyjuvek's guys given very versus guys at the will forward What capacity? do on raise Then think to best you this obviously pricing, you

Vishwas Seshadri

for pz-cel Do you treatment, mean Jim? pricing

James Molloy

Yes. of Yes, course.

Vishwas Seshadri

will that treatment, for definitely, patients we is mean to the I and there I value are bringing we yes, and Yes. price here through think pricing. pz-cel community, the want that capture to value

one-time to can our therapy that And going-in gene about assumption cetera, really talked et pz-cel it durability, Given have is. secure. price the comparable what that is as we

last of $X.X per the treatment. in We haven't a said call, in PG numbers.Â I of floor think we terms guided our million

sure continuing in that of patient and right? are We upper not what to there we like exploring -- options to limit have, on make bounds the goal have a outcomes especially you We table. the our because pz-cel with are want are efficacy and main are payers the product access, when this our we of options comfortable, to its explore is terms

the the recognize is speed course, able I So and third bringing be well expect one areas, all we previously be are repeat So about also creative profitable party a capture to we control right? its them done value back through we to, we as both not Abeona. a as cycle untreated treatment sides and there, exercise we own that relying in-house, itself price for right? and while of autonomy thinking And gives have we being own sure pricing that's a are will us by cost That mentioned, lot are are to manufacturing a the it. that It's think our vector. do of us the that, how for helping to it So manage on to which control and produce that to about come want and able certainly in we to the its are is the we model of billing the it make ability scale. are patients, lever.Â As that we from fact

James Molloy

It you're avoid. Did helping cost of annual I therapy show pretty treatment year hear million these straightforward certainly value to $X.X patients correctly, of the roughly? calculation the a a seems

Vishwas Seshadri

per year. treatment, a a which is It's not price. flash It's

Operator

next Fitzgerald. coming question Cantor Kluska is from Instructions]Â Your Kristen [Operator of

Kristen Kluska

Congrats on It's been transparency resubmission the the with and very us I all helpful. appreciate shared few months. the last over you've

with to you how So including with past the are patients about in potential approved, you you I going doctors talk from have surgical in potential I them to surgeons data you as it? the Do this the the share you're themselves. procedure, experienced mean, the us barrier? see the as and for trial how responded about a really actual think speak But conversations if and think can durability

Vishwas Seshadri

a but don't this for We high-level Yes. question, give Kristen. answer. Thanks barrier, you can a see as I that

We a this of anything surgery beyond consider don't see surgeons pz-cel what the itself entail. the So new aspects as as applying especially barrier. don't procedure would plastic surgery

As the could onboarded we've you experience on of onboarding because practices to the of and and were that that. half seamless way that be already only later was communications replicating based aspects best doctors experience have the Stanford surgical these around aspects our we our through UMass. pretty goal that how practices the comes and sites in across centers add Madhav, seen terms that the multidisciplinary It's we've VITAL site were recent experience for with more cross-pollinated we're from of smooth with to our And clinical perspective, sites a sites you because potential their of let centers. pz-cel travel achieve.Â I think more UMass in that color should these minimize an actually lot between kind time see we with additional once. of potentially study is the through onboarding be site interactions that to X best me our having that the know, that to path be just application burden helpful sites that clinical can at X some trials. patient the working the of been our be of need of ask at had a through the our And logistic

Madhav Vasanthavada

also, this absolutely. are procedure Surgically, for with. they No, them Vish this difficult that's interacting that mentioned, is is Everything the actual the because not sentiment from are we so technologically Kristen, comfortable that other are standpoint. the -- Right. Yes. from really sites we seeing

In or the are fact, not all plastic the with just are privileges a applied OR. are surgeons also having we pz-cel. them, thing.Â We the surgeons It's for say seeing therapy dermatological at have this we working these that and they technology. cell of is they part But even conversations have to And difficult are tend surgeons to coordinators at centers. these the because surgeons

think nonsystemic the the course, is there. autologous there there flow. there cell first is infrastructure, therapy, because because of nuances pz-cel onboarded standpoint, across all ex for I institutions. centers mean, multiple when therapies Yes, are their I an PD. technologies beauty from a right, have these that process And that's be approved, vivo in will pz-cel of out the

back to fact we study that, experience of the nuances they clinical have are The itself curve we of, Xb for trial from yes, a pretty us.Â So areas patients, thing see just that the benefit. mapping with also is Phase patient. issues our because coming gained areas positive that experience as that that real helping now So there procedural And no that mentioned, of the and for the are standpoint. be and okay, untreated are seeing is that a out in with treated Vish certain build they

Kristen Kluska

And line going then are red be was when essentially from solely going at from and did everything any sense time the items were the you agency during you resubmission time? looking be on focus accepted to to they holistically? resubmitted from get the the those Or the new review, whether now for is BLA to the first that PDUFA the

Vishwas Seshadri

an answer just in right? many don't has again assumption short on going application at previously Thank have will and a supposed going is just to components a list up to based entirety all resubmission. yes, to process, period the not assumption going no, sense is they're We complete just you is on up made But have that a the data is it's approval.Â So things really be things to about delta, By that focus is. X-week CRL package, we the our majority the versus been the you, of that comprehensive CRL sense need everything have right? to that is for on any period nature to the focus we on a resubmission our pick look in very yet. our Kristen. and had ways, soon, just of because The requested that reviewed is, that our those additional of be that reviewed we're do having the items items. we focus that, that also X-week the is a been whether opened conversations additional these dialogue those review up spirit, since to So is the have But the deliver going the to of leading be what of are been

continue we months, that, as do So we've will Kristen. we'll definitely, to been all transparent these

Operator

question-and-answer have we of our Well, session. appear to end reached the

back now over I hand closing remarks. Vish for So will his to

Vishwas Seshadri

the And was I of wanted questions about you clarify Thank I the closing one give you so floor. Q&A much. just to pricing remarks, before a

$X.X there had see even not that Jim, finalized pz-cel at or so pricing the our any far upside. time. really from be have million that floor dialogue you We was this just a in could about that had of disclosed an point do asked we the question communicated. for We was the lot

still So that. we're investigating

yet.Â So to believe our XXXX and thank potentially So wanted everyone, to talk potential about have for pipeline, a finishing not price for and soon. given this company. And Abeona, to transformative for we at with focus business joining for just us today's talk to closer calls. step positioned know for the again opportunity did we I we to any a you to think don't on we're pz-cel approval pz-cel.Â So our We people that, wanted and which at time preparations will future in update, for pz-cel, that upcoming significant and today the the well much that we're we'll clarify point just look strong so we one in year forward the we that, priced I closing, think ahead you, do

Operator

This much. very you conference. conclude Thank does today's

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

Abeona Therapeutics (ABEO) 14 Nov 242024 Q3 Earnings call transcript