Earnings call transcript Q1 2023

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Greetings and welcome to the Miromatrix Medical, Inc.

First Quarter 2023 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Hannah Jeffrey Gilmartin, Investor Relations. Thank you.

begin. may You

Hannah Jeffrey

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

to the call will turn over Jeff. I now

Jeff Ross

XXXX. our today Thanks, who everyone has Hannah. us quarter thank and afternoon, first joined Good for you to

earnings term XXXX focusing our hold year submission. regarding we near During call identified of our I address from we letter on within FDA clinical the the to items are full majority the that our IND resources the in received communicated miroliverELAP the

clinical Our full the envision goal acute treat thereafter. of patients in the half second gain FDA is submit liver We butter failure XXXX. clearance response hold to a to to with shortly

earnings yearend our It's call.

within We significant hold letter, identified have of addressing I'll updates items and share the made the you with on progress those today. some clinical

The addressing additional a fluid study items the to third recall, animal As couple we are of a a preclinical lead regarding that FDA you biocompatibility. longer of that comprised relate final requested party we components. study and path the finished do regarding biocompatibility testing

We IND testing biocompatibility FTD's liver The it this risk, components. not submitted part however of the the believe part third was only party our graft low as is time. takes we on the question, of

animal controls. The be control timelines safety consisting for the and request no of systemic study, than group. miroliverELAP an evidence In toxicity other three additional with to item three treated original smaller study there has the contributed that the study. safety safety miroliverELAP six was animals, to of This group original our the our or animal is in extended was

will provide us may all attempt in extend longer morbidity model techniques to morbidity groups therapeutic to However, immobilization and the and also to animals. in in revised improved challenging. and allow protocol all due required anesthesia animal model in The use substantial immobilize safety the an duration immobilization there was The to therapies makes study. treatment protocol anesthesia which pick reduce new

complete the safety the animals coming the We quarter plan to in months. begin with treating to this study goal

phase our we one clearance, forward site sites identified. trial, for and will engaged are clinical clinical that IND once manufacturing with are Currently, and clinical we potential running readiness and The clinical to initiate will part highly them. our interested to the the This need prismatic to from and trial trial. therapy standards, Each ensuring to an plans the move both to In addition the we developed of ultimately specifically are we eight clinical in work, that be our effective with Baxter clinical involves continues are manufacturing response GMP a obtain sites progressing XX highlight we process software positive deliver sites for ensure being the clinical with hold can our our meet quickly miroliverELAP. it. of system consigned potential potential

in engineered we update organs. prioritization from path second the hold of to steps submit clinical the to treating that FDA to the year. half us all In provides this of miroliverELAP believe We response taking a better we status with at are bio believe summary permit the patients necessary miroliverELAP this us to failure of time the of with organ fastest our thorough

After our also entire platform. miroliverELAP discussion bioengineered Oregon reiterate in could very this to implantable about organ important fully to me our validation important And around provide programs. we remain bioengineered enthusiastic this for depth it's we that believe

we a While miroliverELAP gains clearance. slower are progressing pace IND at these until programs

via implantable reinvigorate of or our partnership to simple test. A bioengineer CareDx develop origin solutions to highlighting recent any partnership the testing example could otherwise rejection or organ them blood We arises a if with programs assess circumstances appropriate change. novel fully is

existing to honored be working industry testing. are with such CareDx the leader We transplant for in the

they with need comprehend address We that the trying of we're magnitude that unmet to the bioengineered medical organs. our grateful are

annual gene Spain. like closing, valuable the Barcelona, at on and earlier share in had med In I to I'd interactions some meeting the that month this cell

challenges panel addition opportunities leading companies asked the four executives The of and a been at and forefront from tax was innovation, consisting moderate gene of to Pioneer to therapy have cell myself. titled I As in

stories matrix, And All therapies. always paths neuro and to developing about cellular novel weren't executives easy. of shared the similar their gene

the holds medical advancements prior All to as treating similar course clinical transplant the setbacks, stayed our on with of stakeholders. value. challenging of We credit, the Their delivered well companies stakeholder patient. delivering to placed notably them their and four community, dealt look to and as forward first they all advancements and were

the turn will we I And of be where Douglas, many our see Jim financial officer financial our chief you to American to discuss the at I transplant call to Congress hope presenting. results. will now upcoming over

Jim Douglas

Thank you, We finished unrestricted Jeff. $XX.X the with and investments first totaling quarter million. cash

cash of and XXXX. the prioritization quarter our second have be first reduced operate we miroliverELAP through the end spending to will we quarter With going occurring of will the the of at sufficient business forward, are believe

to operating of quarter million was for $X.X to previously costs the $X.X and The million, in the Operating was compared quarter operating XXXX. increased loss write periods for first attributable the to increase Moving capitalized the XXXX first costs. primarily comparable income statement. of deferred of loss payroll off in

increase a Net presenting write quarter investor in offering look $X.X comparable Hallum credit In increased for offset off or employee The XXXX of of $X.X XXXX. per the costs at the by compared periods month. net deferred primarily conference of time one to loss payroll $X.XX totaling loss retention million, per the $X.XX quarter or for first forward was to a was this we $X.X costs share to Craig later first and in share, million, attributable million. closing,

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

Thank you.

Operator

Thank you.

with Nowak answer comes proceed [Operator question. from will Instructions] session. Our Craig-Hallum first We with now question question a Alex Group. and be Please your Capital conducting

Alex Nowak

to ran Okay, great. the Did wanted everyone. pigs the again. with some study The pigs already afternoon, And study I morbidity clarity into Good it six that. six that say with preclinical on anesthesia? the you safety and rerun around the need issues just you this you then ran

Just around happening what clarity there. was

Jeff Rose

Sure, Thanks previously around submitted. for safety our on the Alex, that submitted we study clarity this, question that. was Jeff. That had regional

no that that study. reported was was systemic it's that in there toxicity So reported

with However, the anesthesia morbidity described we've before, as associated saw we associated longer that. time with

those at those about I we've concerns study kicking we'll the safety that So that talked addressed shortly. improvements in and off be looking

Alex Nowak

it. that? the helpful. called Or FDA, something that that in an saw morbidity by was of got you're something wanted basis? doing ad it you That out studies? on one Okay, more hoc company specifically was to is is and The of the essentially address And original that

Jeff Rose

It's morbidity are you seeing challenge control systemic was. to when that endpoints toxicity that that it only may can see kind that in that model, other longer or things all confounding you to of the that in treated the have animals beat fact With mean, due that that, anesthesia no group. some right, inside continue animals, still the on the sometimes I of anesthesia, of time. see in to or No, go encompassing,

reduce to that clearing of our just reinforce any that up dataset. model further So to morbidity

Alex Nowak

Okay, all I understood. right,

okay, is But that's those studies, as than take through this going might there but test, you're preparing need this real that were anything maybe as going for running originally time making we say, all up and going set jumping additional to any you're didn't you're scheduled. get this study an maybe run out there, the Or, we through to you those that's time we know process? longer is take plan month As to originally you're biocompatibility to thinking? just hey, another thoughts run we also

Jeff Rose

that strategic worked partner looks we've system It's more third through with issue as what to with, any there's Yes, as plan these party with able well I with our that to that be individual like. that. majority say with on close not component. again, final really vast having the this comp component. I'd of Because, mean, are component, third complete just look a Baxter any party of

all that we And So and of plan. on got execution good really I keep timelines. we now those a ensuring that think can it's

upholding dependent out staying throughout we're shipped pointed third are are once is we're But things you and what agencies them do really close for that this think these that process. timelines Biocom, professional to on parties the all I time. these to there the that that off their very

and We're So data closely, submit on we're close so we the to to this. monitoring this it. very can forward seeing have looking

Alex Nowak

third do once how around you the a parties, can the FDA? the get turn to back you quickly from response And data

Jeff Rose

passes are those, reports matter FDA and other mean, and they're because a quick. associated once it trusted you Very back agencies testing once that facilities with because bottom of the it. then the weeks, come In CLI requirements has I have in, other it the those on tasks, from get that of these reports the and and summary stating results that the the

the And tests what into that uploading and done mean. results package. that putting then really those were describing it's and it's what So

time certified results, So and the studies a GLP require testing long time. that the documentation a getting are these side. oversight that lot of The doesn't take facility longest because is on

Alex Nowak

activities to here by given prepare last the ready talk clinical and the you've sites just for forward to get you've to to clearance these trials FDA to, then study. is with out them And identified, reached the question that once move

whether pre-trial with kind limited sign maybe regards now speak Just right IND stage, paperwork, to I they reach to what training more it's it know or does activities. of work until to just what the on but they're kind of you're doing even the can off

Jeff Rose

Sure. of those lot aspects a associated of I stuff the mean, into go a at sign this. clinical looking The of and placement site lot getting off, to contract the in that the with understand we're the baked it. equipment. the trial A logistics that of gets protocol today it's lot

the then to once enrolling cleared the be patients. once then be the first able able do we with So the forward move clearance, the IRB IRB, for and on submission get we'd then quickly to we're we'd

at parallel that we So or are that activities in activity do good those front. of we're Alex those any loading a front activities looking that up can place And the lot doing. may we're normally after we're of take

Alex Nowak

sounds That excellent. good. Okay, Thank the update. you. I appreciate

Jeff Rose

Absolutely.

Operator

answer We concludes and question today's Thank end our I reached you the this session. now have to would for like your conference. participation. of

time. your may You lines at disconnect this

Miromatrix Medical (MIRO) 11 May 232023 Q1 Earnings call transcript