Earnings call transcript Q2 2023

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Operator

Good day, and welcome to the Miromatrix Medical, Inc.

Second Quarter 2023 Earnings Conference Call. All participants’ will be in listen-only mode. [Operator Instructions] Please note this event is being recorded.

I would now like to turn the conference over to Max Forgan with Gilmartin Investor Relations. ahead. go Please

Max Forgan

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

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

reliance statements. undue these on place not should you Accordingly,

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

to call now With Jeff. the over I that, will turn

Jeff Ross

call. today's Thanks, has who joined Max. for thank and afternoon, us Good earnings you, everyone,

items the clinical on to make IND We letter, relating continue miroliverELAP progress identified our hold FDA within to addressing significant the submission.

in to envision gaining response authorization Our and goal a FDA remains second-half to liver XXXX, failure of acute full the patients the to with treat shortly thereafter. submit we

we As believe prioritizing valuable failure implantable the that bioengineered with the to bioengineered organs. with fully provides path fastest patients we near-term, it program organ us provides because programs. treating with reminder, our a in insight are our miroliverELAP organ And to us

may of consistently or partnership implantable mentioned, fully I a are invest longer heavily may hold if organ Specific any preclinical a part As we study. circumstances items to of arises and decide lead that animal to as couple related more biocompatibility recall programs, a the miroliverELAP, you we change. study into to our clinical of addressing

report for portion we and the the commenced study I in-life am study. and biocompatibility that happy animal both the nearing during second the to are completion quarter studies of

that As smaller a IND in reminder, and safety of part original study treats study the our is arms study than as safety four animals eight package. each, This animal safety has controls. was the consisting of two submitted four

group. no the was in systemic evidence study, or of the original our In there miroliverELAP animal group control safety toxicity

reduce in mobilization However, anesthesia study which to safety to utilized techniques required current there immobilization challenging. was in to due The therapy in improved all a animals. in longer substantial mortality pig the techniques and and provide makes mortality all groups anesthesia therapies and model the the mobilized model, animal a

to are to the the We relating our currently to data all study into FDA. incorporate gathering response this

wrapped up part part our compatibility the questions, liver do We was graft regarding the be we submitted additional that components. only requested the FDA's the FDA testing of comprised we about biocompatibility final IND testing fluid month. by the study, finished end of envisioned the third-party not components. biocompatibility path third-party as of the Regarding study The of the will on

In manufacturing ensure clinical with Phase obtain addition plans once our progress and each ensuring manufacturing the IND work, we clinical specifically preclinical part a of our and continue trial. to This readiness running identified process software prismatic the our to be GMP quickly are that X meets initiate will the clinical clinical site we clearance, to sites as system Baxter standards involves miroliverELAP. hold for we can contained developed trial,

in a we as believe year, the we of this to we as X response is liver Phase the failure clinical to submit summary, soon in hold with In treat all the able being thorough authorization forward obtained. steps trial and clinical acute taking a look better necessary the FDA's to to patients are second-half FDA

gain Moving our fully to of continue industry to recognition implantable promise make bioengineered our beyond, and progress the for fully we bioengineered implantable miroliverELAP programs. programs,

awarded poster. second mirokidney Congressional cell at and therapy the We represented and quarter, policymakers Alliance During Regenerative Medicine's Fly-In. to sector Best we for Congress at for in were Hill gene the our the the American Congress, Capitol we Transplant presented

Foundation their with The to how participate how Innovation Association patients is to Organ organs may patients bioengineered Organizations meeting failure the innovative Procurement benefit for us invited in highlighting Miromatrix discuss to National transplant participate solutions someday Kidney Day, aligned with annual of in and invited and us AOO. renal their

flow. ongoing titled, animal Frontiers a our bioengineered of blood using to results to growing perfusion kidney a a that our published evidence platform consistent kidneys the kidney engineered potential human-scale Biotechnology vivo research manuscript could bioengineered a on Those a model add allograft as Bioengineering alternative for with patency had kidneys. tissue to how and established in of an body demonstrated human of foundational also in sustained and re-endothelialized graft in graft We and maintain

Dr. quarter. Medical really achievement award which Director, a and the this Transplant American all rewarding Congress, Amidst Lake lifetime by activity, off busy Jack was our a of capped presented second

Lake thought to community transplant key industry. in being So to a I'd like my the by for acknowledged extend Dr. and congratulations leader the

high-profile workshop well with and engineering ASN's the events therapeutic miroliverELAP. we upcoming Looking Kidney the to and at forward Liver AASLD's to sequence responses year, finally, rest presenting FDA ARM's Week from should be and our of Meeting. These the will tissue

our will results. the financial call Douglas, turn our to I Officer, Chief to discuss Now Jim over Financial

Jim Douglas

quarter We of Jeff. investments through XXXX. XXXX million, is you, which quarter second $XX.X we finished unrestricted cash the believe business our totaling second Thank operate and of sufficient to with the

of by employee remaining for received Additionally, receivable second been retention payments we confirmed the IRS. the subsequent has credit $XXX,XXX and receipt amount $XXX,XXX cash to for the upcoming quarter, the

periods month was million XXXX, and costs. income and development periods to to June to operating attributable in the primarily and loss million $XX.X XX, million Moving the research lab decrease respectively. six respectively, million XXXX, ended and as ended XX, three $X.X for statement, operating decreased and compared for $XX.X periods the supply six The June month for three comparable loss was $X.X

$XX periods million one-time income million quarter per $X.XX respectively. $XXX,XXX net in and totaling decreased XXXX. Net lab and or months six loss $XX.X the for to or per The per attributable months per share the June employee comparable million as share in in three that decrease primarily was ended research $X.XX to $X.X compared retention addition of other share three the six XXXX, recorded costs for was first loss June to XX, credits ended or was XX, development for $X.XX as or $X.XX and $X.X and share XXXX, million respectively, and supply

open that, line the operator With call back the for will over questions. I turn to to the

Operator

The go with question-and-answer We first question will the session. Please Craig-Hallum. Alex Instructions] comes [Operator now from Nowak ahead. begin

Alex Nowak

Okay, Good everyone. afternoon, great.

Sounds wrapping like here up end month, own the Those the ends study at the animal September. biocomp study in words. of the maybe is my potentially are

September, end to you could FDA resubmit -- of there? thoughts your the the maybe early by What are So October?

Jeff Ross

Alex. Yes,

but as progress we that long highlighted, happy by weren't biocomp excited As we will highlighted so on that as And made grades the poles that it's has we've to of in working the happy really wrap the two month, we've the been call, end up the that surprises that kind tent everything on. the many good on to get those with report really There this passing that of far well. you passed. of lead tested there,

month. in two end that scheduled we're just on come So remaining to the tests of additional at the are

we there's those completed. preclinical eight that excited side, that seven the as are total up safety On of animals cohort, highlighted, to that report make

to ready to off that. get and to able submit We that's report to and be have the go then final complete, one test animal pathologist the to

So if aren't with timing certainly going look that. on associated that, at you guidance to the provide additional

a the is year. going well of second-half submit think But very thing response is so to can the strong this think in, to coming still reassuring guidance tests those our I that forward data the and I we are FDA. that looking

Alex Nowak

is it. Appreciate very helpful, That Jeff.

to animal had seven engineer the You was pig to in that pretty I preclinical think speak for model so how with that the a pig maybe it ultimately you you results? upon, and eight rely of regards out did unique study, to pig the the those the happy had with with Can you mile fare preclinical new past animal you know, Were model the problem study. to the new -- how far?

Jeff Ross

for a was was Yes, of levels type mean, mobilize time. with of saw as a do technology, where study it. life-saving the coming this we've of really to that, complication duration deliver that highlighted, And mortality got our challenge the we you really could in be biggest where and but past, our up highlighted model I you to new initial associated able you to with the pig high in

able a of being control, Happy veterinaries, thought we anesthetized, really a the that report to that. team in up working has with that solution. just leaders So study to redesigning here be phenomenal working even with done inside saw which and preclinical the study is come of job a with to fallout

that and really studies tested various that And we out. at pilot proved

we come normally study roll running. So in up of a were when everything to still part not termination ongoing, had We've minor see as study And a some complications lost preclinical the out. of prior like to and any have your is associated the something things you that round able we catheter animals with been model, a that stable, this able subject itself to last in is easily us of is that, like excluded the new boost that the in test to as set. cohorts. which with actually part when data But the out confidence of delivered move gives and it's therapy incredibly lot forward being or be our

Alex Nowak

the transplant hear. doing clinical and study. you're ready picked to to on the trial the to Okay, perform activities speak that excellent. Maybe first-in-human first you getting interested underway Good sites yet? site Have and centers the

Jeff Ross

we about activity last list high clinical a community -- we earnings of call, clinical We interest our the within that, of associated study. see level part have with on our the of be as talked to

we're are that list clearance. gate, once least those out and the prioritizing to But we the additional ready are evaluate lot clinical is that there's that five where we is going as soon receive down lined whittled sites because know go have be And of clinical IND to we've to IND cleared. eight, that ready can sites -- up, demand would what a as eight of an as now well. and three we've be excitement are trying really prequalified to we So go at once our possible we therapy our activated this for to be

Alex Nowak

last ago or so. last patient the had Maybe Lancet transplant Excellent. write-up about question. month that full on cardiac year just happened The a a

there, in As reviewed you the study what case around the hearing Xenotransplant your development how does view you've organ to that approach? Miromatrix influence And versus approach industry? the are

Jeff Ross

organ of itself the bioengineered think clearance. approach part decellularization and the it commercialized before. we're forward And and I matrix our we've I is process, is we've highlights get highlights highlighted undertaking that still going because think importance we of And that two viral with the already things with. it the one process

already safety porcine addressed from and So the feel the that. side we've standpoint, virus the side we

unknown Lancet And big article as and at the well as other immunosuppression. that looks

approach, with look we As the cells. bioengineered therapy at we're in allogeneic human our recellularizing

standard as So immunosuppression donation today protocol be of organ an part gold will to believe cadaveric we the our today. similar that used that's

technology I but So be gone that needs the more I helpful side to in the some to with how that, the had was it on case xeno see associated that that sold of see think highlight side. forward, challenges

those addressed move really has approach well forward. as organ we bioengineered risks our think I And

our before, then ELAP our of fully our really importance to with read-through which So we programs we to to the organ, up to again, forward. product first first a focus that that's the talked why is the start for the believe about opportunity transplantable transplantable the fully opens bioengineered opportunity continue that organ and demonstrate as then platform

Alex Nowak

Alright, update. Absolutely. appreciate the well you. Thank

Jeff Ross

Absolutely. Thanks, Alex.

Operator

from comes Matthew Sandler. Please question Piper go The next O'Brien with ahead.

Phillip Dantoin

for Phil Matt. Hey, this our is Thanks questions. for taking on

Just two one us. or for

stepping of R&D? your you're kind new on give the The us going CEOs double old first I role puts one of into up kind Head Can Thank you of here. you. being just and Research just role, there, how back guess, up takes of and to role kind doubled this

Jeff Ross

the appreciate was Yes, a partially I That question, natural transition. Phil.

the R&D highlighted As background side before, technical have side. came you strong in and my is from the

So transition allows to to that the to go started in us on really of that where we natural continue focus be we was from to that, back things said, as focus that forward a at and we that bring lot very really ELAP, it focus role company. on focusing be standpoint. go a needed as to With able really able well

Phillip Dantoin

final posters Organ ATC, et Procurement at cetera, my being, cetera. of And one Organizations, three Association presented just you've et

saying? what over And Just how building are is docs interest time?

Jeff Ross

look organs to opportunity could of the with about I around to forward. Yes. open mean like exciting and these the the see it's what excitement and going to to future start the those technology types up think conferences go

at certainly, and revascularization show kidney that the on I community that sustained but protein surprised impressed out. think I renal level as some we've the retention data the the the we think of the or also was to of organ, on the forth look showing filtration the quality side, the was release the of starting started stuff ability put ATC, not effect data say, only to we're recellularized with I that that to and perfuse

standpoint, So and the I that that make. community surprised think to to from continue be we impressed progress with the continues

Phillip Dantoin

quarter. Thanks, hear. made again the to on process Glad all congrats the on

Jeff Ross

Thanks a lot.

Operator

attending presentation. for has This Thank now you question-and-answer concluded. session. The today's concludes conference our

disconnect. now may You

Miromatrix Medical (MIRO) 14 Aug 232023 Q2 Earnings call transcript