Humacyte (HUMA) 13 Aug 242024 Q2 Earnings call transcript

Good afternoon, ladies and gentlemen, and welcome to the Humacyte's Second 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.

operator. you, Thank

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

filed made cause with on statements this factors the concerning date to to except results revise obligation information our forward-looking actual periodic SEC. update hereof, no that in the forward-looking could statements, reports call required The made this call as law. from as Additional is speak and contained statements of or undertakes differ during company only the by

in contained the our from Humacyte is call press and we the the this may this on XX-Q, Investors presented Form be issued in website. after morning which filing accessed of release page Information

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

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

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

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

complete U.S. if their to in BLA continues the learn support that entire to preparation the engage we approved. needs and our Humacyte to time the ATEV FDA Although of launch, planned were to team additional market review commercial vascular trauma, surprised

broad Peripheral Medicine received demonstrated Advanced (sic) the of Regenerative ] designation RMAT also hemodialysis, care. The it applicability [ type of Directors presentations, we medical In from endpoint or Pancreas The ATEV Artery diabetes. addition, X BioVascular III the time arteriovenous its promise in Board strengthened Disease. for ATEV FDA. seasoned Bamforth; primary Phase and in BVP, its And over Dr. of in John ATEV's VXXX scientific This access Advanced current superiority the trial met indications. our Keith which finally, This with Jones. the VXX was across is a supports significant Therapy, featured X multiple in and third or Dr. highlighting variety and in its Tony or addition experts the of standard

its is product. we to We the to were review additional our from that apologized in complete FDA of in for ATEV CBER noted vascular call developments detail ATEV leadership, that the in time for call submitted surprised over results. During open your a the with vascular Friday, begin to announced the be On trauma. our Then happy the program Dale today's FDA receive who notification these we and I'll require before turning that to a BLA the call, up to I'll the more will of review review trauma first-in-class indication. our questions. financial we'll this

marketing original months trauma review and our sites. our BLA priority BLA us engaged conducted trauma. emphasize our discussions X-month the assigned of XX, granted inspections BLA post-approval FDA the Based allows cycle only August in to we multiple As was XX FDA's with February ATEV XXXX. remain XXXX. actively which of facilities for date date, most a want review, ATEV the They've a the for interactions of the on program products. the December The PDUFA and Despite to instead has labeling reminder, the in I confident vascular submitted in FDA manufacturing regarding that during a clinical standard and discussions. the the the delay, the in XXXX, course of with the to agency approvability was filing of also review including The FDA

yet The FDA PDUFA have revised apologized a for we not date, do action the August date. missing XX and

an to U.S. prepare continues date As action a from the updated FDA, await launch. we Humacyte planned for

As codes a in October & CMS. multidisciplinary beginning cover XXXX, for the U.S. In Services, last for ICD-XX discussed ensure of we launch designed These program Medicaid we to be quarter, readiness. discharges codes implemented arteries or from in procedures extremities for we've using lower June, and new issuance the the announced Centers company-wide effective or we'll hospital upper X will ATEV. replacing Medicare

President hired we've that and announced at years XXX of most Trauma VP Vice Sales, Morgan Emergency Medicine led of Medical. joining previously Humacyte where Teleflex, Morgan as as Sales, team recently a approximately Rankin also of she at Humacyte professionals. sales Teleflex after XX served

commercialization entire for vascular future. be FDA in ATEV the approval positioning trauma the Our launch of team Humacyte in the to is ready commercial by upon

announce access. to in pleased results the July trial we (sic) XXXX, III dialysis ATEV access the VXXX In Phase Turning arteriovenous were now for patients end-stage who in have VXX to of disease. our positive ] [ of hemodialysis from program incredibly renal

in as first of were At continue patients conduit for XX secondary dialysis for will assessments assessed As X at is flow of functional primary after had ATEV a randomized current XX to the XX% prospective, months. with a XXX evaluate trial designed patients followed study were blood patency XX% or The dialysis arteriovenous this X XX of and fistula. months months or All ATEV endpoint dialysis a receiving of to implanted after well the a patients of compared through usability for These multicenter, be participants is implantation. during the access at patency functional access. which endpoints compared the patency to implantation. reminder, and enrolled as to total fistula, months, the co-primary standard as usability care months the

AV joint longer receiving of the conduit through XX% during compared months test versus with flow and patients X XX first patients patency ATEV At XX as months, the Patients to The XX% XX the superiority implanted as significant. fistula of of months who hemodialysis secondary fistula. ATEV ATEV the for at received fistula. AV for was had statistically blood the compared conduit or to also utilize the significantly an

legs were to arm more this in these by the not We underserved in we who ATEV is reported than look vein encouraged arteries detailed on at also events in There current on treatment We're who ATEV making Advanced in a arteriovenous our a available results, observation they in forward of as analyses of medical disease upcoming bypass many patients the revascularization. more clinical as by currently. to dialysis those Peripheral subgroup highly affecting access Arterial although standard PAD. not We're require including patients vessels, potential meetings. adverse impact of treatment or fistula progress the of in the presenting is that results, blood arm, are cardiovascular and PAD have XX% the clear the program repair demonstrate for arteries believe of to hemodialysis improve care. an do patients leg most commonly lower autologous of the the Disease

Vascular disease the patients. PAD the for own which in for ischemia under patients with severe in and no received appeared standard Rasmussen suitable an limb bypass Mayo with blood June in PAD XXXX, control for were for vein bypass Surgery, investigator-sponsored Minnesota, the having vein having bypass severe patients outcomes limb of Outcomes in all their no patency ATEV vein Autologous Mayo treated comparable published the a of Clinic. had ATEV colleagues salvage with Dr. Journal historical ATEV this of and such care of or the using patients at of Clinic own arterial using at chronic their the severe vein or paper, Todd but trial. to similar Rochester, is PAD. the In were treated In having and the patients, flow

similar from for reported with that receiving highlights Mayo the and in historically. receiving have designation perform bypass their suffering ATEV the that own for an having patients PAD may impact patients salvage their and Humacyte's own also patency In bypass granted ATEV RMAT severe limb of vein PAD result the patients July, ATEV and the This FDA investigators no to indication. vein potential were a operation. on

in ATEV designation. trauma has granted RMAT and hemodialysis, access the third this marks the Following been for indication this which AV vascular

review designation allows This PAD clearance designed or pathways FDA is expedited provide ATEV designation therapies newly conditions. priority BLA. for a for time, for the the also close expedited indication. and with the to received medicine regenerative we for or and interactions of any issued review development At This for same life-threatening diseases in or an the IND of potentially serious

with ATEV in in patients the Phase date, X evaluated has as followed trials X To II PAD for as long been years.

chronic limb-threatening we ATEV the may to All had vein important at alternative evaluating with study ongoing for no the in is treated ATEV for XX have believe with Mayo addition, an and In Clinic patients. patients And therapeutic represent revascularization. the these available the patients PAD date autologous ATEV the ischemia.

to to of to stem adverse in a blood which now The These produce of and In islets. featured X Breakthrough study stem medical to is Diabetes Meeting an the meetings. cell candidate, or Beta with treatment events from preclinical Institute the the cell-derived in diabetes. Research delivery potential from diabetic University TXD experiments data normal evidence type the in of Returning the to in diabetes. At our BioVascular restore mice, survival islets survived sugar June, for continue be as observed with were of mice. the ongoing presented collaboration and enable Results continue BVP performed no cell-derived product Miami. Consortium insulin BVP insulin-producing the Pancreas in islets Cell at were designed stem scientists islets

a this also collaboration Association at study also capillaries Research islet the of throughout This with Annual X-month duration Diabetes survival also in we continued insulin-producing insulin the cells. in production from developed addition, to Meeting American support of June. BVP Islets was Institute. the primate study. and study survival In nonhuman In the primate Diabetes the showed results performed study, implants presented

caliber of We Engineering also the the in X.X was from Regenerative artery small diameter June. Medicine in and bypass Conference setting. studies coronary Tissue millimeter grafting This CABG presentation ATEV results presented at our or

X-month support clinical Preclinical been I planned advancement the trials have CABG. to into small nonhuman Phase studies in human primates in the conducted diameter ATEV of

that has the human observed demonstrates finding coronary closely the of a is diameter to biologic host not that with conduit been the an any the which of matches have engineered outcome remodeling the This to response previously. of arteries observed in native favorable We system. the other coronary vessels, that ATEV

preclinical as pipeline We're they on this pleased advance. results, other BVP and of the small-diameter we'll the continue progress that very studies promising show ATEV programs and and continue to the to of update

Directors. John Bamforth, launch Finally, P. valuable perspectives Dr. distinguished leaders of planned industry as company's veteran, Tony John last and whose extremely Tony system ATEV health be we the in of and and both and quarter, Dr. pharmaceutical prepare physician, to we the experience system and vascular the leader for health commercial are Board Jones commercialization trauma. distinguished welcomed will

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

you, Laura. Thank

administrative report expenses research months for current in period manufacturing of personnel $XX.X There for June from primarily X any out areas and came $XX.X X-month Now XXXX. the to periods increases were the net this compared expanding XXXX, and FDA XXXX. income resulted of the quarter quarter today. and $X.X X net vascular support million decreased to noncash for million of quarters financial trauma. General and quarter $XX.X June and for $X.X the turning of X for for review for $XX.X second second compared of the activities the the stock expense compared of quarter BLA million The second the for in by materials decreases compared our expense were expanded months XXXX XX, to initiatives, ended expenses $XX.X expenses from increased of million that to million the XX, was to -- XXXX, primarily offset during personnel million million of XXXX. to quarter $XX.X expense increased resulted million of morning. quarter of or increased research revenues for in ended $X.X of professional sorry, June XXXX XXXX partially and no of $XX.X net the months for ended the development or in compared income the months expenses Revenue second primarily to June million second fees. Other XXXX and were and the XXXX million the XX, compensation were The XXXX second development were ended reported support X XX, the

for other the with loss of associated months XXXX to expense XXXX the contingent XXXX, additional proceeds noncash of June other ended the XXXX common Net was the million operating XXXX, quarter XXXX as from cash company quarter for to for for in provided million increases loss And earn-out X for months contingent Alpha expense for net XXXX. June remeasurement sorry, the to I'm -- reported X primarily cash Capital loss August resulted XXXX. XX, the noncash used from June increase draw the June $XX.X The For for of ended with was months cash of net XX, of $XX.X was The and $XX.X the earn-out million the XX months June million The underwritten the from in resulted XX, of million net Healthcare equivalents was million an March public previously. X net the of net and its million Corp. Net second $XX.X our XXXX. million merger of Oberland $XX.X and net other of XX, to from of compared for net the cash X primarily funding approximately the XX, $XX.X compared net liability XX, quarter the from ended months second arrangement described XXXX. The under expense increase XXXX. current million Total the of X period of expense an compared X compared $XX.X months compared X company's net months first $XX XXXX. ended to offering XXXX first in second liability million June in XXXX, provided remeasurement with $XX Acquisition $XX.X in resulted ended increase proceeds for Management. cash receipt primarily of $XX.X stock the in million

back remarks. With like to to it turn concluding Laura that, some I'd for

trauma future of our Dale. And the ATEV product, our soon. of entire about We're we continuing and excited in approved. prepare We're is that confident commercialization very Thank to you, Humacyte. vascular the approval FDA for of the are organization first coming if

committed we're conditions. ready Thank us promise We and of our across transformational a questions. range continue is you to the for for injuries pipeline the and us, results for a call encouraging to continued also ATEV we're of chronic programs, period remain underscore demonstrate on take advancing wide This which the joining support. grateful diseases, your and today. Operator, to

Ryan [Operator question Zimmerman we that The first comes BTIG. of from Instructions] have

Laura just this trauma. and Dale, here apologies for focus questions myopic for me. vascular on But a couple of

impact And guess you -- for And if with new the what at I understand I curious expect date then clearance? what provide I we follow-up. as which timing First, have FDA for of it communicate on submission BLA this simply will it does they today? a one your expected year? this think should that, as access, a AV later is have part then you, Or clearance does a future I'm date

is question. Niklason. this Thanks Ryan, Laura So that for

or access, could but what on I as the Again, the hear planning is that will a very had call a for wish far clarity provide I to mechanics the at more expect hard on said the did next simply and to need supplemental would they would can't leadership couple we but results not at this or that weeks we I I Phase time, us of said, CBER got track. dialysis top line several how respect date decision, we processing ago. insight that be still that III into my the Friday informed. That With a and exact decision, that as in reality those we senior results. a expect date me a far months, new on from just PDUFA hoping this our standpoint, in for as I can't. timing give from stage. group, been within predict. file trial of We're The to new to BLA just more still As that's phone they is

a -- Our then had had the perhaps to half BLA sometime in this of supplemental second year, initiate been plan at in and approval commercial filing in assuming trauma plan look our launch FDA XXXX. been

I think a 'XX. late to market So we've messaged in were that we don't supplemental BLA file the going

FDA, So we of in for timing the the in conversations dialysis timing from my from the on standpoint, on would barring remains hope any FDA, the filing same. Depending changes kind other with BLA to sometime file communicated XXXX.

that So on as I track near remains tell. can as

Dale, cash us cash of given how period? as delay and Very Okay. this Are during your update? gas. kind interim steam helpful. result this And Just back of managing right for do Help Friday's ahead, full you're expenses about think operating the foot you the are impact, a anything? you limbo you pulling that then how understand in now kind on you're of period in burn

Ryan. Yes,

the said, but the process don't at that's has what Laura -- from think the to been delay know BLA be instance, I extrapolate iterative. we very will what this been one entire

our so going that is then new of completing on assessment what will and process, how apply to better to we line operating knowledge have be expectation line sense manage our we weeks is. of prudent programs terms we're expenses. that in time we time unfold, a that these as And undertake this how Based and of

essentially our what But very about FDA, in it's terms the looking right of the what there's specifics notice of under to early it out and I we're from line outcomes change we working thinking in we days scenarios terms but how at different we're potential is, operations different lines. limits now. think might to how a clearly, closely. little that time to give being from going know We're respond X certainly to time

& comes have TD Josh from Company. Cowen we question next The of Jennings

data in adverse were call the think much I disclosing you're and I was group. the around and set don't the about out just ATEV events just wanted ask efficacy higher but to not study to Dale, impacted. vascular that, trauma Laura that that

events but there's to assumption share on see any if in Our that wanted other just adverse measures. are these minor you can total, color

Yes.

So Josh, not just clarify, on to that on trauma. dialysis. That's was

you. Thank

I about correction. appreciate the Sorry that,

Yes. on our I don't think was want trauma. just that listeners to

So minor. yes, on are into dialysis, we're Most adverse digging that. events still these of

As these this in clearly signals of It's undergo new maintain for these patency. general very no none. say is in lot to have patients life access, will procedures for we you dialysis just a patients. that conduit, I how access safety know,

it's -- We seen that something have before. not we've haven't we like seen new

of could be not our number adverse something related I'm fact used first sure. increased the longer else. got for a to were during events, and of It the punctures the year that or more needle vessels So time period

for expect it's to So this we're to we at us right me later comment this meetings information of But year. the out, now. that process medical hard and -- on for sorting in share

of of to agreed Fresenius the data, in line, one the and And indication involved collection value X fronts. and how Fresenius they data, Understood. of on down two, ATEV much top has continued the And that One, I seen? next data the use aggregating on terms second line the think where demonstrated. steps has have clinical is just terms access what's then been guess, in collaboration I any agreement cost-effectiveness ATEV and indication just the how in the

is trial. or mentioned, partnership analyzing focus active centers, really certainly, Phase and them our our cost of different of as Humacyte sure. a That as so Fresenius worked with benefit dialysis dialysis part in a That's on of for Well, demographics aggregating data. does health But the access III economics you the the VXXX not VXX patients. Fresenius for analysis endeavor centers ] [ (sic) we've said, number with

the and on And have So who on in together system. publication incurred actually that with that we also some Europe. multiple on project putting Fresenius similar of are working are failures them costs we're what the a access working with a costs patients closely with

adopt So for clinical ATEV centers Fresenius, agreement, make great sense. and have you're our economic in dialysis where the in health the results patients they've results been commercialization their right. agreed partners of that. for they part to the And as

where access. of -- this them So with That's closely patient U.S., economics a become long-term working prohibitive part working that. in strategy health market the which really our identify on those us key -- for very dialysis populations, the and adoption with to they're of

Great.

to And and Just in sneak some the more one updates PAD RMAT you've had on designation. positive indication. just

and Just steps your remarks wanted did prepared moving the terms and you you up of any a or the sure forward earlier to can running. next but in with initiation provide trial that if getting -- this not just outlining of in in call clinical

as Phase I have on Yes. multiple initiate vascular in to from PAD. prior III we've trial requests surgeons Well, calls, mentioned certainly a may had

lot this at we think I on the as are facing are for vascular excitement amputation. potential that option of side there's surgery who patients looking a clinical an designing for trial. And

work But around timing that. think trauma of we're in our to So and in a going of terms play doing intellectual cash remain to by have the I that the the company. ear we it we're pre-revenue approval runway. Again,

so given to mindful Phase holistic be a be we PAD, a in And III start trial Phase as III just program. would third when think that and have that, we'll to about

So after and dialysis. trauma

something it's So we're about cash we're as evaluating to Dale month runway, actively. our very with and our this said, over finances month. But thinking that respect

Bratzel have Allison The we Piper Sandler. next question comes of from

for trauma the review. on couple me vascular A

more And review. agency in of manufacturing area clinical, the of FDA of sense then much something your to what's or going how need needs the nonclinical to the terms filing is additional time complete time that Just review their else. to

take I earlier, of couple a months. you Laura could this indicated think

us months wrapped So that the just to as be this agency help what opposed or in from days feedback will understand indicates up weeks.

vascular in grant or submitted FDA for in sense also, is you to it what you is gives package additional clinical the another data your trauma? FDA trauma need to will confidence that data way, generate complete the approval clinical that able then for to be to sufficient said And review you

that as try those questions limited knowledge I best have. I'll extremely can answer Allison, So as to I the with

said weeks take versus not -- CBER possibly were respect with months could leadership line that So versus days senior this time months. The sure. the they take regarding to

told so market exactly FDA what have messaged we And the the us.

be might be than message is it So a didn't that be. would to or may it do it market days to want not what that, might. sooner weeks this But we when the

So topic. for. to of like on. feel this full was of extent were work the insight literally you they what continuing they need on With they I now what have on time Again, can't answer of my they more part that. the respect the file, parts knowledge provided -- There to file were no

do need of thirdly, that we respect And I certainly clinical gotten with and hear more think we call. to hear call. review, that will indication part the data? in I have did we that never the on the not didn't And on any

where that's so stands. it And

dialysis maybe Got fistula used the it. for AEs adverse And XX study release you events or time hemodialysis. press AEs was access actually in Could on follow-up the just that Is clarify months what ATEV during about comment just just period one talking measured? over data. over the the the are entire then question the of or

because that believe over study that that's are outcomes. adverse typical the way for the I study it's reported entire AEs events

it's the hand. have the of we in So that data entirety

next Kristen have Fitzgerald. we from of comes [Operator Instructions] The Cantor question Kluska

Congrats positive year. III result you for trial the last second in on the Phase

asking for the that's AV why you are which And Can going helpful you data some maybe in that data, ultimately, conducting. talk I'm just not general with to And access. be clear, to believe you I'll considerations. commercial subgroup So analyses about be share? future of analysis with start the going to you're

that Yes. question. for Kristen, Thanks,

expensive they're of synthetic or catheters. not grafts all obese or of and calls with diabetic work These previous higher very for more the and in lot system. are Fresenius are of we've expensive. rates These hard a reasons, mature very and other it's time their shared those lot access. tend with patients So often using to patients have and subgroups They that our and quarterly women, failures clear a And publications complication dialysis have have fistulas are certain of other often often presentations, a dialysis complications, for and are there patients as will women. from that

their literature known it's So this arteriovenous have since compared rates in certain it's our that ATEV are for known study the against maturation that demographics there poor fistula, fistulas.

So women, maturation the et elderly, cetera. diabetics, underrepresented fistula rates, have minorities different

built in we delta ATEV what subgroups to known the is statistical particularly So between analysis in well. subgroup into fistula, to where different ATEV is prespecified our had at not I'm the dialysis, the fistula particularly these try work and looking to plan, and these very understand the sorry, subgroups,

are again, give us nothing of the in the really dialysis. can underserved subgroups from the those of that to ATEV down currently groups will are and This I better known And these So diving benefit patients magic -- there's which sort most think here. problematic. the standard be is into just literature sense which a in are most the

us you just a few in that items follow-up in of FDA on those particular were were inspections then how of you -- And give that. Appreciate a sounds there inspections the occurred addressing. months that is terms Okay. ago. Can went? side the trauma. working vascular sense one just It And like the on clinical and anything required the with manufacturing

inspections went very inspections. well. So had total of I all of those say a would we X

In But follow-up -- that number CMC having agency. are a follow-up small worked there with to do on with we've standard items there's these out items, of things validation of standard of the terms and of are certain assays sort methods.

were of for completed do until those -- the for study post-PDUFA Some slated that of some And is those couldn't pre-PDUFA, winter. during we winter. shipping one are product were example,

in that to agreed we do So winter.

the standard, are test file. say are sort standard validation but there's the want of to believe I not of don't timing -- these and procedures are these cookie-cutter, but -- do So impacting that we

The next Company. of Bruce have question The Benchmark we comes Jackson from

on payment going to and update an into FDA apply get does this delay to how hoping factor was approval application. the I new still Are add-on that? the you for the in October technology

question. very Thank good much. a you that's Bruce,

from this ICD-XX during can NTAP without the As codes you knowledge, NTAP of NTAP but rules of only changed, got -- cycle. for codes best my typically have deadline October they in CMS unless are typically to June, we a that's know, prerequisite approval, around year, we even X. the the my allowed an best per and the file -- is To once knowledge, payment for filing an and application. applications

we an So NTAP for file can add-on payment.

so would we NTAP XXXX. next before And that approval, October year, in long as of of kick believe June then payment I have

for on does end the mind, October. this not front our plans NTAP this PDUFA So an change my application with in date delay our filing

have ahead. Dr. I Ladies the we reached to turn end session. Niklason And our to like and question-and-answer back gentlemen, the Please for call go remarks. of would closing

the of everybody the we to will terms in call, salvage, indication important and our in Humacyte patients interesting Board have I'd provides very benefits and full our on in might that approval limb part thank has that and call including our Again, be for the leadership. This that our Well, of investors like ATEV terms ATEV. we for a any trauma We journey. members believe been of on receive -- confidence infection. analysts

We believe in this therapy civilian is an military important and adjunct trauma. both for

going so our but to well. approvals excited be the trauma forward to looking continue to also about prospects, and as indication we only are it's and not other I we're very pushing very interesting and journey. future And forward a indications be

with along coming for you the journey. us thank So on

and Ladies that Thank you us. conference. concludes gentlemen, for Thank joining today's then you.

your lines. disconnect now may You