NMTC - Earnings call transcript Q1 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 First Quarter of Fiscal 2022 Earnings Conference Call. Today's call will be conducted by the company’s Chief Executive Officer, Dave Rosa; and its 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. Federal Securities laws with respect to future operations, financial results, events, trends, and performance, which are based on management's beliefs and assumptions as of today's call or other specified date.

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

Dave Rosa

and everyone. good operator Thanks afternoon to

Electrode with advancing Platform first the we to our quarter, both Thin in diagnostic I'll Film with During therapeutic and since the Technology make continue to diagnostic respect applications. progress and start applications. first

line. you request for our than subsurface EVO us temporary use to for product is the use the our submitted clearance the the recording, the As to use, fiscal when the sEEG clearance XX February September Biomet, our XXXX. X, days monitoring stimulation and to day electrical been submitted FDA In less of on hours. of February response for clearance received level recall, FDA may FDA the up QX, XX stimulation in and is that a signals Depth of equipment than XX placed FDA XX, Zimmer from XXXX, family orders and company for of we fulfill of responses monitoring Electrodes for recording, the will to received, that with begin device stocking by already submission brain. and for XXXX, on the have acknowledged If distribution regarding receipt We EVO less FDA questions partner our

Biomet. milestone have the payments company the from to opportunity reminder, may receive a additional Zimmer As

at Zimmer Epilepsy cortical line in the meeting December our electrode In in addition, Biomet's displayed XXXX. EVO of American we Society product booth

FDA-cleared money, also device. and continued by electrodes, the diagnostic to device progress a conditions hospitalization, And to meeting clinical a of is as on and potentially this one this recording at therapeutic and monitoring and neurological presented ablation to first today. outcomes we've program. testing are and system film Shifting our brain titled combined diagnostic epilepsy activity, poster for reminder, intended both And thin electrode initial applications intracranial treated the We use. is save time way and into other therapeutic ideally, one improve and the improving patient expected to combining make

QX of we In with in work program, generator, our expect providing Medical to year. development the we -- RF RBC the continue partner completion this addition closely to prototypes resources which hardware of Iinnovations towards to of X calendar the

the XXX(k) expect generator of RF clearance of submit XXXX. quarter we completion prototypes, to FDA a in the first Following application the for calendar

development. use Now, to electrode our moving chronic

with to recording This patients as utilization disease, failed potentially for back to fluid pain testing, this During since the to and issues demonstrated without research year Most QX, back markets. perviation. the recently, any could development suffering of announced as which well long-term expand with accelerated technology. completion surgeries, five of due continued make epilepsy, these Parkinson's recording progress reliable associated electrodes fiscal chronic we of successful we from

quarter. expect the release later to testing stimulation our years of this We results five accelerated

Our market, U.S. currently which initial the focus chronic to is over $X stimulation billion alone. with in target spinal cord represents market our program stimulation the

from as deepens Regulatory Vice our subsidiary Vice joins Group, team leadership capabilities team appointment management as We also Quality of Bracco where we Assurance. our the appointment platform NeuroOne Quality of he Wilhelmy XXXX of Chad for Wilhelmy strengthens future the and and build President bolstered growth HLT further Chad's expansion. President executive was Affairs, our in a Mr. Medical, of with and the of January Control

to company will on we and capital, including us equity gross which a proceeds your made plan turn review closing, which and Mcclurg now financial continue advances with of of in to $XX.XX execute will great development during Thank also call side, a touch the our progress completed for QX first variety areas, Mcclurg financing fiscal raising more the Ron electrode to would of in for On a variety allow time million, wide well. QX, an the commercialization, financial successfully fiscal fiscal In to you applications. attention. neurological I film as Ron? introduce our like for Ron in results. meaningful thin to of over in-depth technology quarter

Ron Mcclurg

first revenue XXXX 'XX, the the was $XX,XXX in revenue first in $XX,XXX collaboration to for Collaboration of compared payment the of of $X,XXX revenue as fee you, revenue portion and 'XX. from first upfront XXXX. $XX,XXX Agreement the December derived was Zimmer Dave. Thank that quarter to in the the quarter fiscal fiscal XX, compared of Collaboration fiscal product was Product quarter development for revenue fiscal recognition eligible represented was revenue of first our initial of of quarter XXXX. Development of

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

million, the 'XX for to was XXXX. net $X.XX per share, $X.X loss a fiscal per quarter quarter $X.XX compared first first $X of loss fiscal share of net million, or the Our of or in

had now to in approximately concludes registered XXXX, an at of call $XX.X of million XX million, open XXXX cash proceeds to stock outstanding That proceeds to of The no had of debt public XX, at a December X,XXX,XXX I'll for the the back compared company common gross at XXXX. December cash of of resulting at $XX.XX share, $X.X Q&A. the Operator up remarks offering XX, price XX, approximately it XXXX. balance December million. shares September my and a $X.XX from of underwritten As Company pass includes

Operator

from is from coming question First Alex Instructions] Craig-Hallum. Knopick [Operator

Alex Knopick

back you on FDA from the that electrode, Dave, the the could you what to was these questions? depth of the hoping nature I expand were came questions on

Dave Rosa

Yeah, Alex.

results. on the So they they really, was if us there that few were questions found And did. wanted methodology had testing, we require. basic basic But recommended. passed just which again, per on the of FDA And to had so this just explaining some before, more where regulations were They said the but in we they the compounds we a on some then the that they what just we questions about about were little things. some more on on basic from, bit and of others coming the the compounds labeling. clarity wanted results. it. a knew more there were the that, the and questions acknowledged that. But just they just But bit was little elaborate a were that the really One we And methodology then follow just some letter questions

Alex Knopick

on And before, you but I it just of this and it. talked mentioned -- but just bio-comp know, again, you've the piece about

confident whether pretty there's forward, job part? you're of clarification regarding -- questions the that their is no on sort of to a So were materials the move on found. sort no There's of more just

Dave Rosa

reviewing that testing. Well, of keep the only the is FDA results the mind, in biocompatibility is the thing

testing. put we two for there's And it they agreed So firmly guidelines as actually that the these reviewing. all that consultants analysis there's of that within pertains tests nothing to believe these together, the we yes, results fall nothing and our outside required were

for FDA have this I come find if And to So any We hopefully, got confident? in am we'll that additional Yes. the to weeks back. out wait couple done. get next just of clarifications, they the and

Alex Knopick

back experience given going other I FDA? with think your another on in say to to question, point, the and devices, going was that just be forth of and is these rounds do you needed medical

Dave Rosa

FDA basing this off of a is it's to two just a submission. And hard full Well, because I think I'm if the always tests. of -- it answer, submission

-- They’re ton there a So questions. of handful of a and weren't really questions.

But if there this would yeah, questions, a look, normally, to back us FDA do we call interactive, come the would this with emailing forth. and likely and phone is as they and we back say, over came opposed some and So back to consider forth.

quicker previous than just the step So I because ones the the be think interactivity. next would much

Alex Knopick

And how just the drill bit centers? with from education then is on epilepsy any their FDA on more then is the approved, preparing once just in Zimmer any submission, and for own this updates reps on updates commercialization --

Dave Rosa

We So meeting the have this. first. details the all later over education go to I'll piece a for actually them this handle month with

So those limited plans, for the planning have been they product. the actively release of

I yet they with think don't something not training back is and We lay heard them, say, We yet, direction when official we're this long. orders, at haven't indicated bit that started should orders, have the they that too not wanted have the from or multiple from in go back placed our FDA. discussions little you to they've I a they But fact for them. more already look so again, waiting

more so, I'm much can I FDA or not that. But assuming should to they give on also expect week on that hopefully, there's from hear the back that. you next So in

Alex Knopick

pretty it you're in And looks then confident XXX(k). on electrode that the like ablation

a on generate put Just incorporates submission you move And that here. need in submission studies, you timelines that into today? bench the could are what's all animal the would XXX(k), data morph the those PMA how as that the to for out chance then forward timelines I just concrete assume that

Dave Rosa

your confident So first on, I'll answer question I'll take first how we. the, are

a lot submit organization pretty that XXX(k). was should this said, by we white. done that that And second very the went as she and would with experience about this I also as ago, outside our a consulting it organization, to a analysis indicated of in think But to XXX(k), they a believe addition initial was it's So consultant we days XX you regulatory look, black maybe this that, has be confident -- well.

myself consulting know successful don't but would with that, this that an I on I consider companies FDA, before. with they I rely do, companies, So what expert have would and been

predicate -- are clearly we've there's there mean, RF of I is do ablation, out tissue. brain identified that So there that that devices

are do if So and more work actually, I consultants will my gave we than suggesting. to than the money were less was us them what confident recommendations that earn as they they're

And testing of the just the pretty feel good we test I itself, or to yes, it have that that. the does So itself, about factor submission terms in perform. in

of got still good where challenges and now, we So, have But given on been we about timeline. supply are from chain, the some everyone competitive some to get still tests Obviously, the done that our of that with RBC is COVID, some appropriate and -- and we've that, all because generator feel do generators. even QX the testing with timeline. of feels the

Alex Knopick

and actually, do? done be to that there the Is on work you that development the any Or design on that electrode generator? that actual the solely point, needs any And is RF of need work is to more itself?

Dave Rosa

the outside with we're the electrode. on needs generator. on the done work is There's accessories majority some doing of with work that that some would of But used still but of working the most now accessories the be to is and There's its additional that hardware. the electrode, be what the testing of we'll be electrodes real

Alex Knopick

next just electrode, use expand accelerated chronic we the last then commercialized just just how data from turn And from maybe steps and products? aging out on the with here for have it question me here the did

Dave Rosa

not time because to associated take of of to months to opens predict fair in Yeah, really door applications manufacturing the obviously to up we'll think next that the be of data with so perfect bit that's of is therapeutic terms you It's us a something process, which a should say, to a expect the harder see commercial a next, much I'll XX, set XX it's I releasing is product. for in stimulation. there's time What that terms longer in going amount timeline. how little It's what the that. still

We that for have enter by market a how some stimulation. has ideas an approved about with chronic pulse more company quickly already that to partnering generator

having timeline of we do the it have should testing of the if redo some initially to that we with help had ourselves. to designed that So really would in terms

volume process so that call, So But hoping that. high answer we the with we long take we question manufacture going perfect in these think to don't is we have to can how yields. think we going high to can take at our have is bigger it the And that to I on clarity be, probably us better the some I'm next time, that. manufacturing but

Operator

Haynor Global is coming Ben The Alliance next from question Partners. from

Ben Haynor

question me last for of up there. just off First our kind on following

discussions like? might might angle. strategics entering And On with then the look you you mentioned release week the And use Can things then a what the a little upfront? in ago, little or press in color market the strategic bit of also market. chronic you upon have give more had licensee you touched on the so chronic on us research -- side a research the obviously,

Dave Rosa

we size then even So, million. if recently from the research finalized. space, that are times. somewhere we a significant and the right And personally the project But I working million, just recording between but is devices there for now project able something can't we for with research electrode of it in company a question be tell market only not out getting are to -- hear so I time million Yes. standpoint. release, that tell years, $XX I've about, research Ben electrodes literally from electrodes market on the you'll now, estimate But with XX could indication start with I've one we're were which five for like what not these we we that much for institution. the recording I what so local put to project are I can some companies for first with me companies heard yet, research million, program do think the where Not are size using Things And and multiple that purposes. that out, that it design years, on markets the been your “Hey, up from every just a can likely a XX an yet me has seems, believe or regarding start you that research research purposes.” to in or a an we're purposes. $XX to asked questions you also we sure five put be. the come you provide a

commented to even So before size there's on discussions for the what publicly chronic but to if be I nice response any tuned Company, dating we what And NASDAQ stay like see strategics. think trying published three And we're had I common the a electrodes the to able is. some market, that with doing, will respect we is back scour that then information to were the ago data had perform. to strategics, on that see was, this really of applications to with we you're years would

we or testing, which to short answer the will I discussions results say, quarter. reappear to release the think question the this So, your discussions I'll is, of expect increase happen those or chronic once any again,

Ben Haynor

I R&D And Mellon. what's then Carnegie front? latest I HD front, for and the it just kind high some was definition you any of devices think electric on Do of get on or feedback kind think electrodes to -- there Mayo -- the

Dave Rosa

caught looking the implanted the so use that up did infections, Unfortunately, wound dying Mayo and before that. in test They timeframe were the we them Yeah, them. pigs to pigs. expired, they

is tests and we’re we not that of taking So only those open not have these because it really mind, don't analyze these some really XX, said keep that so these The XX to for yet, like send in data a to the like week and going in It's out that implanted us. the it an problem Mayo the raw although getting days. animals wounds. to from But I'd animal. has hardware infection preventing XX, are we're the are rerun they these that all electrodes – pushing

back heard Mellon. yet them challenging not So from that's manage. have we for to And been Carnegie

Ben Haynor

the guess meeting? American Zimmer meeting Epilepsy then Biomet you cortical at what booth was the lastly And the for electrodes on here, were Society the I me, feedback in at the

Dave Rosa

from talking you from Zimmer the about force? or So sales are physicians

Ben Haynor

I both. guess Well,

Dave Rosa

dumb I my right. All was a guess on question part. that

booth, came intrigued. that clearly were by physicians the the So

We flexible that that's the thin want that the a special not one for clearance, manufacturer to carry not how have a that's had the another electrode, more the first and electrodes, thing this hospitals to with is that, we all something it. and -- FDA the apparent worked is order product. challenge they know of one we situation I company's they've becomes The until force from cortical until it's and do that the cortical that in volume sEEG It's release past. film is. want And low sales that Zimmer them the DEF electrodes. think is that and or feedback electrodes sEEG we've company's

less Zimmer forget more it they’re no that intrigued as it. volume appears to have you easy is there's a than on has, of of to cause this bit but the they package But the is as that by, lot what properties order. it's question the brain tell it'll about value hand, opposed inflammation can came on procedures. the get inflammation less really device if the that, the the hospitals And kind of a force that shelf of And about these little the to traditional sEEG well it diagnostic So, to then that even or the But when you excitement there's a allow in get doctors electrodes, about sales by neurosurgeons one the I us is. where of it than as hear electrodes. friendly special two,

of a product So excitement lot get both to that fronts. on

Operator

further have We in no queue. questions

like line Dave Looks are dropped. Ron, you there? Rosa’s Okay. has

Ron Mcclurg

it no over afternoon. there's for questions If thank you. this back the am. time we'll We everybody to I turn further

Operator

you, conference you. does gentlemen. Thank call. This conclude ladies Thank and today's

time participation. may You and for disconnect phone this you your have day. a Thank lines at wonderful your

NeuroOne Medical Technologies (NMTC) 14 Feb 222022 Q1 Earnings call transcript