Earnings call transcript Q4 2022

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Operator

Greetings and welcome to Relmada Therapeutics Fourth Quarter and Full Year 2022 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Mr. Tim McCarthy. Thank you, you may begin.

Tim McCarthy

thank for and afternoon. us operator, you, you joining all this Thank me Chief Dr. Medical are, today's Officer, With call Chief Executive on Sergio Traversa; Officer, O'Gorman Shenouda. Officer, Chief Cedric and Financial Maged issued three and months business Relmada This providing XX, XX news results the financial ended a afternoon, for update a XXXX. announcing December release

team We discussed call, the provisions associated Securities Private these with of the today that be risks caution that to covered this is will Act. during listeners note business. and management statements. statements forward-looking those Please could on under forward-looking certain Relmada's the materially Litigation information uncertainties due differ by call stated Actual the harbor making Reform safe implied or results company's from

Relmada's SEC the only forward-looking today in subsequent call statements also contains for no XXXX, These conference forward-looking date statements any filings. including are this revise update time-sensitive events of filings, the qualified Relmada or XX, conference by XXXX. on release March in year the obligation information this accurate and call. press Form company's the and of to undertakes This annual to that contained the report cautionary December XX-K ended as broadcast, issued XX, live circumstances date the after or is reflect of statements

like would over to Sergio. the I to Now call turn Sergio?

Sergio Traversa

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

of REL-XXXX that from to treatment learnings, challenging us from completed coming better are MDD. the we of learned believe for the great a off but these potential realize our We have a studies and XXXX, deal enable

or REL-XXXX in for Study XXX XXXX. the Following December of availability results in RELIANCE topline I

and appropriate months, the analyzing steps. We these three have considering last the data next spent

is two RELIANCE reminder, milligrams two-arm, X sister REL-XXXX adjunctive are Study XXX pivotal Phase or As treatment and ongoing. XXX is at MDD. Study studies II XX evaluating an for I placebo-controlled, XXX Study RELIANCE a or

issues X. in key Phase identified Study that from seen are data in confident differing have that XXX Phase X the led results We the we to positive the

As based critical generated such, study one and will on to Study to implement and as the REL-XXXX data and market the initiate ongoing adjunctive potential treatment intend XXX. XXX to-date changes focus new we an trial on

drivers protocol XXX ready and immediately. mid-XXXX. XXX's the would And depression like be important Study by appropriate amendment broadly, we learned two to trial recruiting have patients will has Our ready to emphasize placebo for response. and that protocol successful controlling to initiate be and that finalized MDD new the are is been the been a our drafted I implemented has most Study with

not inhibiting effect unlike thought of namely It glutamatergic does dysfunction. not have is is effect correcting neurotransmitter except hyperactive it's levels affect by of altering MDD in consequences and antidepressant proposed that it glutamatergic REL-XXXX absence the pathways. and antidepressant by oral It conventional mood therapeutic underlying the to pathophysiology,

would therefore This The the drug major trial. to situation a of proportional to clinical no with directly the be efficacy depressed, effect that reduced of expected in signal REL-XXXX the in of trial suggest in or without depressive inappropriate diagnosis have those the a subjects true disorder. would in enrolled therefore percentage be this

clinical are impact you data quality the You we outcomes. will trial drug's today, going the share on see to from that has with subject

new for making we REL-XXXX Study Chief study in review generated plan future new are Study which influence many During our our the provide That XXX. insight, of Officer be program. our He valuable Medical details Cedric, and call, today's will also to will XXX changes Study will implementing analysis the clinical XXX. key -- then our

for our our Chief we balance execute X say data plan are will sufficiently trials. to our will that Officer Financial readouts financial Shenouda funded and review Maged fully Phase I results sheet. both to comment Cedric's reach Following But,

We will your take then questions.

will stage the is I yours. all turn call And Cedric the Cedric. to over now

Sergio Traversa

Sergio slide, please. Thank first and you,

an experienced failed it's you in study XX in with, points, patients high will a score the placebo change did score adequately It placebo placebo from the XX.X total Treatment XX.X recall points not meet result to of on change improvement primary by you is begin, accepted XXX, exceeds experts representing baseline To about statistical widely response. total that REL-XXXX a that on response. the control did significance but MADRS points REL-XXXX the on MADRS, placebo-treated endpoint. have

Despite response, and difference of over that X favored in average was placebo the decades show meaningful points. that approval has X.X been meta-analysis a drug has delta resulted anti-depressants placebo this past REL-XXXX, placebo the the approximately difference the high points adjusted clinically oral

XX% see study We of proportion X.XXX. experienced a for total in XX% significantly baseline treatment score that REL-XXXX treated patients defined slide please. REL-XXXX versus as improvement of response p-value XXX, greater with XX, XX% a more therapeutic statistically it's with day did placebo from Next in MADRS, or the at with

please. slide Next

Now protocol to day let's take analysis were important to a analysis treated who any and XX protocol study did that was XXX. per is protocol at It the a per of pre-specified refers of population to look deviations. not this who the have major note, patients

of XXX patients statistical favor a X.XXX, analysis. difference a the with This adjusted and at analysis the N only in versus in pre-specified approaching XXX was intent in XX, patients exclusion pre-specified total X.X to resulted in demonstrated primary The the REL-XXXX patients a day robust this of analysis XX significance. treat p-value of placebo

that REL-XXXX disorder depressive including primary is robust the per signal the rates development for is major the said, pre-specified and with From and of REL-XXXX and treatment response we efficacy continued believe justified. warranted and of and analysis, the Protocol clear for

us XXX, for post-hoc to driving success develop leverage following learnings what of as a We further the and we study for continue to the in we could final us, optimize see manner. full dataset to obtaining report Study be help After to a believe insights we post-hoc analyzed likelihood the REL-XXXX. results will manner for substantial the

slide Next please.

reduced were X.XXX. subjects two of on sites a the data approximately the population by two only paradoxical we enrolling p-value communicated, X.X of with particularly REL-XXXX saw When and score favoring and adjusted exclude As data at total MADRS, XX, impacted sites, by highest difference placebo day XX was a our response. points these placebo we the from previously

Next slide please.

We of striking verifiable sources results subjects un-verifiable evaluating divided also study referral, this into from when analysis, found data for of from purposes sources we recruitment. versus different of coming the into which this

coming who radio social and and patients patients Non-verifiably known were Internet ads, found searches as media, engaged as current such the source referrals to subjects source from healthcare TV companies. patient. to within Verifiably defined the professionals. and recruitment those site, the directly were database site's Patients were

had unverified. of The prior from relied recruitment studies of verified history or the on subjects source being self-reported regardless medical the

we their the that to were MDD unverifiable As via accuracy believe sources a medical adequately subjects through diagnosis. vetted confirm not the of use recruited result, pharmacy records or of

trials, our recruitment. are forward mandated pharmacy source of for Moving and of regardless medical records

Next slide please.

Here placebo with REL-XXXX points versus of MADRS depressed we has efficacy. present sources, patients but for the XX the sourced when in of of MADRS post-hoc that non-verifiable amounts we This change difference to XX.X day score a a patients from XX score these strong change recruitment verifiable verifiably p-value verifiable the analysis, again baseline sources total points us, patients it XX.X from from sources point observed assessing from baseline from versus this at X.X on total clinically a data, on a clear placebo. is to versus of signal X.XXX, is a that had

the results. believe on pandemic space, Next trial when the April a related the restrictions the we It pandemic, that data This were a situational we has researchers demarcation also most other for largely during the MDD by that to post COVID-XX lifted, is slide of cut XX negative many day score had pandemic X.X MADRS in please. we have clear placebo and depression, points XXXX adjusted impact other us issues COVID's pandemic patients been X, related seen point, REL-XXXX to likely subgroup. when isolation the favoring difference saw the using as on

slide Next please.

in stakeholders over highest These were long XXX dataset. that with external for sites agreed study in represented driving Finally, the response with various the perspective. up the also too high assessments, were enrolling in duration too we and consulted response, additional final concluded site internal many experts placebo visits that placebo stakeholders with

that elements were screening been have the centralized outsourced. there Additionally, oversight improved eligibility could to of than be rather more

these learnings analysis, a protocol changes. on critical conduct to to we our ongoing and Based study please. changes going-forward slide programs intend study the and implement amendment Next with clinical for

verified identify enroll subjects and changes us a allow with will of or patients screen to failed us These MDD symptoms. diagnosis situational depressive to with and more transient allow accurately will

history. from medical prospective from will sources. verifiable We will pharmacy and antidepressant diagnosis enroll treatment verify More patients and to depression subjects records require specifically, only we

we in mentioned relied these self-report in previously As the on past, solely have regards. patients

improvements. recent trials better sites data be per wealth the leaders We patients our number selection have to now and from going-forward. upon our drawn on will of we to thought will addition, be we input select Moreover, In making a limit quality from intend site that site performance of site.

disproportionate site outcomes. study on no single So, a can effect have

in We abundance detection. the evaluations, we now visits that too previously and site there which very visits secondary sense hertz assessments, to many signal visits. long safety ran very to for that also the were REL-XXXX Between assessments this and some this look safety great and and comparison site plan protocol extensive subject to placebo hindered site while, resulted to the and burdened lengthy procedures is good make study and in an assessments, in changes evaluations the reduce have of duration of recruitment

goal going-forward detection. We and bias placebo the protocols again will of be dramatically also our simplifying reducing enhancing with signal response expectation

again important design data completed also studies, with safety study the very know us improves currently ongoing the half that simplified provide insignificant good it that looks with XXX REL-XXXX a our approximately to exposure. to are data we study just that And not very positive enroll filing to complete In recruitment, in reiterate, which patients patient controlled of first XXX XXXX. the and the is when trials expect NDA. planning comes We

or this enrolled approximately XXX have one patients we into study. Currently third

mid-XXXX also XXXX. completion a study anticipated is patients planned in We intend XXX with of XXX half enrollment initiate new to of in the with a approximately second also

year for Our data in XXXX. one open on-schedule safety label study May completion release is and

call a financials. for will of Maged to I turn now that, the over review With the

Maged Shenouda

you Thank Cedric.

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

fourth fourth most stock December $XX.X quarter. quarter was for The million totaled increase the to compensation. and based This to development increase XX, period an XXXX. of compared comparable million in the in $XX.X the related ended as recently-completed research charge million XXXX, $X.X expense non-cash approximately primarily total For was

of increase XX, fourth for The December an and the as was general primarily increase approximately approximately $X.X by period increase million. to quarter an Total $XX.X stock $X.X million XXXX administrative driven was for based million ended of comparable expense the in compared XXXX, compensation.

This non-cash most totaled quarter. the completed $X.X in recently million charge fourth

December For of $XX.X was and the the Compared net basic the comparable or fourth diluted loss million $X.XX or period loss per and per net in $XX.X $X.XX ended with basic XX, quarter of a diluted XXXX, share share. million XXXX.

full clinical the The comparable period research the results program to XXXX. as of associated Turning related REL-XXXX. execution in increase $XXX.X approximately development $XX.X primarily the was million a the in year and with broader XXXX. Total was December for compared expense increase to to XX, for an costs for million

XXXX. XX, year driven of compared The to increase stock For primarily comparable in XXXX, based was ended and million an for the December compensation. million approximately as by expense was increase total $XX.X $XX.X period general administrative the

ended the loss in the and a of $XXX.X comparable loss per net basic with the basic or diluted per was approximately million diluted period XXXX. For $X.XX $XXX of December or million Compared share. share XXXX, net XX, year and $X.XX

XXXX, as approximately million of of approximately. Based runway As cash. two cash equivalents shared cash ample of XX, updated of XX, and investments Compared with earlier, December short-term we of short-term plan, provides and equivalents to XXXX. December and us Sergio cash $XXX.X million. position on cash, the investments current years had cash, Cedric approximately of development clinical $XXX.X our

turn I'll over to call Sergio? now Sergio. the

Sergio Traversa

Cedric. you, Thank and Maged you, Thank

have summary, Based patients and the all the study execution. most successful pieces in-place Also trial focus in for we to an filing know protocols. CMC clinical preclinical, are that a drug and clinical to identify importantly approvable on NDA confident are for how the most now we of suitable Study our REL-XXXX. reliable and So we need XXX, improve results greatly other sites, on

XXX on are we XXX execute short-term development ended cash progress our earlier, sufficiently on reporting as for through $XXX Study the Additionally, with million to We with fully REL-XXXX XXXX we stated investments. as in to funded approximately equivalents and plans look-forward cash, and year.

And now, up the open to operator for please ask Operator? call we will the questions.

Operator

comes Health. first question. with Our Ear Instructions] Mizuho from proceed Please Uy your [Operator with question

Uy Ear

Thanks Hi, my questions. for taking guys.

question first started the protocol you think my guess much and XXX finalized for you already I is So, indicated I is, that pretty immediately.

re-enrolling So, the have is. Secondly, trial. do I And, in FDA XXX you you my before and For blessing patients and guess XXX, you started start question third re-dosing can need

the open in look study, I at On greater would it your data you molecule? investors do helpful Thanks. gain guess to for confidence label what think and to be

Sergio Traversa

believe, Thank you, Cedric, you Uy. I question for this is .

Cedric O'Gorman

Thanks for asked. I'll the question address Absolutely. order the were in and them they

and a is that necessary is, little moving we get the as was bit over amendments it pace. So we for make make a a worked protocol will XXX more to the at streamline to it it nice past study to ahead sites moving open Yes, study more recruitment? and the add existing efficient slowly quarter

or And trial now for will the was was that it with protocol. never So, re-energize recruitment. closed on the open amended paused we efforts it

the the or come to opportunity blessing FDA to that do FDA trials we've imagine, so give All as and the what to we us need regards the we back had submitted like. have of quite and already they and requirement these about can look run study With the recommendations, with you quite the studies the are to new for to dialog a design study. lot bit the understanding thoughts have but FDA a of and

like would be what there FDA trial anticipated a So from in wouldn't this. any divergence the expect

pretty straightforward. it's So

necessary come That's kind label important to of the what suppose very the community. interest fact study of XX study open get a allows you for that data from your I to NDA running the safety be label as would And open the exposures. filing. month to

Looking real rates future the findings. patients adverse efficacy perspective, at were label the what setting and get -- of events, we'll discontinuation this of in setting efficacy contextualize expect we rates it's interest once they in an treatment always from might and open world

can of look as so. treatment you response quite can at a study, out treatment months to because long-term effect the XX it's You label timeline sustained about bit also and open learn then and or a

Uy Ear

you. Thank Okay.

Operator

proceed Our SVB Please with Goodman is Marc next with question. from Securities. question your

Guofang Li

the Thanks for XXX I taking my mentioned regarding Marc. question for question. on XXX, This is study study have Rudy patients. you line around that a enrolling

new especially of patients studies enrollment think enrolled? in both the impact we new And about powering are should of how So the with the your for kind about those product. criteria, talk who also

Sergio Traversa

great you. Cedric Thank you today. are in demand

it's So for you too.

Cedric O'Gorman

what because metallic voice, Thanks, a of Rudy. And if little kind I what understood your you of the to in XXX your the next one how this that first I was from learn think but the it is the that will saying most analysis. to think efficacy patients outcomes sounds question, around I bit important study should were study and XXX, primary about for say

regard. changes are that in not There

at patients were placebo at amount amount were amendments the the for the particularly the spending order that to we control time response. those basically that So site aimed saw, the issues of of reducing assessments, in

interest, the efficacy is and so the patients approach evaluating much same. dosing and has the of of And outcome unchanged the measurement for very primary that the purpose to

trialists, clinical efficient you the design a So to with obviously, -- work was if leg to confident beginning bring if are learning the regards obviously, feel that and one XXX, can this to second ongoing maybe of to study, assume positive having study, of a there we similar discussed XXX internally we were XXX study. with that to to from us it ways more like,

this be this at have ready to, And just with amending set get And this to at analysis, details. to protocol. a those into not we do powering point, we would statistical moment regards so out that's what by

Guofang Li

Thanks. it. Got

Operator

Andrea Our next with Tan Sachs. Please with question question. is proceed Goldman from your

Andrea Tan

Hi, another everyone. you for Thanks one if Maybe for Cedric, taking my mind. question. don't

And treatment the so take receptivity wondering just how thoughts given in would could on learnings so existing see curious landscape Just if can updated the from speak early REL-XXXX there? far, any far? that MDD the on you for there you launch are you

Sergio Traversa

for Hi, definitely that's the question. for thank you. Andrea, you Cedric,

Cedric O'Gorman

new drugs to approved of to tremendous new I action. population Well, continues be with being -- it's MDD The underserved. patient I just see think mechanisms

And more being receptor I approvals, some particular people realm antagonist. the it's REL-XXXX these the so between to think think of are exciting I opportunities NMDA better. And that there's terrific, obviously, and for have similarities for there that mechanisms access it's we And are willing drugs. very greater develop

early insights I or launch really on or trial And haven't no, think -- design I like activity based anything the don't focus learnings that. I here. would on I clinical any

Sergio Traversa

REL-XXXX, approved, marketplace be add, you bit is may position Sergio a adjunctive. and going if be different. I if that Yes, be quite will here. REL-XXXX REL-XXXX the the mentioned in will The it Andrea, to

single other is right? a to And combination, drug there adjunctive widely be this present. can So for indication, I it antidepressant so that used to any added a will your question. unlikely other to the tablet antidepressant one approved hope as third that an be answers no use. would that be already The it's is

Andrea Tan

Thanks Sergio.

Operator

Our next question. with with Tsai Please Jefferies. from your question proceed is Andrew

Andrew Tsai

Hi, for taking you thanks. Good question. my analysis that I walking through did. Thanks appreciate afternoon. these you us

basically? we to look know is, patients signal if think signal XXXX? way about There's would the a of or do a favorable secondly, question tainted. you a for of are post-talk get similar not what And you a XXX were analysis? similar issues is first monotherapy XXX type RELIANCE first there indeed very then Would study First as II, set to the if no

because technically sources, why of have feel hurt unverifiable correct? first from in II some so come XX% enrolled could RELIANCE have of been the them outcome the confident another should said we patients who Or or won't study way,

Sergio Traversa

Cedric?

Cedric O'Gorman

Thanks, Okay. Andrew.

to monotherapy, in the points, did question a baseline X approximately analysis first did. apply and again, about the much outperformed monotherapy XX study, placebo higher the point. study, from about placebo and we monotherapy yes, mean change the had same for of We So by drug

a but it a little less placebo but than we what problem, was you're right. the higher had also adjunctive, saw So in the delta

verifiable, looked unverifiable, of issues. saw we data When and same post-pandemic the splits at we different and definitely sites, pre-pandemic, the

So issues the program. XXX that don't were unique study, rather the feel broadly to we across but the adjunctive RELIANCE

improving new the with will streamlined The patients decision with, was that and based pursue ongoing out, on indication design was agency. X/X a for pointed And adjunctive quickest as with XXX study, that really of strategic starting to study adjunctive and decision the by to a fact you of filing the path of the that clearest new be adjunctive and treatment MDD enrolled.

Now delta the at can't from you question look can the your work time. a And What can XXX the out as you anything and how really blinded. Well, the how is, first studies to improved. or because the did pointing were you bit spent restrictions little it lifted whether subjects? can of time we after and know you pre-pandemic on over the impact

do so of reflective in the later And XXX. we of have is of the the part XXX think early the more XXX we that patients part that first maybe study

sizing, those And for us confidence trials thoughts opportunity all patients, say, -- to these an about gave challenges XXX of would separate some to exist. despite other the original sample about drug we target well, if had the

to done and modeling clinical the we've sites. number talking to talking so statisticians And and a exercises of

amended be indeed and pretty considerations answer around confident with that we target study so the question positive. could -- directly, with the And this sample protocol feel yes, your size, we to

Sergio Traversa

enrolled localized sites consider that was These XX about that two were the -- focalized, look the if you down, major never also from XXX. the at in Study -- XXX presence the together. that Andrew, on data been two patients sites on not impact Study top

Andrew Tsai

right. Right,

IV. there II, And study Okay. a the RELIANCE And Are it on one in RELIANCE RELIANCE does just start to to more XXX any design V, one? the ongoing sense study differences relative then the is make actually?

Cedric O'Gorman

PIs it that we the and IV let terms to be will about of new the RELIANCE be with assessments the significantly administer in patients. with before asking V. different But the Well, RELIANCE talk scales will we study, me start we raters will XXX the and various -- with

of efficacy your like measure. primary couple standard that things there Now are you don't a change outcome

remove much to again, than it But to a with easier it's the blank kind protocol start slate to is things. of amend

same, be that efficacy. will exploratory on similar duration, of it primary really four the can we outcome, terms the in So less weeks secondary very in and in there efficacy so be focus study, endpoints will X-arm just

Andrew Tsai

you, helpful. guys. Very Thank

Operator

with Our is Olson next question. question Please Oppenheimer. Jay proceed from your with

Jay Olson

thanks Hi, guys, update. for thanks for the And the question.

Could important your that Cedric. you from peers due any decision then follow-on, REL-XXXX? to for First talk to And you or about prior your may consider capabilities what to be the did Relmada? question that you to for And of have the Chief trials? making could, Medical join most for do Officer if KOLs you to the And you success I do learn about probability is I please. please MDD have what spoken diligence optimize clinical a

Cedric O'Gorman

but Thank team. you for January They're feel that be delighted I'm only first part since question. me be professional right. to asked part would you're role, thoughtful people. very family. the interested absolutely and the when X, the been I of taking already to Relmada group of Sergio out reached And And in here I've I of

the that and signal. changed did, what potential. want went reasonably could be study wrong data and and to if order in come the to suggest did still understand at I And believe in the I under the in I what had efficacy if look CDA optimize it drug

say couldn't placebo to other it way very response, points, drug. and was very you opinion key it's you about the leaders when any acknowledge leaders thought at you obvious placebo all hard and hadn't the about conclusions it that one draw mind, uncontrolled and this the if looked my or response, one and was to I XX that kept in that the really an So mentioned

that help wanted to I I and actually coming if them. So run ideas as the of I the trial they look to had be protocols were or then feel I at into could the benefit see of design

think protocols, do believe everything I that that your achieved. by And right streamlining question? to there I was -- now, to be that the can trying second we're was a so part that And

Jay Olson

on powered think influence super I pre expect protocol? And amendment? And That's patients evaluate protocol RELIANCE that's did analysis do to plan versus post then, you you the when see question everything. on enrolled you. II you on what and one No, who follow-up amendment. results. for have pre How helpful. I do see is the the a study post of subgroup the versus Thank protocol results to

Sergio Traversa

want What is Do review? the to answer you that?

Cedric O'Gorman

trials -- in the and should first, part difference because results, the second the hoping REL-XXXX thing won't down magnitude drug common one had my the that on I widen in that the the I'm can has effect improvement. placebo the job and unless of Well, to feel I trajectory will control response bring same for placebo succeeded delta, across I response all placebo that because like is

remind And so me. expect I to we to question -- keep of if related part nice down, would the can the first placebo separation. see a And

Jay Olson

versus patients protocol. post pre Evaluating

Cedric O'Gorman

get are part mean, just and the of demarcation in at that, great definitely plan, just that But do detail I be specifics a but Yes. as of of to we data ready analysis to I and of with that important it looking it's announcement. yet terms into intend you. wouldn't the

Sergio Traversa

of We -- similar of conservative did first we the what Sergio that the XXX. to to reach successful X/X worth did assumption should conclusion And the next the be made be patients. data the the to trial -- trial. what will definitely it's we patients forward the we on and conservative We that have move seen Jay, X/X assumption and the here. on made make complete in assume a also study we

Jay Olson

great. that, Okay, thank Appreciate Thank both. Sergio. you That's you. super And helpful.

Sergio Traversa

Thank you.

Operator

the I Sergio of closing call now question-and-answer the like would Traversa reached for the to comments. We've to session. back turn end

Sergio Traversa

in you mission. the would Thank important through for clinic. to the involved participants on product to my their effort I work this also to to candidate in remain executing continued grateful of and extend the like And I dedication very sincere thanks clinical in closing, our for REL-XXXX partners the hard the trials much. advance and Relmada team

With thank end that of everyone day. good and very you. I said, to to wish Thank much you the everyone, a

Operator

today's conference. concludes This

time, your thank for disconnect and at you may You participation. we lines this your

Relmada Therapeutics (RLMD) 23 Mar 232022 Q4 Earnings call transcript