RLMD - Earnings call transcript Q1 2024 | Relmada Therapeutics, Inc.

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Operator

Good afternoon, ladies and gentlemen, and welcome to the Relmada Therapeutics, Inc.

First Quarter 2024 Financial Results Conference Call. [Operator Instructions] This call is being recorded on Wednesday, May 8, 2024. I would now like to turn the conference over to Tim McCarthy, LifeSci Advisors. Please go ahead.

Tim McCarthy

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

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

Sergio Traversa

XXXX Tim, the afternoon welcome good Thank Relmada always, Call. to and First everyone, as you, and Quarter Conference to

promising cover will progress novel continue in I III the program well psilocybin of major as which in for program, of briefly depressive achieve We preclinical to our meaningful in as REL-XXXX advancement all the ongoing Phase today. disorder, MDD,

financial your and questions. this, review Following quarter we then Maged will take will first results, our XXXX

Phase for update late-stage III with an begin Let's program on the REL-XXXX.

to Reliance the is treatment for These modifications on advance, and developing important placebo ongoing sites. focused The to across our Study implemented Study MDD. III, to as XX and aimed adjunctive our Enrollment with MDD. revision close protocol play placebo-controlled all a for continue reminder, study X-arm Phase relationship clinical of adjunctive executed a the which enrolled. profile Relmada pivotal evaluating patients the leverage milligrams amended critical our an controlling of has continues a is were at As XXX, improving We previously II, role. sites response XXX been ability REL-XXXX to REL-XXXX study

place are the generating awareness put trial positive in results. initiative also we prospective patients drive with to Moreover, ongoing

on appropriate. call, a are and As we said tweaks we on making the productivity as quality last basis our evaluating sites and real-time of

reminder, approximately XXX line a patients Reliance to As Reliance to projections, current continue half second anticipated to top this the completed II plan enroll on year. Based in II. we into with of be we our expect data

that day processes have to order ensure records which Relight. to made criteria in REL-XXXX MDD emphasize safety and to in a in treatment. the endpoint II The We and enroll as continuing enrolled efficacy III enrollment our is those compared the of REL-XXXX XX and qualifying a trial, are on baseline for the It patients. patients XXX The of we now ongoing from adjudication would Relight randomized, inadequate change X to in placebo-controlled for pharmacy Like to patient a response is we Relight comprehensive Reliance II, and patients in primary adjunctive all same. medical this for executing planned approximately of that in studies double-blind, also also XXX. Study MADRS the we within to enrollment are patients has of trial acquire our all treatment desired weeks profile. like REL-XXXX, of experiencing we through evaluating screening score total To our end, an again process as second patients that or Reliance revision background meet to antidepressant placebo. I Phase meaningful have both

in has Reliance Reliance increased the Phase rate this, III, failure previously III approximately trial our this study XX% I REL-XXXX. screen approximately and versus in Given to completed XX%

current these also REL-XXXX However, of preclinical that highly enhance changes we manufacturing studies, required the is the a of and I success are executing probability filing, the all study for confident current and like substantially would remaining Phase NDA have and to X Phase potential necessary the completed studies. I our will XXX of on we highlight that focus III XXX.

to psilocybin novel Moving modified-release now on promising the program.

pharmacokinetic low-dose anticipate first I Phase [ half to by metabolic that anticipated patients disease chronic meeting, and build showed half population on single-ascending were the the We preclinical of IIa rodent could is poster improve psilocybin dose on XXXX. with planned the presentation data, trial the define followed on last this continue tolerability planned in other beneficial a results IIa this of in of study formulation potential liver low, effects associated to Phase fewer dose in the our November's These such the will profile compelling in first data proof-of-concept. Data approaches dysfunction GIP. multiple These modified-release the effect of Based the of glucose GLP-X, psilocybin in MASLD. as obese ] and steatotic initiation safety glucagon a presented from clinical trial or this and AASLD treatment the establish year for psilocybin over to metabolic studies a liver parameters of side conference. model in lipids on investigative

we key to the year. in upcoming this the XX, milestones half second the anticipate with summarize, line II completed next multiple be months, data XX our of Reliance to ongoing top So study over

I our of In clinical the Phase before of addition, psilocybin formulation anticipate initiating modified-release quarter. the end we trial a for current

comfortably like the to our our of significant continue a for on position results. quarter financials, detailed we us Maged? pipeline a advance turn cash financial Lastly, over review strength with hand into financial our to to take while to Maged will I would to of will now Maged first provide that highlight XXXX. I review call

Maged Shenouda

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

associated $XX.X to study, $XX.X XXXX, the compared first the Reliance total as XXXX For was quarter ended million development as was March approximately comparable completion the third in as of decrease of of with for III. a well million. The expense of long-term XXXX, Study the open-label primarily the quarter XX, XXX period million $X.X I decrease and approximately and research

charge for March as $X.X and stock-based charge The the decrease in first quarter. for $X.X a XXXX, for million to G&A noncash of first $XX.X was totaled decrease completed the general to XXXX, stock-based R&D most compared was driven period decrease stock-based noncash most comparable expense by in million recently compensation in approximately million. Total ended The a administrative totaled primarily of compensation related related $X.X recently compensation approximately first completed expense, quarter million quarter. the $X.X to for a million XX, the

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

approximately our into March as compared used December XXXX provides of operations development first $XX.X on Based comfortable XX, us As of had clinical cash of XX, current our cash, quarter million investments million. XXXX. position the we $XX.X XXXX, was short-term runway Cash million cash and to XXXX. plan, $XX of equivalents in with in

questions. the I call will now open for the please up operator Operator? ask to

Operator

and the Ladies Instructions]. now we'll you. gentlemen, begin [Operator question-and-answer session. Thank

Partners. Goodman Your first Leerink question comes from Marc from

Basma Radwan Ibrahim

and Reliance Relight and Marc. trials. Basma on trials have for Reliance the question a about is Relight ongoing I -- This

kind mentioned those if and monitoring some were some larger looking before similarities, provide something color give to to the blinded prior You any the Q implemented differences the from of -- what you you about Reliance placebo Do the that previous trial do the right monitoring just at see now Can actually response? you do data about the you this you strategy color in data us -- from placebo reduce that Relight the any compare call. see fourth in response. you the call see to trial, you earnings that had blinded

Sergio Traversa

let Yes, more who'll sure. give details Clinical first, Dr. seen X And we aspect. that then answer. in the have that for I'll Andrew we've call, the Well, And blinded Cutler, this on thanks a we trials -- from the top-down clinical of is blinded had. There provide about way like outcome to data, absolutely guess last the we me he did -- right? trial. a no Advisor about something Andy the And say our little the is bit you the question. data,

-- the but that get not there that data and help to like we blinded make doesn't or that right consistent, find monitoring is So can that everybody right? get the the -- exclusively can can word, I is not is is something and from see only

is if or zigzag, something goes we with are I'll example, usually, MADRS it a the then patients patient know the it still doesn't that is over is can or you weeks consistent give there and be if the But patient right, responds there up not over weeks. that an can and it call respond down it scores consistent is that week-over-week, X the be that site. individual X

something see like -- that So if signal consistent. zigzag, is that's not not a you it's a

take a that to to And to patients mostly and look so we the the site.

data, not many to a pattern it's the help about So is but the see do, more into something revise site important, from nothing continue zigzag but get it? When on advise kind that that's we is you with details some like Andy, provide call, only it trial. can we of the patients can the monitor red really to right, blinded get flag. to least you that mind And is would there to at this in are you can the of that and these

Andrew Cutler

Yes.

look and MADRS, what -- for look measuring usually MADRS consistency to key agree said of addition indicators. moves being outcome, across CGI, and you the in symptoms. that The with same said. So different also direction zigzag, is scales. is as the -- which absolutely quality the secondary he you a about the primary, primary course, depression the in I And consistency Sergio What what for secondary

allowed rather for we're you a the were problem. So can look as be quickly And enroll that to as the trial, quality would closely in previous watching that certainly now. without sites say that. I doing also

point. and point So this more looking would at enrollment, the we're at much say a we've each things I that looked being overall. the are site not site view monitoring with allowing patients trial the careful from over-enroll until now quality of fine the to of quality, really

Sergio Traversa

you, answered question. I Andy, your and hope Thank that

Operator

from comes question next Andrea from Goldman Tan Your Sachs.

Andrea Tan

to there. one your right remarks follow-up Maybe

see you've just As take I one question. those us steps walk what follow-up issues. you if sites, that to monitoring inconsistencies maybe about, then would through then you you have the are And do spoken the remediate

Sergio Traversa

good Yes, question. thanks afternoon, the Andrea, for

or patients answer general, in you well, more But that before, to go first, that will a provide has some like you becomes And you pattern, details. any contact details in discuss As then process. regarding bit site like would enrolling a you you like a if you give patients that inconsistency XX, the and trial. Andy, don't I would and short the inconsistency. And patients ultimately, then have if the through XX like because affect shows that site to little old old want

close I'm you measure site. color the on But bit to little the So is Andy, more can a I give ultimate sure this.

Andrew Cutler

that is patients said. enroll to problems thing The not in a is that important Yes, allow most to like continue and well have that. to site

does to call also not well, So one X if site this the going many trial. has The can looking best shoulder, -- or see cut them all, But me". knows sites be you patients, knows you corners. know, make sites. as you're on will, if now, do site of if and kill you run too if over having X really also their you're site It behavior, a first my that

that ultimately, have So quality have issues. -- some but sites closed we down

is stop the from chance have you So they interrupt study. you do what that so ultimately to don't enrolling them a

Andrea Tan

Or just to Can the recommend going planning trial? quickly on any mechanism in of in stopping be prior early as -- analysis? an is interim place for type the are you you study if us you have to your having DSMB there remind they

Sergio Traversa

have close is point, to will have the expand in there an data because we It's statistical a trial. or have reestimation. us is interim to will trial very not if -- -- a the will know statistically but They if is committee the have we, data significant at at the let look -- we monitoring no enough this the some the that we close to But penalty. the reach end. simple not analysis So sample

So there is no planned. stock early

Andrew Cutler

of very DSMB, the is And and of function major safety. good other monitor The tolerability is safety the news good. to the have course, the looked

Operator

Your next Andrew from from question comes Tsai Jefferies.

Unknown Analyst

have guess your that continuing to theme. calling been Do you also analysis? closed monitoring able real And I the time any of even Congrats on in to sites you with This progress. specifics reopen on for using And the is or numbers pause, had same we've... Andrew. Matt the

Sergio Traversa

it's Sorry, I you. maybe I -- hear but can can barely me

Unknown Analyst

better you me Can Okay. hear now?

Sergio Traversa

Much better, yes. Thank you.

Sorry for that.

Unknown Analyst

problem. no Okay,

few I schizophrenia you had to if epilepsy quite MDD seeing for year, was you then continuing and real-time the companies even specifics level that you the the then... on the -- terms or And had that with yes, competition in And announced instance had So funding seen also maybe delays over like are any like a any we've we And reopen? right sites asking spaces. number pause, increased just analysis, of of past depression of patients? have close

Maged Shenouda

Thanks for the question.

Sergio Traversa

question. thank very for Yes, much you the

the like at the the beginning site. It process. like you site, decide of selection right, is finish same it's XX the an terms with -- and XX, not the site sites in you fixed, is So ongoing like

revision there the also patient a studies they they closed, for site or can quality some into the So like of exhausted sites for not the is and constantly, site. only population enroll is competing issue that

is a that real you not some number, an like it do specific of review. it's an at process. have my It's I on a point ongoing. don't ongoing the mind So top like but

he the finish So -- a detail little you more sites. the Andy, answer, runs other give because maybe, when bit I clinical can

would the mind competition... into So more he it? to detail the is second the repeat process. of And The question, you

Unknown Analyst

Yes.

-- Just exactly. yes,

Sergio Traversa

a -- not because -- out cannot particular same bit site studies treatment case, -- studies kind are mean, X Yes. of take -- on there. the does mostly adjunctive or are it's is depression. -- Well, not does In that we clearly the usually, there like X, I patients. doing for some enroll competition the a And the little by our of

but there because not Phase sizable that the So X X a is enroll less -- few in I other big study that the the And much the it lot programs, in an do PTSD competition. there in U.S., adjunctive. We hearing believe believe not III that was ongoing outside are many relative is it's really the and was It keep that psychedelic, anyway. And on it's with a -- that -- direct so sites other thus as still, the trials there depression antidepressant site company We patients was of there psilocybin psilocybin, the -- for -- especially keeps MDD. not were psilocybin competition are competitor, of a do ago. busy. weeks that finished majority but high-dose

yes, indication color? summarize, would are is much to Andy, lower. -- So provide mind in specific a competition, bit is but to a like competition you more little the we there where

Andrew Cutler

Yes.

studies X that I'll X significantly a site patient than without Usually, more different and The X want answer you the are will don't the study one second is say, At can fit into right. as competing is depression -- criteria protocol enough exactly too do, studies. that to first, another. the you level, clearly or many that take Sergio second though, impairing

as is the sites. have at fortunately. of it And a it's I say do I true. far the for closed don't exact enrollment the of But sites, first of of some that, as sites stopped but we've down process I think off overseeing that reasons, have various not the lot, a simply can So couple number but sites close certainly that's hand, we question,

that sites isn't that behavior the watched. changes action Now They know being significant quality know corrective so monitoring enough that we're they're that often the and necessary.

Unknown Analyst

positive the would describe soon. kicking design then, you're And you Can psilocybin sense. that the makes off I guess, study data That Yes. to entail? and regarding going Phase I it. what be program Got

Sergio Traversa

dose We'll it's a -- with The psilocybin modified dose, Phase very I start ascending single yes, of simple. release.

much of is is lower, very, or -- volunteer. treatment psychedelic is part the very that dose, it's interesting product the the a psychotic psilocybin a a population do XXX dose it is healthy So And diseases. that in Phase for used the technically relatively -- you I high XXX as at dose and patient or well are but using the much, of known we a safe like the

So the on And metabolic feel but for indication psilocybin safety the we the space. that we extremely into comfortable. -- pursue side, is

and glucose and fatty obesity So liver.

So data mostly obese we the is data for PK in the that looking patients. are

be we the particular And month the volunteer. said is population should within So patient healthy over that obese the the half. next will first we X, start or

So we are short getting a there. study. It's

X maximum. So months, will the X, last whole study like

Operator

[Operator Instructions].

Ear Your from Uy next Mizuho. question from comes

Unknown Analyst

for Uy. think to study then had clarify also II could ] a kind question the XX% failure [ if enrollment. and you if Reliance about screening screening before was also, of on kind is rate This you throughout going protocol? Charles XX% of stay I the that's if And at the failure new rate

Sergio Traversa

for Charlie, the thanks question.

yes, failure look are so -- or It legitimate high, but concomitant the -- reason is medication. screening screening And the at failure mostly interaction we is the usually there the is for concomitant drug-drug reasons, right? and

enroll rate are not the said, doing the to they sites, most in there that in review the without So legitimate yes, carefully screening to trial, from the risk study. or increasing decrease failure that. And of the we failure are these constantly we and the enrollment decreasing anything and the we reason the that come site. And can screening the with listen we but quality from do to very and actually have feedback been is the increase of

than been -- -- time. the or are that have there medication over So drug-drug concomitant on been more have interaction especially changing certain things interaction that that

is facilitate back force and So site. company the should the this and end from that a

that trial, of characteristic the could that see put and it it give the they So inclusion-exclusion. we cannot into with because but us feedback a in we patients fit

of of revision the detailed made course, and a have like in time. a few the we So dialogue we revised protocol over FDA, with

I beginning don't to chance like the great of what III the but question at of And we have don't on is enrolled. we'll or there was Probably on screening the lot But the So a the failure there little patients the a head. the the my better. And know top a that screening we of failure. question, -- at not do II. second a answer are that's get could -- definitely, beginning

the the how So that we Andy much But more number know Maged before or protocol. failure screening I on is the they if -- or have color III maybe don't II some amend meaningful. on that studies

Maged Shenouda

it don't was quite... I believe

Andrew Cutler

Maged, go sorry. ahead, Yes,

Maged Shenouda

Yes, not Andy. -- high. to ahead, there it our confirming Go put don't don't I without want as was internal out certainly quite a I with number team.

we'll So get to have to back you.

So...

Andrew Cutler

I absolutely But exactly. We're put would in a is not failure. screening right that's trying the be Patient important. the and failure of to selection find studies. patients off by source critically Yes,

Sergio Traversa

Okay. failure. made records, as -- some for that doctor like requirement a purchased But in from that mentioned the the biggest protocol the our right, calls, -- from time, -- are big Right. we the this at diagnosed to -- a comfortable also, one -- increased has yes, and now And medical and from of you the itself is by same and actually patient that there relatively that is that's change amendment pharmacy. the has the we that, comes of the patient prescribed pharmacy medication screening medication and

of I enrolled. So an your that improvement screening X question. failure, things they profile a there risk clearly the go but the hope the in patients is together, high answers

Operator

turn time. Sergio at questions this There to it are for back remarks. no closing I'll further

Sergio Traversa

and to further that Thank program. forward grateful do of potential remain the team novel in summary, throughout reporting to with and on the my trials investigational to REL-XXXX, in promising looking as mission. Also, an the partners derivative we drug the Relmada lot in attention are to of thanks Thanks approvable their pipeline dedication would patients everyone We XXXX. our REL-XXXX excited our participation for psilocybin medicine advancement to progress like and clinical executing and the remainder hard the the firmly of next I work in our have to you. forward to for believe this call. And the interest continue and continued sincere conference to for a by look we we always, I development. through extend their the involved

Operator

you and disconnect today. this Ladies your call and ask lines. for concludes participating thank conference that your We for you please gentlemen,

Relmada Therapeutics (RLMD) 8 May 242024 Q1 Earnings call transcript