HUMA - Earnings call transcript Q4 2023

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Operator

Good morning, ladies and gentlemen, and welcome to the Humacyte 2023 Fourth Quarter and Year-end Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded.

I'll now turn the call over to Lauren Marek with LifeSci Advisors.

Lauren Marek

Thank you, operator.

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

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

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

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

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

Laura Niklason

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

of for and highly Our productive start the been have quarter fourth XXXX Humacyte.

the trauma this accepted our BLA in the indication our in and biologics HAV year. completed FDA for of submission the Humacyte of Importantly, February license application vascular in December,

caliber made Phase preclinical results and trial of of heart juvenile HAV small course trial on HAV clinical publication for model. the our dialysis completion in Over XXXX, broader results also disease publication peripheral of in III of access, in the and of the enrollment presentation our we our pipeline, including progress arterial

the up call of results. your the developments During I'll open these call, review Dale today's Then to review happy financial over detail turning we'll to be call to for before questions. a in more our

I'll II/III from supported with by our XXXX, submitted wartime was the evidence In that The robust injuries humanitarian to included data VXXX also Ukraine the we was BLA our vascular the in This December real-world program Phase trauma. FDA. FDA. our under clinical package treatment the included a from of trial. program positive begin in aid HAV supported BLA package that by results

showed lower rates HAV package the and synthetic patency graft historic higher that had of amputation benchmarks. and infection data compared Our rates as of to

X/X which grafts. XX% trials the These of vascular XX.X% combined, York. were compared as at provided who also their was to words, presentations X.X% surgery compared XX-day rates injury. HAV suffer an which synthetic lower meeting were grafts. flow is in synthetic November blood at XX.X% have other for for infection after patency to month, with amputation and infection only grafts. synthetic for historically the as The HAV the an HAV likely at compared with graft. to were as furthermore, the conduit recovery likely VEITHsymposium, X multiple as to their HAV key X/X period patients lose reported the the In for extremity And as of treated the lower held major demonstrated a is flow also a to HAV of a historically likely with or rate only to for through compared In to treated as patients after X rate also of presence XX traumatic for patients XX.X% amputation X.X% days, blood where a synthetic New graft in with had rates results only X.X% patients

review designation The granting of of also August In a accepted Defense vascular XX, and patients reflects are and the given a of by review their personnel. regenerative of are the User of that or action the standards prevent injuries FDA's XXXX, review designation for also with or or Priority to this the FDA's BLA serious trauma, the our American recognition that severe review treat care. their FDA under a to that February Prescription of Secretary life-threatening grant establishing RMAT current aligns with priority goal priority prior underserved for expedite by Act, to military Drug enacted arterial facing diagnose, the decision repair. conditions with XXXX. urgent PDUFA therapy law priority medicine that date consistent Fee many products also is grant are We advanced intended believe for was HAV

vascular data the goal injury. Ukraine, strength The humanitarian our trauma, the are the Based look to on forward with for trial to BLA the regenerative us acceptance product of brings date providing with our package, VXXX step in of vascular in patients who experience closer another we combined an traumatic from medicine confidence. suffering from data innovative PDUFA

dollars to of traumatically care for drive in health HAV trauma strategy. an outcomes, commercial it's of Humacyte been developed derived U.S. we uptake market complications even upon system. In Health conduit are help benefits believe, the out revolutionary thousands well tens provide from databases of economic as of preparation FDA candidate will, infection, product of build this anticipated of benefits injured for is economic historical national sepsis approval, also care of can the Costs Avoidance these extremely team the important injury cost costly Based as the for patients. synthetic are of care. health and the our which results the models traumatic amputation or important adding clear as to in that care hundreds part to high working large of go-to-market have graft

end treated investigator-sponsored being conducted Clinic is peripheral disease. limb-threatening artery Mayo stage presented an the in In the program clinical the FDA-regulated were that's our of results of patients the to now PAD. chronic with Most study as fall, surgery not a needed procedures. ischemia, at HAV in not Turning typically and bypass patients which which from type did suitable procedure. treated the of is and their bypass below of Treated of the patients is vein with knee, to angioplasty a have program well disease stents required that perform own part

lower And critically to so limbs. their received the revascularize HAV ischemic

to observed VEITHsymposium the salvage and is requiring resilient This that for approximately in do since Vascular the have at and XX% important saphenous limb Conference, an did the available the effective flow. arterial vein presentations not patients restore In a of who was vein in a bypass to result researchers HAV at patients study, clinical conduit for extremity conduit bypass lower and blood have Midwestern revascularization. provide safe, not

showing X.X-millimeter cellular Thoracic this millimeter to With Journal condition is in described by repopulation been every remained Fallot. each similar study In regard Columbus, which in XXXX, to researchers large that the HAV affects patients. from in Hospital model a animal X year. the months Cardiovascular potential publications, investigational HAVs study, up October heart in host and of preclinical preclinical and publication diameter human of long-term a small is heart observed U.S. in Tetralogy a patent In cells, the these Surgery for born treat of This the X,XXX into disease. animals, juvenile the Nationwide Ohio, a to to pediatric diameter in implanted for evidence X.X HAVs of what's X in of follow-up Children's babies showed

more adding manufacturing demonstrated heart that extension study also platform, a Humacyte's than The the the manufactured of the for vessels X-millimeter been decade. pediatric vessels to X.X-millimeter have

our X-month human coronary this evaluated preclinical data And bypass. As clinical implantations support long-term trials the in excellent vessels in in filing artery reported artery reminder, We've a in large currently support in previously into are IND to coronary X.X-millimeter an gather large in being bypass animals, studies year heart of HAV surgery. continuing of as advancement future results IND-enabling are bypass cardiac animals. we in

a the The as scientific synthetic structure may had native-like have to of the Researchers HAV These cells. conditions. basis infection all rate. that immune of of a implications Vascular that study compared zone study be observed results in a to preclinical of graphs medical rates published the body to further limitations the infection potential for of of lower and Surgery, due This Journal low the the synthetic found tissue have that significantly results were HAV for HAV's wide provides the trials with indications July, clinical our also supports Science. bacterial resistance a solution HAV's intended superior broad the a range of In graphs, compatibility in our Vascular support been in infection HAV.

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

Dale Sander

million cash as Laura. equivalents cash XXXX. We had you, of XX, $XX.X December Thank and of

our substantially raised proceeds March X We also stock transactions to we offering closed of cash added and completed XXXX, balances. in On $XX.X X, common approximately early underwritten net of public an million. XXXX, which

that development research ended the expenses supporting the $XX.X compared of clinical $XX.X the expanded December $XX vascular of for the There of XXXX services in was March December year revenues the believe for grant XXXX, related purchase million with approval HAV an additional million and anticipated trial, $XX.X studies, XX, of revenue the during increases VXXX no II/III clinical ended including for The quarter of HAV million In VXXX addition, year compared in and December Ukraine personnel, and XXXX, currently quarters external were $XX.X of and HAV was our expenses We no the XX, December Phase XXXX XXXX $XX.X the finance million completion $XX our XX, to the XXXX. Revenue $X.X the use XXXX, XX, year for in to XX, past and proceeds expenses adequate trauma indication. for used year the initiatives XX, net the and XXXX. for well and was in the XXXX XXXX, agreement equivalents for was and we've the ended HAV development and of for ended well Total operations cash under filing dialysis for from in use our the received the Research December cash and fourth development FDA trauma year supporting and million Capital. as increased ended to from our were that resulted extremity our development revenue to as and fourth there BLA are humanitarian on timelines of draw XXXX, million to year XX, were ended Oberland December cash million XXXX. quarter the a for was fourth compared access. vascular million December completed materials XXXX. primarily trial commercialization our for for

in compared for $X.X General million administrative of million XXXX ended the fourth December $XX.X XXXX of XX, were for for December for $XX.X year fourth for from the XXXX. expenses XXXX, was HAV quarter XX, XXXX the trauma compared ended indication. XXXX. and the preparation ended net compared G&A of were and year the planned net December was net $X of to XXXX XX, or to for The net Other expense fourth income the XX, million increased the million driven for commercial slight for of million ended launch the XXXX quarter December $XX.X million and quarter primarily net compared primarily personnel the net the of income quarter of costs, resulted to year year increases of $XX.X income expenses by expense million fourth million to of in income for $XX.X vascular XXXX, $X.X

merger Healthcare increase net remeasurement in above. fourth December XX, of fourth primarily in the expense compared million to earn-out December contingent in the $XX $XXX.X compared the with loss December resulted the Acquisition Net the from quarter XXXX, other XX, Corp. and million increases was for for ended primarily The for liability to XXXX ended other noncash income $X.X contingent operating expenses, XX, for the Alpha million earn-out remeasurement XXXX. described was liability August quarter XXXX the loss net and the year XXXX of noncash The reduction the resulted associated the the The XXXX. net from in the XXXX increased year year net million $XX.X loss both fourth of of of XXXX for with ended quarter

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

Laura Niklason

vascular all as programs, accumulated trauma the in continuing and repair, could has what and patient a complications. including to you, company, to of earlier suffering exciting to dialysis is look a their I'd hard from very we're clinical vascular progress our of experience for incredibly study programs worked X,XXX peripheral already we HAV only this thank in are HAV the and approaching programs. This moment The and Humacyte of forward Thank for with point, the for and the a the And access Dale. continued stakeholders. Across like transformational our to more updated today. to variety years and to has our for a artery for than thank joining us our technology be you team to value. partners entire We Humacyte not you its time potential commitment our in as our our reach diseases of team take but patients well time maximize all full order platform disease. keeping

Operator, questions. we're ready to take

Operator

the from Ryan [Operator Instructions] with line question of And is BTIG. Zimmerman our first

Ryan Zimmerman

me okay? you Can hear

Laura Niklason

you. hear can We

Ryan Zimmerman

It's it. Dale, progress. to so we about health commercial start, you to the the just doing. as can you and close some reach alluded economic Maybe work out you're preparation, touch on think of Congrats

that X priced can you'd to questions like as the what that offerings kind ramp it investors about of prepare extent of you be elaborate and think kind we commercial the have I target like for kind is where and of think opportunity about on how to activity? where spectrum thinking at? looks you lives the should in the of product the you be that And economically of HAV the

Dale Sander

infections at superior HAV and the results budget costs comparable and standard like to largely a the amputations overall will of order. injury models, due that for the is current with grafts, be Yes. impact are such which far to are case the care Thanks, take saphenous of providers, developed that clinical are going I'll this in produced very those re-perfusion which our and reduction obviously, biologic, believe somewhat stage other the treating Ryan, acquisition in and the hospitals the synthetic priced that in today, this will the which of complications expensive But particularly HAV be in has that, But to that of vein we favorable. higher at as it's case, the very complications cost standard try than patient care. show

that And as itself know, a launch usually you vacuum. in at the because pricing time to you announced and is of determined want do don't

But as could in the that But you story. complications the range meaningful it clinical be of going somewhat if You product. benefits and in the at story earliest the we've economic the that and suggested economic are about support we be talked be higher. want SEC due be range. lower, will going to to our $XX,XXX look past, could do reduction somewhat is pricing with demonstrated falls combination that the to health product, health the had I this of the to within think certainly wherever Clearly, filings, in something for

trauma pricing. somewhere hospital and the the the United cases at at specifically in could States, are billing that applicable And immediately at around we information XX,XXX drill we market that, a vascular there's down XX,XXX codes looking when Beyond look a believe, million to this about the year that least of the on kind There's very are be HAV HAV be each within and clear States. suggest United that, question dependent low-hanging other that market I fruit you had like candidates $XXX-plus think used most and is for range which that size. the ones by to cases, within the

answered your I've but [indiscernible]. So questions, hopefully,

Ryan Zimmerman

fully It's still not know out. flushed these I early. No, no. are

will think get emerge more there. you I As clarity closer,

just question other is burn guidance. around cash The

offering of equity pro some and Overland. think the tranches from forma the I with recent

range $XXX today, equity you're million gross and around recent the not think proceeds I'm the about mistaken, on as based [ I $XXX.X of if offering. million ], that's the from

this of So commercial can I'm prepare XXXX maybe you just any kind commentary you for spend say cash directional operating do what as burn, on launch? curious around for

Dale Sander

Yes. certainly. Yes,

operating about view leaves XXXX for And your cash, draw -- $XX we activities. burn million. with cash expenditure back it in our a the million a add math about very as and around we capital net $XX.X $XXX on our out XX in at from little when XXXX million into positioned financing Overland which equity is to well is we've from well, net the than in cash look of burned us million as in entering we're the way That about ended of transactions those $XX if December point with effect you that cash. achieved the I The well through of right view, facility. an rounded year financing the means we additional million some we think more $XX-plus point right. But

with right well that So we're now. have hand on suggesting the very positioned cash we

in In proceed in the relatively we'll expand this that very a time the given super the force upcoming commercialization guidance, we year, haven't to of share on terms specific how what activities to including concentrated the launch, market. year, of we certainly, sales guided I'll during but our address expect near past small is bringing we've

So have, a with year. that of for do the of the we obviously, have activities not follow-up as BLA. commercialization VXXX the the intensive and clinical study close prepared during XXXX we of as costs wind we filing study also will expenses higher had year long-term as in But just and we down certain during this for during out

the be too. the And of down year, winding then second in also will our dialysis trial half VXXX

certainly certainly and adequate or AV upcoming for net but we increase great past a launches hand cash to we that well and through well a is And past XXXX. take basis. not somewhat access us of burn in the an in extent trauma believe to on commercial So expect overall year, on cash the the

point concerns this time. any certainly at don't we have So in cash

Operator

from next Kristen Our question line Kluska with Cantor is the Fitzgerald. of

Kristen Kluska

touch scrutinizes during Congrats very something well FDA I PDUFA closely progress. wanted is as as and on on manufacturing approval. the often on to that this drug

you're to be upcoming So how for about inspections I the feeling prepare that FDA and your will you're wanted manufacturing? conducting? to also ask doing anything And meetings

Laura Niklason

Yes, Kristen, for this is Niklason. you Laura Thank question. that

rapidly after also which PDUFA scheduling file FDA meetings near the in the got inspection, August, So yes, upcoming accepted our was and begin in moved interim is and we our the date certainly, BLA future. to

summer we mock this X FDA did actually Humacyte As on far for as upcoming month prepare And for all to occasions, in prepared in consultants dive brought inspection. this, really we've where last been who last were to really X February, what doing as X run be X inspections, as just we've they helping possible us inspectors. and separate a ex deep

going I execute been we from of on that to is really the this since confident last for to in we're go. very would out, were remediations say how We inspection about able we've is preparing facility that the picked great certainly feeling this shape. that began believe And XXXX. summer, all

and you're is But process. Our robustness a with manufacturing processes understood. of the right, for well believe manufacturing focus are the the in always and we big the Biologics, well characterized Obviously, shape. good facility and on Center we're

Kristen Kluska

the the applications juvenile seems platform. talked it animal to the in different highlight Great. the of And you that HAV then about preclinical study model,

flexibility larger-scale for program? to pilot or it platform So about different how are you go the and about you your this might as on implementing relates how vessels thinking current

Laura Niklason

the each specifically HAVs machines the beauties that designed modular designed year. which of were intention was about with So and to of up X be manufacturing now to this platform, can as XX-centimeter Those right make X,XXX flexible. our so Luna of per -- and the is

of changing grow without tubing. involves same diameters some and of using It sizes can itself. the the and we bag only machine, the So plastic changing machinery of some lengths the tissues different really different

call, been pediatric been as and and making that system in years, we've making animals. them are millimeter heart So the current we surgery, last testing the for vessels we've been in mentioned we've in couple our suitable X.X for of bypass heart those

equipment. and the some added pretty injuries for a conduit. vessels longer, Conversely, and from our trauma future we using vessel. where the disease, It's system our vessels, longer shorter be a Phase X-millimeter the we working us, down XX make that we're have of utility also, growing longer traumatic the that future, vessels, the knee centimeters peripheral programs, are short utilize also actively can vessel, in -- with may arterial because from in believe can may below would extend to hop don't shorter again, we believe, but They patients in to it many in which indication a benefit modify same require that or also II make can shorter the

we're the approval, manufactured we of were using pivot the designed intentional will going So sizes. would say same different that. and And slight our we product and candidates platform that vessels so we tubing. I system And will very follow-on modifications when be make that be in shapes doing forward, just of could after already

Operator

is from question TD the next Our line Jennings of Cowen. with Josh

Joshua Jennings

reimbursement -- thanks I wanted understand just just color to But discussions data, payers [indiscernible] on economics expect and the on up just question health on any any wanted download there's better to Ryan's you how follow for with if payment evolve launch there. and from can place. think private in and trial how indication you And there? kind then Medicare to for and color the reimbursement and of time the DRGs as any evolve about vascular just HAV payer

Dale Sander

certainly. Yes, Yes.

essentially will supports interactions parallel presented the we advance will launch. of of and course the which and through cost presumably model year, the proposition the start date, hospital impact those we've is which then data rolling you as using be impact also complications. interactions payers. implications the It in in in our budget other model. with HAV administrators, published to the extent discussions essentially are The had with value really the hand. HAV of the -- can And to CMS save with and private And budget So out discussions of and of with itself, intensifying --

the being dependent patient is indication where your the going specific reimbursement, the questions HAV -- be that, is and upon served. specific is Beyond to reimbursed around though, also how

trauma, that's to surgical regards an with inpatient setting. specifically So

be you And a reimbursed to generally hospitals fixed a price going are so or as on DRG implied. basis the

the separately that acquisition an the biologic save the a And in patient additional And mind why of be at core, innovative a for cost clearly, new HAV, also economic reimbursement, will health would the so is new reversed implications HAV, would is believe, as to the keep it that technology and we complications NTAP HAV normal qualify which is the or under payment a important. will hospital, these which so of reimbursement the not and cost add-on which ability an for as meaningful technology DRGs. not an But its it's an give benefit. hospitals because get reimbursement provides NTAP they the HAV qualifies because by

both are will be But private in reimbursement reduction the the the associated and money will with the because other substantial motivated equivalent prosthetics I hospital, in the of provide complications patient in NTAP ongoing costs of who the so during leaves payers the patient to of hospital. other and the can think and like HAV and But the once savings payers amputations then an save that. only the not amount terms rehabilitation time do CMS present is a

the leaves in use also we once it the savings provides hospital. believe the production to private existing the of product that DRGs, So will and equivalent pay will of but NTAP the get HAV complications, favorable very from that innovative patient be due nature of the within that the because we the the and

Laura Niklason

that public there, that applying would necessary HAV also be code part has thing a and ICD-XX domain, this CMS the an and NTAP, and a as CMS ICD-XX obtain add given the domain public in of with -- from the on only Humacyte that CMS. meeting recent had we the for to the And it's in code. was Dale but recommended I is unique the coding

It's that's for application year. later filing important step. an precursor an so And NTAP important the this to

points, I due going traumatic are Medicaid say providing going to understand And only for definitely the from that costs Readmissions insurers hospital reiterate wanted initial want this. adoption which amputation CMS injury, for And cost to and strong. in complications and reimbursement coding track. to is a are think be is also I terms sepsis are to payers that just Dale's all very and huge on the initial severe hospital add-on and I and CMS So support the and the standpoint, for very of payments we're costs private in also to to the equation. infection I drivers are trauma, of and case part think, HAV for important

Joshua Jennings

HAV well And the Excellent. as the year on benefit follow-up then when how could their AV from share you've health Fresenius And work from remind if down the indication most that we come here? And patients also indication more done a that leverage just on could any you I'm for sure set collaboration? the or details timing large of with in access can that access just indication. through filing data AV from move there's as as economics, intel us you can the trauma vascular not

Laura Niklason

we're to we've looking forward sharing several as on said calls, Well, information. that

year, picture week, have lot patients gathered event with where a Fresenius, that for data -- a a than that are. of and a the we're present that really of of costly to partner, we're who are we've next so we I our can think going actually KOL Franova paints very to patients do more going the I most how say some clear costly those

really looking will week. we're that, next forward and So be that to

potential BLA supplement dialysis for how data leveraged as will access. in a be the far trauma As follow-on

to within and agency know, will at be tends you As indication, look safety efficacy that data the their primary focus.

will trauma different is a going as part just efficacy of from since be of and also But our that to think follow-on, from that updates course, that providing update I file. long-term safety drug of report really realistically, part Although, trauma. be an just we're particularly the I'm dialysis safety standpoint, sure indication

efficacy the will think thinking. but data, dialysis from but trauma FDA's into I indications, be focus safety would the factor on that I the would anticipate from especially all information

Joshua Jennings

[indiscernible]. and is leverage can And -- my Excellent. assumption you the you manufacturing can on also modules

Laura Niklason

course. and of yes, No, of the be are that. of Yes, leveraged. you identical, the the Absolutely. identical. Oh and -- product all shelf preclinical all life for is would Yes. since that the data Yes. all Thank manufacturing

very So helpful. And efficiency generating. be that will

Operator

Our next Suraj question is from line the Oppenheimer. Kalia of with

Unknown Analyst

Sheamus is for Suraj. This on

HAV guess, dialysis I we enrolled. Just filing? at that? on almost start, us year been to can updates fully has results could for I know top some you this expect Any point, access when the give line a

Laura Niklason

Sure.

enrollment So in actually last April completed late our year.

a at while. the started point pre-COVID we'll is many large next This It month. technically, for XX-month that centers. a on hit So trial went

months So take pull us several it's to data together. going to this

we've what So top we the the the in this year. quarter is would on market VXXX third of in that expect results trial sometime dialysis line guided

Unknown Analyst

thinking for you Got for it. I what I XX How those people? initial And of think you'll force should around give about individuals. the through guess, the then hiring you've have percentage-wise ramp can know there of just said roughly kind we updates would trauma. around and do XX date. you PDUFA sales somewhere as be Any the you us where

Laura Niklason

Dale. ahead, Go Yes.

Dale Sander

Go ahead.

Laura Niklason

you ahead. No, go

Dale Sander

that less be sales to about them in able think centers. the Yes. a we've reach trauma we market. and indicated within Yes, XXX I force that United somewhat with of level than the XX to States concentrated market expect relatively There are

be more built right much is the team team that In brought terms get for exact of as closer commercialization to of management sizing infrastructure when complementing around current group and the will probably in we that now of be launch. being terms our the But of on sales the group. that will specific

approval We'll too actual be whether they X segments or or way. entire the to X sales be accommodate that get day to to on into under decision a we In much team we'll will facilitate it X as terms time But launch whether active closer will that and decide the the are brought brought layered launch of to be far on as as advance. exact close. now, those that that right much, reps, will the opposed make in of decisions discussion are

Unknown Analyst

just it's XXXX last believe guys NTAP to me. cycle, or And XXXX? a you The X Understood. for going one do event be quick

Laura Niklason

best application, that. NTAP file Typically, the earliest we be of decisions our you are revised this -- when the can after couple can on So for made then will that based an year. quarters a but And October scheduled but I NTAP kick of be -- file earliest expect NTAP to rules the in knowledge October. of believe, application to an my XXXX. when successful, Again, date we can be we apply October our would to in, of this the reimbursement is

Operator

the next of Bratzel Allison line question from Sandler. Piper is Our with

Allison Bratzel

for setting. dialysis Congrats vascular the the on progress. on A Really access X follow-up just me. all

commercialization the adopted of success out QX, you just remind Just could the on VXXX for as the for trial that the reading you lead for dialysis trial us being What HAP do and filing plans out? to you show female hope in just in see your bar patients that kind reads trial does would And how widely to ongoing what in indication? play related, that then when just access. into

Laura Niklason

these for thanks Allison, Yes, questions.

patients in in broad at the a VXXX prospect HAV a range again, the than more to compares of fistula trial sites is So blinded that U.S. randomized the XX of trial

so and hope groups. and Obviously, how endpoints our to goal trial across we trial. all the line, Again, our a we and for have going it's is have are board, go. is the this for superiority X patency don't the months, dialysis looking whole So will and superiority are know don't blinded, and at for across at that we we and XX usability primary this patient top trial

would it's Again, However, or data. more of compared beneficial groups. effects it hard we advance as to subgroups is show the that that predict possible have very other would increased to superiority in

be give And either we that clinical that, had data across but HAV if already subgroup, hope the product indication. so within superiority I don't trauma an that be would would in here, the or approved in trial that hope supplemental that with to in guidance dialysis our I perhaps would specific want a to indication, for XXXX a sometime sufficient in combination file the BLA

to and trial, KOL it week. As the women this on women. on going -- comparing newly be that's we're in trial focuses focuses the again, fistula more we've at that far the it's to smaller very trial, as that really female-only HAV a a And event discussing initiated next

are women health based and Franova subsets the in and who in the on patients, around looking And the rates dialysis that general, And so women case economic clear work again, from will for gather ahead with and of trials rates. female we that suffered to help system. our additional complication HAV believe are that don't really complications health data have high complication are have our by high story clinical very at extraordinarily of it's economic make the call. the combination on to there this going extraordinarily with want expensive data in patients the information But I the certain Franova that and data that become get here in we're our

Operator

is Wainright. question with Vernon next from H.C. the line Bernardino Our of

Vernon Bernardino

launch. this forward Congrats definitely looking the the to and on later approval year progress,

wanted few to on questions. up follow Just a

them being said, expenses what you Dale, year. of to the rising according this One

said ramp you -- as down maybe. there's anticipate R&D to You probably as be far a going

of that that's of ramp-up the mostly question. heavily then therefore, the And have G&A? be so follow-up OpEx And will most the And year, the because be from back course, be? anticipate I when would and do of towards would a expected maybe you launch weighted

Dale Sander

right, down commercialization trials And of in of point wind terms sales are clinical the you're model certain R&D mean and right in down the that somewhat of successful there a impact everything is longer winding the -- budget but do of view of place activities which of team a Yes, commercialization, expense. meaningful kind reducing of the of a in that very going number cost as for of second to effect will to to the right. the those launch. appearing in costs in into in date. come manufacturing are ongoing, undertaking be rolls I has because commercial include those applications half part do expenses are ICD-XX the of certain get are we R&D R&D for manufacturing year the And much addition sales, increase heavy lead from which a codes and of like the But also activities that, and because other much force. Much move is with expense part of expenses have you're we time we ready now, a of towards

overall that, XXXX for expect just basis, an slight a on overall really net increase burn with XXXX. we in compared So to

Vernon Bernardino

manufacturing margins what of -- you mostly you're so Laura, making, equipment not the HAVs? regardless and mix small on. improving or the of whatever large alluded say, same or to over Do regarding diameter you time anticipate And had of using versus whether same let's then since using you're

Laura Niklason

I COGS X example, over say are vessel short XX-centimeter down And apply both vessel future, the road. a There of sources we're regardless decreasing would say, main in time. whether that Yes. making a of or, for the

floor more of a just out manufacturing efficient built facility. Right is first of XX. we now, fraction we installed, for we although only Lunas X have our use our have a The have because room

the So of inherent fall amount we're costs all production overhead of linearly. amortizing production across as increases, smaller essentially that facility obviously will a

of prepare will we're bring But which in in to our negotiate there of we are in our result we greater our believe cost we and COGS able raw scale some with materials, to that addition, efficiencies suppliers, of use how how as go inputs raw come reductions contracts and we as also those some improved will additional down. from materials, that

anticipate regardless should COGS type at of we fall it's making a that predictable -- what product rate. So fairly of we're

Vernon Bernardino

X further follow-up, I if And may.

could X a maybe have Or trauma, not point, let's of who really than, say, much longer Regarding, a have and for such application? let's at let's that an inventory X into HAV need even as markets say, longer or something you to say, could launch idea have going say, insight some vision, where longer that the let's be of you has example, term, do know months. month, would vision but patients the expect for to when vascular that you any is you AV need. this need you short-term you much PAD But with really might that CABG what X a have, describe week, predict approval just for the than, really access weeks, year. the next I and

Laura Niklason

question, try understood [ your (sic) Vernon me the take ], Vincent I'm shot. to sure to I question. So let going completely not but I'm a answer

variable certainly, more in a variability. care, hugely seasonal the hugely in than a overall, So centers trauma There trauma will that But market But some others. the some months aggregate, aggregate. are it's there some not variability. some market. is There's it's variable have not

that expect XX% total those, Of at market would think our fraction more. patients, or XX,XXX -- to reasonable patients. we X we about the is XX%, shared in capture market So this of in saturation X have call of some full capture of full or at addressable that filings and be would to be expect we a on trauma X be years could Might those at might saturation, those. we

disease, episodic have current it's is who of standard not met patients locally predictable. do a again, penetration at at we've toward are full by in and HAV -- -- overall, though even their be we trauma targeting and around we But artery care. So needs the XX% the we shared market ultimately bit peripheral that expect because globally to dialysis penetration little more

be capacity answer ramp meet that we'll and it grows. to able production able Does be ramp demand, So production, question? and Luna we'll add we to that believe as tracking your more

Vernon Bernardino

it's the way, by Vernon, is twin. my And perfect. that's No, evil Vincent

Operator

Conference in for queue further will no time. at showing questions all This Thank I'm the this Humacyte you conclude Call. participating. Results the XXXX

Humacyte (HUMA) 22 Mar 242023 Q4 Earnings call transcript