Humacyte (HUMA) 8 Nov 242024 Q3 Earnings call transcript

Good morning, ladies and gentlemen, and welcome to the Humacyte Third Quarter 2024 Results Conference Call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time.

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

Operator. Thank you,

statements proceed materially remind with call would we expectations. actual law. 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

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

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

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

update for has a thank Thank and quarter joining financial us This you, for for been you business third and time XXXX Humacyte. everyone, productive morning, our results very Lauren. Good call.

launch, Humacyte commercial BLA of our in planned the still trauma U.S. if support our engage preparation in approved. While market to ongoing, continues vascular the FDA team is to ATEV review entire

Importantly, for add-on October. and application our Centers new payment, in Medicare the submitted Services technology NTAP to or Medicaid early we

of our clinical of by webinar Dialysis the recently were a study. analyses and Phase presented top-line of ATEV addition, Week, leaders VXXX implications at followed sub-group trial hemodialysis opinion positive results was and the Kidney the in X discussed key from In in presentation who Access this

present the the the results of or candidate pipeline, month. bypass we're X Pancreas, Patent diabetes. a this BVP, program completed design Heart of And a $XX for later preclinical our registered approximately finally, composition our U.S. we coronary of planning patent offering Office the at to and BioVascular treating artery direct the stock Meeting product covering Regarding Type of million. allowed And Humacyte American

of detail. call, developments today's I'll more each these in review During

Dale up we'll Before call of your turning in to open vascular the over our financial to for the to happy begin with call our then program I'll a trauma. questions. review be results,

complete BLA additional to As will you'll that quarter, its the FDA that we recall require in announced submitted vascular review the time of we the last from trauma indication.

the of Biologics reached for to original us time The more BLA they their was program the status out that reminder, in to trauma to Center file was order February it BLA needed was submitted PDUFA review. XXXX. a PDUFA ATEV As the date, to before XX, Humacyte August assigned review priority XXXX FDA and in and an of granted date XXXX, the December in the complete day inform with

remains for timeline FDA BLA of provided the completion Our review, a under yet not has and review. their

manufacturing on sites. commitments including the in our trial agreement multiple our review, FDA facilities BLA of They've clinical labeling with conducted filing, the of course our discussions BLA and post-marketing actively us engaged also well has as discussions. as inspections regarding the During

trauma date. upon with based the the We ATEV continue the to to interactions maintain agency confidence of approvability vascular in our in

year. sales on during of key and representatives executives, upon continuing the successful launch been also trauma approval in ATEV ATEV patients. The U.S. completing FDA. brought contacts a sales were accounts in Our for the of Humacyte their the who been impact entire Surgical to vascular August, have on commercialization science and our is work team have trauma by position identifying within medical the training respective believe their ATEV add-on receives market the accelerate Humacyte annually, Medicaid FDA the only Centers CMS. the the reimbursement with payment, X, the for adoption technology on and submitted decisions occurs new or application FDA window support regions, which approval, filing approval. or being Medicare after we once applications a NTAP, for an to once NTAP Services, made for October will of The To following ATEV

NTAP we NTAP hospitals XXXX coming receiving the to months including as CMS. reimbursement several, technological are for the of the from payment novelty, receiving application would to cycle, proposal receive clear meets effective for Requirements that NTAP forward qualifications, evidence year and X, which for look of well Our the clinical a the October improvement believes approximately these price biologic up NTAP sales patients. the review of of starting make XXXX. Receiving NTAP product. reimbursement is fiscal our allow can in as ATEV Humacyte to XX%

initially foremost continue results the to to observed these XX%. Remarkably, is treated FDA, all the is were sustained from supporting ATEV injuries, mine we program including patency, in consistent high-velocity no at blasts, shrapnel, infections with Long-term the or humanitarian those of severe presentation showed related the the U.S. from and Ukraine and whose very ballistics. patients in with This limbs long-term grateful amputations results featured we symposium of colleagues await meeting. involved the the of decision long-term our XX-day We're ATEV's are This flow, of the generate injuries. August. use nature ATEV in results cases in data there from Ukrainian Department or that As a Positive trauma rates in additional patients and of Military Health continue clinical our of humanitarian the high be pleased or in of we vascular Ukraine follow-up Defense's traumatic those the the System despite deaths academic population, to Symposium vascular were were program. affected blood that were injuries Research ATEV. of of to

needs outcomes be our civilian unmet this clinical month our a vascular website. military replay treating meeting of in event high-impact publication clinical journal. This Opinion A later through treatment trial the anticipates medical Stay extremity where vascular applications virtual trauma. for and studies, in held as event case discussed on military civilian highlighted, of surgeons potential we trauma a Humacyte the Key this addition, September, our injuries. the of in a can Leader found patient vascular In tuned. usage individual and In ATEV

VXXX the the ATEV in trial positive a in Kidney were our of our arteriovenous Meeting Phase X results the to meeting access presentation now Society at Turning nephrology program in XXXX, American Dialysis in premier is world. Nephrology's Access, Week which of from featured the

patients. have XX-month patients arteriovenous significantly subgroups dialysis and announced had ATEV arteriovenous we and all of are patency months at in procedures. Females, superior rates with fistula. The XXXX, high-need and for six poor Week who month women, function gold superior compared and who diabetic historically fistula, of in Kidney months and patients presentation this function ATEV's current patency, obese patients, to by demonstrating obese, receiving of fistula These outcomes the higher six at population further standard As in trial the patients. autogenous which the hemodialysis the the July patency as its and met primary XX received care endpoint than particularly ATEV is diabetic highlighted those

believe these that using our can In a recently Dialysis engineered for of that cardiovascular is expanding to affecting addition, most to Artery vessels. We're results, PAD. on also these the publication potential event discussed Lee. are all website. KOL Humacyte in these over as of by dialysis potential Humacyte's in XX fistula. clinical blood be demonstrate vessels, progress significantly disease underserved months thereby current arteriovenous Peripheral encouraged care, or program the results they of in blood featuring our a found standard Ozaki, the duration improve compared studies, highly ATEV longer preparing the currently also Hussein, PAD Dr. utility legs. in making patients Disease, achieved of results of replay who the well is Dr. the in case first of literature. These Timmy in the the peer-reviewed Mohamed the We're patients ATEV and access as a Advanced Charles were by also arteries Keith Dr. in several virtual and A Access event commonly as

autologous those of vein to have RMAT As is as July, do to and the Therapy standard many XX% available the of who Advanced Medicine a arteries require granted bypass leg the in lower such PAD the revascularization, or for in FDA designation, Regenerative designation, autologous patients. In ATEV for care vein indication. patients the not

indication interactions the of with for be important trauma. BLA medicine that designation the to communications for has clearance or we've of our which designation diseases AV RMAT PAD. in and the trauma provide vascular proved the or designation the PAD has for in to marks helpful In expedited for third time, designed BLA, allows this regenerative also received received during a in designation. same Following with a priority serious dialysis, vascular development The the and potentially IND treat FDA life-threatening close expedited an or review in our review extremely also ATEV conditions. access RMAT and review is pathways therapies this which ATEV FDA in

working patent BVP, Positive studies BioVascular ongoing the we patients And The our BVP show non-human designed the direct insulin, as September, million in islets implantation, production for care finally, other primate U.S. registered which preclinical these diabetes. a our approximately support gross treatment and models now results is months that, of insulin-producing enable covering completed improve of C-peptide in type continue reverse on precursor of ongoing BVP in diabetes. to purposes financial Office BVP BVP, X is being with potential insulin of for the circulation. Currently, the the it non-human to type a survival Turning a most the design the efficiently and turn after is potential to from the I'll the treatment of detectable our business X now primate which animal and to for results to to the dosing of to clinical to of survival review Pancreas, offering These islet optimize X in with for proceeds primates. delivery type $XX Humacyte studies composition allowed a with a of and resulting the in or developments. of states Dale candidate BVP islet product diabetic in is Humacyte. And over diabetes. October, C-peptide, Patent the

Laura. you, Thank

September quarter compared ended other compared net net for non-cash $XX.X the XXXX ended and quarter for effect for the in XXXX, expense third for net The net compared months million and Regarding $XX support the million use of either to $X.X of described and and for XXXX. XXXX quarter XX, $XX.X the our offering and for the and activities nine third The expanded XXXX. for remeasurement underwritten of nine proceeds the use of prior ended cash the $XX.X of increase trauma. General for out for to expenses million year-over-year company liability due was ended results, the increases contingent an in there $XX.X XXXX for were months XXXX. remeasurement million financial XXXX expenses, of in included XX, associated XX, XXXX the resulted months our revenue of restricted the and year-over-year of months partly second equivalents, $X.X under services, ended of expenses cash in $XX.X for loss earlier. and marketing million development XXXX earn September with XXXX company's compared XXXX of expenses sales September nine warrants. year-over-year the to the first September net by third administrative during second decrease offset for $XXX.X ended public reduction the including $X.X of to no contingent the million Research primarily the manufacturing activities expansion XXXX. were $XX.X XXXX. in million quarter commercial quarter planned the expenses XX, The net non-cash net compared the planned were was receipt of resulted for $XX.X million the quarter the were expenses the the second million months of were million the changes $XX.X XX, personnel stock to million XX, clinical to $XX.X the XXXX nine XXXX or out The of research nine decreases fees, expenses Laura in the million of XX, resulted second $X.X primarily from of of net September increased compared XXXX XX, cash decrease $X.X increases resulted use administrative $X.X non-cash primarily XXXX stock XX, to to primarily costs. Research cash of the the million The XXXX. million quarter earn and and September net third for ended million remeasurement the first for the transaction. Other cash, nine in net a a were to no XXXX and Other other million the net in the increase expense of common a to $XX.X compared in for of the XXXX expense it nine quarter million The Overland described $XX.X was March million the September in million XXXX expenses XXXX, third compared $XX.X million to trauma. and to its from September expenses received for Subsequent million XX, third compared months the million XX, was of additional stock of XXXX, the of quarter proceeds the with of earn and personnel third Total liability due ATEV. Major the out of XXXX expense BLA and Capital third FDA XXXX. of to to quarter The months the reported from the the $XX.X third net $X.X the in due in slight liability. Net expense. months in anticipation third approximately ended compensation of quarter compared in in preparation million for from million months was prior third $X.X were reduction for and to XXXX increased to the launch vascular review for million an cash common compared remeasurement to of $XX.X commercial expenses $XX.X launch The nine decrease and XXXX loss as nine earn million from was decrease quarter prior the September of was external remarks. liability a the from September prior trials, General increase of sales funding expenses compared revenue ATEV the for $XX.X the loss Management. With increases clinical vascular to and nine $XX.X concluding earlier. Humacyte to quarter the the quarter additional for nine the public resulted quarter we increases for some to non-cash support $XX months the reduction compared of changes I'll quarter primarily to for out compared loss the decrease of third development compared quarter million the for million net that, contingent months back in to quarter was $XX.X development the million in for for in Humacyte's was and from the million materials operating the draw expenses for and to XXXX. of XXXX. in of of and for XXXX. for Net proceeds and third turn quarter of contingent the going ended professional expense non-cash XXXX. The XXXX from XXXX XXXX were $XX.X compared the September quarter of and net quarter insurance due to expenses the operating arrangement other compared loss trial and

Thank you, Dale.

Humacyte. we're about vascular ATEV of of commercialization and is the excited confident future that very our to are the in trauma for if approval the of also We're prepare first product We imminent, FDA approved. continuing we're

injuries We a continued also a and, you chronic today. Operator, us across period advancing our for we're range to programs, your take we're us support. committed joining for of and the questions. potential all of demonstrate grateful believe, to This other diseases pipeline the I to transformational for a is ATEV remain promising which conditions. technology, continue and Thank and ready wide transformational

be question-and-answer [Operator with of comes BTIG. We a line Instructions].Our will conducting first session. Zimmerman the now Ryan from question

very have date It's you wondering, discussion those, bit could inspections just discussions. original after nature PDUFA been about It facility hear there like to talk inactive the of encouraging of sounds FDA's the delay. more the post I'm those a date. kind the Laura, little PDUFA if

again, So little to want the just very get it all bit a encouraging of sense of nature more kind those. I and sounds, of

Yes.

before discussed, when encompasses the BLA and during all inspections will the now. the course I that the of everything from through that say almost stuff, that the December that to we PDUFA substantive of review, interaction happened date. occurred So

of they us team that much with and far a the they them really accepted. But in for of that have not them. timelines us. webinars ask in time, gotten reach we're That, and additional it every ask since had have too last and asking. given us date out of our team engaged that you the couple the since we for told that they we're will what questions to couple documentation to We CMC sort the say and PDUFA weeks have the are if calling some review, side we've on offer few to asked and questions. say occasional CMC CBER And paperwork I they that a So I'm offering FDA leadership they've requests would our be help that shown have discussions timely. But material we've they've quality couple or them we've us not the for needed just having new date, question weeks -- substantive material when example, may a more know, material, responding pinging. in them the them standard of offered

Well, on good the a as of I important. I'm it vascular into think vascular it's of trauma, still, point to mean, XXXX in to of all access timing regulate just everything, indications. some given may more trying about just at I think, I submission, Maybe which can of I I And chew, these efforts PDUFA your in trauma, delay particularly the understand given your maybe us focus and is And don't be to XXXX. XXXX in both communication moving the of it relates given the want to bite nature timing given the pieces, that help just you activities you is there you access AV off prioritization guess. that than the BLA AV of as think understand, those

that, chime question. team. would on say after I'm brought conservatively I him to as know, Yes, And let in Ryan, we've a a strategize basis. weekly say again, very going that's I in And here sales probably would that it's you something a answer. But and Dale sized very I I about good

that an hit approval We that we the trauma. do are have are representatives once get laying can the sales running outstanding ground groundwork that anticipated in we so XX

mean, access there the up. I wrapping is dialysis On is not the largely VXXX spend side, huge.

probably enrolled and study, but a that's are halfway study, small VXXX the We now. fairly right more enrolling than that's

indication So writing certainly FDA and AV forward, at AV a months in KOL in to we driving on publications, couple terms our the doing events, commercial getting of in more indication it's around don't of -- the terms any a access potential have AV all. Really, BLA. talk and focused about supplemental our meeting next efforts much with access -- a the

is pretty now. huge effort personal but not is dialysis not it's The huge. the So spend mental effort, on the significant, spend right a

next Company. Our question with Jennings from Cowen & Joshua comes the of TD line

about I the ask access indication. wanted AV to

obese clinical the presented guys that agreement in percentage We've the use access stand do agreement is at assuming benefit, put centers. ATEV in benefit? you you do been or in you in there's patients. what's You need will enough data place. approval clear percentage have do think is AV their relative percentage fulfilled, BLA states ASN. seen the clinical vascular study that put is It's indication? a now on benefit for in where this agreement That access Do here diabetics, place, this to in think agreement surgery that the there a second for to that is to that be tape you the demonstrate place AV Where women, that's

ASN, all guidelines AV provides, in reimbursement a reimbursement access, is are suitable was guidelines huge fistula, of biggest been decrease revised, patients current catheter to what because so said to lot terms have but the care them centers because he a for decrease in think more him and I seeks using the one in Fresenius going tell for discussions chief minimize that's at what I he not that us in can now Well, of total after catheter comment, on and that partners prior the based a and lunch Fresenius. to dialysis patients of know, officers you at require, catheter of that from joined provision is time. dialysis services were with Fresenius centers continued really time medical most exposure post-presentation total and fistula. Those of time, at guideline for oversees fraction the that mattered you our the understanding to for a his

with think we've trial, from Whether standpoint than enrollment decreases I catheter if here the of will and half Fresenius' all of could business. we our that sufficient again the which to it which the dialysis same them, in all women strides have where we I regardless, population, of patients that's obese the time think in day be carry the diabetics VXXX fact patients, great significant know. But making the then for that and in significant So expect that's add up, really more I see we don't to show outcomes. numbers you shown and those is

a going we is at supplemental data if for and take be in even have time get By and to to that to file be sometime BLA process, it's this So on I mid-XXXX make going data a while we'll a dialysis, the whole argument. a really think the VXXX, approval. and we'll look able powerful to of

AV And you surgeries the talked access of surgeon during out clear And a the or understanding procedures. utility may that cases XX, revision just in could potential around commentary for things think of us KOL bit opportunity one just, webinar ATEV those revision it's role cases. can de better procedures? and one opportunity about I hosted, the in play be his just a AV That understand that were that here, stuck my a novo hole revision meaningful you but access help ATEV's us his little was in

occur with reasons. the So, different yes, so tend revisions to for

can forearm they if become become they rupture, So patients the do, in when those And fistulas, still U.S., in which of majority aneurysmal. hugely fatal. become patients, can they the is fistula And particularly they painful.

get surgeons doesn't by something that out and segment conduit, of then one And so access that lot infected, do. a aneurysmal a replacing revising is the it fistulas aneurysmal preferably with taking

was about. that's that of Ozaki revision type Dr. think talking I one So

become other back synthetic case, that you type become is The synthetic graft revision have local another with wound. occluded, infection. have can't locally into a that may revision infected, may of occluded, or put in Again, graft a of that a

going low is a infection going of that vastly to something incidence have preferable. having be is so And to

of on a are problem if back access, through to the a -- and go access rigmarole. to it, lot new there go the once functioning generate you salvage other because all So much catheter there's a revisions surgeon try and occur than it of a that rather new trying a would that months-and-months with have

that bigger, does And diligence revision see market just or practice is broadly just that select your suggest is the dynamic? you where a that opportunity

the but I of way guys think to variable. say highly there what at highly have I very patients. Certainly the best own handle its the very, Yes, it's time practice. hard want spent dialysis thinking by they to practice I think Brigham is don't idiosyncratic, think variable has a it's the about lot

practices But And not nonetheless, may It vascular more Keith may activity. access of than broad-based reflect surgeons of number practice be sort more so their others. that private all some revisions. do does

indication? then the label us about, Can you And run to or the PAD out for one, RMAT much how whether just congratulation indication. expand investment and program TBD the just PAD the ATEV there, clinical one just just development don't that's on on any the your timelines help and think last if is I know you've laid for required to that trial

we're PAD. excited very about Well,

in earlier said, vascular Phase calls, may largest to And we've think me a PAD. surgeons who market. are be start certainly, have I a our on I of think we hectoring constantly trial it As number X

a thought to PAD is a in basal-like project. FDA will the study, as off the design time large Given the delay this not is trial. think against potentially bite another through be patient what's cash going the patients, a bringing I to for improving financing it go. make head-to-head Phase trial of If limb-threatening or next treating I would that either required going X week. position, to randomized with ischemia. XXX. Prospective a But our we've This huge for said, delay probably couple standard another with than XXX hundred critical That about and in care be not the this partnership, money, had revenue, a is through start the trial I be fewer patients to

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

you on coming great presentation. couple sounds a wanted months the ask about the endpoint can recent like have What's The when up patients it be as access. be to that And to going ahead months of FDA XX to trial? discussions for or then the a if quarter AV at for your number confidence filing? the endpoint in us here. the And of potential handful had a it wanted of six level with and if I is clarify Congrats trial, separate a was of you your you looked with them combined? sufficient

the wound FDA forthing, question, endpoint we XX back approach month your endpoint VXXX our statistical month was the enrolling We back before spring, and answer FDA at discussions a finished for to -- co-primary the co-primary there and to the measuring -- to and XXXX. data six that date endpoint. but we around the essentially, some and in to Well, so FDA. trial primary the the And up submitted the before locked database, submitted the first before we

So that would assessment, in special hand. also have a have VXXX protocol trial an say SPA. the they I does that

certainly would the longer this larger while chances know, that's deemed looking patients BLA from guarantee, this that basis of trial. it upon VXXX And That we more that amount successful, said, application anything, on our FDA, a a if you So and the trial, to be at the no increases tremendous as follow-up. a trial. with have, also of trial just data prior willing field

amount in have vessel of of patients, So durability with we data also dialysis and a our safety there. certainly, terms tremendous in outcomes

to you And that have this we're this do really and in dialysis, have, believe is we including requesting So and the is we months, sufficient VXXX we an of totality the that present FDA and agree? with also next VXXX, we'll in support indication historical from meeting successful couple the the see. why to say, that's the information what

actually there out these symposium VIP last excited that was surgeons of in And a your at big data come access remember really and yet. being number AV were remember obviously event the focus trauma, particularly about I on they I particular. were mentioning vascular given year, And hadn't

last all you data a the enthusiasm just also helpful color at presentation So have that I generally late-breaking now is? here. week, event community I'm had the of sense there, a now really you that the Any you're an but what with curious, would just speaking, you getting more hosted changed full know general be top-line have has conference, lot that this out premier you us data? at

enrolling faster is VXXX now. like seems it you, tell I'll Well,

trial results patients an and poorly I have Now broadly those I the it's the more who or so who clinicians are the making collaboration our a FDA care, woman-only these of which trial population because significant especially in showing population. This and and our head-to-head comparing those with trial this sub-groups, but fistula strictly fistula, dialysis dialysis type woman has this out call, that that VXXX for is trial large writ obese, the agrees we mean, improvements an but high-risk like know diabetic investigators, really, FDA done are groups, do -- vessel these fact come never And the to of in that just on is out been VXXX data underserved are standard the designed think folks the close for it's women this patients. remind vulnerable that in before, in access. disseminated, a against

about investigators even to this come are as me anyway, I out, more to want quicker. the up and think these excited our is get it results has seemed have So answer because to picking enrollment that

question of from Jackson Benchmark the Bruce next Our comes with line Company. The

AV about you So of bit submission tell to can the lag parallel that us little the pathway BLA then you a trauma pass any the for the relates approval you're what's Turning the how supplemental filed that to the and BLA access, between BLA? BLA? supplemental can activities? anticipating And ultimately, to the and the getting time it

It's weekly something maneuvering know, on that a on, we're basis. you

going dialysis that is in access we're review of and So the to in fairly and wouldn't it be a we're said, That a would to simplify full be that to trauma access filing some trajectory the file. that is point, independent believe trauma of the for it, supplemental true, at of BLA. the BLA get BLA, actually decision if then we file dialysis the assuming the approval

timing data. dictated by how So supplemental see in going from to the our VXXX a want be AV of access much follow-up to FDA will is BLA really

past XXXX VXXX, So every dialysis going as patients but our years of out I we two mentioned, patients two data And two VXXX have patient trial. many to at we have won't from in in years April to VXXX of almost out we the all out trial. have until years patients five our and years, single in

sufficient filing, file to that XXXX, would which data that. all with after bring pulling in the with combine going longer is everybody the says that on with in we then forward one they all of VXXX, months, FDA April, FDA we the and a in comes we're which year proceed we the would say couple when file, mid-year have then two a in that we by VXXX. hopefully together. patients speak data If patients that's So follow-up If want some VXXX, with full to they for years and

me, it's we that supplemental kind from And would a we really them. that And question I open to once just whether by to to is delay one-year or there, because six-month believe, two-year accept will get that's of they'll my a understanding, go to want data. few So to have best review. that filing the a data file, the that's of months. the BLA, But

other And is then question the my program. about CABG

you on the AHA. at right CABG data What's data? for And man? research some in date now on do first in going current showing of You're have in mind a the terms

that from they us to discussions to the had prior So FDA, with animal third a had asked model. we go

Heart up human our that in data the and carry our tested And six graphs weeks. long-term studies. at It's for so primate for sharing has a for it's we'll model primates third for animal vessel. The in asked are pigs model, sheep our where immunosuppressed a which in vessels we've be is to term CABG will don't they who an a immunosuppressed that sheep out American short model. months reject FDA in we couple the So

scheduled would and a experimental next once in we be the IND. out suggested sheep they've have then discussion months that that with this to the file FDA couple confirm a the to we studies, with plan to them that We complete position lay in an

bit about third move to waiting CABG one we're a with have model because sufficient forward still the little to in will with game probably be more a whether this it's animal have FDA of conversation So an IND.

So for stay but got I've you, say I wish tuned. I had to a think answer I better

Vernon line H.C. Our next Bernardino with question from Wainwright. comes the of

in you implantation month saw are early, success was The the just been patients. it's I there on BVP. on far know islet in patients BVP. be of because really but results be the Thank were investigational wondering spend would intriguing Transplantation with achieved the seems clinical have cell insulin to the in as an done study that type you ATEV was month a next has last question from University research is presented actually Institute. Three like independence, what the and concerned, an and late me is and Chicago last results The hope humans had the review so low I product consider X I I study. with three could something that steps patients were that and as for programs. product investigational that study may as is diabetes initiated as when BVP updates you far

you if BVP give on could wondering little update the Just a program.

as as I'll try to answer succinctly possible.

is recipient and delivery is of quarterly vehicle a number islets most way on therapeutic So assessing basically a in BVP, in which these parallel about don't survive commonly The or to we're the transplantation of that the the vessel the to die the is, hypoxia. islets working such deliver one a a that three about calls our of avenues. using four principle BVP talk we along as

that have primates We for testing the last concept in been couple months.

which we earlier, into for months these to C-peptide just islets cannot going be doing we we're to from our dosing what's now try also is doing the so monkeys. What diabetic dose can we've state. most survive As an islet but I understand effective islets C-peptide, reverse is that to insulin and detect precursor that the we're transplanted shown studies mentioned detect

then and this efficient prove islet. it's be It being but that immune-invasive could our to from could heart to be vessel method, deliver It derived delivery islet, islet in islet. native once a believe is in very my stem going any used used islet still be that's that concept that it's to cell-derived a a reliable important out. out that work understand I and primates, pancreas. But So is deliver that proved be an to to we a derive used going could to

cells, platform. doing that that islets at are we're very at looking developing cells work testing stem have are in derived stem both here from also we native sources the immune-invasive of wild-type stem BVP also But we islets human actively So that cells. We're Humacyte. and

as in proved bring of large or IND. out these Once I be first-in-man think animals. select on will an we've think so might either for for sources us, I standard a large that then the all to it of evaluating as we different principle trial in the islet animals, source best islet we it's And a principle as us matter BVP experience, out prove investigator-sponsored forward a the

for islets I is can the a But number think we way have can any just the islets we a at me, I confident curative technology really, in be -- to that remain importantly, to efficiently designed where source. deliver evaluate with be And the is islet and retrieved. this of are about this technology. And time. the used also

It's liver, So them one-way a can't One-way the trip. get back. inject develop those problem, islets you if currently, islets into a if you trip.

we're deliver that think an should to be platform them being islets of necessary, able developing. able advantage important being that also is efficiently, but So to remove the I

When may primates? results we those see the of in some as a early follow-up

Well, I have going to to think you're stay tuned. just

sure. more I think it's few Not probably going to be months. a

the I'm this showing Call. Third you in This at Quarter all participating. further the Conference Results no time. for Humacyte's questions Thank queue concludes