Humacyte (HUMA) 9 Nov 232023 Q3 Earnings call transcript

Good afternoon, ladies and gentlemen, and welcome to the Humacyte Third Quarter Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I will now turn the call over to Lauren Marek with LifeSci Advisors. Please go ahead.

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

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

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

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

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

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

positions positive Acellular results during announcement And in on to current tissue II/III multiple led product us our this approval in our significant implantable indications. which indication submit vascular in human September Our our Phase period the Humacyte, This trauma BLA our for in advancement top repair, by filing line of clinical trial the milestones from was Human third quarter. for achieved which in during was the Vessel this universally we've quarter we of productive HAV. a bioengineered worked or candidate highly

presentation II We're also or other HAV in Phase of severe studies our been pleased PAD. including Peripheral Disease, this shown pipeline that has results potential of in the clinical quarter, Artery

addition, caliber HAV In disease our recently in model. of a heart results preclinical we juvenile small published

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

enrolled for patients. the presence group historically graphs. of comprise blood synthetic injury A approximately HAV in total of synthetic to flow XX% and the for graft VXXX I'll clinical vascular this II/III had we compared trial, patients in In amputation positive The program in patency patency trauma extremities of published rates trauma these of of reported line the HAV HAV study. clinical was the XX% the as vascular trial repair. the begin trial lower top our to with higher results from infection rates and and benchmarks HAV trauma our as had and VXXX XX in XX for of announced the historical evaluation of of primary that the XX-day and trial, clinical Phase compared were function the or and

a of synthetic to patient Importantly, receiving of than there compared for that the important as being failure HAV, to were HAV over It's rate lower for less X.X% that with historically the reported half vascular trauma synthetic the with HAV a note a also rate VXXX also the because of of demonstrated for XX% This imputation chances of receiving no occurred graft. HAV. in trial, the the that chances graft. associated amputations amputation are means

limb of HAV to from implant. flow injuries to the because All and of due the the blood not loss severe occurred amputations of

to is historically X% infection their less X/X injuries. trial infection also likely amputation. have rate an of patients graft to rates reported who for other receiving for half than suffer lower And the In to demonstrated an is were in With of infection. an HAV X% graft. got this HAV graphs patients synthetic The their historically over likely of synthetic words, compared as

BLA on these Since submit priority planned we advanced or plan the or the this received trauma FDA, we'll filing. review allow regenerative that Department a momentum application priority positive designation In the during review BLA, the biologics in a indication. will Building licensing potential the our we year, with Humacyte from which our request of us received designation believe from RMAT of a of results, therapy for quarter. of of to priority FDA have we've Defense, filing BLA this also high a to medicine May

Further buttressing patients, vessels HAV aid in real-world under program. in have hematites treating used been the of the utility Ukraine humanitarian injured

from XX-day to a reported XXX%. believe our salvage and in were survival XX%, was suffered surgeon patient this life XX-day these to or and to of shrapnel During that were no help XXXX with these flow in We the System Military be Symposium the to filing, clinicians Ukrainian also in often blast wounded infection XX at and from injuries patients HAV limb described of treating our presentation save reporting will rate X-year August, setting. remarkable proud war were were patency we're patients In blood the the in humanitarian our wartime with BLA received Outcomes FDA. highlighted results patients in BLA Health effort, are patients an the there success high both limb patients vascular instances HAV colleagues, date. Results Ukraine. and who very HAV. the be filing severe, with trauma a a addition these these Research and XX-day in in Ukraine, able that important

their the is VE a These of which and benefit Humacyte multiple seeks an durable the meeting both patients infection. research, is which most experience outcome to also dialysis identify difficulties access include of patients the of may our expanded access York make dialysis And that from trial. New trauma major and in next resistant which which to our vascular collaborators expect presentations with and an at the vascular symposium ] results presentation VXXX surgery [ week.

Conference. September, the clinical HAV presented In Vascular for to clinical limb that disease results FDA-regulated extremity have bypass study, Mayo with patients and possible promising [ approximately may artery surgery safenesvain Clinic. since disease. advanced were the had flow limbs. a this represent peripheral no not with bypass an In safe, requiring at investigator-sponsored HAV who In patients face resilient a who for limb blood an important also This of arterial own amputation of their on the patients presentation Mayo the in the with available. effective Midwestern do ] severe the lower future, salvage. for result were preserving conduit limbs was is their researchers and and vein peripheral arterial bypass at In restore the alternative treated observed HAV to study XX%

The X up that surgery. of and juvenile With of Children's preclinical In petrology and into Humacyte HAV observed which pediatric for in affects Cardiovascular cells, showed showing months regard platform the collaborated described in heart that in October X.X-millimeter same born in adding for host with from use. study are of manufacturing the to Hospital to repopulation production of investigational heart vessels flow, a remained the to demonstrated of of study was the what's small Ohio is which platform, which HAV the potential publications, Nationwide produce Thoracic every model to in human X.X-millimeter in patients. year. patent a X.X-millimeter Humacyte each HAVs, the XXXX, that extension babies condition treat similar implant to clinical large study, Columbus, and This to ones in evidence this HAV been publication of X,XXX one by Humacyte current Surgery animal is researchers X-millimeter are also used Journal a diameter a

biocompatibility to on of of supports due that, of Researchers the range and In a These function review to HAV bacterial fighting HAV in rates the clinical HAV have HAV excellent human July in graphs, preclinical study wide lower infection HAV basis potential turn found published clinical that infection indications with be the I'll to key in the the are financial Which have survival compared the the it And to Vascular business significantly we for scientific a developments. as HAV implications the material. for over of infection. to that of from a to that the study the medical for a and bacterial trials native-like Surgery This of other the rate. results and the support of results This resistance date. of Science. of broad conditions. our may synthetic immune infection synthetic results were alternative observed intended cells our provides Dale graphs further of an had of ability the resist Vascular Journal low to infection a now all

you, Thank Laura.

As commercialization Oberland of with million anticipated net up of finance we May million funding September our the XXXX. in $XX HIV of equivalents Capital we funding Total $XXX cash XXXX. had indication. FDA of our used of million the funding million. cash the from Compared trauma cash expected arrangement $XX.X months we cash XXXX, for approval Overland the months received believe X which was of In the of for XXXX, cash first equivalents timelines $XXX adequate of and completion XX, passed first and to a We X and to million, $XX.X reported to that have currently the and vascular date. for arrangement operations

months from X revenue XXXX related third million the for no of for Revenue development HAV. for There $X.X XXXX. ended a XXXX XX, ended September months quarter Revenues was third XX, quarter $XX,XXX X the XXXX was of XXXX. and to September and the were supporting of grant the

$XX.X initiatives trauma quarter including to months and XXXX for XXXX and million increases and access X from million $XX.X HAV planned clinical trial development $XX.X expenses Research hemodialysis. for of X the clinical primarily ended personnel filing and the third the BLA were the trials, of period to and and expanded AV research completion for and September for September XXXX. for clinical services the XX, resulted current $XX.X third HAV preparation compared trauma were compared expansion increased million our and indication external XXXX The support quarter months vascular and million development ended for development to the of XX, for of

General ended coming X million the XX, September for compared third $XX.X were months XX, the vascular primarily offset period. for quarter XXXX and The year The of during to personnel million X ended by third of for months HAV to ended September and X compared the professional the costs, compared quarter increase driven September increased for external $X.X during the XXXX, largely slight increase planned million of decrease and the compared in months prior U.S. reduction of XXXX from third million in preparation launch the quarter partially to XXXX $XX.X a administrative XXXX. an from fees, expenses XXXX personnel were resulted resulted XXXX, for indication. $X.X the the XX, commercial to in expenses. services by primarily

with X a for XXXX. the third for Other or to an compared And to income other XXXX. $X.X expense a increases. increase in million net XXXX liability in compared other XXXX for acquisition. third earn-out of from XXXX, contingent of expenses to was XXXX due September in $XX.X Healthcare other to quarter compared the XX, net the net months of million XX, Alpha associated in the primarily income expense ended million net was quarter noncash other with [ from net resulted expense of resulted for expense Increase expense third XXXX $X.X X of net net months to income remeasurement ] the the the compared XX, September rate XXXX for of months the merger $XX.X million September XXXX ended of increase the X The for interest quarter primarily

that, X The net liability With increase to from compared $XX.X for And resulted loss the $X.X it in over Net loss million was million ended months third September of the measurement for I'll concluding third period XXXX Laura months the $XX.X contingent net increased that. noncash XX, back the million of XX, to turn expenses and the ended for for September was operating remarks. million of quarter quarter XXXX. $XX.X described compared current to earn-out X loss the XXXX XXXX. for with

our of This you, time a Dale. Thank stakeholders. all Humacyte exciting very for is for and

hard continued As planned programs. thank first filing a commitments incredibly we indication, like regulatory the diseases. patients be only variety a could their take to for our our but are to well time as from company, our HAV move closer I'd worked the are who Humacyte of reach entire transformational moment point, to what The has for team our to entire as team suffering to for approaching partners this and not in we a vascular

of our full and patients peripheral has programs than the more forward today. the you and patient Across to continuing HAV the hemodialysis experience, our joining for access HAV's our questions. clinical We're ready for order you our thank and study We investors. accumulated including keeping X,XXX the for potential maximize our and HAV also in already to take to trauma, in to vascular in updated years artery now programs, of us value earlier-stage vascular on progress, all Operator, we're look disease.

from Kalia first question comes Our Suraj of Oppenheimer. [Operator Instructions]

line is Your open.

you Dale, Laura, right? all can hear me

can. we Yes,

expect? what data [ we at Laura progress. VXXX on the all on Congrats should Wes], Perfect. additional

addition meeting, that share occur the during going on during a the of safety That's the [ ] outcomes. VEITH share, going results, efficacy presentation Wednesday. podium to some the we're At in to we're to meeting will

at In our benchmarks combination a outcomes and they have the and from and evening, synthetic Thursday where graft also to the look trauma. vascular of Ukraine the outcomes treatment addition, about outcomes in dinner those will on we compare VXXX talk as for we session symposium

Got it. trauma label a How thinking should my about indication. is start -- post graphs. indicated BLA would for filing assuming months not for synthetic the be we X understanding vascular

size you and low-hanging the fruit market up approval? can post the So also

the XX,XXX of injuries earlier shared of every of grafting So or thousands in sort I year that U.S. the think vascular we've in the approximately of repair. probably as repair there's occur terms presentations, some require those that and size in tens market, active require surgical of

or all XX% synthetic XX% with and as about and those, if essentially or done viewed are talk being if traumatic infected. the But literature, at of injuries contaminated surgeons graphs. potentially look contaminated are you to you So trauma

they grafts So if you tell traumatic never will that patients talk in you again, you -- if synthetic trauma essentially with to indicated practitioners, injury. are

takes it more In cases, vein amputation. the extra have the that takes limb the make to in at an many otherwise vein gotten addition, because increased risk that believe we a suitable that hour vein HAV patients extra harvest for who injured harvest going to might the puts many hour it to is of be

vein certainly injury well we'll believe we that use, the a indication. graft take also use fraction but will as So traumatic in sizable we synthetic of we believe eat the into

why Suraj, some that further HAV outcome the the will may data Laura at about uses use it over synthetic Wes And study to of that particular to [indiscernible]? be just terms and and evidence patients said in the from support presented [ use the the would may of instances why ] those will in or surgeons certain choose what provide some they likely in be

-- the wrong, from love color interest liability might contingent assuming on I'm but color. Got could the my just... million if it. additional I you. Dale, caught Oberland, revenue revenue interest liability, $XX I additional attention is the final appreciate be for you earn-out Dale, some question one in the

The Yes, you're is call essentially Liability what Overland. the the with debt Revenue the RIP instrument exactly right. or we Interest

of And so Humacyte earn-out with price accrue accrued. stock debt do the amount million. public as time is if transaction, right our that levels. are The over legacy certain interest holders $XX the now, associated But potentially contingent of the up will going that or is liabilities shares is hits face

that a quarter, down. stock that if increases and goes the liability quarter, the every the expense goes and down there's noncash price so noncash recorded a And there's goes if down, gain liability and

from of Cowen. comes Our Josh TD next question Jennings

is on Josh. This for Eric

process? was vascular could trauma. you that us I to review with designation receive that do if review, wondering whether will priority you RMAT the the if you throughout when share And you received have prior specify secondly, BLA what you filing. could not BLA know entitles or to review your in you On for you

standard which filing, review, as typical BLA to part know, to you as may we for X-month us period more So apply a to review is date as entitle in a biologics. the are XX-month for of opposed would which, PDUFA going priority

So file acceptance that it's of that once whether time XX to us the file determination days, comes agency and at priority the we that the my review. also not or with as within back they've understanding a with granted

days we expect have would I So XX after if we'll file, we know priority pathway. a

hope provides the The and forth agency. and Department. is Again, interaction from BLA process. I priority speedier we and because changes the interaction and not really of it with would I'm the of of have expect designation you really the because always do that of the that amount review review RMAT a the priority Defense a the sure amount once the discussion Certainly, robust. file you and also back

it's I about more So speed. think

with And sticking vascular Understood. trauma. then That's great.

here XQ. us remain With for that make submitting tell the target the submission? the you in you BLA have Could you process what actually before steps

providing without in a much say module say But pages that that much can some of document. I a is BLA public Also, has months manufacturing we actually description been too now complex can X, our transitioned and final time. haven't thousands for is been commercial is ready already X. done manufacturing to essentially for detail module largely for -- years BLA really that a many provided And forum, the that's because been the in we a that Well, our I of has our the which of has form preclinical actually pieces fairly in practically. work XXXX. stage it's

up wrapping the and I the that done of submit really the five and a So or of mostly modules two them labeling. clinical BLA. done been for have about some really would there are it's to while, modules

on We any this not do that be quarter. ourselves as will difficulties filing see we completely anticipate track. So there

Sandler. of comes question Matthew Piper O'Brien next from Our

for couple just I you. conflict you wondering for Samantha first thought like were have Matt. providing off, efforts humanitarian the during if guess, on This past? have We of Gaza is you we the a questions about in

very Yes. question. interesting That's a

think surgeons to our treating have reach Ukraine To out injured that's the yet surgeons I amongst an it's these the to of same date, in and topic leadership. a question. along HAVs who In request not were patients part from ask come up had excellent is lines. conflict. the as we conflict, Israel any we access received us It in for

that be Certainly, seeing. with is casualties I surgeons the consider Israel, the if handle think inbound know. honestly work them don't consider I that teams work regulatory from those and our care to system in requests. had clinical Israeli health better the come may we it equipped certainly to and they're perhaps we FDA requests would and in with

this That's on the ongoing little maybe in launch are And could reps about terms preparations product? maybe great. that hiring note, you how anticipate and number a launching then bit guess you for I talk a of sales

the historically just grafts. utility amputation of really around the not for I'll tremendous improving Humacyte who the compared that impact Dale data excellent say real and useful for infection have vessel economic arguments will clinical the improving results part speaking health Well, budget in trial That to modeling expenditures insurers. is progress patients. ongoing total trauma for patient incredibly I an synthetic a focus and made handle that the decrease let force HAV really and but and launch, hard where outcomes of hospitals been were to of one but shown economics as also us to an the we've and sales for the in the care for provides treated strong make of with It's the patients our

approval. putting now arguments the in and on to really insurers working advance the patients the we the that outline and size benefits clinical we've of Humacyte, to also that here brought health the to even think mapping To those can for going care bring forward bring them of system. dossiers colleagues team into with economics a together problem whole we're HAV we're and out So closely our health at

with But timing doing So very speak work also economics, and work force active on of and Dale that? and streams. I'll all we're sales that's really let coding, terms the in that's in healthy the to reimbursement

time of Yes. much as team commercial those of Laura effort Samantha, said, geared the longer towards the now core items. right lead is

the mentioned impact . coding you and and model As market budget access. reimbursement and

how there force terms closer of is us But the up sizing strategies we the In market itself and certainly, like divide terms but that. sales would recruited, planning that sales launch. brought force on actual territories going on in of itself, be on will for to be brought and

need right in XXXX not now. So underway planning to on certainly, the the But far there's bring is launch. so advance them certainly of a

centers, a patients reminder, XX-plus market. concentrated is those As treated one trauma tend approximately percent XXX very be We've of the talked before level at this a centers. of about to there's where and

highly force qualified sales sales towards a So within this not products force. be setting, will be trauma it the geared surgical a huge will but type

comes from Cantor of [Operator Instructions] And Kristen Fitzgerald. our question Kluska next .

the This to answers is how And Jason just and they on from the offline. need question. some take are evidence the help I'll us. stats real-world for years out. that surgeon open your the further And is and if then Kristen. on -- could who's in is base, options trying insight collect you to plans, Is the launch first second Two procedures

for end of to restoration that replacement surgeons. a excellent standpoint there these be true are and vascular In been important in indication, conduits surgeons, advance and XX going types it's trauma the surgeons years. both of users probably the new trauma in combination hasn't those questions. of really yes, From are So the vascular of an

has with like tools for stuck that X,XXX who having feel biologic as new same have experience much long So we a patient for practitioners time, very with years. now a the as these over they've been

this? surgeons this get trauma spontaneous will be and this? questions shelf? we the the we're surgeons very exciting. I are When vascular fast it hands when just my can at on whenever on find How comments And and I use about getting both think can I podium

surgical that per So out for surgeons trauma also in say general lot as there's vascular there in I not more as vascular surgeons would surgeons, and a they're the se. particular, I trained anticipation think market. of

And not so something really not by would trauma vein. and harvesting that's surgeons, time It's wheelhouse. their rather spend large, in

having a to very that's they I be trauma attractive. for going biologic is, that surgeons, in can pull off the think, resist to going So infection shelf particular,

that can certainly, as cases certainly we're making progress far our the that specific of we'll key on leaders scenarios outcomes. opinion As market. or specific on who and at that Phase injuries coding and with on our with of I -- capture are HAV work and And of post some we various done launch, either who II/III real-world continuing also are data studies follow plan have and our part already look anticipate evidence, look usage that been types after trial so the we we're geographies VXXX at to trauma of

definitely advantage the that after of market. we're to So on take want I

Jackson Our from Benchmark next the from question Bruce comes Company.

any up all of here progress. presentations Are symposium got on you shortly. coming my the that the about. been there Congratulations VEF Most you're of [ questions answered. just -- ] excited have particular I

potential presentations. excited I'm are a surgeon amputation. facing things investigator-sponsored patients he's doing in the excited ischemia disease the Humacyte that doing I'm also about other artery Mayo with there's who's critical we that couple study mentioned. will haven't work who Clinic from of that But peripheral with say an I been about HAV limb a

he's going encouraging. which about results, to those are So very talk

of or with HAV really results in long have problems we're patients types have to infections presentation their term. the of look access, dialysis the some patients where benefit hone access joint frequent doing a presenting a also dive Fresenius who that on with data which We either into [ to access early ], may in the failures from we're

host. the call questions, further I'll over no back seeing to And our turn

for and at to attention. meet time you been milestones. everyone our quarter. an It's hard thank everybody Well, And working exciting much continue to very is your for Humacyte

collaborating went the we on I've As been our our lines time all we that and said so on all whether team and partners. just would continuing just we deliver done our we it, And what corporate we also public, and have which do the of would I'm or work on delivering deliver that. said it's we're we to of hard since proud said, collaborators, they've surgeons

a to big get us helped want give far. out just I this shout So everybody to who's

Thank day. for conference concludes a joining, That have today's and call. you pleasant