- Earnings call transcript Q3 2022

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Operator

Good morning, ladies and gentlemen, and welcome to the Humacyte Third Quarter 2022 Results Conference Call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time.

As a reminder, this conference call is being recorded. I will now turn the call over to Lauren Marek with LifeSci Advisors. ahead. go Please

Lauren Marek

Operator. Thank you,

statements proceed materially remind with call would we expectations. actual laws. call, forward-looking uncertainties risks that could historical the that certain experience to cause These securities everyone federal this to under like subject statements to statements and differ Before results U.S. I are from made are present during or

contained periodic from reports could only the statements factors update filed hereof with we this by information except that release cause contained the no actual Information in undertakes in issued in Humacyte to forward-looking during is this concerning to the required of and The morning our is on made maybe as Form and SEC. as Investors differ be filed the statements this will or page the XX-Q, date made forward-looking which the and press presented call revise from Additional results company obligation law. accessed of statements our today the speak call call on this website.

call Prichard, on Dr. will Chief Chief Dale from progress company’s Financial and provide weeks, Development review summary quarter and recent are Dr. Niklason, President Dr. today’s and Officer. will and Dale Chief Officer me Joining company’s Corporate and of the Officer; Sander, Chief Laura results. Operating Executive Heather Officer; Humacyte a financial Niklason during the the

available team management over be the for questions. Niklason. remarks, will the prepared now their call I your Following to Dr. will turn

Laura Niklason

results and on thank for call. us financial third everyone, our quarter and morning, Good update XXXX Lauren. you you, Thank business joining

completed to Vessel meeting market. of HAV. turning Human drug a has call our development as our the questions. FDA be highlights HAV the public to late-stage and be with arterial qualifies and We an advancing the inform our meeting completed recent results. review third over produces to treated the an ongoing were have indication patients and we FDA plan during the focused on our current late clinical they from in our The that program indication move important on update vascular that a BLA this bringing of biotechnology October. productive We're pathway. discussions to approval who accelerated will the statistical Ukraine. the data that pleased report I'll from in invaluable our Discussions to that the The incorporate we HAV trauma the and for in in for we trauma. Then, begin call goal initiated with key Also our for health, closer the in indicated in to we HAV the trial file for previously We VXXX our appointments mid-XXXX. our exciting plan meeting a had common to review Lieutenant or program HAV Board type and the our Dr. FDA leadership platform, We've Cao, our for and a I'll with General, important up diabetes which Acellular the strengthened also October in for trauma to an our the arterial call, progress facilitate open human respective this Directors with happy quarter our productive who team financial bioengineered pipeline, your we'll of tissue of Dale in and X the of before candidate. Cindy During product indication. our Bruce partnership significant meeting Green in brings of experience development

recent enrolled, has meeting. which XX X/X injury arm patients setting the is at Our and and currently trial, of study, of VXXX the Phase these patients evaluating agency results shared the HAV the were single use with trauma a our

on continuing the needed in market date were We're data the the to to remains Previously, of we've patients, package total and also the with filing we've these treated necessary of to will in HAV, from for around approximately patients FDA being addition with implants to be total as guidance patients shared and In that complete BLA. XX nine VXXX current to the work from agency. the Including with of Ukraine XX guided VXXX support expectation order that our vascular estimate. of patients Ukraine trauma. in an patients the results BLA filing

we're Importantly, the preparation edition also Ukraine sites to clinical planned Ukrainian into trial submitting trial. a in application VXXX for of

of continue BLA multiple reconstruction conduit. outcomes harvest perform to vein HAV to the HAV Vascular the the Surgeons in trauma surgeons patency, amputation, with shrapnel including also or gunshot look noted In vascular forward of only in eliminating and with of the filing September, presented with third and trauma, Annual from treat we're need to HAV the infection as The MTEC article, presentations ability limb collaboration and time of year. date for salvage and next to throughout HAV the the rate wounds. in it that trauma, of to high show purpose, in injuries, our Ukraine. encouraged results the HAV be scientific and we wounded develop to European to $X.X also greatly a at Consortium U.S. collaborate one support. vascular the in MTEC. access improving than trial. the and blast published officials was We an Surgery by saphenous Society venous continued Humacyte to for to Ukrainian use the that publications describing provided and case context has vascular which injuries, Defense the Technology dialogue treating In FDA for funding update The use subject patient war Enterprise quarter. or At million We Army low was assisted the within by observed grateful Meeting for -- the of VXXX the the the rates their advanced task to the in October, more conferences vascular Department and with and Medical HAV vascular war more their encouraged Humacyte trauma,

the in presented for to contaminated results that's the successful, to soon. Top ongoing line built after support of for anticipated in study. for access, October for service of XX, on could the or dialysis designed HAV. completion, Todd infection update Committee hemodialysis, trial of complex members the Rasmussen the is follow-up on a at HAV NATO trial into With vascular Rasmussen spoke access dialysis with be indication we Dr. to enrollment and patients conduit Congress World the especially Military benefit readily HAV program of out the September. in as in fistulas International available civilians the access hemodialysis our XXX to in of AV patients Dr. injuries such for and assess surgeons addition, use year treatment as from a facilitate well track of the results filing of the update current a Phase completed from enrollment comparison concluded the which is provide resistant Enrollment implantation, target injured usability for an If of on audience international and that upon XXX quick will vascular are the Medicine completion enrollment. of would now the HAV's in X that arteriovenous trauma other autogenous based In year of setting quick of wounds. our are I'll as as an XXth one period one nearing patients. the HAV total BLA

initiated our updates patients, and provide of As and dialysis earlier CABG in studies Heart products based a dialysis diabetic. care. Research Institute novel Sessions data opportunity from with bypass provide mortality one structural programs, meeting Association market being in indication, BVP. Research is with research complications infections, artery kidney this insulin the We're in the Heart XXX,XXX Institute, designed the coronary Diabetes therapies. our research in from and failures, patients partnering of which well the in diameter In demographics, we continuing who In we maintained of is Cardiovascular our Association July, in at at owned patients, make months type model, concerning development the happy to with as in In artery services, care results benefit Frenova, for were with integrity the the to HAV accelerate type the progress the patency and the October, partnership presented most is hospitalizations The partner graft. those access we access HAV, diabetic the Diabetes value of post order or Miami vulnerable six up to to for for targeted HAV. eyelids Fresenius particularly anonymized by care which may more to U.S. We're experts in also a facilitate and both Europe. to Sessions from program to information coated as the Scientific or candidate access studies diabetes Preclinical American to BVP we're analyzed implantation stage both complications We're to product and Basic is excited a the grafting and toward to one BVP. at leader in clinical in HAV is our progress cost as than bypass of also Care, HAV non-human the and and American CABG. coronary earlier preclinical that relationship Sciences small month. arm on as Pancreas global commercialization with and deliver a development preclinical strengthen Fresenius our evaluate global Granular in leader primate this our Medical global shareholder, the Biovascular work

address HAVs and the promise of that robust consistency CABG diameter we current our potential term In and host an they remain have of the saphenous model are cell fee preclinical important the HAVs addition, hopeful that vein. remodeling. HAV and care, associated about that issues show to repopulation with which availability is to continue the evidence We're harvesting showed excited standard in patent these small long

team Green of a surgeon Finally, medical Green welcome United States and Board to operations our and relief our general quarter the Directors leadership in strengthen is we Lieutenant and General globe. with Bruce around Board September, General, expert Force medical In disaster appointments and of response the Air Humacyte accomplished this experts. of military industry of is former an Directors.

and Cao us their Dr. a expertise regulatory I'll on In and insights the and and to also have adding and Dr. addition, General for industry global brings U.S. biologics, devices. forward We're Cindy Officer. business over we Green strategy that, our turn Chief Dale results of policy With review expertise it as our financial Humacyte team. pleased look development. other Dr. over to and to and with to very Cao small in years experience, XX of welcome Cao we molecules, Regulatory join now

Dale Sander

Laura. you, Thank

cash, resulted Alpha expense XX, HAV, and and the professional were Research for XXXX quarter We were months public XXXX, term XXXX million of the $XXX.X expected net resulted the all to and development $X.X third million launch. million grants $X.X resulted liability costs. previously, months I'll ended with compared associated and XXXX expanded September year nine of third current nine XXXX. for nine million The for preparation timeline as were nine period compared operations months in the to research September million decreases other ended XXXX commercial ended As supporting expenses the for Healthcare net primarily nine XXXX to third described million million quarter net U.S. spending $XX.X support XX, $XX.X for and we adequate $X.X in to million XXXX compared expenses for XX, XXXX primarily September the months Corp. the and the Other September launch by other believe are million for and quarter XXXX third third ended HAV and for ended the compared net turn had the and development reduction third of and also $XX.X compared the $X.X was third months other third $X.X expense clinical million of quarter loss as insurance remarks. in for investments the cash, investments of of for the the months the in resulted expense equivalents in cash quarter loss commercial personnel and and million fund $XXX.X cash, of XXXX, $XX.X stage anticipated for for were for that vascular XX, the of that, $XX.X $XX,XXX was $X.X programs, nine including was quarter net of September to operating million a from development trauma. $XX.X the in for XXXX months related resulted increased period, anticipated approval the the Net September and of XXXX term The investments earn-out back to including use was equivalents the the cash September income offset other quarter to XXXX, clinical expense of increase of nine September the company's months XXXX loss for of to income of remeasurement for Acquisition to the August current compared short for research General our $X.X of was net short-term from XXXX million earlier With activities compared development XXXX. through for equivalents for increase $XX.X Laura of in it described the to nine months to the for December nine short $XX.X The ended was net million ended months compared XX, reduction September the increase current Revenue cash to ended the XX, being and first million current XXXX. the to XX, nine and merger quarter and for quarter compared for fees related quarter quarter $XX.X operating third million net year and The of the of to million nine of XXXX from XXXX. months to previously. to and other $X.X in the ended September of concluding periods million million the HAV. net $XX.X period The XXXX increases company million XXXX. other XXXX compared expense from for the XX, to partially third XX, preparation contingent with September initiatives current administrative transition $XX.X and $XX.X third million of compared from ended for period for support Revenue XXXX, income XX, XXXX. the XX, primarily months XX, nine for net current for the net million trials. the the current increases expenses of personnel the costs, increased potential

Laura Niklason

significant Thank you, over progress our made Dale. conclude, our in preclinical last To both the and quarter we've clinical program.

coming As now. we're to technology the we bringing important approach year end, we're forward excited as and clinical by and months take surgeons and and updates questions milestones. providing further ready approach patients need, we the prospects look regulatory Operator, to to this in of we to

Operator

is now Cowen Please will from begin with session. We ahead. first Instructions] Jennings question-and-answer question Josh [Operator & the The Company. go

Eric Anderson

in Josh. to Hi. trauma. This start Thanks vascular Wanted the is for Eric question. taking for

your HAV there's enrollment any experience. could Just patient that the Ukraine possible, number Do discussions the thinking where bar Phase XX X have hear that the when this on their trial? you and Do you lowered possibility think the of enrollment would about if about a inclusion your be FDA we upcoming is any for in discussed? do your be target? you meetings FDA thoughts lower with could think And

Laura Niklason

to it ability. good I'll Laura Nicholson. Thank This is Yeah, that's insightful the answer very question. and my of you, a Eric. best

are care of Ukraine yet, clearly, which contemplating the patients. the strongly we world with least is is And are Ukraine that wounds in So them to the we dirty not you Ukraine the VXXX. the although, the FDA or in our VXXX results enrolled positive patients of want and -- patients last real the at about data month scenario a in study, the which sites the humanitarian shared adding clear, are nine where supportive argue, not are the patients have to trial. to difficult. Ukraine were late very XX part the I VXXX both more also Clearly, VXXX scenario in in XX been patients the have discussions XX patients in with add at of and productive. up could be total the use we've Ukraine, We and

early But is say remains to were together What estimate that talking about our our our now the tool total with we're I finalizing that the patients are think you patients, the a include of patients patients really will help? But agency. going statistical FDA XX, now to patients, VXXX remains approach the too patients. all it specific it's that drive will the drive the of and based that number -- is it consideration. So XX. number approximately statistical added if that of is with number of that estimate total under this on the to size at Ukraine be which is Does that

Eric Anderson

approval submissions. commercial may does. think then And and you know set front? and early very more thinking trials you’re readouts to as organize start Is you're to but on, it's there you. updates about at end And Thank stage potential the doing but again, That we up top come Yeah. That hear I on makes an any do know or secondly, that infrastructure? still later it's sense. we early work I line when on, still

Laura Niklason

Dale, you want to that? take

Dale Sander

activities support and brought we've our more Yeah, be all launch doing launches, particular, the expected commercial commercial to is term trauma. in to of long many but vascular the them initial in that around bit planning required absolutely. that Operations, little he a been are going a Head has with the Scheessele, BJ a for Yeah. now has which of on Certainly, Eric, team than Commercial company -- year

place X concentrated XXX is It's It's initial before, we've the about Level within vascular United a centers in trauma launch. United market. talked for certainly the about nice the States trauma States. a As relatively

it to sales as are bringing So we other marketing term such relatively other as and get indications force a activities when open infrastructure actual reimbursements closer then that's And we'll we'll like. force. even patient to date, continue start that get that the access on and actual we things required requires sales nature along than and add closer smaller longer launch anticipated as and the

Eric Anderson

you for Okay, understood. Thank the questions.

Operator

is with ahead. Please question Matthew go O'Brien next from Piper Sandler. The

Unidentified Participant

[indiscernible] on questions. Hey, taking the Matt. this Thanks is for for

one quick a XX I'll plus here. VXXX Just patients trial. on it the call nine

have ex-Ukraine we end patient patient one you to sight the early You accelerate added Do quarter. of QX? year? expect things into kind the here in in Can line adds into and any year of of the next

Laura Niklason

Yeah. That's good question. a

been have We per enrolling in about and ebbs patient month certainly. trial, overall flows one the with

are working all that. accelerate the We time to

frontline several sites recent on we're And to Ukraine brought up working governments Israel HAV to have hospitals several to bring the months. We spring the in I in them in on that using be the been trial. the VXXX to in mentioned, the as try into have already bring going with

in rapid of that Ukraine adding and help Israel will the in setting, HAV to the use Given war speed the Ukraine anticipate sites the enrollment. in we

by during that overall, month. there's I But maintains of the no trial, And hoping somewhat. predict. or we're than rate would to say Although one a trauma, inherently it's more that accelerates per hard nature the we've little patient -- enrolled

Unidentified Participant

just could guess, see maybe on to, when you we you No, And you so gears that's very the here, this some I can start BVP? the preclinical data to speak Miami. DRI, partnership And to with down much. entering helpful. shifting Thank

Laura Niklason

Yes.

leaders with the discussions DRI a number at in the for been we've of think, months. I

the experiments of organization eyelet they've that may decades been probably world for doing non-human may you with is Institute listeners models has transplantation. therapy. Research experimenting primate know, in As with this these and the really, in the not, been premier And Diabetes some

We certainly to accelerator view or is really because what eyelet able And of eyelet perhaps but I DRI predict, said, isolation of earlier. an delivery that a we we're cetera., method we the to so et et primate project for be pancreas think middle on I the important biovascular With partnership transplantation being will going have hate the really models BVP the and that since expertise the cetera. by their as think being with -- and in technology. really I again, year, to updates do next that, immunosuppression

Research of with cell also We work have BVP. use underway, Diabetes work sources would and the various not but eyelets that streams the just with lines work Institute, we in various stem multiple the

bit in duck like underwater. So lot seed and to the probably going months. I on. expect would more it's got a We've a little nine next updates six

Unidentified Participant

much. Great. Thanks so

Operator

Oppenheimer. The next Please question is with from ahead. Kalia Suraj go

Suraj Kalia

right? Dale. morning, you Laura, all me Can Good hear

Laura Niklason

Yes.

Suraj Kalia

oranges was just if as Perfect. than is Hey, clinical conditions of questions Please have asked it, I Laura. I'm setting. equal I'm that they're a we usually been to if different reach become I A understand humanitarian correct if this to and N the XX? And for the try curious, on wrong, use lot VXXX. me in would apples trial curious, and

Laura Niklason

clarify bit hear I more. little So and me a let Suraj, saying, to you're what try

accelerated you pathway. indications. as for in So, or the approval the may specifies for that in even accelerated from Humacyte from or HAV clinical either for cetera., et trials be an trials, laboratory et cetera., typically other often an aware arm qualifies or indication studies, pathway, trauma FDA And single information, look confirmatory they the other based is approval that what

of or clinical not primary confirmatory in VXXX Ukraine fall data. the the category humanitarian trial. into trial They're the supporting really So data in data

humanitarian -- criteria the because are trial. and the actually HAV the the use applied receiving exclusion the we've who VXXX that actually of fall under inclusion However, patients for

These by arteries certain to HAV, et et injuries injuries. diameter limbs, they the of of the a cetera. have are same the with So types addressable and arteries the cetera., that's

of So use the patients the is clinical might think. the scenarios than higher and comparability you actually

level of U.S. mind contamination the worse Ukraine injury of the horrific. actually Although, are and the I the injuries will have than shrapnel blast say a that because is of injuries patients and lot fairly that probably complexity in the these

-- a it more site of but it's Ukraine indeed, So clinical VXXX higher -- as supportive. environment. Ukraine clinical bar success than success sort FDA, view the data, because strongly from in trial the a view our they conversation a austere not the U.S. meeting data, the view as as they in And they with to equivalent

Suraj Kalia

AV Laura, potentially parameters Got Fresenius same on the Dale, many in my on of those terms criteria can you fistula relationship be your candidates the of And And the you could analyzed, Laura. being the what one the and I stuff of way. could specific equation, the Thank token for with in of if part Fresenius Maybe the it. a help in can for give it and XXX,XXX understand some couple terms lot patients HAV? how million being questions where taking on just side throw going you're used of Fresenius' us questions. $XXX Humacyte? on hand, you question of equation, just characterize of Maybe

Laura Niklason

start So, research. Suraj, I'll the Frenova with

So, the so but never official Who press access infections doing catheter but our an big -- obtaining, with patients we're we're U.S. access multiple really per mentioned or data with is become calls, and failures who with in access, and it's that our multiple we're have is understand What left access and multiple problems multiple who essentially really failures. them, as on of to the problems or and se, access the trying likely have respect remarks have is, with is mature Obviously, placed asking who XXX,XXX in and with And repeated this is their I've see then exciting are an infected. Frenova -- in the a profile Europe. who catheters with who's in the then access? see a I that their release, patient dialysis patients initially, the of the previous their to project they're are project. question types who included we’re to very what patients we're their with

(ph). So that if a if considered and from is woman for for the year sepsis to unlikely tell old mature likely diabetic us a old woman, fistula XX from diabetic data statistically may example, a very is year XXX hospitalizations her have and Frenova to three fistula, you're you're being

type really rapid -- of Certainly, HAV. have And patient never have that most really go the in been low who this identify who centric benefit And dialysis the analysis it's who may patients is so because a kind usability that, patient and you trouble to analyzes that route. than different for believe infection probably really But way. with their a patients USRDS we data rate population access done of field. from the has data shouldn't this the it's the in the of approach ever the

So has how XXX,XXX as many But market is about of to hard of what now far full those, prior patients? market at analysis. total deep those right fraction know again, still penetration. as guidance the of we're our it's because been in XX% It the market capture

spend not still a particularly data on conservative fistulas time of it's tend mature assessment. and fairly catheter. and a there tend or So says women that there are to older diabetic that lot to the women Again, out women or their elderly in general

say to for insurers will I have I providers compelling But is quantitative numbers going benefit from healthcare it's segment if hospitals. guess, that HAV. most allow it's and we to that So the to that, be were beauty will would this of that think us project very and hard the

Dale Sander

with to And Fresenius. is second regards your Suraj, around Dale, this question

of of referencing level enthusiasm certainly the have the leadership in we as providing changes cost from savings with of and in for or enthusiasm patient inferred also more that to Research, recent regards Fornova appropriate any the patients, the the and impact change access that within of including improving some structural the may are lack see Fresenius outcomes is changes the Fresenius. You don't care potential well been those treatment AV the patients HAV as Regardless events, of of promises targeted.

with you on next their our closely them continue priority facilities. the leadership Fresenius very within to work offices our is to So that we we're high I tell actually visiting still list, new and month can

continues as been. strong the has So relationship it as

Suraj Kalia

Thank you.

Operator

Jackson Bruce Benchmark with from ahead. The is question Company. go next Please The

Bruce Jackson

and Good trials. you access the thank Hi. of of my question. morning for maybe the to -- trial with enrollment taking start pace I VXXX for wanted

some were extrapolating maybe last around like you quarters quarter, So to up of three place last sort to quarter that patients it patients some of year, got per quarter, think case five we've at and two I out, more this year six XXX looks were you -- go. last to given XXX enrollment it

So and here enrollment maybe anticipated to going in could that changes are there about a any pace if trial forward? talk us you of

Laura Niklason

Yeah.

So the sure we've in certainly that's I'm and quarter was I last that disappointingly than slow. was slower not think representative. quarters It quarter other last seen

sites think going with meetings enroll the tough trial because enrolling fatigue, have we the I the that surgical we that many care new quarter slowdown a been I the been. our of trial investigators. lot sort last follow-on a an cycled of elective high Part And investigator it's with and of on have a think of sort -- And may in lockdowns. of of and throughout several had enthusiasm. activated new have investigator of this in just population to sort this out is COVID COVID. has all during trial pandemic we've

I'm planning is again, that that of going it's not to we're quarters. take more approximately patients So XXX. hoping to number The enroll several certainly

we're hard. leaning can could be And So and say a we're is less. very it again, that could into be a few few very more, close all I

Bruce Jackson

FDA analysis, completed data quick? the the I'm you've the to Okay. with the follow-up that And once to Great. going fairly filing, turnaround a then assuming in is be

Laura Niklason

identical we and By certainly the have has file would in of the depends indication in it already and for the the dialysis it filed to the and would components access trauma. components yes, And amendment but BLA, the indication dialysis already we components an quality always, BLA would be the manufacturing to would granted. indication, place been -- trauma be the as what the Well, on we preclinical time the are, results what this presumably.

summary really comes trial. a to it down the of clinical So

hurdles BLA be right, the going So we're you're to not that I one still definitely outcomes that what to are the outcomes what a timeline from the and filing Bruce shortened. But the say assuming know VXXX to again, hoping are. enrolling I'm could be we're

Bruce Jackson

question quick profile Dale a then on And Great. operating going expense for here Okay. forward. the

then kind how the we of do taking the that operating for moving XXXX, as you the launches? So as over the the changing expense up that of And see product XXXX toward marketing you should profile quarter looking we're like ramp be forward? expenses course current for and

Dale Sander

right. you're Bruce, Yes,

relevant filing estimates get sales commercialization a expenses, the later we can in not are process of we that's, We time that with about time, take going onto the at as bringing through approval But point up the in go those it to after than of much near a BLA mid-XXXX little that time see period come force. the with closer of what ramp something. will going talk in -- the approvals, the with -- Since we're to some the of and to process. to

talk hires be And earlier. it’s expenditures and the going so not come marketing to XXXX that being discretion. somewhat to the But in in our of expenditures we said, about and set when on that side level on XXXX,

You're right other expenses commercialization trial be clinical VXXX time increase, such that VXXX that will down, winding in expenses during frame. certain as and will but

upon some major dependent earlier stage determination, quickly market is we get rate spending got going based be in cash passed honest we're programs. Clearly, cash The growing conditions rate to are now we of going you X.X certain and years right have how inflection of points. burn election move stage development at particularly as on more on hand. programs terms value our today things advanced our of about ultimate with on of of part their hand somewhat to point that from And time. expand actual the we've that how -- to be just in to with pipeline, clinical it's and the So

the what be on of in believe us, as are terms for the going launch. But particularly right a to we're draw the now also of we've happening in available with part data based be for our to some that levels expenditure working capital sand that's got requirements what's line going requirements debt in we move to the We year. depending into world going to not the upon and discretion because XXXX associated capacity meaningful

Bruce Jackson

Thank much Got it. for you very my Okay. questions. taking

Dale Sander

You're welcome.

Operator

is with go Ryan question Zimmerman next BTIG. The ahead. from Please

Ryan Zimmerman

questions. topline But pace this, you do you I the of expect missed Thanks I for submission? given Hey. the together for data putting BLA the VXXX, Laura. Good apologize ahead morning. taking did if when enrollment

Laura Niklason

and is cover a we good so didn't that question. So yes, that,

that will we're patency, So patient the day the accelerated continues limb other survival that and of secondary position as pathway, because in on endpoints. this same it's to trial. And patency, really be be such be approval the endpoint primary XX the FDA will this primary that endpoints salvage

we So because XX last their line day and we've all following the -- will hand. endpoint, and because because have results once patient label trial hits top been this is a in single arm along, open --

our and we time the much enrolling IND, short. be will when of will enrolling line couple because a It'll already So finish we because we our between this I the when months. be the of when have only think time that manufacturing be also and submitted delta and that we been BLA pretty BLA finish again, results has in file when terms And top think to of between quick. we

Ryan Zimmerman

other that makes really a it's Yeah. that Israeli submissions, waiting done you're assume a that this and I last No, that lot sense. similar -- And to on. of would clinical of lot piece

you as sites at, and Israeli numbers they are aside, on enrolling know sites? patient where Israeli running bringing those I are at numbers are but Just Obviously, those the -- actively they're stage? point, at an up were this are this the

Laura Niklason

actively They're running. and up

they from has fact, but will. we to In yet, that as we of enrolled one just not Israel Israel a anticipate our operations visit people last week. had of

Ryan Zimmerman

then And helpful. very me. That's for one Okay. last

Just BLA you guys side commercial you preparing the commercial ready, on with VXXX activities if the some getting for, think hires have about BJ. to are started you what make and

preparing to at curious commercial think as making it kind was are what activities eventually you about market. this I you of for so VXXX, And stage

Dale Sander

ahead, I'll Yeah. go -- Laura.

Laura Niklason

a the No. certainly, clinical have little bit, and I BJ Dale. we're of just out terms mean, building commercial I'll we marketing. in team say the --

staff us a the price of to be and board third-party think healthcare they vendors access. lot looking to analysis at and We've trauma. far as the as as using useful been hospitals team at HAV most providers also look in for as far do market would market We sensitivity economics, have and scenarios and where according terms growing of in we're on health some to

outsourced, down that lot represented third-party far vendors, but this hasn't So, hires the feet it bit se been, again, far but been underwater, market of per a fair has the and as like, of analyzing path as duck work Dale fairly we're I'll continue. actually because of a has these let virtue by

Dale Sander

all I you No, actually think covered Laura. it

Operator

Thank you queue results further this call. for questions third participating. concludes you. This in Humacyte quarter time. Thank conference I'm showing all the the at no

Humacyte (HUMA) 10 Nov 222022 Q3 Earnings call transcript