Earnings call transcript Q4 2022

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Operator

Good morning, ladies and gentlemen, and welcome to the Humacyte Fourth Quarter and Year-End 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 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

periodic from reports could statements factors with information that cause contained actual in to is concerning our on made SEC. differ filed this the call Additional results

The made the and and presented or Form filed Information as statements obligation company website. in will during be this the be page may forward-looking except only which this law. our release update is call in as morning date undertakes on call the of XX-K, today revise to the statements, contained from by Humacyte speak the press forward-looking hereof, of the and accessed required Investors no this we issued

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

questions. Following will remarks, your available prepared their the team management for be

call over turn Dr. the will I now to Nikalson.

Laura Niklason

enrollment XXXX universally and close trials Human We're human also has made quarter very Thank in the update access, Humacyte and year-end progress results you continue both arteriovenous joining advance trauma and throughout the XXXX Acellular HAV business HAV Lauren. stage for we us or earlier programs. to for you, tissue vascular product in two to morning, our and candidate, in in our implantable, of Vessel. completing fourth everyone, Good thank our and call. bioengineered advancing significant financial

remain commercialization, on towards vascular focused regulatory we begin we advancing milestones HAV and the with indication. beginning XXXX, As our trauma

VXXX review key the recent trial review and that your humanitarian I'll Dale bringing be HAV completion. We program will pleased a currently of treated trial, the an the the this Ukraine, results, with All XX our have XX who've for our be will begin traumatic highlights with additional up BLA program before call progress turning patients who I open financial our FDA. to the in our to HAV total the of treated included results for our enrollment vascular we'll the questions. During patient then of in call, happy the patients, trauma. VXXX call our upcoming nearing under HAV with over a total to Phase received been X/X with our to patients, is in filing in programs We're and the XX. injury HAV

injuries or torso leg. trauma, who caused of physicians patients, of an efficacy iatrogenic the by trauma efficacy who include the trial. in trauma trial, in XX the analysis endpoint patients enrolled in the based vascular will extremity, suffered VXXX the arm on will is the or the The patency which be in XX-day primary either from HAV VXXX not The and trauma were

contribute will from data Although patients safety these to the database.

HAV. population trial, in the injury extremity VXXX with have comprising Currently, treated been the patients XX the

working meeting. BLA past should was FDA us the discussed enroll to support the bring the approximately patients enroll patients This recent additional to to We're filing. target in remaining with VXXX. that of XX expect six expeditiously six the We patients in

the in enrollment. efforts underway to Israel, in trial of speed add to we to to Ukraine addition now order the recent VXXX addition In sites clinical in have sites

Within trauma. months BLA out indication our partner VXXX a we been in to is autologous after map file of repair indicated with targeted trial to be with U.S. completion feasible. when the for additional The patients, extremity approval We've filing vein FDA plan the in for approval synthetic accelerated vascular six four and approximately pleased indication following BLA the for when trauma. not of an trauma is and HAV the graft will an not for arterial accelerated strategy

plans over Our pre-BLA other the consistent analysis, including the filing, the the for past with efficacy that BLA the several recent held FDA with meetings and are we've months. primary meeting

setting, Sokolov; HAV trauma, in to Dr. vascular injuries. Dr. particularly with hosted further and that potential the patients treat surgeons, Oleksandr a shared Dr. wartime of featuring Shaprynsky The Stanko, wartime who experiences their Vasyl Alexander in highlighted was in traumatic HAV we in the December, webinar the Ukrainian using

Ukraine I and mentioned they're and series previously, types the been HAV Ukrainian a colleagues now studies patients successful to-date. highlighting have case our their in HAV, the injuries of treating the with XX treated As with outcomes of shared

is that Humacyte of in zero can page patients A webinar, highlighted cases of [Technical Investors As the demonstrated website. all in found excellent a replay the Difficulty] webinar the the infection of be XX-day treated. the with patency on results

our the Ukrainian two Angiologists last the this HAV December extend Ukraine, the positive experiences in for Phlebologists presented The for Munich addition Surgeons, of our community. in joining and medical Vascular also gratitude Conference conferences their for webinar, webinar XXXX. to year, sincere in colleagues us colleagues to of and Congress vascular sharing In at the using and patient We Vascular outcomes our

our Phase an to the is patients trial our VXXX hemodialysis arteriovenous HAV nearing completion. trial, X of also trauma vascular in access Similar

that’s in Top autogenous to We're BLA have period filing been built disease. enrollment up will a follow-up the this remaining a study. designed will after in with for complete into about today is are of the This the support the in to one of patients this XXX trial completion, successful, we results this done a are meaning secondary in usability track be that patients end-stage enrollment as As trial, to report the renal access. patients XXX from VXXX two for reminder, to pleased is year indication shortly. with anticipated on enrolled on trial dialysis fistulas. that one hemodialysis assess If to very HAV line year and based the results comparison

Turning on to our we're bypass grafting in arterial type diabetes. to particularly from in our artery peripheral updates earlier-stage and in progress, or Disease, were X Results published recent programs, of six-year of patency XX% observed recently X Peripheral our to the coronary limb describes Science. HAVs researchers provide patients Journal of Arterial at disease, analysis publication and happy flow Surgery, Phase trial critical six years. Phase study. This X Vascular long-term rate a Vascular provide blood that secondary with the with ischemia the PAD,

of long-term this over of and relevant these period, evidence a patients of no HAV in was rejection We're clinically graft patient highlight the no the there limb. infection or and a results the durability that Importantly, treated population. pleased follow-up amputation underwent complex

it in post CABG host In grafting, November also update oral progress patency months promising and evidence Scientific integrity to of thrilled Heart Annual also structural repopulation six an robust preclinical providing in exciting program. heart maintains look coronary about We American forward Alan into and IND up to as study. bypass CABG preclinical additional showed cell for as the highlighted updates We're at Dr. the XXXX, the artery we or to at bypass six diameter HAV In Rex models presentation CABG our small HAV in HAVs implantation model of baboon that Kypson meeting. month his results a Kypson Association preclinical and this a presentation, patency Dr. a on remodeling. graft, program of to the Sessions of advance continues UNC enabling of make continue Hospital our and presented

Humacyte of directed research. award Foundation, which BioVascular will JDRF. and development Type of Humacyte's patients with Juvenile largest product X diabetes Pancreas, to treatment addition, Humacyte candidate, from the happy JDRF is funder X JDRF a recently the or on the the announce is In nonprofit world's funded at Type diabetes. collaborate is Diabetes the the of Research

turn that, review other financial of developments. and over now With a results to I'll our business it Dale for

Dale Sander

you, Thank Laura.

December short-term we of XXXX. December use million equivalents XX, period, short-term the compared and cash million resulted the December programs $XX.X cash, XX, and to of $XXX.X The commercial as of As of for cash earlier and activities $XXX.X had research stage million, anticipated operating investments the development related XXXX, net preparation ended to our and XX, year clinical equivalents launch. for XXXX, spending and including cash, investments for net from

We $X approximately prudent use and with our million less expenditures budgeted. was have had been for our of XXXX we than cash

cash, of approval XXXX, vascular investments our continue of we past trauma. of the through for that and to short-term lines the time fund end our are our expenditure, cash operations current believe to We expected equivalents potential in will monitor rate HAV and adequate

fourth quarter year million December XXXX. HAV. year XXXX, XX, to all the the related compared was for There to XXXX, to of of XXXX, revenue $XXX,XXX million revenue December ended the quarter fourth in for was of supporting for the periods Revenue for development revenue grants $X.X $X.X and the ended compared XX, no of

ended $XX.X and the expenses fourth of quarter compared ended million for for $XX.X Research year to XXXX. were to compensation for from $XX.X the a resulted year prior stock-based ended XXXX, The compared December the decrease decrease December the were million they development XXXX, compared expenses. XXXX, XX, fourth quarter December $XX XXXX, year the in quarter to non-cash the quarter of million million for primarily and XX, XX, for

increased XXXX, compared and to ended of prior year clinical expenses personnel support resulted clinical designed the during from materials our expanded initiatives increase and XX, the The to primarily studies. December support in research year

public XX, the costs. for compared to year including $XX.X December U.S. million company for expenses costs, were personnel fourth commercial preparations compared primarily $X.X to General of million the HAV, were and $XX.X XXXX, administrative XXXX. The the current being million external the a for XXXX, resulted the for insurance of services, to XXXX, from and launch quarter the ended year $X.X quarter December increases transition increased anticipated ended and of XX, and million fourth for smaller the year

$XX.X the of other XXXX, August for $XX.X fourth income associated was compared contingent with million year from million XXXX. Healthcare ended XX, quarter reduction non-cash Other related $XX.X with the quarter to XXXX, December the the and quarter fourth fourth ended the XXXX, remeasurement for $XX.X net XX, net Alpha primarily compared liability resulted the in million for for of XX, earn-out Acquisition for net increase Corp. merger was the XXXX in XXXX, year for The the December income income the to and of gains of million December year the XXXX, to other

$X.X resulted was December for XX, XXXX year of fourth XXXX, million $XX and loss quarter quarter from December compared ended the fourth The the million compared Net ended for current for XXXX. was year to million described income decrease the in increase net quarter, XXXX XX, other a net the loss for of $XX.X for fourth loss And to loss XXXX. net net previously. in $XX.X to million year of income the compared net of

XX, in partially the from decrease in income resulted year the The described described during operating by loss expense also year December XXXX, prior to other increases compared ended above, net the net previously. increase offset

it concluding to will back Laura With turn I for that, remarks.

Laura Niklason

updates significant clinical up are filing year, we're in build further we vascular our momentum and Thank be To conclude, in to Humacyte, the our you, we We're trial, enrollment ready soon and our take to and programs. to year preclinical pleased a we to trial. access Dale. VXXX shaping past excited to questions. made approach XXXX milestones. on for trauma, as progress AV Operator, and clinical significant both be to now throughout look BLA regulatory the move to providing closer will and our close XXXX forward from we the poised in we've is our

Operator

question from first proceed Zimmerman Ryan of line Thank Our your you. comes [Operator Please with with the BTIG. Instructions] question.

Ryan Zimmerman

like you Good for bit. of get appreciate maybe you and you utilization about kind speak and impacts and how the the the was little forward specifically of had in both trauma? Dale want FDA taking Laura you if in that think guys to morning. that some how commercialization sounds the VXXX product questions, the of it. I about HAV market? trial that to terms and wondering going a feedback could talk to for Thanks usage once Or I It

Laura Niklason

Yes.

FDA on as for targeted statement. the injuries patients, actually the So that our who really injuries. grafts. number both the vein but from trial for that traumatic of fact falls based vein/saphenous patients treatment indication do their not well in for for synthetic trial have also far and most always happy are designed for gotten direction suitable as The as vein contraindication saphenous vascular statement autologous fact the The VXXX we're synthetic been graph and that not we've indication out design, of really of and is really has the deemed VXXX the clarity analysis VXXX, as

wounds penetrating that known to example, all but for high for So -- many injuries blunt contaminated injuries, are at are have infection. also risk be

most if is graft most a so many speak of vascular really of will suitable people you these And in synthetic or most or with cases surgeons, that indicate trauma. trauma not

do the indication which as the saphenous limitation VXXX who to the available patients not enrollment the So vein, far is really as criteria speaks have trial. in

the right Something in that the designing that currently granted we we FDA earlier FDA trauma speak study gain comments X an after with Phase And accelerated approval fact to our perform after confirmatory we're the didn't confirmatory a with approval is approval, now. we're that we also indication. -- in asked the study that,

confirmatory gates we and of of, of to that allow would sort anticipate broader would a study the anticipation the would, indication. broaden open patient that Our population, the the us to study, is throw design completion

statement, that is But resists narrowing standpoint infection after not is the surgeons the be from who are to treating of hour that's immediately doesn't injury. going that something said, acute require harvesting that for the indication believe, sought highly and do we available that traumatic vein saphenous having very

Ryan Zimmerman

potentially the And what you're extremity Okay. just the limited -- is about you it limited is be to new safety -- that you HAV the injuries cannot or some I I what BLA? use -- think -- the to after your other but appreciate clear because including to be is though, or is in -- those you clear HAV just of can injuries can data, want the where

Laura Niklason

the So patients, on in the extremity. have extremity trial in the indication injury, data we're on statement is least focuses focused one because who trauma analyzing subset at an that anastomosis

more pelvis in And you do this of these is least injury This a would focusing of variety heterogeneous. slightly or sort an very of, group patients, because thorax, extremity in patients traumatic but -- of as to injury, patients homogeneous have asked the have imagine, also wide of, the extremity. was the some focus on FDA the one is is at injuries. these So the anastomosis anastomosis still a way although us a on

The you reality isn't isn't suitable aortic anatomies that current the match. But HAV HAV talk a about, the diameter the for example, I've is millimeter is diameter injury, of about. suitable traumatic the because if that the good really X for talked there,

believe very where we extremity HAV focus that the in So doesn't indication really the much. change the functionally will used be

Ryan Zimmerman

Yes.

makes sense. that Now

then Okay, and and then I'll just for queue. hop back last question in me

sites of maintain timing In I terms mid- of Or kind completion because nature the back think thinking you're it for Israel targeting? just VXXX the maybe and ‘XX? HAV still getting Do little do of you the we're, up the terms of, know some kind trial you of complete. bit you're patients of you're push a year enrollment Ukraine. I previously in think timing, this in bringing and of think middle

Laura Niklason

we're possible four six to Well, enrollment hard work We're hard remaining the enrolled. we predict more Technically, to of get a in six. Certainly, to minimum as as targeting trial. going always enrollments. trauma a it's need patients

per that So I the more. X would we're bring our of month up Israeli Ukrainian a will the of per the tick rate up all I recently sites. themselves one or bit enrollment the expect say has month, to enroll Ukrainian If above sites, frankly, with one prior would that the per month up little by able sites addition picked enrollment because

after would of that I in but predict, would that, next we'll and file. to enrollment XXX couple months we then that hard days the complete again, hope about So

Ryan Zimmerman

for the Okay. Laura. questions, taking you Thank

Operator

Thank you.

with Matthew proceed of Please question. O'Brien your line Piper Sandler. the from comes with question next Our

Phillip Paul Dantoin

our Thanks Phil guess I there. this for just piggyback Ryan's to taking on Hey, is Matt. for off questions. question

the trial, there? patient here can to additions of quarters. over, pace the you only touch number would it just on that And what, VXXX at X more, needing current that you almost just current imply six? the Can XX four of for X.X but which you're going two is the between guys For not and six remaining call to adding, a speak go delta you XXXX, are end for then quarters,

Laura Niklason

was historically, like other of Sure. in COVID one little patient trial -- mentioned, just couple VXXX, as sure, the I America, addition per by we've North these the every which Well, around has the negatively sites. a enrollment of months for been impacted That month. up with but pace in bit in of previously, picked last

we patients. that say we're it with these saying all having of because is I can months injuries. six six enroll will to So take again, reason each four patients to right a the heterogeneous and The is think now very few

is or patients the FDA. of the targeted that a us little But strategy cushion into provide with reality discussed we category focus the on. that have the of number slightly the patients currently XX buffer current to we've like FDA a would bit Our is to of XX that fall that above

that would patients And XX. so, target number we minimum, need four more to a of hit at

of be for want emphasize patients on our on patient been I us think to And -- really very had recent I able with provide were one in and do types the would lot with that to to analysis clarity getting the number they thing most them. we've well months a active focused allowed very dialogue glide and like more they filing. the of FDA has us on subset path a partner to that clarity and the do really to is have

Phillip Paul Dantoin

eventually for and for this preparing you. any on, front quickly. for And making it market you as that on way you activities? going then really That's trauma? helpful. in What's Thank gears prepare stage Are to just commercial shifting

Laura Niklason

and as also But bit you out even to team commercial in began XXXX. we Heather in and that filling part little Dale bit, may more. answer ask then of essentially, latter I'll recall, weigh a a the Well, little our I'll

effort have and So on focus we Marketing are health place market economics few staff weeks. next the currently, in access really we lead bringing the commercialization of a a reimbursement, VP in although on to with and

the really the providers groundwork the the provide So payers to economic health that is analysis we're able be into around cost-benefit and bring the to HAV patients we'll the around can that now to system. care laying and that health the benefits analysis

to staffing manufacturing Heather commercial let speak speak up ask our our And I'll to Dale I'll Prichard, to for But also commercialization. COO, readiness.

Dale Sander

that Thanks, and Yes. that a as be model Officer, W. seem team much core from both trademark in through right includes have think for prepared impact like of to time preparing to are important our that to items And there J. pass-through naming for described, the did the certainly, work is mundane, that, in marketing we budget Lauren, which product, that the in long advance underway time emphasis in Scheessele, are Commercial we Chief going beyond FDA. now as that us. addition launch, CMS, the issues, need items on longer the of reimbursement lead requires Laura which now, also things lead may NTAP, right be will the but well

that, there's and Beyond certainly I'll point of address that. to Heather of manufacturing on prepare a view, great going a deal effort let from

Heather Prichard

able update product our standpoint, preapproval commercialization. prepare for also our modules to as any don't Laura. on Thanks, continue to a for you to are our From inspection Dale and anticipate our be complications, BLA and track, filing. we we manufacturing And to we but produce know,

Phillip Paul Dantoin

helpful. so much. Thanks Very

Operator

Thank you.

from Jennings Josh your line with question. Cowen. proceed Please comes question TD of the Our next with

Josh Jennings

questions. Hi, for the taking good morning. Thanks

also, it? an market. Sorry or or to update hasn't make total that ultimate you no, update FDA, the clarity again. incremental once of the get addressable but just there. to has of BLA assume to sure wanted the reiteration thoughts bring changed, -- just And get That And any approval. just on pricing get trauma HAV wanted with But just this indication the from I

Laura Niklason

the Yes. this really We statement. being don't materially total indication impacted -- see market we initial again, by addressable

financial we diameter extremities. suited lower never most at is and mentioned anything models. any the millimeters in really contemplated know, our of as the was HAV you earlier, aortic upper X that I really in for in And injury injuries As

So that here. I impacted really isn't the think TAM

although any will product get HAV statement. best of or I trauma that of think will centers, pulled in the would where the again, letter off instances patient, Humacyte shelf indication use, the And the market get and never it's reality the surgeons independent used advocate for off-label in for feel the the is

think So I'll TAM clarifications. addressed product really speak I is the these let pricing. don't to by Dale

Dale Sander

to Josh, to Yes, good you. talk

that commentary put in made is As something the that placeholders in HAV generally I were around at our decisions you filings where the to know, until if we suggested will there, launch. were to pricing back time to time isn't per of about earliest potential at although there the pricing required range, SEC ranges, is price guess, a which launch. the you $XX,XXX decision time announced dig of be complex

you kind date said, or impact discussions of being tell that the care to versus That acceptable I terms even price be would that budgetary HAV with of that, looking suggest in within the the originally standard work of had we particularly other is higher can pricing certainly we've trauma somewhat treatments. our of also the using could And done market. than at vascular the that administrators strawman and hospital

infection original viability filings to to costs. impact the and of indication some years cost more associated and of ago, SEC other kind this and we've that on everything have pricing major level as to So that the so and the of since within than length nothing two amputation savings hospital in that's at of close avoidance the avoid our other such indicate progressed due seen those even changed stay with has things

Josh Jennings

are I very ultimate understanding some with I to the our get mean, And mean review these some of the VXXX. patients want follow-up and -- just on just understanding in enrollment can Excellent. that hurdles of for questions our And the enrollment? consent. terms opportunity. hard we you of for I thanks connecting pace to the dots to just just surgeons, on and talking market about vascular

wanted market you get patients. addressable approval, But you of the guys once realistic. total to face on your investigator addressable just and enrolling enrollment so some the translates And that how that total out laid that thoughts have and of hurdles just the that pace your sites these market is into have

Laura Niklason

a question. Josh, really Yes, excellent that's

ever of injuries number per really in the U.S. the of time. extremely by they been traumatic is By and death. injury. So encountered means that highlights definition, again, is year acute that it patient in that require peace type interventional a thousands if But done to enrolling HAV, big this tens the in enough treated patient repair of the trials even few to that just is artery what that injured is have vascular that bleeding It's enough the the an is. we've VXXX difficulties this of essentially reason hurdles be

events off the definition, consent. also, bleeding to in that by the if hours much, night. middle in patient Typically, provide a of the typically occur is not these And they're able

finding but a So acute who that are just give who repair, and consent enough require or to member give becomes right pool. sedated a consent to not standing are targeting with them next who can have severe to injury patients, able or small patients vanishingly conscious family

all places hurdles realities the and abide are of have So patient. that, enormous But clinical this it enrollment. for on trial, type regulations to just human every of we course, research consent by of

deal to believe to marketplace the constrained with from in sort continues Humacyte So are realities this trial. that limitations very we've of had different of the that that tightly

Josh Jennings

different going of taking the pipeline pursuing terms is that. or the that And any on thinking to to how prioritization the for HAV, in there questions. is all projects? those pipeline allocate it think and just you're of you're appreciate investment for I Thanks dollars indications lastly, about to each way the

Laura Niklason

we're are the focused intensely artery graft, coronary well pipeline vessel the the the as most as products small-caliber bypass pancreas. that Well, on biovascular

those Now those -- in trials. large both candidates of animal product both are of

And large is for So that database for application candidates, really pushing preclinical in thing with certainly is implantations filling the same both CABG indication. true the primates of we're pancreas. on very animal and the exciting. We're those which out the forward biovascular in

on there. it's III dollars of primates is those the small dollars, said, going our million the fraction low total That really obviously, for so in manufacturing, total a aren't areas single for the Because several spend. of active primate on clinical work, it's that's of fully couple total even hundreds, because scaled spend digits, Phase or and digits programs is with of majority order a the -- double which programs, of numbers different vast still the

we've of made forward as So total a believe total outsized is important incredibly decisions to building pipelines we strategic XXXX what think But the pretty the push for continue value programs spend in there's these on But to value for are the the company. budget we actually small. fraction there.

Josh Jennings

Thanks a Laura. lot,

Operator

you. Thank

Please the question with of Oppenheimer. next Suraj Our comes your with Kalia line from proceed question.

Suraj Kalia

Laura Good all morning, Dale, can you me hear right?

Laura Niklason

Yes.

Suraj Kalia

Yes. Perfect. Congrats on all the progress.

and trying FDA, understand questions XX non-extremities, number? the adjudication all. efficacy the and for about got enroll during XX? my number this to supposed versus if were headed I any which forgive your in with discussions numbers to the trial originally led So Laura, Just where efficacy I there me at wasn't to in difference wrong, VXXX, safety, I'm following up new on guess, if is, just the

Laura Niklason

are Yes. Suraj, those very good questions.

required to and to enroll XX give that yourself to take, file. been really of in that XXXX approximately the that then really be. we what patients and on of focus number the guidance -- estimate could summer So FDA the discussions we've would subset ongoing has market, with an we since VXXX based before And was on patients and about patient providing we the or which would been total expected what was

a FDA patients. number, as the a the So effort by more subset, But to XX at currently, that XX really was mentioned, we're again, patients an of as set homogeneous. total I focus was on

patients. actually So so is injuries that five only just of have small. the the specific, number number torso the -- we pretty trial be to in of It's

than extent very and the a of your you if those really different vascular disruptions, disruptions definition, injury. torso, thing a mortality survival very vascular injury is And because patients by your just is game the vascular in different a limb in ball you significant have have if

to wanted again why set homogeneous exclude also FDA more patients. that's the the And had patients. on they a So us of focus iatrogenic

don't iatrogenic FDA more as to injury subset So XX wounds actually I which views -- more we have sterile the be patients, to a discrete. environment. tend or because be tend gosh, in know, XX these healthier They a patient

severe, So purposes injuries, statistical of asked out patients, the with injuries, FDA iatrogenic carve patients. analysis for were the and more then fatal to the perhaps actually were us torso discrete which which patients oftentimes

limb vascular really of And middle the civilian sort are injuries both majority majority occur the settings. So of injuries that military the left in with vascular injuries. of in the in the patients and the that limb

again, is number a population. of more on homogeneous to majority, focusing but So yes. this -- slightly the trying the get But

but was number. estimate. not number our hard So -- always was a XX It the

Suraj Kalia

on an enough. is patients additional Fair VXXX, label. Laura, enrolled. remaining Obviously, be open to two this

we So between I'm do to the need curious also. why the need in -- statistical just we in understand -- trying FDA's VXXX, happened is Just given difference still XXX? approach that still are there issues here what's some get we to to

Laura Niklason

to prospective that I protocol the not outset of based but privy certainly, at the This performed And Humacyte of number we patient VXXX calculations are just the number and of staff with power emphasize a ago. blinded. randomized to that the to trial we trial. target trial the the results. on following but is XXX the the was Well, just the agreed is we that to a Humacyte And want is open FDA years trial label that “open-label," are is investigators, Humacyte

to to trying been we just the we've FDA. agreed to with hue what So

a really as are rate are and COVID, again, these as hit patients. are acute obviously during surgeries patients patients obviously -- know. the as enrollment These we And trauma took dialysis elective not

trial enrollment target finally the the So just pleased we're getting we up to agency. to wrapping this with to and be that agreed

Suraj Kalia

questions. Fair taking any going you involve, all enough. finally my hop BVP, from you And Any The Laura, color in to any appreciated. plain I'll genes, but additional iPSCs, with congratulations say for knock be going lines? partnership. that on is time greatly any in queue, Thank I that genes, would back are vanilla shouldn't JDRF, side, my out to edit

Laura Niklason

Yes.

of looking native islets. closely cell-derived at commercial be taking very manufacturability potential we're -- stem control on of of cadaveric obviously, going of in islets which program, We're because, a islet using sort setting. mean focusing in brings we're islets as are the BVP multiplexed I approach. looking cell-derived also a important we very the is these So but stem any and at to that supply, part

We are certainly looking cells. at privileged immune iPS

do looking generally not community overexpressing investment as will that broader the what I privilege rule, say yet we've therapeutic types be with at. a shared of taking I immune line we're in But stuff general generally out. exact patient little and a from new for standpoint a to going genes then than adding regulatory a a into harder stuff is cell believe that's

we path So be anticipate might might which adding in removing regulatory that overexpressing will be proteins, in new genes or rather add easier more immunogenic, an other words, forward than hurdles.

Suraj Kalia

you. Got it. Thank

Operator

Thank you. Bruce proceed Benchmark question comes the Please [Operator The Our with Instructions] Jackson your of next Company. from line with question.

Bruce Jackson

yet? inspection net on Quick follow-up you good for scheduled taking and for morning, the my Hi, pre-approval questions. is manufacturing, that thank

Laura Niklason

Heather, that? you want do take to

Dale Sander

we go -- ahead. Yes. No Bruce I'll

Heather Prichard

No, Bruce. to you. talk Nice to

had We scheduled have yet. not that

after get scheduled the that FDA filing. pre-approval BLA will our filing, inspection our they So by be

So it after scheduled will be file. by we them

Bruce Jackson

one be Okay. presentations, then on earlier stage CABG this any Great. cetera, And et BVP publications, program on or there program year? the the Will programs. quick the follow-up

Laura Niklason

Yes.

certainly So we expect that.

international presenting are at, a on we're present to expect we have not we to the and both to the know already position really which on submissions let BVP -- programs. I'm you primate level are meetings meetings but We program. these continue program, made CABG various active to national, in

to And appraised. so we're going market the keep to continue

Bruce Jackson

Okay, me. quarter. during progress the it the great. again Congratulations That’s on from

Operator

quarter participating. further no you conference queue this call. XXXX all Thank Humacyte year-end in This the and showing fourth for I'm concludes results at time. questions

disconnect lines. may now You your

Humacyte (HUMA) 24 Mar 232022 Q4 Earnings call transcript