RLMD - Earnings call transcript Q1 2022 | Relmada Therapeutics, Inc.

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Operator

Ladies and gentlemen, thank you for standing by. And welcome to the Relmada Therapeutics, Inc.

First Quarter 2022 Earnings Call.

During the presentation all participants will be in listen-only mode. Afterwards, we will conduct a question-and-answer session. reminder, is a May recorded, As XXXX. X, Instructions] this being conference Thursday, [Operator like the to Tim now would I turn Advisors. McCarthy, conference LifeSci to over Please go ahead.

Tim McCarthy

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

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

Sergio Traversa

call. afternoon you to am first Good pleased always. as Tim conference everyone to I welcome Relmada the XXXX to you, Thank and quarter

call, for as and our with our today’s treatment developing disorder REL-XXXX. or give clinical are will we MDD. review currently adjunctive you trial for that achieved patients readouts timeline associated recently I candidate and an milestones During That is with major the product lead monotherapy multiple expected anticipated depressive

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

catalyst-rich trial. ongoing REL-XXXX readouts many to As you XXXX year X know, intend data of to a RELIANCE Relmada. Phase clinical we the for mid-year generate We expect be for beginning

anticipated we II, trial, monotherapy midyear data enrollment III, RELIANCE XXXX by I respectively. timelines RELIANCE the guidance. topline unchanged anticipated followed These and from ongoing RELIANCE of from prior remain Specifically topline completing the registrational followed by X and results readout Phase by

REL-XXXX abuse topline XX is this To RELIANCE development loading in a participants Phase I which significant monotherapy of RELIANCE that X, a human sister adjunctive pivotal and one intravenous XXXX, three reminder, end potential the or XX day the REL-XXXX study, trials MDD. X-arm, two February take as potential our problem. in Phase are placebo-controlled evaluating versus progress a ongoing treatment second of All As milligram on we dose advancing catheters. placebo-controlled tablets as evaluating studies milligrams from for in ongoing X We made RELIANCE REL-XXXX. potential II is reported our RELIANCE HAP treatment study compared the REL-XXXX MDD. III registrational two-arm milligram for data XX

states ketamine comparison potential depressant oxycodone significant comparative Schedule the II that d-isomer significantly derisk that on data drug successfully July versus oxycodone REL-XXXX significantly the for that studies comparing esmethadone Schedule statement XXXX consistent that XXXX. lacks were the believe the study data HAPs Most was derisked the HAP the that respiratory first liability. completed We addiction these from III importantly, confirm findings REL-XXXX Our in two action candidates and and DEA potential. and

that have as growing a experience. Scheduled potentially As be previously, indicates our we drug years initially could generated or of non-Scheduled believe said with REL-XXXX a one we today IV that drug the proposed to two year program development data eventually following marketing from

Moving on current Phase the to status X the of program.

monotherapy. to have We midyear. completion III, antidepressant time and who been for X have have study monotherapy standard XXX days. RELIANCE followed treatment study and eligible an REL-XXXX. major to milligram enrollment diagnosed tried with be RELIANCE the as current in their randomize XX as MDD episode topline at one by Patients depression a the for and may continue III placebo off the previously in Conducting The are XX arms, X for least reduce two ongoing could to REL-XXXX no not anticipate study includes of depressive readout aims RELIANCE data be antidepressant. standard taking of potential III Phase trial, of more the Phase the by approval to registrational meaningful up to than currently the patients a

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value most He years. currently oral serves and as retired multiple of advances that recently and successful He presentation creation value strategic U.S. REL-XXXX with were has skills. development Corporate pharmaceutical He’s different private Business broad chain. the and from International a am appointed on month Strategic investment He continue a companies. a in executive P&L network Compounds I and As Operations at we report a Conference Related and track is Gino that public of Gino highlight a very this banking of also private Lilly member two demonstrated pharmaceutical experience executive, to SVP biotech, continents the expand Work Development. former Corporate see role. and Santini both last three strong operational poster in to to our program Eli as REL-XXXX we December biopharmaceutical today and in the global senior data after pleased Ketamine President one in record Hybrid To Lilly, of equity team. has in XXXX. industry would of XXXX biopharmaceutical companies. end, Development XX Boards veteran I Strategy Advisor. areas like of in the presentation various global that & Gino presented team career he

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all XXXX Lifesaver over a local the sponsored occasion a Maged, now advancing Awareness is health, Maged I May for so that, initiatives that so hosted is that be Annual increased passionate like Foundation the are the we around I yours? our the would is at visibility by which our sponsoring that participating the XXrd by members as participating Suicide we to including National Month, mission this Illness. to in Finally, why Several -- With will are will financial. number about the for on review Prevention. Mental works mark stage reminder team of Mental Alliance highlight turn are Gala a To core Relmada. why we call American us Health of of mental for and serves the month,

Maged Shenouda

will months for business we review. now you, release three announcing Today Thank I our Sergio. ended XX, issued results press which March a and XXXX, financial the

quarter administrative The totaled ended period first compared first the quarter million, XXXX. the increase for the to R&D was the program quarter completed for $XX.X to March XX, expense million. million million. compensation. to and of was charge ended development for $XX to $X.X associated $X.X was an quarter. stock-based million most of $XX expense execution expense comparable the to was for the increase a million, amounted period general approximately $XX.X For of $X.X Total This due the The with as million XXXX, increase research REL-XXXX. approximately broader an first total as the XXXX, in clinical related increase primarily XX, XXXX first non-cash comparable XXXX for primarily costs compared Non-cash in recently in and increase approximately March of

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

and now XX, cash, equivalents million and of Operator of I to XXXX, will cash $XXX.X short-term $XXX.X cash call cash, As compared we million, open questions. XXXX. December investments of the at the to Operator? XX, for approximately March ask equivalents investments short-term add please

Operator

Thank question. the line with Jefferies. Our first Instructions] with Tsai [Operator proceed you. Please comes Andrew of Certainly. question the from

Andrew Tsai

for Thanks my everyone. taking Hi, questions.

X The Phase the coming the kinetics adjunct the first It out. monotherapy question of on to is applies data also study. actually

curves okay, the look of esmethadone particular, from foresee So I or seven day in like, kind no or you to my is, XX. guess as question some in expecting efficacy placebo rebound Should how actually, do day of view? as terms your Thanks. well for be we the rebound

Sergio Traversa

Well, thanks, Sergio. It’s Andrew.

Let not work on long-term. me short-term, course, this have especially NMDA the Well, we from channel. any have and But monotherapy, treatment strong experienced, we we don’t data of other not adjunctive so compounds take data don’t one. have have very we also data, we data, have that

term neuroplastic any just time. do based and on don’t effect, what efficacy just we drug and compounds, that and from we efficacy the should mechanism longer over Phase on do believe on based So improve. experience really It’s have we the from loss the then believe other expect is of what seen similar based if the X we of

expect of loss day efficacy seven. any after we So don’t

expect be stable, hopefully, than better day We to seven.

Andrew Tsai

Right.

conceptually, COVID it’s guys think do Okay. you high Very And open this of what question, ended Phase more maybe good. study positive more just, a is to have their maximize you for done guess, I level secondly, X success? be companies inclusion the placebo anything with differently about even the you programs, drug the What or doing something protocols, maybe in than great. effect? response color or Any are depression other criteria would a

Sergio Traversa

is we X, drug that it Well, about seen detail drug, time safe, have efficacy. too down, has making take Phase confirm what statement we effects have what to tolerated, But, done drug it do the go more This without some strong many is to in the we one Phase done. but of Andrew. strong believe is the in the well data. based will -- possible have it the it think to on make a works, to without thanks, everything we also very X, But top

but what why we especially every so in the program. everybody’s And the reason that any in the in placebo trial, is afraid don’t the risks the same are drug not should see potential effect. Phase effect depression potential? confirm Right What X trials,

a to placebo is have the clinical to the possible trying same to we that CTNI, -- selection, time, raters what on making control by get experience publicity to but train the the I company the administered that So been called with actually like site for selection, company studies, in is site that safer not depression, interview anybody, am means, it any patient. effect, the do train rater is they the the raters. focusing At everything is

is the the from at patient taking the looking so showing the affected every that state support, read reduces [ph] madness and placebo the that that be that patient day, patient, say, the that depression not patients that the profile And there’s sites, he a the the has the reading by -- free tablet, video patient, chances the safer exclude statement, to XX% like, to sure be support drug, a selection little interview patient the that are sorry, raters, of should every is patients interview on that taking that is the half compliance upon that the the placebo would like video, uploaded the is that effect. to

is patient, control strategy magic there of we there compliance the believe can support, hope to guarantee that the quality no should again… no do placebo is done right, and we the far results. so, I good support And right, have magic, that effect. the so But all

Andrew Tsai

Okay.

Sergio Traversa

bit to but more answered. answer, I answer I long I The detail. in hope little wanted

Andrew Tsai

Yeah.

Right. think. I

you question to of addition kind is, Yeah. on important. before if you the rates discontinuation a I in last think and monitoring rates, for then have very basis. wish And blended disclosed rollover it’s

basis? confirm or no committee opiate total madness seeing don’t still Thanks. And let’s you dissociative blended Now, of at DMC I be looking to Are the else also a clear. changes. know, are you anything then on signs is effects? able

Sergio Traversa

DMC first is saving last meeting this are the plan. I second to continue Yes. of question. and Yes. answer the The DMC It the Yes. from not, easier. is they

We have yes, the were problem. if effect severe change side -- suggest anything that the not The would any in heard anything yes. about different any or answer is, there to And the in of have will there risks would mean is any anything if symptoms that withdrawal that patient, That we something not. would pose study. for also change then unusual the is

any the review, we was there sign this well. assume yeah, from no of So, that

Andrew Tsai

Okay.

Sergio Traversa

I have remind first And the a short… the lost I -- me because question little a bit.

Andrew Tsai

are seeing yeah, anything, you If right.

else If a on you seeing anything basis, blinded basically… are

Sergio Traversa

no useful I or trying are it. assume am side that we not we that effects, to safety placebo look, blinded assume and -- not avoid side No, there any no, effects, the data, they of any for give is does nothing. severe are severe if seeing sign you extremely

assumption fair the well it’s that drug safe is So and tolerated.

is It’s Until would effect, working. everything zero would nothing will a at be to assume to look placebo the be there the On draw right, it what and you right, highly If if efficacy, Probably, that does. any blinded make statements. risky data is we conclusion. zero, see impossible know you any to right?

So drug right? don’t that’s work, Yeah, can not tell, believe… We the okay. you would all

Andrew Tsai

indication effect. … not we that’s But zero will of final any see a an result.

a have patient, we to So yeah. be little

Andrew Tsai

Understood. Very thank for and my good. crossed taking question. Fingers you

Sergio Traversa

Please join me as always.

Operator

Our proceed next the the from of Please with question. Tan comes with Goldman Andrea question line Sachs.

Andrea Tan

you. maybe everyone. Sergio, for Hey, taking Thanks two for just question. my

a additional supplementary monotherapy need think of speak we your data do you and submit run opportunity? little or could prompt to filing bit estimates Just positive III, you thereafter? size do from label curious inclusion envision of study a you the REL-XXXX RELIANCE the if an would on on you could then more And

Sergio Traversa

Well, have for we be the and the market, question. call, to Thanks, and afternoon will on forward the you Hi. -- of precise on with moving Gino next probably as more well. good the Thanks Andrea, size the Board.

he role us give what size held the help of in are. different to the be us determining guidance opportunities really One the would of and

data. the There’s, adjunctive antipsychotic. competition related much difference, are and no the with in they and the drugs there it only is be is three antidepressant treatment, because there will all right, very monotherapy, clinical Now big well, approved,

is a be task antidepressant treatment, not the to and available the make if but market REL-XXXX easier, it bit an that only as favorable, exception, more Monotherapy, competition So there generic less so the adjunctive makes to definitely one left. and competition price is drug, would that little power because I that XX, only direct. more the is be going with the XX believe antidepressant that brand

because factor you hope one to side to few effective It that it tablet the a and is whatever after close a to rate Phase is have data overturned, competition. in we is be patients do in is we payers do any seen one a effect pretty and what data. works exempt have I morning very have XX% XX%, And take be effects. and size work to so we competition price in about show expect Price frontline drugs are difficult be anywhere of you month be X, will even the effective the least patients chance, of we days. traditional price clinical at If and they be the close responded. drug responded going chronically And good that take but to to not a you then If believe, it in monotherapy to an the believe antidepressant. Phase out go only critical, and data so six to against they antidepressant. efficacy XX that’s Response X XX% traditional that a a recommend we X.X as X about not Phase in will can from for was

the of the It end few and size important be more will be next factor. market clinical -- really will very toward the months. the So, data like will drive price

a what see frontline answered I I of hope we understanding put reversed. the with work therapy is your want more if have a it We closely it a they will and -- to better to make payers will REL-XXXX to is even question.

Andrea Tan

second FDA, based Perfect. an be somehow existing this use label on with the to Sergio of just have then adjunctive if additional conversations idea just part, into case? guess if an the could for or whether would grouped the off maybe initial you, study you there, and if need run I, you an

Sergio Traversa

X the Yeah. a line the data as fault two read indicator. Based compelling to X, with the not aggress will FDA will on plus was see a FDA, discount data kind right? any to be We of long-term with that run running second to that Phase monotherapy show the positive be an the don’t we doesn’t direct, And so this with We the positive, but, issue. be three the aspect, compelling. go the risk of with did with, could to we the safety And all. potential a if trial should adjunctive seem abuse be doesn’t have there the of in though drive, there Phase data instead at trial. trials will FDA for We -- why be reason again, is seen positive,

So make very a that would the powerful package for FDA.

way, won’t more to available. any think information we a assume we yes, that is then don’t have already if that three the Phase run everything successful, goes We see add we any what So, safety and we be will trial. won’t hope risk, and monotherapy the second think X we trial we

Andrea Tan

Great. Thanks, Sergio.

Sergio Traversa

Thanks, Andrea.

Operator

Partners. question proceed our Please your Yatin the And with Suneja with line from question. Instructions] next [Operator Guggenheim comes of

Yatin Suneja

Hey, quick you taking a ones. question. I my for couple guys. have Thank very

is you over the just seen are you be your the that’s rate outpatient in what four-week that about that data? given expectations So modeling because now first And far, versus this have two-week timeframe, inpatient the study, can we so you placebo is, conducted? talk one how question. the might First just your

Sergio Traversa

Sure.

have Let in from the topic ask the been then one critical -- you -- The thought effect, and second every the a me been give one. line is really placebo that about answer that first has and angle. you can we right, different it

we that about Let model. the statistical numbers thought me into give putting you the

So they have higher placebo effect. in-patient treatment, in clinic to a tend

with running our advantage an the X side, the is trial, was program. are treatment. So seven there other way outpatient an doing the RELIANCE At in days we Phase

seven So a increase a placebo for over days. was of for taking tend variety time gradual Placebo reasons. to have

correctly, believe right? I placebo So these I seven that X days, high look did do after we the balance a effect placebo points was, If you response. factors in at that’s believe, themselves, X Phase pretty two if remember

We other that have trials X, seen in number go X. a X, from

lower they to So tend in be setting. the outpatient

played was a weeks. for assumption, role placebo in with in-patient the a then than we higher So In now trial effect outpatient. have four the the in that

in the statistical number the plan the XX that think points. we will I placebo assume be

from highly should points, then be the will has XX below X, for if today would then will I term be like, from So the of use, delta very, trial and the day assumption Phase successful XX that XX points successful. a trial. with REL-XXXX Anything to what placebo be and XX also, very baseline way the placebo baseline be perform done kind delta very, behave but in will will

Yatin Suneja

Okay.

Sergio Traversa

these If above XX these, is the manageable. that -- see is baseline don’t XX any numbers. is haven’t it do the I If be it We of placebo XX, believe I depends, see problem. seen have trial a points, placebo performed successful. But I much. it still will from then it XX, don’t above still above XX, we

Yatin Suneja

Yeah.

Sergio Traversa

to If can for is it… successful. from assume will the XX to be placebo the day baseline below If look is that trial delta it number at. XX You highly key points that

Yatin Suneja

it. Got

Sergio Traversa

be above very slightly will still successful.

Yatin Suneja

are Got confirm Thank what then also, if dose specifically much. a you bit it. you requires pharmacology that loading Phase Then studies dose is just dose, And in three a and and the the you go X all XX XX can about you good. is patient using? receiving it. milligram that about dose Got talk it into can a a Very they are little very then maybe dose? if loading

Sergio Traversa

milligrams. for that is the yes. the I three safety day, have severe is starts first share new in industry long-term even I am well discontinuation dropout taking Yes. rate confirmed happy Sure. effect. that is loading depression a that study we All below answer three to Happy terms by for believe it That is dose. the do side with dose, also patients, tablets. of are trial. to XX do the that. the average It’s loading The of three taking And also tablets serious, nothing the that the seen studies

So it’s we well you below have pretty patients of XX% over that the so even day XX% seen And and low in rate long-term study. complete XX. dropout have the a

have the We study. now is very the rate patients drug dropout well in that long-term over are -- for low taking have the been months and six safety

XX So protein. highly long and is loading going The has REL-XXXX binded very to to hours. well half once-a-day is plasma a the dose, to between very It has natural That a is back XX been therapy. [inaudible] life. It’s accepted. simple. pharmacology the hours

implies that -- well high. It’s the is over So bioavailability very XX%.

a the So you -- absorption. five. very regular four, we the clean, molecule. Taking state the have loading will three. take two, no very The easy dose problem dose, And handle, steady shorten at state if small day the is to with very day is profile steady the

the to is only the state plasma the that’s loading there reason So dose, level. shorten of the steady

Yatin Suneja

expectation assuming? studies one any to you than is, or what you. helpful. blinded do the stage final just question below different question. Then upsize your to that from just an these Thank of came have And client. what opportunity data be a if are coming might Very it. This the Got either similar you

Sergio Traversa

The direct The XXX have well would up I good -- -- a answer. believe mean big it’s the to a question, and I patients, -- number. I it’s say That’s no. don’t I no.

drug probably you to That XXX best most the is not in it. done way then out Let with work something have If answer patients, definitely, the way. this we me -- answer the does wrong.

So would just that don’t any value. number see have that we beyond going

Yatin Suneja

Thank appreciated. well. you much. I Very so

Sergio Traversa

Thanks the question. for

Operator

next Please from Marc proceed comes line your of the SVB Goodman with our And Leerink. question question. with

Marc Goodman

is it let Yes. everybody. a gotten if I well figured and couple Sergio, us studies of way? studies. then but need there’s the next? do or Thank do? either question if answer question you What’s read-through One that two you. is understanding positive understand help as is What other for you positive so the them. to I is monotherapy to negative, with the monotherapy just I the FDA? do does the is what guess What have is the of it do of adjunctive might this study is what kind I adjunctive Second one of times negative, you positive mean your

Sergio Traversa

Thank you, question. Marc, the on

So still question positive and if positive, two are trials is the one if are well, are file. There doesn’t will and the we work, one first mono one J&J like three population adjunctive examples one is they was had or same with the and Spravato approved. got design -- the patient that positive, and was five the trials, failed, as not two trial

the not FDA trial in a -- take we lot p-value setting look. So, depend different, lot do a will believe ultimately, the of depression how on the If aspect that will will the consideration. like. X.XX, fails would with third data a is FDA It’s difference the -- it look it’s the enough this between is monotherapy critical and in but adjunctive therapy not not

good I data see a studies. don’t the how So the can question... failure a and failure, that not total zero, think with we is if the good just two are chance And is we happen, second it then have

Marc Goodman

the with about FDA and to discussion and filing if that? to adjunctive open were was one positive Sergio, mono point you all Well, a that of have a at they been Like has the have positive? spoken the you

Sergio Traversa

look them whatever they they few give until you won’t in FDA, look, my -- won’t have interaction have for full data. Well, No. with years tell I the seen the with last FDA, the or you anything seen what I the

of And time are go then of indicating kind will They usually NDA. so you the we discuss if will things at ahead never tell the like that. they and tell you you

that’s FDA, So but we very want They discussed on with data. We normal. data-driven. won’t real any have guidance not are They expect the the see that. to

second was? question the so And

Marc Goodman

Okay.

help into Like kind or understand second would is know study the walking us first does better The read-through if studies. negative, was positive last two us? what help the of we question what that

Sergio Traversa

Yes.

-- -- data the adjunctive therapy. we an on So as have

-- we based XXXX depression. So done and one results, confident on based comfortable have a good feel right, quality that’s we standard everything high be to on will Phase Phase show the for to III II that make

monotherapy if conducted thing. would that been be indicator appropriately. clearly Now at good successful, have It’s a least same trials is the the then

So they same the do problems. all for thing the exactly

would that So similar, I read be the monotherapy trial Phase could adjunctive the III -- through successful. successful the

Well, not very another if happens setting, Now the the adjunctive is is definitely, but positive the we there going do signal, it’s is in what to -- fails, question monotherapy what be drug. there then? can a also

So the potential difference, only don’t know. we

it now, there we will the work and an results we will itself see for of If then NMDA well, blocker, Then not have if it but there but mean you know. synergy, by that synergy doesn’t We a adjunctive. add is between channel soon, know don’t the seen. monotherapy the fails, for SSRI much any you success the is good

therapy hope gave could. There is well. conclusion with very way base monotherapy best you different success as there’s fails, I but fail channel So I I the is monotherapy a a signal, combination be a good successful, alone SSRI am adjunctive. non-satisfactory of good I clearly alone, for the of adjunctive I answer If biased, even little the NMDAR the effect not can the the blocker. give draw if you -- the a potential that if of role the will the summary the treatment would in then I sign could

Marc Goodman

you just you to us Thank a is can what spending you. sense Maged, can be year, going this whatever of give disclose?

Maged Shenouda

Sure.

Marc. defined to $XX quarter, $XX you a guidance, a haven’t given million but can target about We million

Operator

from line the Securities. Please of question. with Truist Our proceed Joon with next your comes question Lee

Unidentified Analyst

for Asim Good [ph] for is taking June. Thanks This on afternoon. the questions.

first you a my to I antidepressant guess in And have as I question in So for Do have plans strong saw question Phase follow-up Phase II. ongoing effects the that well. durability any after is, you durability III? assess of

Sergio Traversa

question. the Thanks for

Well, will For trial durability, XX, beyond mean you -- assume. I day open the becomes day label. XX, we after

numbers some MADRS have will measured, open we it label. So is score but

a like it nothing. general, mean And strong So would for very data. be FDA, the that in not would

have major of but be we label. anything. It’s yes, that like data, a indicator So will some open will not

not thing more data day The after FDA any XX. efficacy one on Sorry, does that. require

So they long-term as XX day effect, consider are chronic effect. very a happy. They

Unidentified Analyst

Okay.

in that keep will We mind.

was BD any from with have Phase hold on to studies? expect your all I once any off positive the a just data, until III Do that hopefully, partner have -- you you potential is you have about results of sort to So you ask first discussions plan Or going BD. midyear?

Sergio Traversa

it the potential a the may big potential we kind least licensed work can -- partners. good, won’t to us The we It’s work it’s help have we now data when If Yes. couple molecule a do and own you the after with decision. -- the diligence. Phase They the on he at in -- program want before we III. know III constant don’t be on have We as this does are you out they real can to happen well, after that think they -- Then what making due all imagine, doing. diligence, not that their But well already on very distraction. on but start They -- contact readout. the due of diligence to partner is takes is have days. they of -- due the that the the What will I Phase the a nothing a potential have done partner tell first be board Gino And competitive. And very that will is done. already data have want data. ready

months have We are talking it. And we about done process. two

So I any partners, serious a diligence process even we the think potential we -- like Phase postpone the due have least everything through bandwidth won’t with III -- now, if and go readout. right will capacity the so the at to after it’s first

Unidentified Analyst

Thank Okay. again. you,

Sergio Traversa

Thank you.

Operator

[Operator Instructions] your of the from comes Please Vamil proceed next with Securities. question question. Mizuho And with our Divan line

Vamil Divan

Hi. Great. for taking questions. Thanks my

coming of trying think the to I up. same most So data for here get on of this the theme questions, other ready just

patients the lot get screen you are couple I for the have. of put III a disclose of of you screened you of sort number to that here in any don’t sense or various seeing. you you Phase right have failure I trials have the that One, questions the rate disclosed So patients. I place know steps know a or if of can

not. I that’s just So curious. I And of been also or am sense trying then am successful to a get if

to powering don’t Phase As in have your drive you mentioned, monotherapy data assumptions. you the II kind of

sort you to talk it of the about done the for monotherapy are can So you have compares for what powering your assumptions specifically adjunctive how trial what trials? and

Sergio Traversa

extra in material is believe use effective with randomized, you failure again, on And the second the another depending use numbers, trial. is selecting try it SAFER and affected industry. rate, I depression different disposed the meaning have not we an line. XX% XX%. depending and patients these period more rate, -- are are not mentioned, yes, as -- SAFER depending on that to XX% That further as it’s is interview have the of It get -- they interview. the line diagnosis, we XX% possible. screening the SAFER, we but to as are The in -- line to the we the and failure And -- by we between time the Vamil, in on, trials, be the that but of patients Sure.

don’t but the get of randomization. there’s a selected assume our data make We That screening from patients line, out process, -- got of the and go in with a it they probably XX, bit little you lot CRO. So it’s XXX to is we but XX can published, that industry average. not that SAFER, that to below about through

second round XX% And so in strict the is we selecting rate Failure to pretty to another XX% in and at XX% of XX% round. first are patients. terms

have The anything really second Well, the of the did monotherapy. at question to is not look on monotherapy. we directly powering

assuming way the did same of the assumption for took adjunctive we we therapy. So just the

there plan So is assumption. the we statistical exactly And the the believe in do same. same

Vamil Divan

I in that I of said confirm, powering you the point just based two think on getting to combination, is Okay. correct? sort separation think a And

Sergio Traversa

correct. That’s Yes.

macroscale. and significant. We the So points placebo X XX on statistically drug between is day if the delta The study will hope… be

Vamil Divan

Maybe one…

Sergio Traversa

but… there …

Vamil Divan

Yeah. that… is on This one follow-up

Sergio Traversa

case... …worst

Vamil Divan

for you separation or... have X-point do for meaningful a threshold monotherapy maybe Yeah. that beyond of clinically But would to, looking the be sort either in are say, results what think you really you

Sergio Traversa

the meaningful. probably what to change tells we say Well, another two It It industry would and points, If the the FDA KOL It we is way be it will show going us. treated. not. and to have is X-point depression is clinically depression. won’t the antidepressant. delta, be going in the points three difference. and to That it. with hoping treatment we that game points a be make will changer But make -- two different. our approved it’s to are change BUs. the like what be big the of above, would not probably

would points We it and is standard, meaningful. that points, three we clinically to two do what for, above much clinically do meaningful. more much better, considered So the hope we and believe expect, be

Vamil Divan

Thanks Okay. Great. for the taking questions.

Sergio Traversa

Thank you, Vamil.

Operator

next your question Olson line Jay of is with from And our proceed with Oppenheimer. the question. Please

Matt Hershenhorn

This is for much for Matt Jay. so taking on questions. our Thanks

you IIIs REL-XXXX you development. interesting recent how if on detect in the Olney am data. Compounds thing a scans view the to the as that guess, abuse were as already I about, brain potential first on of have doing any Ketamine on well. generics And received abnormalities, feedback from publication they similarly, antagonist any be might that and tolerability in & some So the were the profile corollary, in would lesions on any Related I wondering NMDA the we imaging just we the that. HAP on And or if any are is have secondly, then received and Phase Appreciate just curious that of just curious, versus preclinical safety includes patients feedback feedback Conference. human physician you other if studies

Sergio Traversa

question. Sure. Matt, thanks for the

we is So I by and one feedback this nobody it data. from share human abuse data. the that is make very -- physicians feedback And made got the their The confident KOLs mind from first DEA on was up surprised on a understands the from very, already question that their has whoever thing can is they really and Yes, the potential studies. website.

community. confirmed So already the the the data abuse, have we known if generated by what can I was just abuse call

risk definitely, that really has And got the the so potential by this the surprised been confirmed But been nobody -- very is It’s for of positive. there. data. not abuse feedback

So that’s one.

was effective, one And was got was by of there long-term there background that lesion, are lesion toxicity -- in the but -- Olney’s Olney’s -- the that than very is but we concerns interested the NMDA that was antagonist. -- about use the potentially the I On probably MK-XXX high. thought. more was created more This

very do doses, brain very no in can [ph] but terms that of higher are REL-XXXX than In of of of in So long indication. Rasimic we we safety, long-term no, potential and damage some lesion. terms years it is we hope everything any -- the the if was We based It’s we damage. any very brain -- positive signal human no Consider or that III, have the doing are human sign give been Olney’s there for brain any efficacy is that seen Phase been means don’t a case. at when MRI any a that no been connection feedback using. actually of high improvement XX effect in or effect, report much so of has There’s not far anything it then damage. can an some was -- in of history the in in we for risk that that have is mechanism, through nothing expect of anything for and there brain detection a and there there any or a function terms of believe on -- is form We the atrophy. chronic functionality on based drive -- and generate in potential neuroplastic there that dendrite stress,

look patients brain change structure. the is to tend for -- life all at for depression brain morphologic you many and of the or in that if some the many, there are by affected brain So years, their

start here the based So takes it. patients not it potentially they and the the early REL-XXXX data, to it’s to -- improve should take -- only show long-term, we in enough, damage -- because could the but conditional don’t -- a not if use potentially brain functionality, have on mechanism, could for it

Matt Hershenhorn

just were not thing, it’s we appreciate sense. it. wondering since arbormentis announced And current makes Really the it compound. about just that. Okay. of other yet, been Got the one the status That has psilocybin perfect

where and much. very of indications. steps currently next stands development curious any that Just on thoughts and potential Thanks

Sergio Traversa

for the on is keep We Sure. with but program. few the the are moving psilocybin really we reasons, is main a psilocybin forward. But one REL-XXXX I the Yes. low a believe we nicely are profile busy finishing proprietary it disclose up a -- manufacturing anyway. but not, know or don’t make going it the if with The disclosed synthesis. -- do the psilocybin we am process. to manufacturing I -- will we I

buy we So won’t it.

is you it’s will much buying can than and cheaper that -- the and have economically We make as parties. third from ourselves. as want you much it it’s And

the And we so step. finished, next the that then will will community on update be when

show, are studies. of We it, doing that the is also number confirm is as a preclinical to the to and goal a show X-HXA effect certain psilocybin that studies agonist to And and the wants see FDA neuroplastic has preclinical a of well.

fly I where animals. zebrafish model are form rodent, so of it’s and that being And believe neuroplastic in of detect certain tested the currently compounds. some there effect

information, and any and the So be we what with will manufacturing. of kind in want safety discuss see, they the preclinical to if -- and information FDA preclinical, psilocybin. The of big on will difference ongoing

low-dose using on a using using. are a chronic. substantially lower that dose are everybody else in the psilocybin And what We is is space we

the start see that a an will And preclinical big already a Phase then, to a the if early safety, and we then a Phase terms readout. FDA. in give sufficient, role have in but we to manufacturing they And probably be of use time make available of information with save Probably update play catalyst data the II. go couple year-end we FDA. and of discuss to would again, XX so the the would III psilocybin should straight the that and conversation too after the for the may a still we toward months -- able with our could and statement. That into results the are II, have is be of Phase We after will years I then conditional finish

Matt Hershenhorn

questions. taking for makes That it. very Appreciate progress. Got sense. much. Okay. you Congrats the Thank on another

Sergio Traversa

Thanks for asking.

Operator

proceed question question. is your line with from Guggenheim a last the our of Suneja follow-up Yatin Partners. And Please with

Yatin Suneja

Hi, a allowing for guys. Thank follow-up.

you you can could especially guidance a monotherapy provide data like line the are, close how And on stands? reaching the study? on enrollment, update time where you quickly, current narrow Just on the enrollment. Just or the full the little to

Sergio Traversa

Well, media. narrow Yatin. the time the we Thanks, on Yes. the data, stay with

week detail. or in give that like not So to are even it’s variables I cleanup specific very go And the like really there will data reason’s more impossible and so months. the

So we keep buffer. like a month plus/minus as a

year, some enrolling, mimic terms We very In this CRO. the that earlier well. board and we of took it’s brought measures going actually on infrastructure an

medical have liaison. They our So are called own we MSLs.

We also the go to that they one have people or internally. research do all clinical closely. two we data site And own have the our do and CRA, the very associates, they and follow cleanup study

enrollment and to try you the the I we in Enrolling up agree, right? patient sure at very am speed look time, as Yatin, ready At same data as and to depression read So possible. as the be quality we first, want easy. fast is

more little And bit you difficult. patients the terms quality many as find as but in a can You find want. of to enrollment, it’s --

and well. we focus second. So get -- want quality. time, on right first totally We the it to is and the But enrollment going very not

Yatin Suneja

you. Thank

Operator

this at There questions are time. further no

Sergio Traversa

this wish important as wonderful With a clinic you product much. the that in the will speak quarterly end soon and for I said, possible. effort Thank expeditiously as we everyone day, next and their for to to thanks and closing, like partners Okay. extend continued And participants the I Well, REL-XXXX sincere team on am executing also the and dedication thanks. the work grateful my clinical very clinical in mission. call. everybody the the candidate very to closing to to involved through our in statement, advancing I Relmada for trials of hard

Operator

you That does thank you disconnect for for conclude and the that your today. participation lines. ask We your conference please call

Relmada Therapeutics (RLMD) 8 May 222022 Q1 Earnings call transcript