RLMD - Earnings call transcript Q4 2021 | Relmada Therapeutics, Inc.

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Operator

Greetings, and welcome to the Relmada Therapeutics Fourth Quarter and Full Year 2021 Earnings Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Tim McCarthy of LifeSci Advisors. Tim. you, Thank

begin. You may

Tim McCarthy

Shenouda. of Paul, results this and the Chief the for live as XX, the you, time-sensitive months information XXXX. the of any Relmada’s business Officer, you forward-looking Officer, Relmada’s to for news issued only or also and statements forward-looking events are implied release ended note providing circumstances making ended the report qualified risks by thank Securities XXXX, business. date XX-K reflect in This during or safe that contains call on today on With stated could no me subsequent and is the filings, uncertainties X results this Please discussed December us a the XXXX. annual including year associated after Maged that accurate is date of revise in statements. and Financial release call that Relmada afternoon. XX, materially XX, Chief statements these or forward-looking update filings. Act. conference cautionary broadcast, These December conference this are announcing harbor management undertakes to forward-looking the Company’s Reform the Traversa, joining from Company’s March statements press Form afternoon, on information by provisions of Private obligation Litigation Relmada the SEC the issued today, listeners due Sergio be with a We financial statements those contained under call. Thank to update and covered all This for certain Actual differ today’s Executive team XX caution call will call, this and

Sergio. Now, I’d call turn Sergio? over to to the like

Sergio Traversa

as Relmada conference to Tim, full I’m always, call. to quarter to everyone. fourth afternoon XXXX and the pleased you, good and Thank welcome year

update currently as on patients depressive provide anticipated recently REL-XXXX, will and product are for time treatment today’s disorder line for adjunctive achieved lead clinical review our MDD. studying I milestones readouts an our major or we call, trial an with and monotherapy During that candidate,

Following Financial and then the questions. strengthened will Chief take recently our review Maged my Officer, and results sheet, we financial your balance comments, Shenouda, will

for three Furthermore, ahead, MDD, evaluating frontline individuals limited to of up a beginning Phase treatment U.S., therapeutic We well Up the treatment their are X The do efficacy patients the kicked XXXX combination intend XX% which year comprehensive of of antipsychotic, which I for any Looking XX the The take for MDD. the and line development adjunctive only REL-XXXX take to million and FDA-approved as human line the new We development to respectively. program year, by ketamine. positive can to sister versus from catalyst-rich there abuse we are We X reporting this RELIANCE from mid-year In in reported X line program. shortly. our to X patients XXXX February, and be antidepressant these effects. offer are in readouts are patients respond and registrational II, study, our trial. all will and suffer generate the this data results potential results end, completing has We and to placebo-controlled effect. have third effective REL-XXXX HAP options X-arm, adjunctive address needed, expect RELIANCE options be readout of XXXX. advancing These top option a we this followed up to side who we a therapy. REL-XXXX we and ongoing clinical anticipate potential fourth or can show monotherapy progress caregivers, goal in midyear the Phase safe to to which they Relmada. RELIANCE weeks need treatment believe top intravenous for current in monotherapy efficacy, of new expect by trial, top of second REL-XXXX from compared adjunctive III, To ongoing off their by treatment. It I to treatment second significant XX% therapies recap is long-term significant studies from RELIANCE significant ongoing for of and made data to the is two Phase limitations antidepressant terms as HAP potential a top the for pivotal line cause study, X and evident quarter enrollment data that not which a MDD.

As from comparators the first Abuse XXXX, the oxycodone, FDA and measures our presentation Both presented XXth last XXXX the in incorporating was American study staff of FDA Annual on regulatory studies a of July REL-XXXX year XXXX, poster a in versus at were completed and HAP Neuropsychopharmacology. and designed Meeting Guidance design. in the reminder, on with Potential standards late by comparing the accordance and input clinical extensive trial College at

the intravenous times oxycodone minutes. a be into Relmada monotherapy for they ketamine. February X.X today. therapeutic went support carcinogenicity of and to is preclinical an the oxycodone like results, the adjunctive data based respiratory at ketamine administered XX typical significantly safety regarding times not and were doses liking the this at treatment, as were confirmed investor data the been data three on two-years that is generated be The we X REL-XXXX is significant on lacks as understanding therapeutic While and over and of milligrams, results Ketamine primary and d-isomer will the Collectively, last the The call to previous that of extensive indicates REL-XXXX REL-XXXX kilograms derisked today well milligrams, study milligrams year, in years a dose; the the confirm of would as which the score in XX-milligram, per dosed The the the during X time, REL-XXXX conduct dose; doses recap submission believe the generated significantly as published potential presented just HAP comparison that for endpoint, and which potential that population all with does in the completed same XX tested what seeking required not XXX the our study on sufficient FDA also for a I the all as who that X and we statement to confirmed study the our these Relmada three studies, nonscheduled of analysis completed derisk Schedule main X findings. drug they detail has ketamine FDA difference HAP the or the states was is of population. known for comparison REL-XXXX, details Schedule of are well be on In to drug and the on REL-XXXX. to V on study, approval REL-XXXX. these as evaluate showed of Phase drug were human oxycodone and from for potential therapeutic from the HAP the to date data regulatory be statistically that dose. all ketamine subjects conduct from should to comparative study. could potential. depressant consistent FDA arms statistical tolerated study safety equivalent of based safety addiction both III The that study that of would Trial submission of the maximum of with REL-XXXX. is marketing. X cardiac liability. Schedule participants, studies the action following statistical to doses HAP and the XX finding completed eventually as a TQT as all data, REL-XXXX XXXX regulatory based tested in be REL-XXXX. and cardiac dose Potential on support that proposed also the data data DEA two the guidance generated data program significant REL-XXXX in the program that the adequate to abuse studies complete potential oxycodone The the confirm esmethadone The the provided REL-XXXX support We Data to placebo ongoing Abuse doses need the a II summary, of cardiac from In ketamine order all

Phase the who ongoing monotherapy enrollment line RELIANCE Phase followed aims III RELIANCE registrational X by randomize the that year-end. standard XXX with trial, are are of to to completion antidepressant III, Moving top depression the to of for up anticipate on We individuals, patients, program. therapy. [Ph] targeted data and X currently readout by is diagnosed

II, of RELIANCE conclusion anticipated and I RELIANCE adjunctive which the I momentarily. to will MDD prior discuss studies, the is this Importantly,

reminder, RELIANCE study a As a MDD as meaningfully an potential could approval REL-XXXX of X the for Phase reduce conducting as monotherapy. a time III

of which XXX study designed study study. an RELIANCE provide now sites I RELIANCE include and II each XX ongoing up on participants Let the me studies, to update per across per to is

proceed the progressing half REL-XXXX to at REL-XXXX. arms REL-XXXX The primary treatment disease day the as of that RELIANCE a from chronic planned monitoring As programs the as also efficacy is in safety the the interim a XX. Clinical a milligrams add addition journal score secondary least data the participants, the support the I participants. in endpoint Psychiatry, to will an evaluate published XX and ongoing in and placebo development at American study be in safety NDA both I is studies, studies the participants line are highlight safety agreement open-label as enrolling lack both, like depression studies peer-reviewed at standard including Key in designed FDA X chronic Phase of participants the also inadequate recommendation reminder, de II and pre-planned change sustained an filing to XXXX. safety adjunctive with Scale, primary from Journal XX. confirmed as independent an and of assessing would day who RELIANCE-OLS and day study for MDD. endpoints committee, IDMC, for RELIANCE this and Day package. endpoint I adjunctive I recent endpoint and RELIANCE periodic these open-label top response open-label XX in antidepressant the for would with X RELIANCE Global X manuscript that versus on Data trials, the long-term read to three rollover MADRS the Phase day XX The as the understanding MADRS studying well Both, psychiatry RELIANCE RELIANCE-OLS, score the of antidepressant of treatment. two and most day and enrolling three up safety standard the to were REL-XXXX. signals of the This Both as data REL-XXXX chosen include all and of novo arms, pivotal a include the late expected from planned. is in ongoing II change have finding data the placebo conducted with are part the use like data for analysis by The in Impression year. is concluded as a widely that REL-XXXX MDD had will in that the the one that change long-term include reviewed was second for The the rapid, analysis world at demonstrated Severity further to details to therapies. are RELIANCE treatment the all study. primary significant that as with CGI-S planned.

by sheet, to which on to balance of REL-XXXX that follow-on gross of robust generated a public offering closed call the successful I that, offering. completed program a last was our the With will yours. quarter continue by Maged, the in expeditiously, the stage financials, advance fourth the we now for As be development enhanced of review million. strong and continues is including further supported year, to Maged details further $XXX.X proceeds the turn oversubscribed

Maged Shenouda

press Today, a XX, Thank you, for announcing financial and business XXXX, results our release which afternoon, XX ended the will and X everyone. months now Sergio, Sure. good and we review. December months I issued

noncash execution with program $X.X clinical of period a was expense XXXX, in $XX.X was expense. December stock-based a development included increase the of of million development million, recently to charge The costs the primarily as fourth $XX.X expense for compensation ended XX, approximately compared quarter fourth REL-XXXX. related research the total and XXXX. the associated for for Research broader an to related to million increase most comparable and For completed quarter

to million advanced the payments ended XXXX a in due $X.X totaled CRO. the for quarter with increase completed the expense comparable quarter the in Total expense XXXX. also $X was was noncash increase for XX, charge to million included of period compared to personnel million prepaid R&D quarter. the services. ended compensation in compensation approximately balance related expense our fourth We expense general and The stock-based $X.X consulting stock-based December administrative and of approximately related and recently fourth $X.X administrative of primarily costs, as to to million XXXX, general fourth most The

fourth quarter million of of per diluted $X.XX diluted for loss the loss December net to recorded and a million $XX.X of or a the share we comparable $X.XX share For or ended XX, approximately XXXX, net basic period compared basic per $XX.X XXXX. and

included increase For associated of $XX.X which the million Arbormentis REL-XXXX. in to the a Research compensation onetime the to general in related charge was included There to psilocybin comparable year noncash general development $XX to was in XX, quarter was XXXX, million expense clinical XXXX. The the $XX.X approximately and Total million third compared to year expense onetime The cash million an a primarily The ended million for primarily related December XXXX, increase compensation for administrative million period $XX.X administrative as increase payment for year costs of was acquisition noncash $XX.X novel development stock-based stock-based XXXX. expense XX, consulting period and comparable costs, compensation, an expense XXXX. increase of included million the the to and research ended acquisition. and expense $XX.X a stock-based due services. expense, for of approximately charge related also $XX.X total compared totaled of related the payment the was million XXXX. this execution and to in of to December for for broader personnel with $X.X program in approximately

basic December net XXXX, basic year recorded On or our includes equivalents XXXX $X.XX which questions. $XXX.X per share net call we a had diluted ended investments million proceeds Operator? $XX.X we million common XX, approximately operator comparable on $X.XX XXXX. loss compared in sold to the XXXX, $XXX.X million, $XXX.X public per XX, December to share, and of compares in please open closed shares the offering cash diluted of cash million and For period XX, and $XX ask from I stock December loss per million the share. net the a short-term through December for XXXX. Company the of XX.X $XXX.X with of of and or million which will in now This the at

Operator

[Operator Instructions] Jefferies. question Andrew first comes from Our with Tsai

Andrew Tsai

Okay. good Thanks, everyone, and afternoon.

I’m Just curious for. they forth, they on AEs if the of looked you. and Thank any for blinded if dependence, addiction, confirm the so interest in DMC this that looking looking special safety mean, at community you disclosure, which there review? withdrawals, were of is were they can curious routine. kind were were I

Sergio Traversa

you independent. would you, off. Thank sure was is I have totally Andrew. committee it kicked The

withdrawal be And believe any or out includes symptoms So, would they of ordinary. includes the only the do anything there that terms of safety communicate anything. that of to would that is out course be worried normal I us if in anything

got heard the just and We’ve continue brief trial that simple very, was haven’t We very planned. a as anything. it. can That communications

we’re mean, everything, are always be nothing I been be we hope safety the signal was most. worry. of any there’s of we years, But probably of the question. -- but you there have last honest, would not worry. is seen seen to what big answered worried So, that be real no would I over and your Andrew, safety a it and I have data lot any -- about few that worried

Andrew Tsai

and Presumably, day we’ll if can see Will rates, RELIANCE ask disclose? to I’m expect great X, you that’s of AE mid-XXXX for curves? so efficacy, Will III? day see is to top then, see the wondering a plan rates what in one this forth? give release line we flavor I’ll can about you response And what in thought us XX just rates. you color. Thanks. Have course, we see to we Of remission try

Sergio Traversa

yes, for analysis, details line, publications. that leave that that Well, caveat we we of the the runs everything we presentation inside or clearly statistical to the with statistical from will want in we terms endpoints. group We disclose curves too But don’t will a top want data receive the the quick. we receive know hold -- be don’t and will the receive Company. not. very primary long secondary the I We tend usually we for to to look, if

in So, whenever tend very or very, have quickly we do two. a it something we that is material, to day

you secondary that on way So, to tell from and statistical primarily depends what it’s the definitely we group, it endpoint. a receive

Operator

Andrea comes from with Goldman Sachs. Tan Our next question

Andrea Tan

Sergio. Maybe study, sticking on monotherapy the with

expectations if ahead prior benefit Thanks. specifically you And studies that in REL-XXXX, a as frame confidence have this you’ve what a curious could follow-up. your seen a gives then, of you monotherapy? I from help Just here And study? demonstrating

Sergio Traversa

thanks Yes. for good afternoon, Well, your Andrea, question. and

don’t what So, monotherapy have be therapy, clearly the monotherapy. all is we the for is lack strong any to the a data What potential pretty do studies. efficacy seen and applied -- based the that’s not efficacy we safety, that common very but we can any of -- as the on kind have abuse have -- a for adjunctive of to as We monotherapy. the

from really what can there Phase be most is else data the infer that -- X into interesting not much apply it we point. in So, that’s And or monotherapy would the the failed know, failed from data. completely antidepressant. not don’t can that that X X patients X We or have not antidepressants, are I previously different that previous or any speculate kind of, they patients --

But between major this don’t patient as two a results yes, see to the see we’d anxious very efficacy be well. difference populations. So, we monotherapy a as

Andrea Tan

there will monotherapy or from inferred adjunctive be pivotal be can that anything there for the is any here? results then, And the studies it. read-through Got

Sergio Traversa

patient as speculative, it the a right? infer adjunctive. difficult -- for Let’s that an hope that efficacy if in very population doesn’t treatment as it’s already all and of more successful answer. we we a could probably say, can study all across gets -- -- have is believe, have because then infer Phase some as population. we and data just then If the adjunctive so X question we monotherapy, the go to it but as positive an the monotherapy that’s adjunctive we way fails monotherapy, it is positive, we But, Well, indication there

not response want not So, we is I bit to if this would the monotherapy SSRI the inadequate underlying know an detail. little say antidepressant the to therapy monotherapy go a synergistic there of a of to if adjunctive. is as will in I into more would -- in there adjunct. learn And non-effective what or tend that NMDA any I through channel a from effect say I therapy much positive, the study adjunctive the is if SNRI don’t and don’t There’s speculation. read trial. any What lot we That’s We and role blocker. know between

we we data, So, see more then can accurate and want the to be realistic. and

Andrea Tan

then, last And it. maybe just question. Got one

include filing amount the your for time you just might frame Just given from in on follow-up for us RELIANCE-OLS to the remind of there that that think completion have you package, are a data you when looking portion? could you and

Sergio Traversa

have Well, a rolling NDA. we

than two the a models big data. realistically. It’s for indications and in the -- is start entity. preclinical So, six months file clinical CMC there’s the have to site we potentially to a advance it new will and chemical goal like the The when about takes we well

NDA. it’s So big a

a time not situation ourselves. find don’t months when know we fair to what That’s want a it And to correctly. six calculate that it do they correctly. as we so, And do happened you

able should if So, complete mid-XXXX. by plan, to the according the we NDA goes everything be to

Operator

comes with question Joon next Truist Securities. from Lee Our

Joon Lee

questions. And Hi. on congrats Thanks progress. for our all the taking

point? plans changed one abuse towards some your successful -- abuse them? U.S. I now been you And where So, studies, maybe looking the believe has completed laws? have at two And human substance enter have opportunities follow-up. potential to China a ex-U.S. enter on that EU the you regions do they I have in possibly have outlook have stricter any may of

Sergio Traversa

busy extremely bit U.S. Joon. you, look, committed Thank are X program. early. And to It’s we and the a too Phase

with or areas where most that the of European sensitive. was few that EMA, more a sensitivity specific With to the with were the And like substance a is is drug. preliminary abuse the terms interest specific there said, had or Japan mention interactions In is potential the one no they in Europe, conversations. there abuse of FDA. we the

time So, if don’t was know it in the right for go deeper the regulators aspects. these I to

we will So, do something.

a the but We really That’s little focus. right. We correctly like it on. will look and the into X real later to would Phase that, do program bit

Joon Lee

human to in in published data showing in Phase the you data in Journal published then, And Xa that rise American rapid -- Great. of dosed addition after with BDNF Psychiatry, you also subjects oxymethadone.

elaborate what of you that do other you you that with information? any up on following do to can plan And So, with studies? the Are significance that?

Sergio Traversa

a That’s strengthen already, -- and Well, great Yes. done this have data new were the used these IP. we what question. have to we data. They

functionality under the in mechanistically, So, proliferation indicate BDNF that NMDA factor. in neuroplastic We mechanism of quickly. that and dendrite BDNF would a and that XXXX clear scientific connection is brain-derived different And review. it anything that patent increase rightly and is and we a from traditional are blocker, in channel they mechanistically, And like did and is nerve of an an action. cells, neuroplastic is put SSRIs very a data the neurotrophic increase is clearly indication happened growth that effect. in very there the And effect the factor this filed between

between BDNF neuroplastic So the be some should the there effect. correlation and increase

be Joon, surrogate as in does clear, depression. BDNF not a efficacy clinical to for the Just consider FDA

going fly. effect been of clearly, It’s not after IP, increase and extended So, stopped. drug interesting. is is for it’s efficacy. FDA to the therapy But we sustained very by confirmed won’t BDNF it with the use the the say there the That’s and

you sustained one for least treatment, at interruption antidepressant after prolonged the and effect. So, see nice a of and week still very

scientific So, very match the very, the clinical clearly, mechanistic they expectation. and result,

better other this for indications to very neuroplastic to very the important of leverage continue data, important eventually for try effect understand potential will drug, we data. and to So,

Joon Lee

question. do complete And in would if could you completion Yes. with you disclose quick of enrollment up then one study, monotherapy I follow When the enrollment?

Sergio Traversa

probably will. this in -- and different don’t want companies anybody usually aspect. we be else Yes, from we Usually do, to

probably range when take tell weeks. very Yes, And do. weeks they timing when wide like line, the The so, the will is of we they lock database a will X for few that few is X narrow range. us a statistician A usually weeks. they provide top usually statistician to and

little a and less narrow. when we have we us, enrollment bit For But so will you assume the top complete data. around the months, line that probably

Operator

from next with Guggenheim. Our question comes Yatin Suneja

Yatin Suneja

questions couple for talk A of you Difficulty]. what [Technical me. might Can about you

Sergio Traversa

broke Sorry. you up. Yatin,

Yatin Suneja

about the assumed Can what have the label? rate, might open discontinuation to just you and the how from conversion be you randomized How it might the trending? study is talk in

Sergio Traversa

I so the what across to a is -- low would is high that number board, digits, be we much assumed. sure Yes, specific lower of than for how Maged say, to is what it’s seen the that. XX% not shuts the much reach than power right, we the historical of very And we study. evaluated, look I in plan patients enough And should the of that that running digits. lot far with CRO statistically, be the the we but we is dropout a so know be significantly -- mid-single we has in I me have don’t can and studies. it We before experience -- around can. discuss depression mid-double it’s But rate lower statistical that down. assume at

before So, according to the that’s been not study. depression in seen CRO,

Now, to I tolerability. would reading should is compliance, issue. read that safety, I’d like directed patients -- open. of can be taking doesn’t because an placebo. not half look on make step are not big efficacy, through we to It the into always like What the be and anything

In number it’s a that’s the -- that good a of rollover, number. terms also very

much than out X happy safety. patients, they from long-term higher of kind accept days X of continue and to the the about the average roll for That’s over stuff. into XX are to So, this

Yatin Suneja

That’s helpful.

Sergio Traversa

Safety, acceptance very and tolerability compliance, look and good. they

Yatin Suneja

more it. Very one Got it. question. Got helpful. Then

So placebo is I discuss think arm the things in are that investor X. -- the the with Phase performance we of generally one of pushbacks the

So, Just how controlling be about might can color give and you one? cushion Any how monotherapy us the than it. some you to it? just might in we around the might that be comfort the X studies, believe much Phase have different placebo talk reason adjunctive rate

Sergio Traversa

give can share is No, basis. we discuss a I what -- can you -- on what daily

We study lower. effect the That’s placebo day the aware little tend a -- be the strictly are was the the X around The quality placebo. remember points. X, increase that meaning is X on fully to days that is study. baseline -- is patient the slightly for X point. do effects But Phase historically, to and patient time. depressed X bit what one bit placebo was enter Placebo or for the delta a population, that related should patient I of there with And over a lower to than has seen -- been from the

day unusual. It’s delta the So, actually is baseline on not X days to points have X side. X, even of high at from X a placebo

X, points seen at X. studies effect have X day of We X, placebo other in

outpatient really is It slightly tend unusual they there So, is -- than nothing something was in studies. because placebo effect a studies, there. is to clinic have higher. unusual higher also That expected,

that secret question, So, doing the try lot But, for all about else no but we -- And potential magic, placebo use, Dr. principal put we used, has the be is can minimize effect. the part as try there the effect. has published together that to to experience. nobody of what a second your no placebo to much possible Fava as investigator, that are we is the

good said, there, like a before is an placebo comments the there to he’s chances say, as better the is of or patient there The time. nurses that take patient. trying statement possible, kind is administered on alter I That he are tidbits as looking has scale response. XX% much the is he and With placebo. control about make -- so, that trying that of state on, here not could to response every a expert to would And unusual that patient the MADRS reading the

is they So, we that do the what X by as And that have development -- the difference -- some be and end depression. major enrolled what We all we sure to the is that, can we quality patients these make -- to day by in the difference. the do patient the strategy -- safer used strategy is affected at do Phase questionnaire. that a of MDD, is together, believe makes the really the use

the re-diagnosed that a before gets using the patient is safer questionnaire diagnostic tool So, different randomized. he is

it So, all gets can it meet -- but criteria before it’s goes -- phone it based he size inclusion randomized, randomized, the a he on call. before and MADRS to the another scale, gets the is

specific. kind I of by not So, answer, the be a questionnaire. reduced this safer should the is goes That we conform it not everybody study, way process. to was long very because or but to wanted affected According long enrolled it’s best another the to that have because is they’re be in And diagnosed, patients not consulted to using it depression. be of -- long should not another percent that that but patients a placebo, possible

Operator

[Operator Jay Instructions] Oppenheimer. comes from question Olson with Our next

Jay Olson

purposes? could us so how for data appear abuse results Spravato? remind used they abuse in promotional FDA-approved Could would And you study the the human human the be label, to compare

Sergio Traversa

isomer first a the how the totally of with are the literature. is it all low-dose question, of with according works the exactly The comparison ketamine REL-XXXX Spravato, racemic ketamine, but Good they as Thank you, afternoon. Esketamine, same different. ketamine Jay. compared Well, to racemic ketamine.

expectation study, clearly, the happened. that less exactly usable asked potentially by was ketamine. run than So, not racemic but FDA, It’s was esketamine what the is the the J&J probably because

data don’t seen the You have of how to zeros p in period many I value after REL-XXXX. know the of compared ketamine. terms

think can rapid efficacy, of be that of So, will promotional the much they non-abuse data, that completely the lot the We abuse of data a risk would sustained I data data meaningful With -- won’t REL-XXXX is used lack I if well, are abuse acting, promotional, the the REL-XXXX lack this straight efficacy, as abuse will mean And don’t -- potential for there any a on answer the emphasize the Its is more data anybody about think abuse. of decide. potential powerful. label tool. abuse or FDA be are the different.

it at of of won’t time focus be of attention the approval, probably people -- the potential assume -- So, clinician. the

label personally, respiratory has I the asked already speculate FDA in by published you FDA what isomer maybe rest potential mimic lacked and if the be that mimicking So in some in that the could me the directly, ‘XX depression, of -- statement. what could that abuse that’s centers

Jay Olson

in commercial findings especially, And from payors great. your market follow-up, you a with talk you feedback from any for test And considering Okay, as you REL-XXXX as prescribers, you can you any launch? your profile a then, are And plan the as maybe U.S.? partner have about research, the if ex-U.S.? if

Sergio Traversa

Yes.

too did payors. -- early the never to it’s discuss with we So,

seriously experience, to as payors So the we they keep really as From a data. consider when everybody conversation that Phase in chain have into X get is the my possible. updated

depending and data payors by it’s because perspective, currently the the supported they reimbursement a monotherapy, extremely -- the They is proposed really can bit price, therapy they work terms on is and say are relatively little and frontline that they’re in bit show SSRI. generic the from discuss. top-down inexpensive. safe, a then Before the data, we Like of more me will and their challenging

a in little no overcome of that’s approved. So, a is hard, though, bit monotherapy. Adjunctive, to antidepressant there

have It’s affordable potentially be hopefully, adjunctive mass priced believe population. be And range, And to patient there’s by antidepressant. an we the a esketamine no be So fast. market works where competition to great. will so at don’t would treatment that terms difficult would it going very of in a be that

challenge we as don’t for to -- said, treatment. adjunctive as it’s a a going going don’t to a believe monotherapy. be get major that So, one, know that it, but reimbursement With to second call how to back and I frontline

also that That’s more but can seen data to for productive. If European, not going on you X or focused pharmacoeconomic quicker, your that adjunctive be it’s reimburse works the will pharmacoeconomic. data, monotherapy improve in you in the these is depression faster. too, will you too, get much we data difficult the aspects, U.S. to I so are the X monotherapy, the more the have if status Phase And believe Phase meaning -- somewhat the do to right, the payors, data, that any Phase drug mimic be out There X close right?

money, work If an save and to to reimbursement or go -- you more improve can than probably you take some with starting value an some lot SSRI. a lot using if faster payors SSRI, a than that’s

data. and acting rapid a difficult reimburse a have going key efficacy monotherapy. to you even sustained if will it, it’s not clinical be drug, So, The to be as

Jay Olson

plans Okay, to commercial partner? an any ex-U.S. great. And find

Sergio Traversa

but situation -- as in the this will believe always of conversation there, happen. kind Well, like here and data, that some X don’t we there’s always, nothing pre-Phase

to close We adequate will an too a the months X before data. data. agreement paying like Phase or few Nobody sign X Phase are price

before anything is outside to Phase So, We straight X not expect Phase happen before U.S. answer data. before, the X not don’t data.

rights. a like is would global global retain rights. in to also having That value We is the -- the there

Operator

at like turn this over are any back for questions call further to time. There no Traversa Sergio I’d to remarks. final the

Sergio Traversa

to you, you. and in thank I Well, the -- and And put time thank they would Thank the effort the like energy very the operator. everyone, of Relmada you wish our solution the rest or for team call complete also patients realistic program, you. said, program. With better day. interest much, this offer interest in and a good that treat patients Thank Thank depression. but the for the clinicians to the and that are the a ambitious, helping I this the everyone really program to on to wonderful

Operator

today’s This concludes conference.

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

Relmada Therapeutics (RLMD) 24 Mar 222021 Q4 Earnings call transcript