NMTC - Earnings call transcript Q3 2022 | NeuroOne Medical Technologies Corporation

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Operator

Ladies and gentlemen, thank you for standing by. And welcome to the NeuroOne Medical Technologies Corporation Third Quarter of Fiscal Year 2022 Financial Results Conference Call. Today’s call will be conducted by the company’s Chief Executive Officer, Dave Rosa; and Chief Financial Officer, Ron McClurg.

Before I turn the call over to Mr. Rosa, I’d like to remind you that this conference call will include forward-looking statements within the meaning of U.S. or respect which operations, beliefs are as today’s with trends, results, and laws of performance, date. and based call Securities to financial future events, assumptions Federal specified other on management’s

required information statements our which cause those I’ll as earnings SEC factors, law, actual expressed release forward-looking involve and materially by implied for to Dave results may call and Dave? risks no NeuroOne. to to we over risks, and and of uncertainties actual could unknown obligation Except undertake that Forward-looking uncertainties, statements. cause regarding may such differ. other With or differ results turn to specific from known by statements. update such filings CEO that See Rosa, said, the

Dave Rosa

operator. Thanks,

the balance development OneRF of reductions. and to a fiscal since deal great third the respect our program, During and to our sheet the electrode improvements company accomplished sEEG cost system, quarter, ablation with

stimulation previously special on the process earlier appeal. denied was substantial specifically submit company FDA stating a the of had with equipment previous let’s our evidence, and the to First, we increase to August with line. deny subacute had the use clearance we the FDA that completed X, call, On than appealed stated use our with of decision company from to XXX(k) stimulation submitted address XX, we new product XX sEEG a relates which as toxicity the XX data than recording, endpoint, the finding The support of targeted. for level signals electrical days release The the brain. discussed hours monitoring that and issued a monitoring duration less company new to On the collecting May press at XXX(k) also progress recording, this FDA to made a and equivalence. than subsurface it of the the less may that of our

that device Emory the sufficient milestone believe level for for the at brain it to time for for the of sEEG we continue electrodes materials meet University sEEG our On with used as mapping reached major biocompatibility. electrode the XX, design clinically first We guidance the and was used to intraoperative July FDA at brain. Evo are the a subsurface

perform future We more expect cases gain to an clinical to electrode. to the experience the with similar additional in near continue in effort

OneRF. system electrode earlier Moving generator progress to named allowed diagnostic and successfully another ablation than milestone we months on full by Medical. over quarter, therapeutic the us We including of NeuroOne’s combined completing testing prototypes accessories. including We X electrode, anticipated, system, the and tremendous major full accomplished the our complete which the RBC which RF made other have to from

in the Next testing use up is preclinical our project FDA. for additional complete XXX(k) the submission to to for

We are FDA an XXXX. the of submission calendar still of end targeting by quarter the first

and milestones. purchase This my provided in reduction We the sEEG completed product we partnership. the with appreciate as lines, to million per certain in In management, respect chain successfully Evo strengthen and providing cortical strengthen company requiring risk Biomet a both of mentioned supply diluted With of to source electrodes second warrant also exchange, opening sheet existing comments, for Biomet, highly without financing. initiatives both lines. we NeuroOne to of product reducing qualification NeuroOne’s for cost our excited XXX,XXX an As continue for agreement Zimmer’s supporting Zimmer the supply the $X manufacture interest to the we payment at relating an a amendment our to company $X.X shares received common additional with through accelerated Zimmer share. stock balance to capital to are

process manufacturing to currently aspects the Additionally, in-house. weighing bring certain the of are potential we

a new validated In our we terms of for manufacturer, component. cable cost which significantly cost reduces assembly successfully this efforts, reduction

the which cost chain We line the life the Evo to well cortical X to as for the product supply extend of reduces risk. shelf expired also process years, completed product as

use our to program. move electrode chronic now Let’s

to to pain a As focused and on the surgeries and treatment we technology. we will remain customized with capabilities Global The XX Investor set neurosurgeons system experience to develop the Later of provides leading the extensive and exposure failed Conference board technology of framework our technology. expand these a the the to to have and of continued systems. group electrode advisory at company comprised chronic begin the We the electrode due presented its develop developing that thin convene anesthesiologist implanting a for month, the Wainwright that feature Investment recently Conference. to this we the continue of advantages and stimulation, of HC back recording back established film NobleCon physician

American – the exhibited Biomet established partnership and Association Scientific Meeting, Surgeons also Neurological cortical cortical We for and Biennial the in also Stereotactic we sorry, American Evo Meeting. the Functional with Zimmer in electrode of Society partnership electrode Neurosurgery Annual at Evo

of Evo Neuroscience results We’re April. electrode also this XXXX. South was proud Evo thin the journal Stereotactic X, paper peer-reviewed to have & X be sEEG to Korea published Neurosurgery, implantation past podium in our presentation September the Also, through were we held as in the subdural for informed at film the World accuracy presenting that Society recently first study biocompatibility the a frontiers of Functional Meeting accepted Biennial for

our FDA company pleased I’m consultants days Evo a forward to of of XX the thankful we past early expedited the for and the accomplished look and remain product major discuss the line, results clearance for resubmission. August, that team process the number resubmit to employees in engaging than with near future recent the that electrode milestones. FDA and to test Over We less quarter sEEG for with sEEG of use. the

from our to was do also Securing highly key Biomet achieved In addition, successfully than to building milestone as million Zimmer continue time CFO look objectives. in like dilutive to now our would a forward OneRF the quarter attention. earlier also system accomplishment. financing we address momentum of the $X.X by turn for need Ron testing exciting long-term a completing results. and for I your early you major over in the generated both much a ablation the fiscal the short-term We Thank to team review for we without to to Ron? call McClurg, quarter the functional and July expected. August on have company over last third financial

Ron McClurg

of fiscal was of FDA delayed third $XX,XXX you, in compared $XX,XXX XXXX. is of upfront fee quarter to derived Thank about the the third the of Agreement represents XXXX. decision is collaboration to Collaboration revenue Zimmer fiscal revenue XXXX the to that Product fiscal payment of eligible the development in June of in revenue portion XXXX revenue product due $XX,XXX Collaboration the and quarter of from quarter compared for in XX, recognition the XXXX. of was third quarter fiscal initial the third revenue as revenue Dave. Development

year same compared the quarter. $X.X compared quarter quarter third of $X.X XXXX in $X.X year was the quarter. Our $X.X SG&A quarter period million expenses of million with third in with million XXXX million, fiscal in XXXX. prior of $X compared with fiscal total was third prior of the fiscal in fiscal the operating million million the the expense $X.X were third expense in XXXX in third R&D

was million a loss quarter net third for XXXX. of $X.X $X.X XXXX fiscal of loss of third the million, compared with net fiscal Our in the quarter

my of As I’ll Company XX company’s for is of million questions most which debt to back as had $XX.X XX, approximately to XXXX, the now had the open XXXX, $X.X remarks. company the June XXXX. XX, compared you. of end the as pass of and September Thank fiscal to up cash recent year. million it concludes no of outstanding of the That answers. operator June call

Operator

with question Thank session. Instructions] Alex conducting your this Craig-Hallum Please At from time, with proceed you. a be question. we’ll Capital Group. first [Operator comes Our Nowak question-and-answer

Alexander Nowak

Great. just that Good is background? everyone. the sEEG know animal you used afternoon, special Can was other here what resubmission? study in And several [ph] underway on the XXX(k) biocom company was working us I studies remind the then studies.

Dave Rosa

cut-off. your repeat of part that? you last the Could Alex, question

Alexander Nowak

Yes.

Just studies what underway And for submission background. the XXX(k) that underway? studies study? used other are animal then animal the new in special What other are the animal the

Dave Rosa

Sure. Yeah.

study we us had the this an to or endpoint, particular of toxicity. perform, called and was to redoing FDA gave the either that subacute one what’s option there exhaustive meet So extraction test

analysis So we time that’s the done. it time no we last to perform needed subacute was toxicity is this test, subacute the extraction. be performed pass/fail an There’s test. And because really a toxicity, exhaustive

So that extraction. FDA didn’t the chose we with exhaustive was on why reasons that. discussion And of the agree obviously, our the one

to because And if data submit there sense my mind So XXX(k). redo needs in special done, provides are subacute the of with required lot a it in that the opportunity and it data no there’s then number to toxicity. FDA, no case pages it analysis, the just toxicity, is that that analysis made be we so memory under of more any analysis Whereas the obviously extraction of what was subacute test. and review from by that’s so analysis, test lot XXX a serves, my more a test exhaustive did for to

all other already additional requirements outstanding biocompatibility we’ve terms any The other perform tests, met didn’t In to the have biocompatibility testing. requirements. any of FDA

of to a look that meet done there to other on us the when in we’ve need terms subdural testing already biocompatibility. at isn’t So all the do electrodes, requirements any you for

Alexander Nowak

Okay.

answered maybe that to XXX(k), little do doing I normal got think to special the to at so there. moved a speak the the question that this first a because was just a special more? rationale you time reason a they XXX(k) But bit normal, versus a XXX(k) time

Dave Rosa

You under a mean, why submitted special? we

Alexander Nowak

to it last Yes, when time especially special anyway. normal from went

Dave Rosa

Yeah.

accept on to a under FDA that’s came review a one, we for But a substantial wanting the to when extraction. a the amount said traditional XX-day will submit as a XX-day – or opposed period XXX(k). traditional rationale transition to for number is the to we one, and XXX(k). obviously, FDA is, So it required not And a there’s to so the special that, need it, cycle analysis it under need we that it’s under exhaustive of first back submit

a So from notified started they [ph]. to of last XXX(k). us FDA receipt, converting the technically date which time has X they the the after clock XX the days submission And were traditional the is that days August it that XXth the date night today

So provides but analysis FDA. is obligation discussion is under a data exhaustive a And not have solid extraction under XXX(k), like a accepted test, because with why any doing to accept as as did should under there it to we toxicity a with be is XXX(k). the it subacute special us FDA no there special argument

Alexander Nowak

it. Got

what to Okay. to pass commentary like? I speak sounds for it’s like its could what some helpful. look the back resubmission, that the mean, That against is I results of a date, And push FDA study assume for maybe speak but the pass/fail, then the would maybe that

Dave Rosa

Yeah.

be is it going pass/fail. blow, the wouldn’t we anything And, submitted So testing. by have without I submitting wouldn’t XXX(k), the if blow we guess, didn’t pass we

this going what you’re So lot none of I of animals, there in mean, there’s course looking through the the believe sure that to for XXX there in any what over to ultimately, isn’t terms of make we that to a were But, when testing, I is exactly implantation roughly exposed device it. passed, period. here associated during there XX with about that the days, toxicity the device

non-toxic, very non-toxic, red was our and case, came of there no that out are it. was results end independent that lab substantiated the And some in flags It were there was the toxicity. it or So, short.

So what FDA be I’ve been the company been guess I successful might honest that as in, come back haven’t to ever – to with, any you. in trying to with I doing

say we’ll would same back what know don’t I pass/fail, the I have especially case, to and this in see. come with, but they wait thing. its could So since

Alexander Nowak

the was Okay. And them. [that then expand [ph] from payment delayed] with maybe the Understood. milestone That latest makes on sense. relationship, Zimmer

I what’s So waiting terms other any here, on deal warrants? commercialization also plans? were they’re status the on And but they’re their know, own there the amended of approval Obviously, inclusion waiting approval. the than then of Zimmer’s

So just any...

Dave Rosa

Yeah.

deal the for exchange warrants. in just in reported million with So payment what it there was the $X.X wasn’t else Zimmer, terms anything we the

a And, So It – helpful the I – look at they that at think is before they’re us, that and they I’ve they’re in felt up look they we relationship, I least, it the I was stepped transaction I did. said it that growth. develop that way help think always for solid relationship. was that could think, with always investing a platform

So helping us going them. is also help to

a get actually with had we time of when FDA come special think no this have where here, year. the shape if that’s I that answer good we don’t a drill in Zimmer under supposed occur. – data accepts to should or or to extensive that any end as for waiting left commercialize we’ll the to thing only The when they that? So there bit feedback the they’re the the looked is I the year. way There’s think I not be information have clearance it. few before be they as The this parties The And, idea both want early in product was sure. weeks, a and same maybe expect XXX(k). around might obviously QX, to idea, at that that’s resolved to exactly is is FDA. issues I far And they are, the was FDA as know for the cleared. able submission will possibility on then of have the our next better launch And, we that for to goal though, better their

Alexander Nowak

right. update. All the Appreciate Excellent. Thanks.

Dave Rosa

you. Thank Sure.

Operator

[Operator the Your next Instructions] Haynor with your Ben Partners. question Please Alliance with proceed comes line question. of Global from

Ben Haynor

Good on revised congrats on the and for taking the the agreement submission. questions, Zimmer FDA afternoon, gentlemen, thanks [ph]

that? are investors you the me, months first feasibility of the getting be doing talk that and at] developing can on congrats upcoming plan provide in to But testing for – to sorts updates in to you and also system the Just about [where [ph]. off going OneRF you’re on can it’s OneRF

Dave Rosa

Yeah, first. maybe second question I’ll take the

what the test initiate a egg-whites well prototypes this we you basically electrodes, initiate the the you device, which prototypes as going. And nice this years the ablation. but were hardware that’s and you We solution, That’s to keep did at our And time Cleveland will very, you had the traditional the it’s testing we what incorporated finished do them. project benchtop performed as of ago as beaker. really us, is testing. software they a ablation, facility generator and lesion, do RBC’s we electrode accessories updated is, the the when how progress actually to egg-whites; people the where recently in the at the on and the our to we and in then presented electrode connected it and and very first of the see is And And these the in tests creates that to are when was Clinic. all way well. done you’re way put finished really started you So accessories

In – perform fact, thankful well I’m did. I was did. expecting to I as as it wasn’t expecting it But, it

we of it what a ago. we with worked pieced testing system be University to not actual done the demonstrate Emory animal already prototype. that doing So month testing, together we’ve have But type are going a from finished at here, to

studies, performing as We’re making redoing animal going is to a still to. be everything needs of way way sure it the

you’re what that obviously looking create demonstrate that you that that. safety you’re harming, certain animal. isn’t harm consultants you be of animals. idea submission. an to have type with it it again, FDA live a a We an determine has the worked specified can been be is lesion that to already But doesn’t we not to testing as study. And as do the the well what within causing in And will animal have itself need device We’ve of range want, to for data determination

the piece another components, what to of we that’s other then expect in components, expect which are waiting couple be don’t on them order, And doing. what we’re final is on months. So that for

development, our behind and the working, really we’re then the in is we’ve no the sure of But how to to come of final now more work us. to need very the fine-tuning It’s submission news building kind chain that supply design terms But hard with is units timeline. verification, And is the experienced everybody’s this of testing, feel for that’s FDA. software that, making fun way it good glitches. the Now, we good there’s is here things, delays.

more project. with say, development then So, it’s that’s I left fine-tuning the would

Ben Haynor

Or then mostly standpoint? hands it dialing from that into and a the that kind is of such? it of And just getting I KOLs is Okay. fine-tuning, technical mean, them in

Dave Rosa

But, the No. working of that to we for We’ve have board closely of been of because with parties it feedback. the sharing just getting addition, that the come while of system. already with in we now. some they’ve hands advisory yeah, using to mouth KOLs. advisory been actually have. physicians And, a will board quite It’s new some be as progress word and us in the mean, well, we give have, us I actually our

to looks the to they that, developed obviously, like. develop are customers. system how the that’s And in And what easy want getting product graphic don’t is indications been least interface feedback going something system early – this to use. for is to So pretty this use, the X% functions, case, at easy user top apply know, already we’ve to everyone the a only quite you that that’s really we’ve because

Ben Haynor

it’s then a And you bit the Okay. there provide share point the that to bit I a research in your a for a bullet maybe different? that’s existing have new you the on That’s for targeted milestones on could completely indication? organization or electrode or application something that wheelhouse mean, helpful. of develop partnering an little with more is kind something in little – clinical

Dave Rosa

about epilepsy it’s cord things tumors. spinal So the that meaning for that’s ablation, meaning stem, application tissue all we’ve an different talked recording for

to the trivial. application only not probably it’s the you is in paperwork get reason why really the getting signed institution’s I contract So the is, these mention takes of And as appreciate, paperwork, and can the time a don’t this different institutions, and application. it amount signed name,

parties an to both do, come exciting. lawyers to going to groups’ to be are both but on what we’re going So it’s – agreement working still through

things I have on be two could are We talking talked more. a we’re that we’re that different But, to not to today. the in quarter next I about think, yet. I that we few that wish or ready working I’ve everything be will you talk about from

Ben Haynor

is and about? Okay. the – this with or thinking jointly Could on, situation of you approaching where there’s them? share or the the you’re stuff you how organization working something potential that more a you applications technology maybe if seeing of kind are you’re where organizations, kind Or approached research

Dave Rosa

both. So it’s been really

do a probably And yet well we far So things, couple program. trying what as we’re recently, then, here’s with to case, probably the to what with anything. we’d really work coming FDA. and cleared think other well. hey, do trying this, like as to and it’s this particular accomplish. sEEG we’re to have enough you on them as focus other But kind that our ago, initially of technology we them where seeing obviously, been more kind recently, us, remained of years to them. weren’t parties moved started will we that’s in relationship say, – you But the our ablation through is you, with along approached to to the of us to us? And get work really We but on And

Ben Haynor

Evo there? lastly, there, on Stay any And that. the Okay, every curious case, for that how color for sEEG go, interesting. tuned just me, feedback

Dave Rosa

it. done. no robot a that, or using the get of frame, images, feedback a the Yeah, apparent there’s been already sort a going being any is, – device reason is not placed for giving other there’s high And it’s of craniotomy Ben not the with than quality that images has you’re because stereotactic it’s issues lot to

just map to used brain. So through passing completely they’re being electrodes It’s during bone. procedure the the the not

or brain, using in map well cortical as the so are sEEG to So within that as these able both well. deep there they’re as X – electrodes, X electrodes neurosurgeons the cases,

that But, you using and fair checking going place images, skull – boxes and getting a now. maybe getting I that having you’re about, that to you’re to taking connections to do. you of when always have In especially Zimmer worry is the will equipment we’re anchor these bolts, the that hours, getting get, devices procedures that not not the not it’s the has one are electrical are used those the But, your the expect through X that. shorts, base, So to be things test. that you’re when hours you’re do true is X, test these you’re and X that’s robot

Ben Haynor

all guys, it me. That’s makes congrats the the progress. That and color, Okay. for sense. Thanks for on

Dave Rosa

Ben. Thanks,

Operator

the Dave we Ladies reached the remarks. and gentlemen, closing call to session. of Rosa question-and-answer would like end And for the turn Mr. have I to back

Dave Rosa

want you afternoon, progress, I all as Well, of updating a to we for to Have really our forward across make late thanks, thank all continue progress good look to spending listening everyone operator. to just evening. really platforms.

Operator

conference. today’s concludes This

for disconnect your time. you may lines You Thank this all at your participation.

NeuroOne Medical Technologies (NMTC) 14 Aug 222022 Q3 Earnings call transcript