Humacyte (HUMA) 14 Aug 232023 Q2 Earnings call transcript

Good morning, ladies and gentlemen, and welcome to the Humacyte Second Quarter 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 is being recorded.

I'll now turn the call over to Laura Marek with LifeSci Advisors. ahead. go Please

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

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

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

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

financial results update for and you much XXXX our morning, joining second call. everyone, Good quarter business Laura. thank you, Thank and so

Vessel, about progress human advancing universally we far made into continue we've Acellular candidate, enter or the bio-engineered of this we second HAV, in year to indications. be product implantable multiple Human XXXX, excited the the As in tissue our so half

of with In pivotal Phase July, the trauma issued remain or X we recognition in vascular Licensing during a to during May. or the outcomes of humanitarian with Foundation, program of filing of for Biologics results this indication trial RMAD, Medicine BLA, of the on designation lastly, Ukraine. recently Research with this biovascular of we Juvenile HAV, to the trauma. scenarios, We target completion a trial, our in of groundbreaking advance importance And JDRF, present the on this trial our Application, we topline Therapy, Based endpoint the announced of HAV Reinforcing Regenerative year. highly the in for the our of FDA or As Diabetes the in enrollment product candidate. our QX will nature Advanced our date QX successful we're FDA pancreas collaboration the year. the XX-day proud announced for wartime

trauma the for before highlights to up I'll target During repair. X/X vascular turning this questions. recent detail take We're Phase of with trauma. a to more Then review the call, HAV our vascular in of over of in to have to program Dale your be begin our financial happy HAV the trial recently the open call completed results. review VXXX our I'll enrollment these call excited we'll in

vascular based Vessel As in of of extremity. study vascular primary who pivotal trauma from a trauma trial a VXXX an patency suffering assessment efficacy Human Acellular injuries. single-arm reminder, of the the patients is is The the open-label patients on have XX-day

HAV population of trial the the later for XX which the will settings. trauma patients trauma VXXX topline In this grafts this is study of the of injuries results synthetic single-arm traumatic trial looking civilian military the in this the literature. injuries had the July, the and in later a majority VXXX comprehensive Database and trauma, of vast of patients, the vascular occur is both received VXXX month, At from of in of in presenting completion importantly, a for performance target are Stay injuries, total forward quarter. lock comprised extremities. we're enrollment Extremity target review of to which XX benchmark derived Our treating for tuned. the

VXXX will current our not backbone indication graft autologous the treatment vein that of feasible. serve HAV extremity anticipate trauma vascular when the not trauma for is We the this later is when and trial indicated, year. filing as for BLA The synthetic of target is

the the with review our trauma BLA Our standard review priority Department, recent chance designation six compared BLA review as from a typically process. filing our Priority review time the RMAD in approximately indication. from us to to reduces gives Defense priority combined after for acceptance FDA, designation of higher planned months the

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of of of of settings. along our treatment real-world submitted will data wartime from infection HAV there HAV. VXXX these The of our data additional be in BLA instances evidence traumatic the trauma Ukraine the as injuries, experience no utility were the the with submission, wartime the in in Importantly,

disease. Turning to kidney access in arteriovenous of trial end now our with patients hemodialysis stage HAV the in

may laboratory, comparing evaluating of function may Journal be bacteria placed to rates off the primary human when multiple evaluate of be the we've grafts but thrive come of the can of conduits literature observed quickly, XXXX. Teflon the the in anticipated that of announced a die our topline the X immune fight the We'll the available April with to in that very for to trials the date. grafts. HAV found to HAV, provides clinical that infection. and of XXXX. of the of that We support an to completion on arteriovenous with a and to fight publication we quarter the the Surgery-Vascular when Vascular to have be human in as HAV enrollment compare recently commonly not XXX human is in rate arteriovenous immune to for basis efficacy recall, all of of quickly surface. contact HAV. supporting the low die survival in infection HAV immune may favorable for HAV provides they're mean synthetic Both clinical such access, With for Since infections HAV the of those we scientific in the vascular will our infection cells immune in difference the intended that around is our This low to the of that method our trial contrast, made Improved a the regard system Teflon for In first dialysis of across been study problems on preclinical infection the thus observed add dialysis its also patients VXXX endpoint. synthetic As its trauma, because the to the cells results low our low some meaning A cell access, these year, announced can secondary particular, the the of indications, shows off the rate most as Science, resistance which cells. out that to as due trials In Teflon. fistula. HAV observed indications. bacteria development of body's function second cells publication analysis Phase a placed leading HAV in rate that results interactions Across rate publications, HAV than of the we've solution are immune recent observed basis and disease, clinic. avoiding rate in to a the broad same continuing of This grafts, we've autogenous in usability These a strong implications of the cells during over for the you'll scientific it the able infections the dialysis-related on publication attached in used that infection are endpoints potential body be has appears Teflon. growing reported we're the important substantially HAV. When the to material, peripheral artery what and function further lower infection will immune of

Going risky Foundation, product insulin-making injected the collaborating are whole JDRF the patients been diabetes Though in the on Vascular is all X.X autoimmune announce a collaboration diabetic is XXXX. nearly happy JDRF is research. diabetes, dearth the X patients. people April the problem diabetes transplants because pancreas funder was last in candidate and Pancreas, transplanting of than the with X from a than development the X curative JDRF. year, world. the of risk, with are treatment of is liver Type X less for decrease Juvenile largest US, like islets, Type of X,XXX further, Research were the of Type a world's size, Diabetes pancreas or we're To of our growing or which diabetes. millimeter underneath million the to other BVP, fewer Type announced which have is Western in The performed. skin or Humacyte in This our diseases, nonprofit transplants into procedure. Humacyte’s suffer highly

to that to can often nutrients need injected are lack islets die and stay oxygen of due a they alive. that However,

Our using BVPs by BVP the already HAV can previously as the enough is We've to delivery bloodstream rats. reverse diabetes the in carrier designed nutrients them survival and and that insulin-producing islets the patient. of of oxygen into rodent-size reported a providing enable

These BVP the of XXXX, because results ability in the Recent after is to multi-week that large are islets model in in implantation the diabetic implantation. testing supports use of animals animal. versions curative the into the islets extremely continue of encouraging patient-size number animal, including primates. of we've a going insulin been During BVP deliver a planned make BVP insulin-producing BVP have forward, experiments in large survive this the in into a Work to and after the animals. shown

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

Thank you, Laura.

completion Oberland of we $XXX.X June timelines no funding HAV. supporting the Oberland million. XXXX cash was the of XXXX, past of and We for to have and months of May million, the million for As the XX, $XXX second and There which second XXXX. we in believe arrangement approval $X.X million was XXXX, our was June the with equivalents June anticipated a to revenue Revenue XX, funding funding up trauma. cash and commercialization ended cash for months for ended Revenue of the the of of from to $X.X million. and the HAV had fund six of adequate development vascular for the grant quarter reported of operations a planned XXXX. are XX, and In $XX the related six agreement XXXX, Capital XXXX we quarter equivalents received cash

preparation from access. expenses, clinical NAV expansion and HAV and the and period compared our development vascular for development $XX.X were ended for the The second million million six million Research the quarter of research resulted BLA months planned XXXX the June clinical current June for $XX services of trauma quarter well and XX, including of primarily initiatives to million the increased of as HAV compared for to supporting were and increases the second filing, expanded and $XX.X six external ended XXXX, months for the XXXX, trial XX, expenses as $XX.X completion personnel XXXX. development trials,

were the $X.X for second XXXX, million million million $XX.X XXXX second for $X.X of June to $XX.X six quarter XX, General of were to the primarily compared June for six compared and for months costs, external months the of launch personnel by resulted current driven and XXXX. and for vascular increased million preparation services the increases period ended The HAV commercial primarily from planned administrative expenses quarter the XXXX, the ended and trauma. XX,

Other net of the income net second $X for million XXXX compared $XX.X income million of quarter XXXX. income second or expense quarter to of in was the of net

period million XXXX, net compared the current XXXX. June expense non-cash with associated from XX, XX, of resulted other with June primarily in $XX.X ended other net other months merger the XXXX expense the Healthcare $XX.X months Corp. for of to liability The of we million the six net the contingent For increases had six Acquisition earnout Alpha remeasurement ended income August

million Net the second of income million of ended net loss operating compared the XX, to six in $XX.X June for compared in expenses above. months The was $XX.X net And $XX.X net XXXX. increased of loss million the ended of the XX, and million quarter expense current net was for the $XX.X XXXX described for loss as increase from second resulted income months to net six XXXX, XXXX. quarter non-cash period June other for increase

from appreciate and launch. to commercial selected commitment repayment the arrangements We're with and it year the runway with quarter the the $XX.X had Capital, arrangement team with in and the as in Oberland that extends We was debt-type current expected structure We XXXX, matched excited million their planned the our us, we cash partner XXXX BLA second development life move to use our the cash Capital and for to funding as growth transaction. closer related second were net for Oberland to Total we quarter Oberland to future decrease entered industry. at with science of provides compared million support particularly additional commercialization funding $XX.X best to proceeds in our of experience extensive revenues. filing cash our very pleased our Oberland initiatives, into to our offered multiple resources have and used

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

Dale. with you, Thank our We're XXXX. far progress very in pleased so

vascular our a commitment their partners take well As trauma, our Humacyte we in move like thank I'd closer to to to the team, for to moment filing BLA as regulatory programs. as continued

only in from the and a patient of but than deserve more company, transformational artery suffering colleagues including vascular the lives already limbs our programs, years also for HAV trauma, range a who've access, and accumulated patients disease. and diseases. AV in for patients, used peripheral war-wounded vascular time, Ukraine appreciation Our to also our clinical save Across has HAV of experience, in not approaching We're X,XXX thanks. our

starting manufacturing potential in And Our large are studies of continue in full to support our impact updated topline and trial and Type to are patients to maximize VXXX our our that forward study X the for and we potential animal surgery We bypass ongoing upcoming diabetes, for heart flexibility of transformational later look the the HAV's keeping HAV value results investors. order platform. continuing the to this you with with quarter. the our reporting anticipated progress,

Operator, to Thank we're joining us for you ready questions. today. all take

[Operator Instructions].

your the comes line Please of Ryan with question. Our from Zimmerman with proceed first BTIG. question

and that the patency enrollments far, progress, morning maybe seen context the we've It's in those Good about the all on see appear prior what talk congrats Laura, the They by than of and to I'm thus of Ukraine we in can far the struck to seen. Laura, Dale. these be some you've that studies. I rates you better if and have wondering nice was seen in complete. prior studies

so, does And of next see view your to maybe inform around when expect what topline that how results kind quarter? we

about vascular this it's of patency rate, talked different the early disease. healthy Ukraine The the in outstanding. patency relatively patency lot Ukraine would results some in calls I from that have that They're in results for XX-day have actually say a warriors done patients. that we've don't not earlier. some in we've is that of Well, been VXXX young also and a peripheral

into allows people. people healthy that injuries, relatively severe it's relatively healthy shine sense HAV really but the in this with to So, implanted being the

of days And patency so, really XX reflects the inherent the XXX% at properties HAV. the

how of And that's we in No, or think year, kind should very coming certainly excuse helpful about then quarter, later me, later stated? that as that should quarter, fourth and of encouraging. about this that as BLA line this submission I kind de-risk say getting what process to goal think of in across and the kind are guys doing and just you investors time

done things of BLA number we've a there's that de-risk think to filing. the I Well,

First and years has the for commercial process, results. data our our back part package importantly, BLA, written, perhaps in use comprehensive already currently fact, with years. which manufacturing the And comparability is most been XXXX. in our scale ago, FDA reviewed current in the system for preclinical manufacturing two at a last that Much of has two along frankly, of been

together going So, needs the be BLA Ukraine data our the to which pulled clinical final from piece outcomes BLA supplement are of VXXX, the also to filing. but is the

patients of - is primary XX-day both of Importantly, the on these groups these endpoint patency.

come the quarter. is patients something of as doable finite having for number this very that data So, we together see in fourth

it All Congrats question. no that's progress. the well, for Yes, right, me. on

you. Thank

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

thanks echo all Hi, progress. can the and and to ask Wanted about HAV that trauma. Humacyte Ryan's good for take cost in effectiveness morning just Laura, angles potential and the Dale, congratulations on

reduced the infection Maybe the support and re-operation versus think about got reduce grafts. angles time data I talk saphenous versus just graft how rate launch. those and accrue just HAV potential and you ultimately cost synthetic could effectiveness for work

in going topline the time review suffice results With and that amputation share to actual vascular for believe the And put civilian wartime costs infection. us of thanks trauma. limb of show of to - synthetic costs terms for the We the savings published will understand the Josh, say that outcomes comprehensive our at we've benefit, provides compelling but and of outstanding the salvage grafts, we both cost we're clinical literature of in we that offer from rate of literature to in The a clinical as outcomes, conduit done that of directly HAV and the outcome great to that that we injured cost us call, really in Yes, both both the We not results, data comprehensive the what decreased HAV rate what shows compared and the literature that at synthetic a be. graft systematic infection grafts. in earlier this share can to together claims HAV compared patients, respect grafts an synthetic alternative will mentioned this improved to will saphenous question. but is also effectiveness and vein. improved there's synthetic that believe to really actual of look improved terms allowing the offer only models review,

vein, vein compared to vast HAV to compared to fact As it vein shelf, from the improvement available as can leg by and prepare the takes mentioned, be from its This and and you is what the two see operating is harvest room patient, a that and the time a leg an removed hour. we just container take then in saphenous the easily is vein about the close prep minutes. the time which in in the we've wound, off that's the out always

for a that to revascularization, So, having demonstrable decrease also speed for vascular injury. amputation patients in leads hour rate of patient of with that extra the terms in of the

as there clear grafts, economic be both synthetic basis the believe vascular in trauma vein. for utilizing we also compelling compared but will HAV So, health to and

the those line. hoping indication, access could And Thanks review that they for the BLA the for just and filing the for down questions. new filings submission ability indications for to that's on review modules subsequent modular to in just the I and Laura. you was vascular play Thanks trauma that, PAD taking just gave and like the wanted leverage

Yes, Josh.

in in been the So, you different all The all the same. is though dimensions It's know, the clinical the same even are vessel. same way. it's indications, HAV, as studied grown three

will means going that file, the for clinical our in safety. to efficacy identical that would AV modules, this the clinical access summaries most then five submit are of of manufacturing that is to we and for All quality to data PAD. preclinical across identical indications. and or example, be trauma and BLA different a BLA of the we're do follow-on having with in and and Much BLAs data are even characteristics What modules,

allows so data so and prior to clinical that really the work us just utilize done product in follow-on that add HAV we've additional can So, we on leverage clinical work that our candidate. the when available, indications same far become

Excellent. Thank you.

Thank you.

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

any Great. important, just And on for Thanks so just we we be for that specifically results, considering overly with that there the data? should to my need that but should that be probably aren't what Laura, factors that up we aware questions. pop confounding may taking looking of? topline be starters, for clinically then, are

this Well, in share to later we're going quarter. topline results

what patients highlight have to say extremity which those than who've And going efficacy in lock. our database I had But advance so, we is to comprise of are I hate will set. trauma XX injuries, that more

we're provide enrollment in addition, data safety trauma to HAV their have the In roughly data or patients patients going consented the XX VXXX we patients from the in that use and vascular addition total is to now, so to Ukraine. XX receive who the all of on

as It caveats to far product same can't to functioning of say year, candidate. the any. we've analysts being I unexpected after the the say the and tend regardless keeps roughly just same observations, that The keeps or HAV investors, As year had indication. really as HAV, I

to So, of going on prior there's here information the shared I too calls. based surprises be think some that we've in don't many

that's Well, it. great hear. to Got

it's do more like been one why not well. getting more for seem just if know something don't them. Why points follow-up that have As working guys do, it? or you a not far I of have as patients deployed Dale. point, is more Ukraine data affected lot all available you've and this but so I'm terms just it's at but unfortunately, many I of had would and that, patients are being this XX conflict, And that the are goes, are XX just logistics and getting more it about that's there's patients in by wondering it? I like to It so if because getting don't

Yes, Matt. so question, good that's a

the I humanitarian May was one Ukrainian year, of agreement our So, for in with Ministry last last Health, which we entered would think of effort original into, year. that the

And understood Ukraine, doing Ukrainian just frontline nor how would we the so, go as were patients the vessels to went been this need. last time. Again, five We our to The XX of outcomes the best heard, hospitals. Ministry year, we delivered they and help to have you different neither in Health at clearly excellent. over

our Ukrainian lasted initial the However, agreement only a year. government with

working with add currently interested government is as actually though patients filing, hospital actually we to the The to We’re a Ukrainian enrollment data sites trial, we're VXXX because for gathering continuing to reached accrue can. our trial. safety even VXXX as few in much we've

really second And in interaction. the Ukrainian that's phase so, now with dealing Ministry the an that but of of may Health we we're issue Ukrainian add sites, this right

if Okay, about Dale, quarter? did in that quarter million think plus math XXX Because the left you that the got the cash announced. right, you then hear it. in doing recent I of And you Makes used the I total right XXX you I'm sense. deal or $XX capital have about from

So, XXX-ish. that's about

look how Thanks. about about So, year close I that a think burn XX. burning through rate you’re commercialization, to is probably we get does which away? And as

numbers the accurate. Matt, you Yes, are quoted

calendar and past in on approval expect Oberland XXXX expect $XX vascular going we commercialization cash But us combined minimum transaction, end the how well we the more million. to a not net in would And to half a from that year. the of Yes, the hand view, operate, takes operate. of point for of of a the than we For the at with remainder terms also of we first trauma. we've of that means expect burn given a how burned the a to expect XXXX, I sense and million $XX.X

you Got much. it. so Thank

Thank you.

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

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

We can hear you.

Laura, I'm most so VXXX in on should same itself, studies of curious the Hey, for these you because terms single-arms how on benchmarking grafts, benchmarking think somewhat about we with if graft lines. you Perfect. that and are mentioned could of synthetic expand PTFE

are of of synthetic So, just kind there array and - diverse grafts. pretty

how if comparison. us additional about maybe some control could the So, think just should or we you clarity give on the

arm, benchmark of the review. trial and a literature control control the we structure before the the the literature So, based review And undertaking something with is that the was comprehensive actually the historical for agreed FDA on VXXX meta-analysis this. upon

a review XX of comprehensive the is this graft. the of literature over using synthetic world's years last type any really So,

anything out means plastic. made this a So, of

So, this for is years. any of graft excluding like used studies. things is example, XX over xenografts, type CryoVein any But trauma high-quality also last or vascular this synthetic in the but

is from FDA. and Suraj, lot were point, your studies sometimes to Those are the So, single-arm surgical messy, of literature a excluded agreement there's of quality. low that studies with the

HAV excellent and of we on eventual of that, support So, we're trauma. approval benchmark we've provide focusing And because robust that the studies. the high-quality will obtained, feel is and for feel we

just again, we - that any. site enrollment curve? so if us about VXXX, or of so get should Remind think many sites were patients actually how bell how concentration, have enrolled the the Laura, for assessment XX it. an can Got the in we

because don't my have but fingertips, XX or have at I is So, here, XX enrolled estimate total sites Suraj, estimate have my right these a total the that of numbers I'm to XX trial. going to patients about in

So, on is per would enrolling three some to site, There concentrations. or clearly four patients site. correspond per average, that

sites have some are trauma that. more are enrolled than there active very So, that centers that

number. for I patient Baltimore that all and more So, Shock have example, enrolled, think, than Denver Miami Health, Trauma,

terms you did correctly some from obviously in components been derived of have Laura, BVP, it. I HAV. Got hear finally,

So, with BVP two-way right? communication the does not, surrounding theoretically environment, HAV would but

understand didn't I'm question. sorry, your Suraj, I

So, the BVP? glucose, and you’ve be communicating not with right, sense the to insulin. has some HAV, it it reconfigured release BVP, components curious, should was for So, I environment, HAV just of theoretically outside right?

Yes, is this correct.

cells into product monolayer even pancreas. every derived implanting consists be BVP of the cells, HAV, be derived immunogenic. that also They with patients day. our the can genetically from outside HAV candidate and These a we're is a coated making stem are minimally can stem donor engineered But the So, potentially from of islets. which of islets

were for primate is the this is they an several animal. of of into islets mentioned curative from human-sized trialing what's these in delivering secreting primate essentially HAV we've the loaded can shown immediately, of a would we've course, the primate pancreas for Type onto islets weeks that primate diabetes. islets but implantation are about platform for with and insulin. that that that not the So, they're I've human What's islets The number islets after because version exciting a another patients agnostic X us survive islets, is these that model, of been reject exciting the islet HAV in we've And BVP animals. studies

this an HAV that of important continue to overall proof exciting. this platform we that but concept view we excellent and data very is So, sound, islets as to is this deliver work, and the likely the point of says have using

Got it. on Congrats data again VXXX to the forward and soon. look

you. instructions]. [Operator Thank

Our Company. next in of comes question Please Jackson Bruce proceed question. with with Benchmark The line your

bypass a on morning just all artery the question good Hi, program. progress. and I'd congratulations coronary like graft to ask of the on follow-up

FDA still the terms just where into do the XXXX. the currently believe was that's first-in-man if in XXXX. of transplants you planning try discussions get curious stand you're I about idea regulatory in to in still to with the So, case, and the if to I first-in-man was

I'm that going to to take Heather ask question.

Sure, Laura. Bruce. Hi,

continuing else? we the primates, do studies IND-enabling So, to continue the with bypass those we're primate now where and stand coronary do to is expect data remainder our the program this preclinical right we of with that through the to - that year do want to for part for file IND the IND, of Laura, gather you XXXX. in anything add we still and

to Well, how these see I have out. turn we're results think to going

FDA discussions suitable about what package begun have would the comprise. with We preclinical a

I so, tuned. see. say And stay would We'll just

going in look at And animal durability first work a few then Okay, the a of therapy? BVP, with the The generation, the great. anything large be future for survival are the to doing but were for studies months looking any insulin the great the do you to of take in durability? results at involve

before really we our We're can be a to to in longer prepare points large of animal really out first-in-human looking for model. be absolutely studies. questions going that time couple proved need There’s at

production. support first just weeks. construct The BVP whether our in question is you a that question islet few can survival insulin answer really can in minds That's a and the

don't You survive weeks can't at and oxygen expect time. nutrients to where an have into a islets enough they for implant them environment and

initial data proof a construct we the is concept point this is around that foundational important of really science So, believe the BVP valid.

a As the looking then survival of require animals will durability in at to time. the line periods we're of diabetic and insulin and over This studies second islet of investigation, longer production. look going

those we up so, now. studies And are gearing right for

taking my again. for congratulations Okay, great. and questions you Thank

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

You your may lines. disconnect now