NRx Pharmaceuticals (NRXP) 14 Nov 222022 Q3 Earnings call transcript

Good morning, and welcome to the NRx Pharmaceuticals Third Quarter 2022 Earnings Conference Call. All participants will be in 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 with Stern Investor Relations. ahead. go Please,

Andrea. 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 U.S. 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 made today in date in revise contained on statements company's the well, to undertakes during forward-looking presented only this being is and accessed maybe which or as hereof. no the investor's Form website. XX-Q call's press Pharmaceuticals the from the update as company Information NRx the call speak forward-looking release statements. And filing the page issued the this today obligation of earlier

today's Officer, the and provide then making Stephen of review call the Stephen will are will company's from a Pharmaceuticals Van Joining results, financial comments company's before Officer of Treasurer. upcoming Stephen Financial opening Seth progress; Seth closing me up Chief questions. the for and milestones on and NRx Executive review summary Chief and Willard, Voorhees,

session, of Chief and Scientific to During Operations the Officer and Q&A joined Javitt, Head be Company's the Stephen investor and Seth Officer; Robert Besthof, will Jonathan Chief Commercial address questions.

Stephen. over call will to now the turn I

our lead we development and results our franchise we late-stage a our strategic of Good provide announced discuss Suzanne. company and compound. Thank you, March, is the NRX-XXX, going quarter update. forward primary us. you morning, everyone, for that In our on focus business will joining investigational psychiatry thank the third for Today and

bipolar to estimate the for billion. around suicidality. drugs $X patients is be are suicidality bipolar sales we with currently only for none approved indicated U.S. for depression, of with five There Today, depression which potential peak annual

clinical their were excluded such fact, trials. from In patients

Our suicide to patients that with high special agreement therapeutical only such enrolled of breakthrough the FDA Phase potential improved allowing approved X why study and provide outcomes with is levels electroshock is showed in and XX patients. a designation currently us has therapy protocol gave is who alternative risk clinical study therapy. for That registrational specifically the NRX-XXX patients,

processes recent months, In treatment made the in sale trial the completed decision to Phase with of using of for of ultimate suicidality In for announced release we progress we and That we safety milestone NRX-XXX indications. demonstrate our bipolar initiate depression our commercial have week. also announced while our advancing X last medicine strategic of suitable efficacy. and substantial PTSD, should other NRX-XXX psychiatric was following March, exploring development the and

in special agreement XX Thus, the X as initiating the FDA trial with this under Phase anticipate FDA protocol the we patients by of pre-specified end our year.

report of in been data XXXX, line with half We NDA efficacy has the second expect to top met. year-end by a XXXX potential assuming safety submission and of initiation

in which this development knowledge, support or debt To commonly announced PTSD. with d to a patients antidepressant typically approved used in dose NRX-XXX suicidality, of depression Last NRX-XXX studies and fixed financing week, the that NMDA-receptor only depression either is combination provide that an active an project adequate X clinical our and Phase also bipolar is disorder. bipolar oral this in a we capital drug with the modulator program. lurasidone, criteria of we for is D-cycloserine, targets exclusion

are five will if condition, two suicide. that you is that this the suicide. this people if die depression the one are bipolar know of people reality odds odds condition, And with attempt know that one tragic The will you from with

to and seen be human clinical non-clinical Ketamine kill and and of with known [hallucinogens] patients cells reports. treat many to depression benefits also achieve with induce ensuring that is brain known Ketamine to increasingly therapeutic (ph). the models used is both may X NRX-XXX in animal neurotoxic, suicidality. well to and is evidence suggests Phase ketamine, Our which in

FCA reason. has of anesthesia about repeated ketamine use for warnings and issued this

that the ingredients NRX-XXX demonstrated potential toxicity shown deaths. the XX not generic times at have We of had expected even

unlike released NMDA have findings ketamine, We preclinical component NRX-XXX demonstrating is that in the non-addictive.

depression populations. and both therapy be warning suicidality, and knowledge, patient in no carry bipolar has who labels suicide showed drug initially tendencies clinically this patients significant proof-of-concept potential vulnerable acutely of with who and increased therapy To is Our study would statistically in stage able the relevant This X oral stabilized academy. been to were depression in ever standard because Phase a compared reduction for a regarding suicidal depression, both our were population. suicidal in antidepressants box reduction demonstrate to risk black in

options. population PTSD. NRX-XXX a the on and outpatient have program enables setting registrational unmet to-date. by accept allows depression advanced us that patients, are successfully with truth. clinical Please us significantly today established to press commitment significant our This to our suicidality X expand efficient we a a address treated foundation to for sub-acute who Should profile, milestone with patients medical the who for safety bipolar issued with efficacy Based potential to determine differentiated from milestones that us. we treatment currently of underserved believe in therapeutic the previous and FDA's see strong we NRX-XXX and earlier achieved and regulatory are to the on release This foundation enter those highly regulatory addressable Phase patients, available need finding demonstrate also an embark

our to cover quarter. like achievements in Now I the third of some would

Phase daily. to ability clinical depression in objective track in ideation sub-acute XXXX. top with X significantly data taken of six quarter report NRX-XXX to first patients study suicidal weeks improve of ongoing is line demonstrate and of depression suicidality bipolar double-blind when clinical and our NRX-XXX's for trial to the the both on are over The We twice

and and sub-acute suicidality of depression does bipolar not use with the patients involves study require The ketamine.

to studies us indication NRX-XXX, the enable an is more well potential for previously, setting. convenient on one expand offer option mentioned As as treatment outpatient as the a this that could of

plans clinical in track year-end to will of registrational bipolar initiate in NRX-XXX trial double-blind with on are We XX with and be NRX-XXX patients trial versus lurasidone severe This patients. X alone randomized Phase ideation. depression of trial by suicidal acute also

We confirm single in the expect population. to standard-of-care would findings our to of lurasidone, with treatment a trial infusion NRX-XXX to Phase successful a patient current response the X ketamine, be superior following

to by showing a these in nature Rating patients, medication lurasidone, We and our standard-of-care to drug will of depression of by as the differentiation. the successful FDA than will with agreed placebo rather and clear Depression symptoms this acute do Because we of Asberg Montgomery measured improvement to provide Scale. this compare the commercial

indication and approximately is back in [indiscernible] experienced X we announced million very XX as XX last PTSD, unmet our suicide. of area need. our room the between this country high September, an in are plans another in individuals medical million to In PTSD, additional million at one-third day view every PTSD for of the severe We

expect will that medicine antidepressant our We show effects PTSD. in

are these fear also there studies PTSD components preclinical demonstrate our that of we memory is associated PTSD reduce in effects specific depression. the of shown directly have on medicine no peer Today, specific However, will for and approved reduction medicine symptoms memory beyond symptoms PTSD with hopeful and our D-cycloserine.

our that our drug last manufacturing registrational -- with as in commercial ready we review net NDA seamless that and particular, [to process can commercial (ph) could X we stage so expected the process submission, As FDA, now in include a to this about approval announced excited believe product submitted adopting We're Phase to upcoming begin] studies. need this without we lead week, milestone process manufacturing a more trial. the

our not upon published on that Yesterday, franchise. to company part with to institutional be XX-days. we pending to into We franchise entered More reasons: to analysts, and have that held have who with who The we CNS focus will be the at following on of settlement on and the CNS November and core on advise XXXX in evaluate this in us unit a XX, franchise. is closing our the will Relief definitive the we Therapeutics settlement be within have the X-K SEC announced interest agreement settlement. litigation a details for the that in company Holding shareholder's found is filing book-to-bill capitalized our committed terms believe focusing our investors, resolve settlement our future a next release

The the while terms development, trial in settlement use. further committed the the all of us paying the million in succeed. both NIH of of build in is BARDA -- Under $XX potential failure costs widespread Relief royalties [indiscernible] for to limited they and indicates risk to should to of milestones and book-to-bill up the

shareholder. a it's benefit a that think NRX So is real deal I for

is expected for support financing debt $XX proceeds million November clinical on X, that announced development we NRX-XXX. to with Finally, XXXX, our net activities to

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

everyone. with our financial pleasure today. And review highlights a you, the I results. like of Thank to now to good morning, Stephen, It's third speak you and would again

For ZYESAMI. related XXXX. development to the decrease related trials to compared clinical $X.X period million R&D totaled same million, three ended The for period decrease expenses XX, a month $X.X R&D in and XXXX expenses expenses September in the primarily in to

of announced in going are As our year, of our psychiatry this expenditures R&D focusing most forward. March we on franchise

paid we by regulatory regulatory million anticipate to in development of nine consultants, in R&D costs $XX.X September $XX.X For that XX, expenses development to process in compared development and trials the ended a of same XXXX, COVID million $X.X of do ZYESAMI, to month increase expenses the offset to to $X.X a and costs partially both clinical period million to related XXXX. nine $X.X $X.X is and includes not of period related related net decrease incur fees to to forward. million development, period R&D vaccine increase ZYESAMI totaled costs. process The as going month million, for and million an in The decrease

same to partially consulting XXXX. totaled million, For XX, million was from September XXXX, fees the G&A a in period in XXXX. $XX.X in compared reduction the ended period to three expenses for G&A decrease related expenses $X.X The month

XX, and we fees professional to includes same primarily of also $XX.X million to nine decrease insurance vaccine expect totaled G&A accounting in a a in period costs expenses. For as increase that related consulting XXXX. forward. an million for $X.X expense, which XXXX, the legal, decrease The by month month ZYESAMI of million, increase compared of expenses to COVID of going million are million partially $X.X million period ended to was stock-based not the to nine $X.X million $XX.X an The fees, period compensation in costs development, September G&A do decrease $XX.X $X.X related of and and offset incur

September ended With XXXX, $XX.X to period $X.X million loss million, as XX, month our the was the three loss XXXX. of net period net September XX, three for compared ended a month

ended million, the period was as For to period net of in $XX.X -- compared for same with $XX.X loss XXXX, nine loss month our September XXXX. the million net XX, the

first quarter of expenses settlement its for of XXXX, nine expense In a the million non-cash settlement value XX, XXXX. had grant date. to the increased company recorded ended We fair of period reflect no the warrant on September the month the Gen $XX.X

to like I'd resources. on comment Now our cash

a operational debt balance the of announced has As added activities. we annum of XX-months. trials an reported per X% of note clinical we proceeds million. rate September of interest maturity cash our will a date has and XX, $XX.X balance support million of other sheet and net financing to XXXX, that our that This $XX Last week,

X-K, be found Securities which with may the the Commission. in Additional Form was filed Exchange note X, the on company's details and November regarding

G&A financing, necessary that if and clinical believe sufficient necessary. development support the least ability for if funds to we non-core next expenses the our to have we at With reduce XX-months this plans

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

an depression, a bipolar Seth. individuals suicidality. Thanks, could change meeting NRX. disorders. but also a for is the NRX-XXX saving CNS the This that exciting treatment behind with mission We medicine experiencing are believe serious our underserved potentially life patients This for is paradigm of time that of is force driving with needs

of with variety commercial to options a have development. regard We

by approached robust Our interest IP been NRX-XXX. partners we strong technology potential have attracted number for and regarding of a partnerships commercial and portfolio have

relatively to company drug also medicine as to need of of launch the we U.S., in the this to first-in-class very prepared support number a unmet a will medical We is our of facilities us small capable are that be approved. granted the product small psychiatric support marketing for However, this still should such high commercial specialized NRX-XXX. appove believe be due

of decision have major patients, the team shareholders some plan addition, that options In launches to largest debt carefully meets needs best pharmaceutical the make evaluate our the includes of professionals, managed and company. world's and all who available to We NRX.

Phase with track the end We new to and execute trial, year, the the endpoints [indiscernible] across by the and next near-term a initiate quarter Phase for submission clinical application on fourth to multiple X our and year. rolling the efficacy assuming continue of portfolio plan of catalysts next for FDA we X drug

are ready take we Operator, to questions.

We first session. H.C. go of Our [Operator question comes Vernon will question-and-answer ahead. Bernadino Instructions] now begin the Wainwright. from Please

Hi. Thanks since taking on my on question. congrats coming for the Steve, made progresses And board.

Just the type NRX of first suicidal what are you trials, in the the clinical SSIB, in for with ongoing quarter points with data [MDB] considering what we a Xstudy regarding with from end NRX-XXX few X questions the And sub-acute (ph) could Phase ideation behavior? PTSD? expect Phase

Yes, go I let me Jonathan. my ahead. -- Go Could turn of to ahead, that experts? one

you, Thank Vernon.

is by is quarter of enrolling able talk to underway, that measured scale currently Those the and the On the demonstrated scale. be is superiority we and is the by line the we'll by the end the data, mattress trial in measured that's Phase Xb about first expect the where trial trial. depression the scales X endpoint was where actively CTISS top are suicidality Phase

will depression endpoint. PTSD, the primary to With scale be again, regard a

we're flashbacks on difference to commonly PTSD in and measures CAP-X, symptoms memory, which the call people a debilitating However, directly see terms case, other that is your a also what that of in hoping symptoms PTSD. of scale of

U.S.? as that do process follow-up for the And from your the Terrific any runs, needed the clinical you regarding have and process capability establish fully to when mentioned, you. as what expect supplies or are if activities one trials? in manufacturing to Thank manufacturing you that such testing

that the released release FDA. the file press been the supplies Phase that and module three Well, was been announced has issued filed for manufacturing clinical X the has trial with

X will the runs for of to we'd that studies. that the some efficacy of so the F&A with now demonstrate using use additional comments So there manufacturing have and replicability be to additional processes, manufactured able to course, Phase demonstrate and inspection was when Steve order we practice. emphasized, we're manufacturing will hope file. material And should commercial for in that's the directly FDA distribution released be as we around replication move plant sure bridging been safety But

Perfect. questions That's had you. I today. all of the Thank

your for Vernon. you Thank question,

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

progress. Also congratulations Yes. the on

would when you for do initiate a PSTD, specific have For guys timeline you guys indication? that

early. too it's think I No,

Our work developing in with its stages. PTSD is

under our belt, once be you we'll So a some to timeline we've give work of able got more for it.

for is, Great. you international And have NRX-XXX? guys my opportunity thought last question the about

Yes.

have, of deal. I we have interest us with and they great people We interest the would from to -- have international are NRX-XXX international who -- a partner to an potential appreciated as mentioned, like

that the treatment France showed antagonist, depression know, trial was an the more trial in context treatment depressive of you has those major much fact, and perhaps the bipolar both disorder. And, depressive ketamine effective to note bipolar in depression. the closely with published follow that actually literature major most who NMDA will extensive And susceptible for suicidal of disorder depression, of that

considerable published So being our pipeline there interest if you literature. the demonstrated in is follow

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

Thank you, being us. your Ed, appreciate We with

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

And received. to is couple we for it also preparing would NRX We Andrea. potential submission you, is to a team, have and this and the questions NDA study XXXX? that of management our Phase go will Pharmaceuticals like address in X Thank question how

the we said are we've in by to year targeting a as end. suicidality with initiate Phase acute X call, bipolar planning Well, the

corresponding confirmed as on for be investigator, invested was Further was the commercial We've FDA. clinical trial. update we will in sites recently to clinicaltrials.gov. transfer working website principal we tech identified information our with have and our are file We several full developing manufacturing the have CRO, submitted processes, manufacturing completed

for as our So those the all we not are of prepare some we're any doing than means but things, Phase X. by

medicine? And then use we have healthcare gotten is The cost increasingly environment constrained. from you, feedback your additional the one payers investigational Thank question. Stephen. of What regarding have you

bipolar approved therapy the today's electroshock patients with only have In is reality, therapy. suicidal depression

suggests mitigation, analysis healthcare annual acceptance the A of payers regarding payer patients tragically more of ideation we such harmed formulary show often. incur interest. and that $XX,XXX $XX,XXX per go multiple support suicidal and behavior high-class The an patients of and of the oral payers no feedback are research with hospitalization patient experience strong medication less likely high than of for hospitalizations Our should we treating patients data received positive that experienced themselves all in costs, prescribers a such that a restrictions development. might marketplace be that and benefit to could too with up two the for can than therapy demonstrated indicated weeks costs for aware

actually last And Stephen. you, question. Thank one

have If you patent protection? matter other your do for been drug used of previously ingredients reasons, why have composition

its because cause newer a it in has So, we have important black its it's it field of drugs bipolar its D-cycloserine quite -- terrific. schizophrenia medical propensity think propensity bears class by warning, and to we to I got tuberculosis, nicely. is hallucinations. cayse but box of largely suicidal to and And to worldwide been to Lurasidone it have this we regard because used depression, so our been the with but part all composition replaced are with effects treat to that anti-infectives been treat has competitors glad has clears so drug, ideation. when question, used of Akathisia because of shared of I'm

D-cycloserine administered otherwise shown lurasidone, together, the be and classes one these Daniel block antagonist, the Our drugs caused the XXXX discovered XHTXa component XHTXs is between synergy by is to that would are unique drug. NMDA scientists, hallucinations antagonist, quoted of of as who the the when Professor as world's such most Javitt, such Co-Founder, NMDA to

component discovery the prior the Dan composition the had examiners would and this shown world Jevitt, that of be over been block drugs otherwise And to identified novel by caused it's NMDA synergy deemed patent is XHTXa seizure the by all to a now active to constitute by never matter.

you once for the the And conference Thank all you all quarter call. questions. thank this results third And XXXX concludes time And for again. we Pharmaceuticals that today, for everyone participating thank have you NRX again, participating. to is

Andrea, we're to close ready the call.

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