Earnings call transcript Q1 2023

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good afternoon. Thank you for attending today's Relmada Therapeutics Inc.

First Quarter 2023 Earnings Call. My name is Forum [ph], and I will be your moderator for today's call. All lines will remain muted during the presentation portion of the call with an opportunity for questions-and-answers at the end. Instructions] [Operator

my McCarthy the McCarthy from now our over please to Tim host, LifeSci pleasure is conference pass to proceed. It Advisors. Mr.

Tim McCarthy

us Chief on operator, afternoon. Chief Executive Medical you, and Cedric you Maged Traversa; for Thank O'Gorman; Shenouda. Dr. and thank Officer, Sergio With Officer, call today's joining me Officer, are Financial Chief all this

information providing months This afternoon note discussed the announcing three ended financial is the XX, update the covered that Relmada Securities issued of safe on certain Reform a a today call harbor results business Act. press the Please March release Litigation XXXX. under for Private provisions

We the Actual XX-K qualified by SEC statements the due contained caution These subsequent team statements. Form on results in management by Relmada's statements could including December ended filings. associated Relmada's to and risks differ filings these forward-looking and those cautionary forward-looking during today the release listeners implied this company's XXXX uncertainties company's XX, materially press business. call for or forward-looking will be year with statements and the making report from that issued annual are in the stated

the live also of Relmada or the that as information contains date forward-looking date call. call statements XX, any undertakes update or May is only after of this events accurate conference This no circumstances time-sensitive obligation revise this broadcast XXXX. of to reflect to conference

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

Sergio Traversa

you, Thank Tim.

As quarter welcome conference XXXX everyone. always you to am good and call. afternoon Relmada first to the I to pleased

program sheet. for financial will disorder. update major provide results an clinical and our overview Maged During our Cedric and review today's Phase a depressive of will in balance call, X and ongoing REL-XXXX review will provide we

We will take your then questions.

major on we to for said we results an disorder Study based focus from last or XXX, the adjunctive primarily on intend treatment as depressive MDD. our as call REL-XXXX on begin To

adjunctive study pivotal a trial Study implemented our placebo-controlled X and we will MDD. milligram We initiate Phase the two-arm evaluating to critical XXX REL-XXXX ongoing changes new for XXX XX have Study

protocol Our study being amendment protocol and all be mid-XXXX. by now Study finalized new initiation drafted has The will clinical study been was ready is XXX and for across XXX implemented sites.

glutamatergic Study two drivers full success patient that with It results by or and no unlike mood does correcting MDD. XXX pathway the the is antidepressant regulated recruiting most MDD reinforced patients. REL for receptor taxed pathophysiology. It the the affect M&DA consequences the important situation in that independently the of blocking not for of placebo of REL-XXXX believed the levels pest of underlie XXXX RELXXXX neurotransmitter for true study altering these and monoaminergic controlling conventional pathophysiological in The has to the response. believed by appropriate effect

MDD with true pathophysiology its appropriate So diagnosis dependent enrolling the on signal subject a trial. is and into efficacy

appropriately detection. diagnosed our call are Both Since study signal we the for on on enhancing detection the subject, we of via streamlined been and our that have result trial recruiting Study amendment concentrated placebo XXX optimizing protocols and XXX last protocol focused clinical new in design protocol. the a response of signal controlling drafting of

on we selection and the have and trials. our we as strengthen clinical collaboration Additionally, have visiting these been our been of the with finalizing preferred sites sites relationship them clinical

for all for occurring follow-up I'm treatment the Study REL-XXXX the Therefore, the is safety next long-term necessary that weeks. of filing. NDA of visit open-label purpose visit safety also exposure to report finally study attaining required completed safety our pleased in one-year and the couple XXX with concluding

expect release We this data study, to from this year. later

readouts that like plans, from execute quarter financial to reach progress trials. clinical is to detail fully I results, our in on emphasize to moving X our funded, to provide Relmada further data Before would on sufficiently both first Phase the

to over the Medical over call the provide moving Officer plans clinical to on and in forward. now Cedric, turn an the the update will go our quarter Cedric? progress Chief I

Cedric O'Gorman

Sergio. you, Thank

amended Sergio lessened -- already amendment high protocol now both optimizes at the our the by trials, we The those were As screened spent indicated, site. the the been streamlined IRB XXX and being significantly seen approved completed the reducing for our time from have under exploratory removing burden learnings and studies. placebo controlled has potential by and of by Study This duplicative subjects protocol, protocol assessments interest. in in and has was completed achieved evaluations, reduction that to required amended subjects subjects on sites, are the the response, capitalizes which

analyze difference. recall, verifiable meet when from versus analysis its were saw known as XXX primary in sourced sources we endpoint to of study, post-hoc the from results striking professional of and were defined subjects non-verifiable as the we patients Verified you the patients health As a sites, the which failed such a current patients the database care to who obtained site referrals. patients,

having and and elements subjects, these confirmed social media as the contrasted agencies. of subjects, through ads, non-verified those a recruitment were the TV MDD through these confidence in recruited of via the radio increase subjects with All non-verified resource diagnosis source Internet

of day that treated points for placebo. with to of amounts XX a versus placebo-adjusted difference, sourced had baseline REL-XXXX subjects point reliably a XX.X p-value from a on the observed total X.XXX. score This XX.X with MADRS We change X.X at points

sources REL-XXXX data, from MDD post in hoc strong diagnosis. signal In this evidence XXX is XXX efficacy. patients their patients Study, ongoing the sources have of we XXX verifiable us of depressed the our require clinically documented analysis Study to has and it upcoming will clear a from of coming Study verified that From that

MDD medical prospective We verify and from antidepressant diagnosis, subjects records to treatment require history. will

at allowed Study response. high favoring to our per we difference placebo-adjusted and we were XX two intend X.X moving approximately these enrolling day sites in site from only and by the data better make on as particularly trials. When XXX MADRS post-hoc limit REL-XXXX. improvements data prioritize can the prior of on the Additionally, highest score the effect was all recall, site, excluded a were two the reduced to selection so important response. you population XX and number sites, impacted paradoxical by controlled saw point with we placebo patients learnings disproportionate control us in forward, single observed patients no outcomes, sites, study of enrolled Moreover, those These a for as site have who to was able have total placebo

planning also planned that enrollment half We with enroll Currently, the the a XXX, over anticipated to of initiate this we or expect XXX ongoing of patients currently study. have first to in Study XXX and are in of In patients, to over in trial new approximately XXX patients into plan mid-XXXX, second complete the one-third completion half study the enrolled XXX with we approximately XXXX. XXXX.

as Additionally, REL-XXXX the weeks next for safety couple long-term mentioned, exposure the over open-label of is safety our Study XXX, with concluding for one-year occurring filing. visits our Sergio fulfilling final NDA requirements follow-up study safety

expect data year. be this We from this available study, to later

our continue product X we enhancing we published REL-XXXX, on to late-stage As for support focused data our further are Phase program promising the advance of in candidates. also ongoing of and presented troll

meeting we upcoming XXXX or posters end, had the May. accepted Society Psychopharmacology presentation end at of To Clinical American ASCP of late-breaking this at the for two have

Study results protocol per the efficacy highlight will presentation XXX. from One

who a set. have This resulted and to exclusion the major did of As patients, this were analysis protocol day XX treated of a in pre-specified not refers full was analysis, to protocol deviations. per only compared reminder pre-specified analysis XX patients to the the population

for at XX Per a Relmada protocol comprised of placebo-adjusted X.X a XXX day total full from XX.X score in placebo subjects, p-value and The was change statistical the baseline significance. for XXX and points in X.XXX to compared approaching REL-XXXX of analysis points for difference set. points XX.X

indication the abuse withdrawal XXX, potential the results signs and The absence symptoms from trial. of second the presentation of lack review will and safety in Study specifically of

abuse no There was REL-XXXX the to will terms potential turn between in of groups placebo financial and over effects. now quarter treatment call Maged and I review our results. Maged? likability withdrawal difference first to drug

Maged Shenouda

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

XX XXXX. quarter of decrease primarily expense in XXX late approximately for Study associated research ended XXX million Study completion For and the with total the million, $XX.X XXXX to The XXXX. first $XX and the was March of period as compared was development comparable

to administrative expense decrease The and stock-based Total million $X million, quarter for $X related as million compensation approximately of period totaled the XXXX non-cash charge first a March the of general quarter. in XX compared $XX.X million. first for ended approximately most comparable completed $XX.X recently the to was XXXX

The decrease was most driven totaled charge decrease $X.X completed This quarter. million compensation. non-cash in first by the a in recently stock-based primarily

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

XXXX $XX.X million, the $XX.X Net XXXX. ended cash activities operating compared totaled in XX months XX three the to million March three used ended for for months March

as cash, and equivalents of and XX short-term $XXX.X $XXX.X As investments we of March cash XX equivalents short-term December compared investments cash, of million, cash XXXX. of to XXXX approximately approximately had million

cash studies this with development us or discussed end Based our provides of of as XXX the runway. note, current ample Sergio clinical earlier on of will We plan the as provides through runway well conclusion earlier-stage XXXX. with of our -- Study completion ample -- certain position support expected us which cash

for call Operator? ask I'll questions, operator open the please the now to

Operator

Certainly Our is question open. of first Marc Securities. with now Goodman Instructions] Marc, [Operator line the you from comes line SVB

Q –Rudy Li

the separation? the trial? is RELIANCE my that I is you move and Thanks. taking based on was may the really And full RELIANCE maybe Rudy for a current increased just with trial do you think for line the have This five data weeks from believe to wondering Thanks six week or Marc. longer like do another I question. II, right forward Hi. on duration

Sergio Traversa

is Thanks for I It's for Cedric, the here. question you. the question. believe Sergio

Cedric O'Gorman

NMDA improvement, had agencies also placebo the to the for observed think Thanks antidepressant and placebo and that have with trajectory improvements pursue separate trajectory in in the four have looking looked believe that can to what of essentially Yes. sufficient the order we regulatory weeks through with study. four and is see we the acting we've a agreement at and And the an response a weeks. We completed at still rapid of control if is we drug positive studies, question. the antagonism. that And

also, protocol now per to post-hoc, approach best duration. the the that being is the other the four sufficient look that if weeks post-hoc analysis placebo think prespecified protocol be control And analysis pursue weeks. and you four we of when can would believe we So in response we at per

Rudy Li

it. That’s Got helpful. very

Sergio Traversa

a the very it response response. placebo the by unusual may behave high should in Thank add, this look on doesn't can XXX you, like was Cedric. at misleading and like early not be if you because it that. the trial that. little If extremely placebo I data, placebo high It was curve because Usually a characterized behave

weeks that normal on response it answered four an would endpoint rate So, primary a XX show would question. time line. appropriate like I be hope placebo your curve, we days

Rudy Li

sense. Appreciate make That color. the

Operator

Thank you for question. your

question of Our Uy from next line Ear comes Mizuho. with the

open. is Your now line

Uy Ear

taking Thanks my for question.

two So said think questions. you I XXX have for I sites have selection the -- question have you is, My studies. you completed first so

I Just And you of enrolled studies. sites. wondering, each of there's if the patients number limiting indicated any in overlap also you're the these XXX with think

the indicated like, -- XXX many safety of the And that enroll if guess, out you that? mid-XXXX, RELIANCE expecting each share And my wondering many you seeing with but Just how you would you what is, you're sites XXXX. second just previously in there for are I now can at long-term are patients read question to think how studies data and I the sites?

Just a wondering, there's change. Thanks. if

Sergio Traversa

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

Cedric O'Gorman

Sure.

be XXX on hit XXX. for first of selection about we I'll all study -- will one sites because XXX here, and there's the the hopefully No, overlap middle midyear So but of this was year. whether questions the the with starting

so XXX therefore And ongoing. is

studies. unique And the -- so they are across sites two

think said guide. think -- I good per XX you you approximately I is sites a trial and asked many how

the so number cap of sure that on same not an cap, time of patients per on of the they but -- which one going at rest have activities, to a to the we're the that of don't site. sites we not we're outweigh performing effect are monitoring the the providing we any terms that doesn't make we're trials. allow arbitrary carefully disproportionate In site going But number

We label. weeks. And of last guidance occurring safety the next think question did open is data the about two and was completing the around I by study the last the middle say follow-up in from year the business

get how the to question it data quickly So then it's and how, we of can a claim you. just

So Sergio still I add as wouldn't outputs. data the to it that just our there? say clean can soon as know, are don't want and that able you expectation -- because meet maybe I are we we -- changing there, the wouldn't say I anything generate to we

Sergio Traversa

Yes. in the I study the No, fine. think completed next completed weeks. to that's or has be on this mean, is I been way few

patients. So it's XXX-plus

a the will of lot of want a data And before them. And provide that quite new data. we release understanding of a complete be there's So they sure we bit to data. have we

we to And the in want appropriately. be time half. So it will it do second some

Uy Ear

Okay. you. Thank

Operator

Thank you for your question.

from of is Andrew, Jefferies. with line now the Tsai Our next your Andrew question line comes open.

Andrew Tsai

the getting afternoon. for job question, great up Okay. good Great, thanks, Thanks speed. things to

how you for sites getting investors? you not holistic start. shortcuts you a And operating taking would you it's high-level so question kind as of of that is question question and patients At guys. stage, this so such the say quality data balancing versus you as for you whatsoever? first are are no a in to Are way fast possible high-level Just a maybe

Sergio Traversa

Cedric I'll give Yeah. you his and and the give and opinion well. expand as top-down

we of course, reasonable time. the is experience driver. be concluded time clearly that have we with of to other studies the quality consider a on Just of the had because to in light And too have the amount studies two

in investors. want And think it results as as be don't way from you Let's to the three this of put difference make months positive. a long add? that do plus/minus will we the study Cedric would And for

Cedric O'Gorman

that Sergio did better selected and on placebo more also of that patients. sites to focus terms being we eligibility the said into the you think a better were controlling rigorous based to sites speed. job diagnosis not learn quality response what patients in echo right the just review on at applying now. on I being would quality I process have versus And get verify a And unverified confirm job the from of versus able able really Yeah. those been the Also, not. we're trial sites a resource did what

that most a So sure here in rate it the somewhat result slows of patients that we corners records into don't and requiring we cut as of medical studies. down making really sort the that, appropriate obviously the and get

Andrew Tsai

sense. Make

-- maybe post COVID. And so mind you thing my perform subdrivanalysis where just how pre another to patients I I time a is differently showed came think and patients last

a later would wood. you for If So maybe me on here. this kind of to happen you. new were curious year thinking variant think what what Just enrollment? knock if you there that COVID to gauge was would do your be would your pause Thank study

Sergio Traversa

you would Take mind? it... Cedric

Cedric O'Gorman

very drug has lifting much I What versus effect across restrictions wasn't a And trials that question. obviously numerous of impact just it COVID-XX placebo. post-pandemic can already for interesting better say saw a It's the been so study. of documented our and separation is

showed when confirmed a you consider I But which did versus verified analysis a with the we would aspects profound diagnosis valid also more patients unverified. concern. there the it's that in So are that other say effect

protocol the that was per the throughout entire there analysis showed study. retention Even good prespecified

low has particularly data this the is discontinuation And very benefit interpretation placebo. distinguish from paradoxically it's unblinding really that and patients continuation senses, study. in through effect looking side have at. That's my And it would in other the been rates. drug that of two We the aspect functional placebo-like cannot REL-XXXX sense somewhat between often trials aided of truly appear this I've profile.

is to there and that's that this that set getting new now running I'm I the look we'd the importance right hoping the studies have are that we're past pandemic, was So start. and study up now. if at to And think a closely. in

another we let's pandemic. So don't COVID hope have

Andrew Tsai

yes. Right,

Thanks Very the for Okay. good. update.

Cedric O'Gorman

Andrew. you, Thank

Operator

you Thank your for question.

from line comes now question of Goldman next is with Andrea, Our Andrea the Tan Sachs. open. line your

Andrea Tan

please. Thanks for taking my everyone. Hi, question. me for Two

respect But with failed rolled that treatment study, I data the about the know you've the to in set. that through First are X who and the trials. potential over from X open-label of to these RELIANCE understand given both spoken patients past effect real-world the just safety

data interpreted read should you they Just frame that wondering be that how and for expectations could if context? within help

be of recommending then And early was just XXX. done curious XXX with monitoring will to data XXX in the what stoppage committee utilized to if study so Thanks is for a and much. secondly, similar respect

Sergio Traversa

believe Thank should you, -- Andrea, and answer, great question. hits Cedric. Cedric I

Cedric O'Gorman

Sure. Thank you.

So can information important the provide tolerability It in to drug the open patients right label continuation, study Andrea. of which you're world reflect it in a might number study. response, the it in really is regarding nice long-term absolutely have drug has world and the really get how the XX durability, does subjects real medication and It real the of very exposure. quite months, you out and

are completed as also has And in some into adjunctive. open-label you also And rollover study. novo XXX. monotherapy XXX from de have point and it out you mix from some a and rollover then who patients came of the XXX, the And

there sort with to parsing to share you. being look out able that forward So, of and numerous subsets we

So with again, have see the have data be more is completing to safety we'll to will and there'll we -- follow-ups, study the what on come the that.

as for for And with data have the to monitoring the would and to committee. that's always data on a we regards the the committee, monitoring rigorous internally table look size of to continue safety, well. the to then review a we our both potentially study, regards increasing use at us And have all certainly trials with safety process the

Andrea Tan

size. provide the color bit one considerations for could that Maybe increasing comment? Maybe just a study follow-up little around more on - the just sorry you one if

Sergio Traversa

ahead Cedric. Go

Cedric O'Gorman

or up -- its like final our development. protocol finalized what given to for -- guidance of we so will say be design. going But only that's was when sort around stages the interim was, I I clinicaltrials.gov. and for shared actually trial haven't be in in analysis of the they And jump three take example, the about finalized design four, any Well, into details upsizing hesitant is because we to or would the be haven't plans will

spoken yet. our in haven't that plans about regard We

on So I that. wouldn't comment want prematurely to

Andrea Tan

you. Thank Okay.

Operator

for your question. you Thank

Our line final question your Yatin Suneja comes from Partners. line Guggenheim open. Yatin, is now the of with

Yatin Suneja

questions added your and Have patients of Could with And there amendment the you so the the comment discussed the protocol to are interactions you A X? RELIANCE made with that then, for on modification. were them met Yes. few modification, me. you before the FDA?

will agreement the has just be data the been. how curious interaction the analyzed So of -- mix

Sergio Traversa

Cedric. ahead. Go Yeah.

Cedric O'Gorman

have regards on assumptions in this has analysis around run first calculations that and based confident XXX the a subsequent But the with that specific interactions comment So to clearly if positive expectations forward. versus the based in of around analysis the the the can finalize plethora having and patients plans I for plan. ongoing modeling the patients do we have a regards moving the the XXX approval that efficacy statistical dialogue the calculations. regulatory the with of after and we our -- to we amendment, authorities and on REL-XXXX anything XXX, an didn't on specifics be but communications certainly our do ultimately our wouldn't before will plan With FDA, I that FDA, mean of And planned don't we FDA. any to decisions FDA. or question with signal study of And we around submit a feel the the with the statistical won't comment

Yatin Suneja

I And one this regard with may. more action. So of to the if onset is Cedric

rapid post-hoc, I little you the and even has was first a slower separation take a not you the a was a the What onset done nice within are bit subset changed? the pretty week. So look when all mean that study looks curves similar. first the analysis we onset precautions at and do in -- very Like if

what's on? going So Thanks.

Sergio Traversa

Go ahead, Cedric.

Cedric O'Gorman

sir. Okay. Thank you,

X.X% XX.X II really And the drug profound compared glad week of you to and points to Phase one So order absolutely you're placebo. because sizes that X.X. with question I'm saw X.X% asked of effect we improvement was in right the with like the

well was that So inpatient study. an incredibly controlled

from is outpatient mentioned. then the is difficult that II have well also what analysis from do know is a we control Phase that little a various but challenge Phase I've going we itself, III post-hoc already seen -- in more as the population outpatient bit Now to to

to -- is placebo what majority response that first change from seeing happened -- and striking But that in came long. by long. We long. at The almost example interaction in X. ultimately protocol you're placebo And very getting the in very, another so by points. the in visit with that and they a day And And staff. screening has able looking study visit on-site XXX was baseline baseline an they was the visit majority vast the the had when occurred were is were for see XX.X we day of then day X the visit four with the of XXX the was week the which was having extensive in

So placebo you're what patients I different that a maybe effect. as full is seeing therapeutic what having is were the best think that described that's

more really efforts be a site whereas this Phase see REL-XXXX hopeful I what week. careful amended able And you'll that to with gradual the saw are week less hopeful design we've that that in first to that our effect minimizing potential placebo new we we'll crucial that and will planned, focused patient implemented. in closer trial I'm interaction in for now significant the change with see isolate new and is that protocol for all the study And be II of it first on I'm think what so, to that

Maged Shenouda

And I Cedric. bit can add a then if little color. you, of Thank Yes.

when the we like has so press from the data a by patients. and marked affected is data have there We patient really really of the a now have REL-XXXX MDD available significant like effect amount seen

not We studies patients situational and been that believe were liked. or the that percent by have shows the thought in at depressed and we of because have XXX that by II. would significant affected patient the early the patient direction of similar clearly response -- we do is it didn't -- we to the see enrolled way other will at Looking we the kind like Phase skewed opposite depression work selection. was data the and we -- all that affected if an There and would the in two a patient of should pressure the data that so have by

Yatin Suneja

Very helpful. it. Got

Sergio Traversa

we answered your question? Hope

Yatin Suneja

that’s No, One if a more will on little Maybe quarters the can very Yes. to Thank ship helpful. think to is three the curious Maged G&A question understand control may. R&D about would the still Nice love you that expenses. side much. next up? and how on I comment bit higher. so I how

Maged Shenouda

Sure. Yatin. Thanks for the question

So would with the $X of I the in the for -- quarter per it expect regard G&A stay to remainder year. for next to the range million

So the second slightly we and moderate then to quarter. given R&D the on having can R&D think quarterly in of on And of but as bit the fourth the start haven't in remainder then but for guidance, spend the really quarter a third around up entire average year the spend R&D slightly basis down, little year. should you a more and

We have start-up in the all range But per would quarter. -- $XX million say this I $XX of quarter. spend around third in trial to million the

Yatin Suneja

Very helpful.

Maged Shenouda

the Thanks questions. Okay. for

Yatin Suneja

Thanks.

Operator

Q&A your pass you. for This I Thank any concludes today's closing session the back remarks. you for to call. questions. team management will our for Thank now

Sergio Traversa

optimize chances the we And that success. the confident plan remain for we place summary, In to and you. then have right an approval we drug. team the thank have in Well,

patient and affected MDD to believe how suitable by have patients most reliable sites know identify the the also we We major most identified depression.

pieces filing study We sufficiently funded preclinical other protocols greatly with and and plans our REL-XXXX and progresses have also of XXX forward in remainder We fully reporting year. place we CMC to development. Study a our for REL-XXXX. on the are reminder for the look for as execute a are and to and throughout clinical improved successful NDA all XXX

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

the opportunity for their continue chance grateful doing. awareness that and they our are supporting initiative month support appreciated we health advocacy work to the and mental may our important partner are the Finally, this to

the participants interested we'll real time. we said, development to the you. the you you next thank and and on update progress Thank Relmada That all everybody and on in

Operator

quarter XXXX earnings participation. for today's your call. Thank you This concludes first Inc. Relmada Therapeutics

your disconnect lines. now may You

Relmada Therapeutics (RLMD) 11 May 232023 Q1 Earnings call transcript