MIRO - Earnings call transcript Q2 2022

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Operator

Greetings, and welcome to Miromatrix Medical Inc.’s Second Quarter 2022 Earnings Conference Call. At this time, all participants are in listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Hannah Jeffrey. ahead. go Please,

Hannah Jeffrey

on thank Chief released and months joining Earlier afternoon's Officer; currently us. June Jeff at Good Chief call. Officer Ross, results you will for Miromatrix Executive available is release financial XXXX. Jim six Company's the today, website XX, www.miromatrix.com. Douglas, afternoon and The for the Financial quarter ended this and host

include that provisions and risks cause pursuant implied to call the forward-looking the timing differ from facts, get statements. INDs I including Litigation Safe within are Any of uncertainties this could material statements. historical in upon of would clinical management These Harbor Reform various initiation place everyone statements. XXXX. reliance trial, Act involve this will started, statements statements statements remind during contained which be of of regarding be to Securities of on we potential of Accordingly, not forward-looking Before are or call assumptions. be the these that forward-looking undue these current statements related and Private forward-looking those by meaning deemed are should to based to that actual materially the and statements the laws, federal statements making All like not pre-IND securities should anticipated results you filings estimates that made and statements

live now or with XX, and any information, or call the financial associated statements, projections, because Jeff. other conference information except will or to turn risks Miromatrix For to in new Securities disclaims as The by material August, Commission. XXXX. our please information, the call only required to law a any Exchange events, I provided over see of speaks revise today whether otherwise. forward-looking update list descriptions future obligation, or and filings the and uncertainties business, our with of broadcast this intention

Jeff Ross

has second from to given CFO, will our quarter joined a us update afternoon, review by second Jim Today's everyone followed today thank Good who XXXX the and earnings quarter, Hannah. our Thanks, Douglas. business you call a by financial call. for cover

First, before our application external IND to product year-end. liver our on remain assist we for track file MiroliverELAP,

from I the X program this an to initiate share exciting IND to kidney you a of implantable clearance Phase we clinical FDA, our plan have Following with coming out trial. fully quarter. update

and have time the model. that kidneys liver pathway. made testing important is progress demonstrated protein in production dedicated in this development kidney We bioengineered We urine it scientists. talented is a and of extremely have and represents first an retention our in preclinical believe produced urine, we bioengineered successfully has programs The a the of team milestone our and result kidney bench our

company, fully at new integrated as team as this clinical than This has speaks bioengineered XXX number talent as the organs more scientific year the trials. our and of Our headquarters. towards move capabilities of we our and and save positioning this our like organs Transitioning from improve patient is fully to bioengineering is a to differentiation and set sure transplantable life level lives. everyone to appreciated. our novel those make pioneering technology on updates I'd organ well scientists, capacity manufacturing scalability the help fully highlights, a astounding to bioengineered call for of science Miromatrix

donor the organ of transplant. We forefront a group developing to companies are of alternatives at one of small human

cells. with decellularization process. include this our unmodified the xenotransplantation, decellularization other acellular step such category editing, are a consists that which an and gene recellularization technology proprietary creates The as differentiated meaningfully organ seeds and recellularization of technologies in We step matrix from two-step by platform matrix human the

bioengineered accounts livers organs. and is waiting organ list, the platform focus on for our is nearly to our proprietary of bioengineering initial kidneys, applicable While which XX%

to of regulatory the discuss to meeting failure. the This Miromatrix potential topics organ advisory about community any field, to improve medical quarter, the relating and suffering patients from lives excited the FDA organ scientific xenotransplantation stage transplant xenotransplantation, are hosted day and some committee public of specifically the and a save

can to solve xenotransplantation working realized, key and virus technologies pig Before that challenges, rejection. potential are be transmission including organ

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human points received facing organ xenotransplantation continue our of we believe the versus decellularization provide technologies human cells, In unmodified we with decellularized believe the challenges could of and a summary, organs profile provide some significant we to with a bioengineered differentiation which similar recellularization recellularization, matrix rejection organ. technologies. key with to us donated our During faced

an liver our Miroliver on Mirokidney. outside will three designed is setting. ICU that system to body product Now, patients. and reside acute temporary candidates, provide failure liver updates support liver treat in perfusion our an human I to consists the like provide our lead would bioengineered external liver MiroliverELAP, to assist and product MiroliverELAP, of external MiroliverELAP

of beginning call, an MiroliverELAP this file the on remain application at mentioned I to year-end. before As track we for IND

Phase from we clearance trial. FDA, clinical Following to plan a the IND initiate X

we to excellent proof-of-concept fully on both treat excited published have our large we patients. in with study animals. MiroliverELAP remain patients. candidates implantable provided The a our end-stage intended Mayo We the organs our the to to about Miroliver Communications liver study the are better regarding failure trials We Biology, clinic responds livers progress to bioengineered implant a pre-IND for XXXX. fully and towards heterotopic collaboration for eager the in Similar and begin FDA submit human pre-IND of our request and sense we'll implantable are milestone after organs. product XXXX implantable fully track our kidney in to timing path transplantable are to clinical Clinic, upcoming bioengineered programs. Nature of extremely submission, for our bioengineered announcing Mirokidney the In treating as

of that team retention protein bioengineered bench VP leadership this in Program. pathway. We production Manager kidneys under a first call, is important our our the bioengineered and has the of R&D; Emily successfully and of an demonstrated Mirokidney time believe kidney has produced urine development As the marks Beck, I mentioned, start to in milestone preclinical Kidney Barry, model this our John testing urine Senior and

of We financial turn are continued planning future. Thank scientific Jim now to in and our Officer, discuss team will Emily to our to results And near for call Chief you would for John, Financial publish findings entire quarter your the our XXXX. I I thank the this Douglas, over the support. second these to in like wonderful achievement.

Jim Douglas

sheet, start as to XXXX, of Jeff. June XX, investments off $XX.X XX, as XXXX. you, and cash million balance million, of with the March totaled I'll compared Thank where as $XX.X

fund sufficient through this believe to is continue XXXX. We company to the

Additionally, accessed. celebrated during one-year our a which have allowed ATM, the shelf to anniversary company, us an second quarter, and not public as a we we file which

compared increased and $XX.X $X.X the million and the income was ended and Operating June increased $X.X to periods administrative public $X.X was six-month three and million costs, increase lab XXXX, and company. services development ended loss well costs as comparable primarily cost statement. million attributable six-month to costs associated XX, and for loss periods being The and relating notably million XXXX. and research Moving to with three the as operating for supplies as XX, payroll, to in for June periods increases a pre-clinical general

attributable $X.X periods a net increase XX, XX, ended for to to as ended $X.XX six million and or was or respectively June in or three share a weighted open XXXX, attributable and million $X.X I operator was Thank that, will you. six in from the within operating per period described share Our first six-month loss same in share for the the increase to recognized periods The comparable shares share the increases comparisons. -month for -months primarily $X.X $X.XX the the the over loss largely plus average The a loss $X.XX loss the per June cost June one-time million IPO million back $XX.X or net above $X.XX to net questions. that and XXXX. XXXX. in XXXX comparable three gains compared significant and company's the to was turn With call quarter for outstanding periods impacts in share for reduction of line resulting

Operator

time and Ladies [Operator a gentlemen, will question-and-answer session Nowak conducting you. Instructions] first from Alex is question Thank Craig-Hallum. from Our this at be we

Alex Nowak

exist to the as gotten afternoon, resell here. maybe a pretty maybe now that the to just nice through process you've kidney going what you the liver process organ insights have you're lab, process on do experience the with if speak on in reselling new times porcine I on you're going well of And couple Good Have really to everyone. sort through variability you resell of how the hoping what we the maybe Can sort of learned was side, documented going speak start a could that's organs? still to the speak well the the achievement. to side.

Jeff Ross

Alex, Hi the thanks for question.

the in facility aspects think lot our at do the our various scale the together not inside gives magnitude the of a are those both the picked was data for process just A good organs manufacturing you we as what resell point look call, sense but of consistency putting what demonstrate of in highlighted we able we're on good from new overall to that facility. that up been this standpoint in I controls arise that and to organs ability that, those of FDA are for you is only a also to other development and as package it we've capabilities utilized our process.

on continue to well and execute that process we side stuff just getting well, on from side, saw we standpoint. moving the as So, some that submission. that reproducibility exciting kidney, see resell then And that the That the on documented IND certainly the well. is well of that moving starting shows to refined well that to on as kidney level we're released and you that into

Alex Nowak

Understood. the requirements here. the the reach get you any of stage? doing IND study, [ph] been to within bench say particular or IND roadblock team kind for a at package Maybe study, Has generally analyzed current the would for the this that on you're in that here

Jeff Ross

at reach stage. current within well the Yes, it's I'd say

been high what are features the looking those As part that can and that of then always have need one liver of function, honed we've also as the in well is that be done functions. at is, in that really creating functionalities we of IPO liver data liver the our do. for the key grafts those liver really those we're acute our that failure. subsequently functionalities for What of other but especially is Many demonstrating and package really energy-intensive and also on,

from no surprises. that So standpoint, big

continue function, premise I that the bioengineering of have liver we data see. had think that's that is the and that liver we've the always level should to

Alex Nowak

the for once launch clearance. trial you the get the ID to do speak to activities liver prepare versus Maybe

you those potential that have here? or the with Just going, a we sites conversation do TBD any get sites once of how yet is signed accepted or IND this kind up was

Jeff Ross

No.

And sites get If have the the thing clearance to that we potential process. with in you then clinical and very those not look then both do initiated want last they're to forward. is at starting sites move team, active conversations our the

to So, stages the we the really clearance. get able sites, to at get ready different be multiple qualified through we're to with accelerate due-diligence and IND able well being once underway that them

Alex Nowak

willing patients, branded a with say, I think you a the And roll We've regard by to landmark patients. a studies, to maybe transplantation, specifically it with living conversations number probably the pretty artificial willingness in FDA that progress of Is peak study? them that reached the seen on would a topic, KOLs artificial organs. of broader the organs. in it's getting we've in space number there's helping but recently. and field in seen Do in

Jeff Ross

I a think that's as we that, speaks some mean think to -- question. yes, stuff. mean, right, of I I is of some at this on Yes, that just is I look great what Alex,

there really some need I of general. I to leaning that's of then forward. for of can really the further But with that have that need I tremendous to that towards think in committee speaks with trying or move in just our advisory think various think center in to moving the takeaways that's centers. I we from to a And And forward. really the the saw interested the goes organs out recent isn't even patients. was board have talked on we've felt in. we approached KOLs yet that say the stuff kind that xenotransplantation I

Alex Nowak

then questions time And two more Jim. maybe just it. Got this for

we've that seen as then investments, the a here. that launch? you for acceptance future the Any bit make after Regarding company hires you following ready and or type get little and the additional IND increase count then want investments trial to

Jim Douglas

thinking to company our we I growth be would trial, burn with corporation as need of no get No, just build the I that growth here of going into as IND there's on to up with And additions the and here, what other year-end need we'll through help significant profile. the go historically But into about be we additions consistent to we've within made. kind made any that to submission. start side say clearance seen think we're operate

Alex Nowak

the sheet balance investment Perfect. long-term assets. for the Okay. on then $X.X And million

long-term Just consider of investment, at that cash the to cash a is confirm, we end into put the but day? that should

Jim Douglas

mature some new months couple every investments We've that rate just next advantage Exactly. to of out different environment. take through put year interest the of

work. how quarter, reasonable doing our see interest putting to a that of and earned you'll cash that's income So we is amount this we're

Alex Nowak

sense. update. Appreciate Makes the Thanks it. for Understood. Okay.

Jeff Ross

Alex. Thanks,

Jim Douglas

Thanks, Alex.

Operator

you. Thank end the I back we session. would and like of question-and-answer And to closing remarks. Ross Jeff call have Ladies the reached our turn gentlemen, to for

Jeff Ross

Thank our Excited the look Great. quarter Thank on you. year. the to executing before and today. about in the our and Thank you, everyone, of end IND for listening filing update you. forward

Operator

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

lines. You now may your disconnect

Miromatrix Medical (MIRO) 16 Aug 222022 Q2 Earnings call transcript