HUMA - Earnings call transcript Q4 2021

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Operator

00:00 Good morning, ladies and gentlemen, welcome to the Humacyte Fourth Quarter and Year-End 2021 Results Conference Call. Currently, all participants are in a listen-only mode. Later, we'll conduct a question-and-answer session and instructions will be given at that time.

As a reminder, this conference call is being recorded. 00:17 I will now turn the call over to Lauren Marek with LifeSci Advisors. ahead. go Please

Lauren Marek

operator. you, XX:XX Thank

statements Before material we remind call would to or actual Laws. call, forward-looking uncertainties expectations. risks that present could on with that certain our the cause These Securities everyone Federal this to under I subject statements to statements and differ like results US proceed are based made are experience during historical

in our before during weeks Dr. financial results. quarter recent and company's Officer. Chief a December a Form of Laura to is it made accessed XX, Dr. progress contained year XXXX Development results concerning review our Operating the as page to Dale cause differ Heather President call is The for on only Dr. Investors factors Information this with statements forward-looking of XX:XX we from Humacyte company Executive hereof and ended Humacyte and this other company's Chief the Dale update Sander, information from during the required Officer may the presented Prichard, summary on year the call Additional Report on Officer; Financial the and date which in and Chief website. obligation available. issued the made call the and actual Niklason statements in or statements the me the from over Annual forward-looking Joining by SEC Form XXXX will that materially of this call forward-looking of provide Niklason, for be revise made law. except are speak XX, release when the filings Chief press to Officer; could XX-K as and and contained ended on XX-K no today's morning this Corporate turning December undertakes

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

Laura Niklason

and everyone Humacyte morning, Lauran. on you, thank XX:XX Thank us the inaugural call. you results quarterly joining Good for

intent XXXX, company with the Healthcare we're build has that to interactive the As and Acquisition Humacyte progress our and closing of on outreach investor us combination foundation to on dialog. debut it's XX:XX early our strong XXXX. regular discussion significant we and NASDAQ, for your look in business our our our provide expand calls. quarterly including appreciate made future which attendance upon We stage, of progresses part throughout Alpha the agreement Corporation toward forward the with continuing to today provided commercial opportunities

our remain our towards a just our a commercialization. HAVs the focused regenerative vessels in milestones trauma, of summarizing moments on our progress. Dale the human few we acellular or call financials. tissue continuing brief platform before developments advancing regulatory late to recent forward, we our for medicine clinical As over vascular II/III and that XX:XX I'll and candidate which first-in-class I'll progress trial lead review begin HAV Phase with bioengineered to turning human is product evaluating is spend

enrollment enrolled that Difficulty] we've about the working ongoing look use department of with trauma date, the Concurrent with and pleased with our updates conduit. subjects with for Furthermore, designation vascular XXXX. expected malfunction of the of As XX:XX or [Technical personnel. incurred trial for and assigned to be high we for to Currently military DoD and patency of results number guidance and support XX:XX of occurred We to our reports in HAV the in of HAVs advancement injury. a relationship seen when by a had low XXXX from evaluating the and X%. this we've we've grant of finalized. amputation approximately and the FDA, we'll at a priority replacement HAVs this XX the to a infection continued with un-blinded the provided anticipated repair. vascular in design filing DoD. provide for repair trial $X defense no and the discussions of The continued support result trial address or injuries as of of of enrolled our strong Results limb study unmet from completion the And HAVs traumatic trial has this the a are to rates the are forward a have FDA. is repair, need open our trial label vascular total Using single-arm reminder, HAV million development reconstruction approximately rate for the very to patients study reconstruction we showing

to if the as hemodialysis. journal continued or patients addition will patients. In evaluating reports for HAVs use end, We're to in We or Last in trauma. this collaboration, Humacyte to HAVs Vascular disease. There dialysis trial month, HAV and of the expected for well thus, period patients of no enrollment trial in HAV In EJVES vascular nearing XXX topline treat work enrolled for II deployed. a Phase commercial that is care patients injured the five-year access supporting and in supply to Fresenius launch data and further supply with advantages. usability hemodialysis continue approved the Forum. are we Care, enrollment from To follow-up five-year we in veterans, also period with this currently closely a this stockpiled military clinicians year. based to expect development built in for a be by HAV on follow-up end-stage leader result XXXX. comparison we're followed products trial, were hemodialysis where partner hospitals insights HAVs completion and the the XX:XX the of access the care, to shareholder filing Phase that Medical AV the toward as to receiving long-term III designed our for in kidney FDA, in be valuable our providing published renal XXXX of XXX results study, progress trial services, soldiers we infection than strategic of more and up Based one-year by with clinical and value personnel we arterial into usability which assess in during completed be observed immunogenicity, of commercialization, market BLA a As of as may our XX:XX anticipate the to venous [indiscernible] military for the in the HAVs of major expect later areas

successfully our deployed our we of for production the XXXX, HAVs. During manufacturing commercial-scale system

presented those ongoing running the implants thereby II the and that producing great achievement, Congress other and that progress clinical the and Medicine company's reinforcing we're manufacturing United clinical HAVs. is to our results our Moving in of to were ongoing Phase scale use safety agreed portfolio our clinical similar system HAVs our in programs commercial it's the onto and In in Related XX:XX Society and in scale supply in from hemodialysis trials on earlier commercial-scale of produced efficacy developmental the access system under the XX-month were produced making States, be XX of indications. readiness HAVs the of our Engineering manufacturing launch broader are Our To to Tissue with an confidence this in in XX:XX the pipeline, in completed program International limb November by using World systems HAVs XXXX, than to commercial vascular peripheral we've up more and Regenerative highlighted systems. used US the this legacy trial which positive scale trials. EAP, for FDA conditions, data commercial-scale PAD. Xth to last produced vascular the critical presentation of HAVs continuing This or disease our under our were for of FDA date, year. manufacturing in program. authorized expanded is including patients ischemia or HAVs the

In exhibited pediatric grafting in predictive primate each instances diameter HAV of no well first in the the that or a vascular non-human HAV. studied Heart the preclinical from and highlighted up of artery high-risk no salvage Humacyte the XXXX. patient bypasses disease exist. Advanced Surgery: a Sessions group a Furthermore With opposed this few the at in graft infection December regular ranging Innovations to XX Annual and the activity observed model follow limb and XX:XX current Vascular options positive heart first the EAP presented from Therapies of noted. the XXth have that six no Association prosthetic small outcomes, remained cases coronary diameter patency XXXX In as an regeneration patient the the the study, our CABG. and of HAVs We of of and January model of January XX exhibited were In Vascular being performed Techniques the presentation of the potential primate has of in primate in programs. and trauma Scientific currently that results performed Meeting critical of study use of to highlight in vascular with of outcomes Endovascular use believe the Researchers as series eight simulating throughout investigating of a this researchers This believe published respect HAVs resumed with are pediatric The used is XXXX. our with reconstruction for maintained and diameter the of for we Winter the patients where at vascular programs, in CABG other the as in five heart study XX:XX are of of results we vessels months, millimeter Surgery human were functional the preclinical patient use procedure Week. and of has remain is cell first limb HAV for the of HAV XX:XX in compassionate results both CABG, signs the XXXX and the was ischemia addition, HAVs XXXX. our HAVs Journal bypass physical having Society of In highlighting thus, models cells. HAV of the Cases, in November our options X.X infected that The under potential revascularization, presented American repopulation of observed clinical millimeters X.X HAVs in was infection and vessels disease. with months from in of millimeter HAVs positive to host times at been treatment highly

we to organ addition, as efforts our developing by systems. be continue in HAVs complex In encouraged

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catheter commercial demonstrated exposure infection approved are potential access In and there HAV believe that use addition, to deliver Dale highly prevalent HAVs business the a been by developments. the stakeholders, And relevant and opportunity it now to approval other to value XX:XX and over the receptive We dialysis potential FDA AV the patients. are efforts is of in financial I'll review launch. our surgeons has in for to plan excited to resistance to turn for patients. to date that, results of continue substantial the HAV especially for And to reduce for if due all with our we to for

Dale Sander

million Past initiatives. increase million $XXX.X PIPE were ended XX:XX Alpha cash investments material personnel, XX, operating, all liability XXXX year of XXXX. December The costs activities million and in compared expenses the the the and the primarily December $XX.X XX:XX for Other in year million in for December the ended compensation year by December equivalents investments supporting manufacturing approvals net net related for of the cash in for of Corp had to short-term financing, periods for clinical transition $XX.X $XX.X net increase external in Thank to to The and proceeds financing short-term XX:XX to XXXX income year vascular and other the support resulted back of Acquisition and XX, December associated the ended to We and $XX.X primarily short-term that, for current XX, in quarter current December ended XXXX. net our concluding Net fourth a December non-cash in contingent company XXXX income fourth the $X.X to ended grants loss being growth. XXXX year and million fourth for from the the potential expanded of XXXX XXXX. associated the studies. loss related costs personnel, General the was of resulted million The net to will year the December compared quarter net million services The the XX:XX cash, the to was primarily expense of the investments equivalents offset fourth in in of current for administrative expenses for public of other the year the or XXXX. year partially equivalents for With turn merger. non-cash you, current XXXX The the expense $XX XX:XX were the with to cash for fourth investing fourth XX, compared of $XX.X with cash, the I to with to XX, XX, personnel for for for as hiring loss quarter ended were from compared the two million XX, year XXXX. fourth expenses to $X.X XXXX. used a in of the compared of it for cash, $X.X end the net million increase compared completion quarter December XXXX and income adequate ended compared net in that to for XXXX related The Laura. company compared through in income net XX, quarter $X.X and $XXX.X for year quarter XXXX. ended for was million $X.X increase XX, Revenue development earn-out remeasurement $XX.X the XXXX by resulted Revenue of support to expense for merger and from related an of loss XXXX, $XX.X million ended gains in December are development $XXX,XXX increases to additional XXXX. from in remarks. year Research in of the cash expected ended XX, XX:XX HAV. $XXX,XXX during recruiting compared quarter million and HAV believe fund for XXXX year XX, for insurance We $XX.X and were XXXX. professional million other fourth to from $X.X designed compared expense $XX.X $XX.X of stock and fourth XX, to Net XXXX year XXXX, million of our as and leadership $XX.X December compared million decrease merger XX, quarter the income. development the the hemodialysis. AV trauma of access was net income quarter of for and quarter increases year timelines XXXX to resulted of the resulted million was a million fees to August for related and XX:XX research and Healthcare the quarter was and net Revenue for fourth million fourth $XX.X Laura in for million increased million the $XX.X XXXX XXXX. of XXXX million income development December increase net million year current XX:XX processes commercial-scale operations the

Laura Niklason

you, forward To preclinical move updates we questions. exciting quarter quarters year, we've now we're as our look the last to the and clinical through commercialization. Dale. made our advancing providing and throughout the Operator, Thank programs. XX:XX and significantly XX:XX next submissions progress continued and over year take the conclude, ready toward to regulatory several We

Operator

XX:XX Thank you.

conducting We will coming Jennings Cowen. Josh first Our Instructions] from question be a now today question-and-answer from [Operator is session.

is line now Your live.

Josh Jennings

to vascular Phase for number Hey. Dale. on the to enrollment about Phase call. the pace for of trial those in to trials? COVID trial presented updates and but enhance be just the public your headwinds it’s the taking just or about questions just the III centers thinking for Wanted great AV past hemodialysis months, terms the and pace plus morning, first of II/III XX Thanks environment, for enrollment ask Laura any trial, the some XX:XX Good and earnings access clinical the two any over trauma enrollment just strategies

Laura Niklason

this XX:XX Laura is Yeah. Niklason. Josh,

on focused are imagine. We that strongly might as you

to efforts spur adding we from just sites. clinical clinical week trial last [indiscernible] for opened new four Israel our enrollment up of total sites a in returned additional where fact, In trauma team the by

XX as into We're really sites sites located That that increased to enrollment and areas to population So as seeing that trauma COVID has in -- the see pick our four with started necessary. are offering support of the in in up said, in site that also Phase both additional of our help trauma has number civilian with them leaning logistical recent that amount receded total in and have and months dialysis trials, actually new we've we're US higher XX:XX III to in access. currently we're in Israel.

Josh Jennings

with these the are is are trial a on there follow-up FDA they can development is plan? two investor but Excellent. It's program. Thanks in and is understanding that. the one vascular their the access finalize next then with efforts negotiations to just calendar XX that pivotal Thanks FDA terms for for with Are just AV second and can an think just And on program. patient and hard follow-ups, patients, kind requiring questions. the are FDA on that quick taking you partner, trauma regulatory a you just XX:XX these And for development the in any in clinical the early in of the of Fresenius, program and share role steps? reduced, number anything XX be chance that there meetings they stages the clinical how And what I collaborating Humacyte?

Laura Niklason

to any this you the have don't been patients trying to But more your in FDA yes, discussions is point, your that to for to nail previously continuing XX the response at we've estimate guidance the So, down quite trial, the that XX:XX have approximately respect size that, will first be trauma Unfortunately, give time. we that required. guidance question active of I with to number. final we're specific that given with

the courses, that trial have the speed both we dialysis, we have, we dialysis a VXXX with we number are As So are patients also as We're might patients our excellent complications or role presenting coordinators which appropriate with is have Europe, HAV to trying working and their suffer as the the the those patients that XX:XX regulatory or XX the to larger to true colleagues, who program, and we they as trying patient the expensive relationships access. targeted clarity understand have XX:XX far most complications from sites certainly from pass steps as bulk our numbers identify -- certainly trying in access with trial as time. the maintaining think difficult and for I care for of III we're far whom dialysis to most databases in As it's will that marketing. Phase and that access of with the really you our dialysis, at for of imagine, think have with working when in dialysis trial, affiliated Fresenius to some next for our care with the there coordinate the US cohorts benefit but who somewhat most commercialization more Fresenius patients, actually to uncomplicated we and in estimating really think respect we're most but be enrollment. are about who along their which in and still Fresenius will get with to

Josh Jennings

XX:XX Thanks again.

Operator

XX:XX Thank you.

Your next question is BTIG. Zimmerman Ryan coming from from

Your live. line is now

Ryan Zimmerman

think Good I a for And Laura, but the taking scale of commercial and few a we guess And your I kind scale producing time, about XX:XX of kind not about, on kind of up your LUNA call. you first of afford? over again, have public today, afford necessarily, what HAVs. can about and you the you just that ask follow-ups. running start could questions, system have and sentiments, echo to to Can commercialization, questions. now the thanks then benefits wanted as that morning, I congrats couple that the certainly talk benefits

Laura Niklason

HAVs you're manufacturing describes Ryan, in of system submit module trials. commercial current are FDA that far our on in a our in licensing Well, that that the that. XXXX in is We commercial our ongoing biologics were methods. as they to effectively application pleased using made what signed XX:XX And right off to as complete the

building But have large be modular address HAVs years’ a and shelled in Currently, the for worth the view of per for we footage approval XX:XX we have HAV. also more gaining year, anticipate of sufficient units. eventual that important of derisking installation which essentially So that event capacity the potentially the in has an out that the demand to manufacturing FDA approximately two building grow X,XXX will square amount we or of ready the post-commercialization. importantly and as is we for one first these to

room can vessels actually and each modular year. units XX X,XXX building unit call We the produce about units, have per which XXX in for we LUNA

So in we where believe the commercialization. per building produce we least capacity through the of several reside currently to we lead first should which year, have years at us vessels XX,XXX

well So or standpoint we've we really very we can from that a positioned of manufacturing that companies. commonly feel afflict companies many can cell meet risks demand technical that tackled biologics and the therapy

Ryan Zimmerman

it. surgeons how thoughts your that about appreciated? launch Got with surgeon be the XX:XX use a the I'm trauma us helpful. whether And XXXX for follow-ups critical position working And cases, may then perspective? vascular is then give Who of derisk seeing question, could Dale, you. about Dale the if users potentially And limb trauma the patients that the a you talk your benefit little just That's from Thank me, in the appreciate just kind And who -- But cash I you if could much just kind with? help be for burn comments that cash does two on of company. XX:XX would there? maybe wondering are you or are just, second in just the bit from say, similar are ischemia? one, these to, compassionate those

Laura Niklason

that areas, whom as sphere in Ryan, surgeons care trauma are But surgeons our there of majority overlap with clinical surgery. vascular as been XX:XX of and vascular reach really with the surgeons trauma PAD of but trauma of our you're trial, as certified XX:XX there's and some ischemia the access the no the XX as and are to In the the because vascular expanded numbers really extensive seeing that lot of were vascular with critical out in US as the working So, as various facing vascular trauma there is at American we're as amputation, are treating who for well In -- AV in cases, patients trauma many who for trauma And they're connections board we've reaching Medical we who your also other level have both surgeons. our care. one vascular with vascular centers some and and surgeons options for far in trauma large in cases the trials, far that's system, mostly and or correct, actually question, patients answer surgeons, our between surgeons limb cases, in a who access surgeons. have in well. surgeons

or patients, gunshot on industrial occasion have treated patients injured trauma who severely suffered We have severe wounds really accidents.

And typically out so reaching in we surgeons surgeons and combination vascular have trauma of situations. a those

Ryan Zimmerman

– then just XX:XX And the cash

Dale Sander

of comments years three and for around over and vast But earlier including well burn the X R&D our view, And our guidance. shift certainly – probably XX:XX be more detail, those manufacturing will focused stage the by point stage expenses specific in R&D, pipeline as years prominent a obviously, diabetes. of runway. the But including currently a the programs extrapolated that's AV planned obviously we next specific next from burn pancreas three down haven't pancreas cash start cabbage will and flow clearly, ramping until coming on in ultimately sales the the Yeah. type human towards geared is market our be AV up. CABG our access access, years trauma upcoming course AV of in the Ryan, and as we CABG up is specific given cash marketing late-stage the we guidance, majority BVP the kind in of and average ramp ultimately of with this trauma readiness. can as trials over burn of in biovascular -- is up at portion A winding launches and also access providing program and expect very

Ryan Zimmerman

you. Thank XX:XX

Operator

you. Thank XX:XX

Our Street question is O'Neil Brooks Capital. Lake today coming from next from

Your line is now live.

Brooks O'Neil

commercialization Laura of caused your change can XX:XX there's change? if a any bigger your if curious, to picture of morning, describe what's so, programs? big ask Good and Dale. And I'm big just just you in for expected been questions. I that significant couple timing -- want

Laura Niklason

need projecting trial given we any that, of for timing patients late be in Yeah, that perhaps that have that XX% with as to early of in With change more that in not the continuing make the or are we've XX:XX guidance on we But filing pivotal big Phase our enrolled is dialysis, us Obviously, BLA filings this regarding for would no and FDA XX:XX the number. of we patient depends XXXX previous changes XXXX. trial we and today in filing trauma -- late BLA access access. trauma are in XXXX The respect specific number the hemodialysis of this XXXX. early is dialysis or that III of FDA are from total trauma discussions this BLA our enrolled. than total anticipate to projection guidance

in discretionary have were vast last operations. simply call, of been headwinds the earlier at has majority as certainly viewed years. over provided canceled country, There because were medical enrollment analysts two operations other the mentioned centers they sort dialysis for COVID the dialysis in the As periods have where time of

year. the line would we say up access late would has COVID, later XX have anticipate in starting it's I filing support after there completion have Since of top slowed enrollment, trial that dialysis trial, trial, a completing pick months XXXX. after to in anticipate in we that XX been this a would VXXX and that results month endpoint our would enrollment would I dialysis on enrollment So we but by XX:XX

Brooks O'Neil

on Any based there? XX:XX your then, Great. updates continues relationship And just comments quite Fresenius earlier to strong. I'm be with comments or your guessing that

Laura Niklason

Fresenius year, have this really half. a several last that I'll and Humacyte each other the I but embraced would Well, XX:XX as year on Dale say let and on projects well, over mutually comment

the of access I are As call, mentioned earlier with and ourselves their commercial in Europe identify really working far sense like the Fresenius from the and in lot this design as planning would would might be it's by in pivotal trial, Fresenius based US. work in we also Europe a of discussing Phase include right that potentially to addition, and but patients trial these in also In II we're now. which of the US target benefiting US with XX:XX suffer the are site. some who sites probably from work really be a as some PAD And HAV. Europe the who which Design a patients by complications and perhaps in those will pivotal to dialysis in preceded Europe, Fresenius registry we

in stages, markets. a for it's projects are planning variety the on but say closely of still synergistic different us. is that Fresenius of working in And Humacyte this I both would very several and been So,

Brooks O'Neil

just seen I'll guys just of you comments and more, -- Fantastic. to competition, anybody in with Great. are what significant of out one seeing I a have just you are the work now? you about of help you any be overlap else doing, ask might love else anything broad the XX:XX there terms in kind outlines the right for sense get doing marketplace

Laura Niklason

past the Humacyte a essentially XX:XX start Well, year smaller certainly in to terms what unchanged a that biotechnology companies attempts degree, are of small say and mimic is making situation has the remained are doing. engineered that over to up, of who number would there I tissues,

these looking smaller there's Just are. objectively as where where pathway those other between gap Humacyte development a companies are and competitors fits. where far as XX-year other at potential probably

is XX degradable but synthetic Of evolution said, a tested there they'd electric are or course, are Teflon significant synthetic of the march traction. continuous And that been clinical years. really used of evolution are of that the non-degradable gained Dacron has continuous system remains two XX spun, in That and them being or whether new the be a there none for materials being new materials -- have that vascular XX:XX widely brought in there despite new forward, of vascular continuous is a system. fact products, or the synthetics

Brooks O'Neil

Great. work. XX:XX great the Thanks Fantastic. lot. Keep up all a

Operator

XX:XX Thank you.

Your coming Piper question Sandler. is Matthew from from O'Brien next

line Your is live. now

Matthew O'Brien

I thanks is kind for and yet. the of thought more and to the don't FDA. design think Because actual there would we taking up morning, about Good patients up for talk questions. have buttoned the we're just any Laura, full way that I buttoned number of XX:XX The now. discussions by a there vascular with bit trauma,

clinical of a is or kind you? concerned study lot there just with the more they're that your sort is push busy you of back moment? with you're makes is of So there things Is doing agency at what any commentary some about it giving the that of

Laura Niklason

XX:XX do fact And the is the trials. standpoint, difficulties commercial-scale that that have and very and use and with Humacyte we and reviewed a clinical illustrated fundamental it from by our regulators. clinical the our I can busy. think they've with Well, manufacturing technical scientific agreed the any I FDA. great ongoing think I the agency receive think not a in to we with respect technology I system that's have standpoint actually relationship that

we but first I secondarily, a feel through relationship new I is the device, fundamentally we be to this though we're cautious regulated have a and technology, that. more working biologics. a with although FDA, think this fundamentally XX:XX product tend even So, sort -- bodies of with of like a as regulatory is And all, good think new working we're

the by the caught in the two Biologics COVID at for Center been for up as regulated all years. we're the trim FDA, So which, has know, nails last we

with So know a with after leadership as between also of frankly, group, only and has combined, we [indiscernible] our the FDA, the ago weeks in that with in combined to commissioner. huge long biologics interim the the as technology newness Rob provided a came all an distraction changes Commissioner the COVID hiatus few

of is company or and a I respect the contributing are agency see lot problems science. what between factors there think I that our the the medicine fundamental here, the are but or don't technology So, with to

Matthew O'Brien

with mean, the DoD hear. think you knock How for approval it? to can the great we using purchasing I get about product they on HAV? the relationship here? and do do quickly That's how start the Okay. would XX:XX When

Laura Niklason

going I'm I I you a he'll XX:XX for to will. that ask better answer field think Dale question, to than because have

Dale Sander

the Matt with importantly, more Thanks, the in mean, I been support their in the -- probably have the from key we for had trial advocacy trauma, the terms question. ongoing of and Yeah. appreciate certainly, we've DoD XX:XX discussions FDA product. the for in our

we a that Because, point be can stockpiling military forces world support from pure think are needs products forward point view, to would the deployed in the patient. point the the of their this expeditiously to the be deployed be at conflict. itself obviously, in expect in throughout a nearby our I ways, wherever product of of commercial one vascular time view, two in treat trauma event from manifest to to of injury

the be system. to that be would that used based think also use Department hospital And timelines that been from stockpiling able terms exact post approval discussions So be our think comment I approval Beyond date. of more actual to that's is treated the limb we have the to we'll of as we of Defense in get but XX:XX timing in now, when this you many have going compassionate aspect within clearly veterans have heavily expect a give of on are, guidance severe the we any of fact, our ischemia. that, to on been right closer VA at for difficult ongoing look as those cases, -- history been

Matthew O'Brien

the CABG a maybe That trauma of on and that but time a I was we little one the like don't a then were And vascular newer AV access there seems and bit know if little little focused updates. just spoke. other update. it. for some you, more was Laura. bit Everybody other last really bit it progress than maybe Got XX:XX and PAD, last is

highlight So maybe can that outside to real you've area you indications, where want you just you. three today? made those of Thank emphasize some kind really progress here one of

Laura Niklason

imagine go of choose XX:XX a you CABG. is on been our So, But working But CABG and a which and development children. studied January program favorable outcomes a smoother. animal diabetes experiments. is which program, bypass a this artery yes, good model between like as conduit University, We good currently if development underway it's you're street human research from non-human our developing bypass at We've might lot two me choosing sized makes coronary is And and just -- primates. surgery between functioning leading they're of doing Humacyte, of that been non-trivial in in and a of I'll a so down had biological to with set couple results graft. of on now heart asking program the sort really the I development well non-human so and saw organization primate and -- reported good they're Duke that we primate years patency six-month very remodeling for we actually XX:XX guess

we ago. of on access of preclinical the non-human patients. results baboon So work prior the with because see these that in we've going we're by all is very to to more as meetings, baboons our particularly We I've in into model, a and highly in encouraged did what predictive the in prior this AV very went results, than mentioned were decade was primate believe humans. what And we seen very baboon of predictive in

encouraging. We're pre-IND to positive and that to So going fact model baboons in a year a this baboons results on expect the is getting progress in CABG. filing do coronary in very me for work to coronary we're continue more to

Matthew O'Brien

much. Perfect. got Got you Thank it. so it, XX:XX

Operator

XX:XX Thank you.

next Suraj Oppenheimer. Your question coming Kalia from from today is

Your line is live. now

Suraj Kalia

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

Laura Niklason

Yes. XX:XX

Suraj Kalia

in for would Laura, clarification the envision production may, with XX:XX rates units? I Hey, endeavors. the today? quality of Laura, sampling you thanks of so, a if XX,XXX LUNA, bunch do Perfect. quality What capacity where terms sampling that And the be normalized on rate? the will be how

Laura Niklason

as -- in an public haven't Suraj, have the really phone sampling COO, and with who that's XX:XX our by yet. of the question Heather But I’d the on call rates might to we shared excellent domain also Prichard, us. supported I be is

the that well term. would on in under I I long though be Heather that projections. sampling phases to in long would the weigh I But of You would term, also commercial rates in will they be because fairly can XX%. we're the early still sampling are in expect say rates scale those our currently, than can expect ask, higher production the

Heather Prichard

products. other commercial we biologics Sure, similar XX:XX to as one or have as it are sampling Laura higher said, two we're somewhat Laura. that What predict predicting, to now, rates our year but

that rates Laura the to. was speaking in So

Suraj Kalia

I market enough. you least provided Fair target referenced the on XX:XX whatnot. with at and you Fresenius or efforts Laura, identifying Hey, your know dialysis

basis Forgive contractual I'm there this post-commercialization more -- are any of or post best drawing blank post-commercialization Laura, approval. a a is me, efforts minimums

Laura Niklason

I any Fresenius. with are our commercialization we have built XX:XX believe don't minimums set agreement that into

with Fresenius PAD may in for you recall, will in access charged is and marketing trauma lead analogous the and leading while Humacyte AV efforts commercialization those US. As and Europe,

Suraj Kalia

that? segments my So sort Laura. And Hey, just from the it’s I'm reason example, I you centered how you any are forth. you so Fair on the FDA? other of I in, if questions. right, the literature, baboons for agree. following to model, and it's sailing asked, right? to And doing exploring, target for whether the data, non-human so side, Laura, It to right? And would in smooth, curious XX:XX through last CABG, it's more makes it’s the guys overall? or pigs, whatever look enough. primate preclinical question sense, whether data my the but are at sheep, risk there interesting, diabetes, around say, all the have Most apples is body apples calf’s, would shows, have a mitigation of enough view smooth taking eventually FDA a that let's how evidence you're Thanks of CABG

Laura Niklason

very certainly our KX at looked more pig Humacyte Yes, to models products. years evaluate early than XX:XX XX Humacyte’s or And question. a Suraj, XX good using ago that is or models in development,

weeks lower human comprising human when of animal matrix HAV cross cellular However, these period these it’s implant tissues recognized that months eventually dog peg to not engineered is that and or linked. into a a rejected. because HAV the are human over extra we of rejects, by matrix, models that's the or And a

support we human. of access also of not program submitted XX:XX advance smaller, are utilized high fidelity. it's than of Phase program for Certainly is so, we typically terms what in with of animals that did the models of of certainly high primate numbers in packages data, that these and FDA our I PAD preclinical in primate XX very AV tend FDA a Phase FDA types in the And to that we've for US. experience work. again, are the models these have II them providing our So the get realizes to because fidelity non-human advance which the less the to animals But

questioning have the them of body difficulty encountered with work. we any preclinical So never

Suraj Kalia

you. Thank enough. Fair XX:XX

Operator

XX:XX Thank you.

next question from Your coming Jackson Bruce Benchmark. is from

live. Your now line is

Bruce Jackson

thank was XX:XX Hi, data and questions. taking you great. good compassionate my morning, the With for which use regard to

to With product support that? program, a you the from little plans compassionate any have an do indication might could the clinicians? bit why use get for to us you tell required your expand about what's it of expansion maybe And that and be

Laura Niklason

expansion driven. is Well, program, is it obviously actually XX:XX been an with but there in terms of affiliated has that Humacyte, the not Humacyte EAP

is has we for this on Rasmussen, Todd as military is now that Dr. patients FDA, use and fact now a the a service a to times addition a not the results a of vascular and compassionate is Minnesota. Dr. multiple to under That Rasmussen the sponsored Humacyte, be at long very enrolling advisor he's encouraged the taken Mayo East Rochester as Mayo who Todd in term a regular in surgeon Force use but vascular basis. So he surgeon underway is Mayo Recently, which protocol being left has will and yet, initiated are operating more a to former the deployed Middle those IND. Air a the surgeon that compassionate Clinic with liberty was was share protocol up in kernel program. program the And we're by at

Bruce Jackson

question for XXXX. a operating then the And expenses Dale for great. Okay, about XX:XX

terms should levels quarter development, to for Difficulty] quarter? we are similar change and be the in And cadence. will [Technical fourth any the for of look that research In the there

Dale Sander

far. advancement in see second Yeah, first. or pancreas, of terms XX:XX in with this out of address first at expansion -- little me, cut You cut part, least of slight during the the on biovascular about uptick out uptick expenses you terms expenses, an CABG we on R&D guidance Bruce, a part will of cut question. on part, the I we've of heavily And Bruce, our second as in out didn't somewhat so the given the and as or for I'll bit think year, a but the the much that's think any I part I second of the kind you

Bruce Jackson

Yeah. XX:XX

So, sorry about that.

quarter to going there straight quarter or the be of will pattern quarter? in variances, the to differences a any line terms be quarter fairly calendar it to In quarters like candidates

Dale Sander

I change. XX:XX individual can the Yeah. mean, components

year preparation quarter as and relative for an uptick BLA we of the start qualification basis seeing the for trauma from launch. planned consistency an dependent quarter. on later that get timeline upon associated with My overall think you'll I very in that, is, the of see the to expenses sales specific in only filing you'll marketing

Bruce Jackson

on right. Well, progress all All for XXXX. very taking in and Okay. congratulations XX:XX my the much thank you questions

Dale Sander

XX:XX Thank you.

Operator

closing you. We reached session. Thank of floor over end to management our question-and-answer back or XX:XX the for further turn I'd comments. like the to any

Laura Niklason

XX:XX quarter the Niklason. first of and XXXX. Well, this Humacyte Laura that, has say grateful very XXXX during I'd the is just beautifully executed really like team, to to I'm during which

investors. development irons and programs lot We multiple growing have a our growing well with also analysts commercialization programs, also with and our as and terms the preclinical development clinical of communication of efforts as in efforts fire in

also advancing has and regulatory very final milestones. far ask, being forward comments. further a also to been growth, any you as of exciting from like sticktoitiveness So I'd we look our tremendous this time And Dale, to clinical but really milestones tremendous team. XXXX have our XX:XX do as

Dale Sander

was mean, shareholders We've part supported public to pivotal legacy period be private August. us clearly in and by the we've the very our XXXX transaction shareholders during as add I will XX:XX Humacyte year. that pleased supported greatly a been No, been of completed

support our So of shareholders level of without to and care patient appreciate we be support. that the able clearly, wouldn't improved

Operator

conclude you. today's Thank XX:XX does webcast. teleconference That and

disconnect this wonderful participation at your time for and day. lines you your You have a may We today. thank

Humacyte (HUMA) 29 Mar 222021 Q4 Earnings call transcript