Earnings call transcript Q4 2022

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Operator

Good afternoon and welcome to the NRx Pharmaceuticals Full Year 2022 Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note this event is being recorded.

I would now like to turn the conference over to Suzanne Messere, Stern Investor Relations. ahead. go Please

Suzanne Messere

Danielle. Thank you,

statements proceed materially remind with call would we expectations. actual Laws. call, forward-looking uncertainties risks that could historical the that certain experience to cause These Securities everyone Federal this to under like subject statements to statements and differ Before results US I are from made are present during or

periodic from reports could statements factors with information that cause contained actual in to is concerning our on made SEC. differ filed this the call Additional results

The filed earlier and made accessed Form release date be revise contained on the sections press statements to undertakes during from forward-looking presented only the this is issued or the as hereof Investor in no the today call which the the website. tomorrow, NRx Relations update company Pharmaceuticals' Information may to in be call of speak forward-looking statements. company's and the XX-K planned this obligation

on and are Joining Treasurer. me NRx Chief Officer Van Chief Seth Executive and Pharmaceuticals Financial Willard, Stephen Voorhees, today's call from Officer

will the making Seth comments. company's review the milestones then company's results, review closing a of and Stephen will financial before Stephen progress; will summary provide upcoming

Seth company's Following to Duffy, Stephen joined remarks, and Javitt, questions. the your be address their company's Jonathan Chief Chief prepared by Matthew and Officer Scientist will the Business

will now I turn the Stephen. call to over

Stephen Willard

World Day. for We scheduled us. Bipolar thank this joining Thank to Suzanne. you everyone call coincide afternoon you, with and Good conference

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a the Acute as Based from DSMB Phase Type our guidance on guidance recent the received broader Suicidality FDA sorry, indication, Xb/C potentially its registrational the as meeting well we the the -- year. and the evaluating advantages from consolidate regarding study I'm NRX-XXX B Data enrolling in is speak currently commercialization. and is and the regarding Xb/X trial company This clinical to for may the current to changes expected will of broader offer end this significant registrational indication NRX-XXX, by its clinical of also trials. in program comments

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we B forth you an update our activity and FDA's in Type meeting by months clinical to the of database forward investigate our to with division This our us allows for put expanded indication trial in the look registrational providing come. all Psychiatric to the

existing The existing support their become and potential to successful. from commercially our CNS on people serious continued the and clinical based financial trials, NRX-XXX commitment disorders with to data ongoing our shareholders, of living demonstrates

for XXXX. at Finally, without in including of major intellectual noticed we corporate depression suicidality. Patent to significant the from February, we recent In depression, NRX-XXX, patients bipolar achieved until This that of treat the depression the position use months. number suffering strengthens or the of with issuance NRX-XXX which patent milestones or company's least property covers a US

Officer has Banking. Investor and Relations. of pharmaceutical be We leading for his in Pfizer including Investor are companies, his Many company. and joined Business Chief that at announce Matt including Matthew Investment you and range him Duffy from the of pleased of as know may will time to biotechnology responsible Relations duties, a efforts and MedImmune

other leadership corporation Johnson Brecher, positions serving AstraZeneca, Dr. is & distinguished leading Medical trial. our the FDA, has a and Director who for held as Similarly, Martin psychiatrist at Johnson, clinical

year a NRS my difference development, strong patient, would I us the the the and investigators, enables in clinical achieved disease. we clinical NRx shareholders like to since foundation of team, with express drug the psychiatric reentered their for psychiatric gratitude our make continued support. milestones patients life-threatening to advance that efficiently These for and establish a to in trial lives trial

results. With Seth? our to will over it that, I for Seth of turn a review financial

Seth Van Voorhees

our our financial will XXXX Stephen the you, highlights and now expectations good I XXXX. for afternoon Thank review year everyone. of fiscal results and

The NRx the primarily in recorded [ph] related related work. trial to Pharmaceuticals development million compared is ended of $XX.X year million R&D $X.X for For decrease XXst, expenses XXXX, expenses and discontinued to $XX.X clinical in December our million of to decrease the XIAFAMI year the $X.X million earlier. clinical

the related December we million value stock for issued. fair of ended XXXX, general The For in million related primarily which earlier. million the million expenses $XX $XX.X fees, a common to $XX.X to was of year recorded $XX.X compared decrease consulting XXst decrease $XX.X year administrative the was million of and of to also of

was the of the resulting ended year. the ended improved for million, XXXX, loss period December $XX.X net $XX.X which the net $XX.X months compared to loss XX-month million million is For prior our XXst, XX

In fiscal to expect both we further annual the year XXXX, on fiscal focus decrease XXXX NRX-XXX. R&D solely we and development expenses XXXX our of levels year as from

reduced we legal settlement, to to especially a as cost us and have potential other will costs to including number cost factors, the that as lower D&O the -- of relief we Furthermore, which G&A to significant annual coverage; decrease initiatives future; costs, due the in therapeutical undertaken. a our in royalty therapeutic XXXX expect related insurance payments for related has well

$XX.X end, we had our Now, on I'd cash to in cash. resources. At like million year comment

were into ago Agreement with in cash we weeks accredited several the investors positions Purchase Securities ownership when enhanced Our resources had a established entered who previously company.

unit at these issuance of approximately -- The The following these to for transaction $X.XX shares direct exercise the securities. agreed company's stock for market the not X.X involved combined common issuance above or of six per of sale with warrants the a five-year sell shares offering the million slightly common of months stock priced date. in the investors registered warrants

The aggregate was from proceeds to gross million. company the $X.X approximately offering the

ability of the filing, for operations is our evaluated fund if our the there to we XX-K months. next As doubt XX about

right trading make current stock the our have and for in certain volume subject limitations. payments required to common We ownership indebtedness to

If next ago. strengthen our we year our are done as payments not for several was operations for we capital the able to sheet to balance need the will raise make required anticipated offering additional this support done indebtedness, weeks with currently the successful to to

savings extend resources. additional In cash cost addition, consider we initiatives to may our further

for turn will to it I Steve that, remarks. back closing With Steve?

Stephen Willard

Thank you, Seth.

year, we population our two advance future we NRX-XXX also while depression program past additional the broader both the strong with as the growth potential bipolar Over indications. for as well momentum indications, as NRx built for have in positioning

for which momentum, an paradigm of year that we NRX-XXX as be individuals behind treatment continue needs to the on suicidality, mission underserved multiple believe potentially that the even change the medicine that our depression meeting on a Building are is life-saving serious with of patients catalysts. clinical execute with force XXXX We and bipolar promises experiencing regulatory could to more CNS who disorders. productive driving is

We are on coming on for the milestones, look to near-term forward our you track year. which updating

plan drug application endpoints safety with by efficacy year for this in of end end a XXXX. the that met Assuming the we the of and to potential our rolling submission approval by are of X Phase drug initiate trial, new

the to are we audience. ready from Danielle, questions take Operator,

Operator

Instructions] We will now begin the [Operator question-and-answer session.

-- The first question comes

Stephen Willard

Hello?

Operator

James. comes go of Kolbert Dawson Jason The from ahead. first question Please

Jason Kolbert

Thanks. guys. Hi,

Stephen Willard

Hey Jason.

Jason Kolbert

what really, is really -- update. I need. mean, good, Thank the very you you? hi, how for are That's that detailed. appreciate we I comprehensive very

understand efficacy, lack is active equivalent although significant. utility, statistically yet kind better than little implies Can of comments and DSMB competitor, talk of Just or the of it, behind want math drug couple The a helpful? a that just showing that bit which even you about that statement be you made. the not to would

Stephen Willard

Sure, Jonathan.

Jonathan Javitt

be as plan you we've the the it's was that place protocol know, and are on superiority, Jason, no the by their identified. in for be to that trial, trial in superiority reached could leading this And statistical for statistically futility we is authorized have offer is that a significant Dr. set DSMB analysis this say conclusion for numerical the that comment we the blinding trial up, said And a methodologist identified. Sure. critical to been Levine to additional clinicaltrials.gov. would way though all the not keep the that up signal

There trial liberty long designs you're still in some to the are we as place all we're worse as that's not rule than placebo, at put where a stricter futility not really But futile, say. that. you're than

Jason Kolbert

that Right. that if you designed. you're most that's comparator, the they're that's to because are trial how -- But what very talked non-inferior to or comparator with. sentence the last familiar critical, But equivalent actually designed when I that's in about was mostly clinical

if that right? is kind and Is that Layman's because between of interpretation what if because no -- about powering comparator and trial futile the understand the I the because a trial your around not that there And bit I'm the a is was different, design. that stacked because superiority design numbers assumptions shown, and -- until of against you are of it fact, in you're and otherwise active in because is powering effect of the the moment little didn't differences tough this suggests fact, futility assuming

Jonathan Javitt

Well, think optimistic. overly I I want to don't wax

I get care hit think in that fairly don't signal most think had we didn't trial but that permission from methodologies. us futility I to would we're given we our a about necessarily it place. for be strict did designs, we rule talk delighted a

Jason Kolbert

half the of Let -- the understand. sure. me I second ask

potential -- because to you about I might So, that the up you're what was limited a two of clinical when point of was say. timeline-- what little want talk talked bit modifications the interested can yes, trial and together. X the particularly Can by you Phase mean? trials about don't the from I But And perspective very particularly a combination I this beat also you

Jonathan Javitt

we where talk about Let's we are. how got to

Jason Kolbert

Thank you.

Jonathan Javitt

great were treat And thought of off this everybody a of repeat a days began, to ketamine week. ketamine because use to that And it depressed using lot When wasn't wears ketamine a patients. people idea. saw began a people acutely after couple that

So, perhaps ketamine. maintenance the people a to suggested of as develop NRX-XXX therapy we prolong effect

that what results STABIL-B did in that's got quite encouraging. we the We study. And was

know, good X.X difference As originally points. a point X.X beat and was you effect. drug on and placebo lurasidone between by we Pretty impressive yet known approved lurasidone a lurasidone,

Remember, Avelity because available against went placebo it just approved patients. to against wouldn't point four and placebo that a go Avelity [ph] we didn't best between drug. and be on suicidal do We the standard-of-care in appropriate difference got

way, this said, like enough Therapy that our that's we as a Along got we into use patients study a to of good ketamine. X of why how be had is just to were asked if this. actually what And So, do we Breakthrough a year got to without question we material and we just enough NRX-XXX we benefit that's psychiatry getting prior smallish well, where the the old ago, into Designation. back Phase

having let's see where of We based And availability against commercial this ketamine point. actually just enlarging we're drug lurasidone believe if that on potentially if after capsule that's test we there its potential to without on and prior pill having are signal, study reached and futile. effective and a newly see And own this not that Phase there's to -- as right, this manufactured said take at point drugs, home-use is the based it's X now to because we a not oral a scale ketamine. for in be now registration real NRX-XXX a

we where are. to how that's So, we got

Jason Kolbert

And you've go of been that to on sense. it Designation. kind Breakthrough something that you encouraged Makes feel also last touched Is and was just perfect question after? you

Jonathan Javitt

helping -- is the dedicated Program you a after the awarded to Therapy is a committed, possible, of at for resource been to Manager the who important Breakthrough at we've Breakthrough process. part if use FDA, Therapy indication NRX-XXX of Designation get it ability all the Well, Designation us ketamine. approval through the And gives drug original gives that

in So, we place have now. that

the key other it Designation right the drug a rolling on is submit new you to your And benefit gives approval of application Therapy Breakthrough basis.

said going is submitting. data so to we're the have year, submit data, data end the manufacturing We're the submit. to by that by we've of file the reviewed time going whole preclinical we So, start the the to the finally efficacy

benefits So, those are in Breakthrough of already Designation Therapy place.

Jason Kolbert

you. Got

Jonathan Javitt

And I that-- mentioned

Jason Kolbert

I and Well, understand--

Jonathan Javitt

We a specifically when conversation more our data path any may have not Breakthrough with are in to I'm the but about meaningful to Designation change available extending sure FDA would this use really NRX-XXX, of that way. approval that

Jason Kolbert

answer And you. of Thank Perfect. that timeline some actually answers my questions.

is So, patient, the patient really to last is the -- then hurdle once data for completed only right? if right, you treating going analysis and the I'm be, you enrollment critical just

Jonathan Javitt

data enrollment, database meeting with Patient patients. FDA B see we Type announced want and to analysis, that of the they after a safety X,XXX

States database This, the than you treat countries non-lethal is target other Treaty to smaller all a safety recent safety of drugs conditions. on is a happened the X,XXX approvals at agreed United but lethal condition. the database size for if that, actually Now, at EX approvals, course, and of in look sort

NRX-XXX. enroll, are how safety database that program And us would but you've amount access enroll that through the there's also we're and through medications to of for the this access way. fair to depression approved expensive for have our treatment start with in programs to an take precedent of trials, and a expanded of clinical which going to only have bipolar access while use who a doctors such talk patients And depression building expanded exhausted gain to seen not bipolar about allow

we people horribly extent safety the $X,XXX, COVID, formal $X,XXX associate access trial. to of be of on one recognize with the kind was order opposed expanded database horribly, would to controlled that it expensive when randomized as will that in patient costs the the So, a imagine did a

for expanded which standard access to We is going reimbursement know to access, to ahead. the way can guidance, Now, for, NRX-XXX know speed as to going gain FDA time, we if we clinical able to at full be whether efficient you applied do the cost for see while look we're trials be don't don't but get same our yet. it and efficacy the NDA, in us what in continuing an safety

Stephen Willard

Jason. you, Thank

Jason Kolbert

you. Thank Understood.

Operator

from The Vernon H.C. Please next question from Bernadino ahead. comes Wainwright. go

Vernon Bernadino

Hi, everyone.

Stephen Willard

Hey Vernon.

Vernon Bernadino

progress Congratulations perhaps taking ask trial Phase on with question. Xb/X study, Seth. the may about current registrational is thanks and a for being and Hey, my What upgraded for is me to important be for to Steve, that the filing. Jonathan, used

the to nuances the how registrational and they're has occur fulfilled because nearly population it treated, that's you've need of are been that this occur or that changes to something any or it patient an there specific that upgrade With asked to going and are a already study upgraded requirements? is you've just for

Jonathan Javitt

hope the will The to we when -- and endpoints, are Well, one certainly to do on trial our the upfront is of thing important efficacy. the journals are that see about show did we how things we posted them. protocol we what scientific reviewers transparent the clinicaltrials.gov want an for and that's were because measuring

that extent transparent way, the there to along a in that known are manner. those are the So, changes

between investigational us when not and registrational investigational ago Apptec Phase Xb/X difference with Phase in our X as product China main said that's I started we in is five that for be all simply partnership during medicine to years was warehouse Jason, had Wuxi our made we and used for purposes. that The Phase this, was X can

put the to shelf medicine of you're medicine to is Registration intend you with the on your study trial the means identical that that that clinical essentially pharmacy. doing

So, those upgraded validate that methods. methods X from analytic level to the and bring to we're did point at control level. transfer, of We've over Phase China the tech we to Phase X hard a now from where North impurities work to a the do Carolina, our

that that medicine would is we a that pharmacy medicine able couple Xb/X substantially registrational now a actually in the on we shelf trial. this put to a So, years, of identical we have to make believe we're Phase hope to

really not that's a per change se. So, protocol

more failures possibly so in Dr. how investors often more manufacturing And to a Technology think promising I experienced drug have than to who biotech, are of drug failures Officer. Chief realize why trial. experts one in CMC is likely these efficacy an And as fortunate days world's that's manufacturing we're the in don't bring down and Panicucci, our

Vernon Bernadino

are I And study also, Got successful, say, X certainly could commercial for it. because conceivably, it's important material a Phase Okay. and you conceivably use that's supply. the very that if

getting study a those fine-tune specifically such was I of is enter it change to what that that of Phase is, guess the is screening be to going X would registrational? patients there I any pass type at level that

Jonathan Javitt

of are And have of Well, the the one that study possible. team built we things ratings one expert a There's in talk space is focused raters accurate think in study this company things some psychiatry that on results psychometric at are intensely site. is little a evaluating yield what as we've done of lot psychometric different is ratings of from getting that sites. top the the about achieved are ensuring a of surprising being who study been done on study within this in that the sites we've and as we're achieved that real-time the

that up so published rating on raided information those between happens clinicaltrials.gov, And at this recording get we the an people by adjudication we're and rating of about immediately to of evaluated our being session than CTI on look on adjudicator. more agreement, the constantly in-house who an you looking they being an score by if in goes site some three points master-raters do and our suicidality it audio are raters [Indiscernible] that. as system and we how So, independent appears accordance that out sessions session of set each we've scale same the

we're expert you a subjective months, the give where or score. some a questions in think clinical investment test based out a to of what's or community this get lose of a sense going is trying win we of I scientific structured tissue, on asking lose a and based this publication to control you or blood get an assigning don't process win coming that the a on under hope inherently psychologist piece examining where will whole And to how process trial keep approach

down and the difficulty as statistical standard very between easier a statistical sites an of prove standard a great possible versus improving deviation low significance study ability and between drift significance. the keeping tighter difference as having And a having deal deviation to high is

market. to So, job do where we we're to focusing this that's as medicine try our every to bring day

Vernon Bernadino

Sure. with questions. and screening because for know, That's chances increase And wish the kind can the of as these unfortunately actually attempt if I and I the the it's you that's study. sometimes suicide. providing studies, additional luck question for placebo like fine-tune possible because the in the helpful they you success. appreciate of problems my the, the you the that and unless Thanks as why as But [Indiscernible] effect, information. to somebody's well taking process, I asked you suicidal know impossible in that said, for best information of

Jonathan Javitt

it may comes You and goes known patients just FDA when met important about said very them. of symptoms pretty be and first depression. as of suicidality as well on it's us that early guided and not talk that one readily something the we that something things with It's

thought endpoint that from because guidance was the got for guidance was original we depression make indication primary studies our The suicidality the primary the we early our our be to So, we FDA measures that scale. FDA score. got from on

improve of ketamine use, there's but have antidepressant That's from win. exact antidepressant great. patients patients that’s encouraging these that oral oral been who enough able & in where that's have no words, that's suicidality, been suicidality, indicated if previous there's with excluded And who product, to to there because use you're antidepressant data no does no for in trials, Johnson some Johnson with the this prove you depression indicated is for population

show improvement secondary suicidality same CGI the the significantly to on able also is better. of endpoint were And the if drug. that at even the Well, scale than that's time, better comparator

primary scale. But that's the depression endpoint is why measures our

Vernon Bernadino

you Thank you. am I the patients my hopeful Thanks and taking there. that. appreciate out very for And again I for question.

Stephen Willard

Thank you, Vernon.

Operator

[Operator Instructions]

comes The go next of Ed Ascendiant Woo from ahead. Please question Capital.

Ed Woo

year? readout. DSMB any Do the data on anticipate readouts either or also and this we for more interim progress studies any the one on of your congratulations Yes,

Jonathan Javitt

expect but signals again the at they an readout in going look before that safety look ongoing be, they're they but emerge, the that sooner. QX, that monitoring told going to to is study there the would to do exactly I at us the end is are some when to haven't way extent We might going DSMB of guess be data point the

they're because population But actively of at are risk been a self-harm, is excluded this us with who working they've antidepressants. ordinary very closely patients of is why which trials from of

Ed Woo

questions thanks guys you I Thank wish for Well, good Great. my and you. answering luck.

Stephen Willard

you. Thank

Operator

Suzanne I back like conference to over Messere closing session. question-and-answer to turn our would remarks. for concludes the This

Suzanne Messere

have Thank thank participating. This time is the Thank the all everyone for NRx concludes you, year XXXX conference you and Danielle, That for full call. questions. we again. Pharmaceuticals' results you

Operator

now today's has The conference you for concluded. presentation. Thank attending

may disconnect. You now

NRx Pharmaceuticals (NRXP) 30 Mar 232022 Q4 Earnings call transcript