RLMD - Earnings call 3 2023 | Relmada Therapeutics, Inc.

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

Operator

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

Third Quarter 2023 Earnings Conference Call. [Operator Instructions] Following the presentation, we will conduct a question-and-answer session.

[Operator Instructions] This call is being recorded on Wednesday, November 8, 2023. I would now like to turn the conference over to Tim McCarthy of LifeSci Advisors. ahead. go Please

Tim McCarthy

Chief forward-looking these We the be for and statements and risks today's in contained all is and filings. associated this ended company's With Cedric during annual afternoon. making cautionary Financial issued the Act. differ XX-K are afternoon, harbor that Thank Relmada's due and business this press a qualified are with discussed will certain update joining filings, for press report Actual including Chief X on business. These uncertainties release O'Gorman, Dr. by and call the Maged Traversa; Officer. the the statements. management on by results Securities covered September Executive and results could safe ended team subsequent me This Officer, Relmada you Private the stated today Shenouda; that forward-looking the us Medical XX, for Officer, listeners Chief forward-looking financial a XXXX, those in months materially of Form to XX, SEC today under Reform information provision the providing the call announcing X Litigation call, caution issued from XXXX. Please company's note statements statements Relmada's on December implied release or Sergio year

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

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

Sergio Traversa

Thank you, Tim.

to afternoon Quarter to Third Conference As always, XXXX Relmada's good and Call. everyone, welcome and

well REL-XXXX I Phase in in our preclinical as important psilocybin achieved cover have program depressive novel major promising today. will or disorder for a clinical some We MDD briefly program the in that as recently ongoing milestone III

your will we and the will quarter questions. results, third then Following this, financial review Maged take

III Phase continues program planned. the proceed on this update an with to which for begin Let's REL-XXXX,

treatment for on As Relmada focused reminder, a is MDD. as adjunctive an developing REL-XXXX

implemented communicated, ongoing study XXX XX-milligram critical XXX rate we to MDD. close study clinical As X-arm, Reliance evaluating have we changes REL-XXXX with prospective with sites as previously and the across protocol is awareness number has made initiatives stud trial sites. Enrollment amended all a The leverage been to our III pivotal relationship progressing a of placebo-controlled ongoing for Phase our II, adjunctive the drive patients. study

half approximately an and III in As the Phase to a completed reminder, enroll the we most In patients media. will likely XXX, first adjunctive toward end of XXX the response II, a evaluating ongoing placebo-controlled of planned half what REL-XXXX this in second treatment Reliance enrollment is the double-blind, be like safety treatment. trial we enrollment experiencing as approximately expect begin the be we also quarter. XXXX. of MDD X-week Relight to third reiterate and the study patient said planning of has of first previously, continues in have continue XXX randomized, named efficacy inadequate REL-XXXX, second trial patients Relight dosing so to or Reliance the XXXX, background II during patients. Completion a in are that of Relight around half, trial antidepressant of for anticipated To to

purpose NDA placebo. quarter, Study for or third are for X-year day-XX the compared is REL-XXXX, total filing. to MADRS Also, The in required the during we for primary announced and efficacy exposure study results of from same. change as studies from These safety endpoint long-term safety XXX of XXX. REL-XXXX both the The the data the to score safety the open-label baseline

a patients subjects. the with safety REL-XXXX the to shared to de results sustained treatment were long-term XXX all new patients noncomparative and will in XXX communicated and open-label and we daily in up served efficacy de study was improvement the patients. -- specifically, registrational evaluate results in X in patient Rapid of for to Phase de III designed novo administered population. with safety previously trial REL-XXXX, MADRS MDD in or X some for September, XXX efficacy in for More REL-XXXX novo results open-label year. I X-X-X, the and of now the entire study score novo reiterate -- the Study

as the total of defined MADRS novo were X improvement de with than or mean As and score points When score month MADRS reliable the XX% High score which improvement in XX.X from rates XX.X X X score both rapid clinical of REL-XXXX XX. is picture was resulted that results. equal the at reward The will baseline I of score, to a response patients. this a with by MADRS mean reflect and to in X, in XX% points more the total points the XX.X% in increased and in XX seen XX. MADRS day clinical REL-XXXX novo -- greater the novo month novo baseline. month achieved by response the XX.X sustained treated X, patients XX.X of de in month patient patient total the de month and condition, patient de at patients Treatment at at at like

X, month of pressing the by XX.X% the at novo clinical then to month or XX. increased And symptoms at X. XX.X% absence day was again, patients XX.X% [indiscernible] achieved which of de remission at

a meaningful to and functional symptoms MADRS total patients impairment. equal daily rapid, to summary, of is up score as or defined sustained remission Clinical with clinically depressive year associated less and in for REL-XXXX than treated XX. improvement In the X experienced

XXX response analysis change de full results both for the and and patient in groups. the the MADRS novo in were overall in study remission consistent Importantly, set REL-XXXX,

subjects, For were shown all events. low new events the No due well discontinuation was and to detected. REL-XXXX, dosing, of safety tolerated long-term XXX rates with adverse REL-XXXX adverse signals

poster demonstrate or the will this next dysfunction AASLD presentation. disease the weekend rodent a Moving associated now At of steatotic data liver new non-psychedelic/low week the novel data to metabolic effect multiple metabolic on presented modified our program. release The MASLD. in model beneficial in dose of or promising psilocybin preclinical meeting, parameters psilocybin be

As a treatment currently the for GLP-X. We and dose on there for potential of could non-psychedelic/low side support effects lipid the therapeutic psilocybin. and other fewer initial MASLD this reminder, and data, improve as Phase drugs with single no levels Based ascending establish potential psilocybin formulation intend release patient safety approved results preclinical investigative non-psychodelic/low-dose steatotic are with concept. glucose such proof in over same approaches, in I trial the in initiate and psilocybin obese XXXX disease tolerability clinical our to a a population population. Followed define liver the modified patients to Phase this early in to profile of dose trial of pharmacokinetic IIa by this

review data financials. both trials, But Phase detailed Relmada Maged? emphasize like review to over readouts and of remains second now Moving results. Maged financial REL-XXXX on, will Maged plans call that our I sufficiently III funded to Reliance to for quarter to will our provide reach our would I the Relight. fully a to II execute turn

Maged Shenouda

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

The $XX.X expense development compared study third The period XXXX, the comparable research was decrease to in of associated XXX million and completion of $X.X of quarter completed with Reliance XXXX. September totaled approximately late study third for charge decrease compensation and the ended For related million that's Reliance I, primarily million III, most a XXX quarter. noncash in recently the $XX.X $XX stock-based the was total XXXX, XX, million. as approximately

as general driven stock-based compared Total most third the for $X.X ended and XXXX, totaled million. charge in administrative in comparable $X.X third $XX.X quarter. to completed million for primarily the approximately XX, $X expense an XXXX, period increase recently increase This September of approximately million by was the compensation. increase million an quarter The was noncash of

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

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

months the million III, $X.X was totaled completed development of Reliance decrease research to and period the charge noncash approximately was XXX ended primarily a study $XX.X XXX the study compensation million. associated completion Again, late for million results of most September period. and of comparable X-month the with Reliance XXXX, I, XX, $XX.X to in decrease expense for Turning compared $XX.X X the The to approximately as stock-based XXXX. XXXX. the Total million related recently in

primarily most $XX.X ended months September months cash was ended in of stock-based by million recently XXXX, the X total months noncash completed X-month the the XX, was X compared September approximately totaled XX, for million XXXX, comparable to September This expense $XX.X million as the to of For $XX.X administrative approximately general increase compensation. and increase an an $XX.X XXXX, XX, The X $XX.X $XXX,XXX. XXXX. million increase totaled charge activities for million period ended period. Net used in compared for in the driven operating

net share loss For comparable a X XX, million and and of share for XXXX, to the and the period compared September or months was ended loss per of XXXX. basic million net diluted $XXX.X basic diluted $X.XX $X.XX or approximately in $XX.X

XXXX. short-term investments approximately million had as $XXX.X equivalents million. $XX.X $XXX.X XX, As December and XX, in was we million to the for Again, cash operations used third September of of XXXX, cash, cash of compared approximately quarter

with XXX development our clinical Phase I as for I'll the the XXX XXXX. modified position III Of as the study of now current end time psilocybin to from includes plan, note, planned the us our and over readouts ample both call cash Relight And this data release that's our our formulation. well trial study provides Phase period, of II, through operator. turn Sergio for as that's initiation mentioned, on Based runway trials Reliance

Operator

[Operator comes Partners. Instructions] Goodman, Your from Leerink first Marc question

Unknown Analyst

Reliance Reliance-OLS Marc. any the had participants? the Congratulations us the diagnosis after a Reliance average is the you remind the of the the you MDD inaccurate the data patient and the regarding a you and noticed I And age Reliance III. quarter. participants the Basma about the I of look on between correlation again of and also you regarding on at III had characteristics. study. as And same This for question age this data? Reliance after have unblinded Would sites Can study conducted I I about question

Sergio Traversa

our is thanks the do them. address Well, believe Officer, the for Medical to question. Cedric? appropriated that I Great. Cedric, most Chief

Cedric O'Gorman

thanks Sergio, Yes. Thanks, the for question.

trial yes, So very you extension you trials, have also common open-label offered. an that's when is as controlled have

yes, XX III to subject to contribute depressive And adults years a then opportunity that of Reliance represented Reliance about part the know ratio you question the in of sites was course, these therefore, at So be that study. Remember studies also study age. were long-term and XX disorder major than age had to average in there and and open-label the females of I that part is X:X the run are of males. a --

We There's haven't outcomes analysis can't by age. that breakdown. of will comment area or looked in average on lots of a But correlation the probably But the XXs. or was the at do. interesting age age we XXs

Operator

Ear, next from Uy question comes Mizuho. Your

Unknown Analyst

is This patients then on adjunctive Phase that a was studies? patients open-label to a saw monotherapy and had that. you novo also other between the difference to of for open-label. de Charles follow-up kind any And Uy. If from there I read-throughs if from I question the III guess,

Sergio Traversa

It's Sergio Thanks, here. Charles.

go like top-down can me Let to more then and you try bit in Cedric give little more a detail.

safety learning significant MADRS experience. these the months. improvement XX represent look so real-world -- data. long-term are the is material conclusions we at the And but the and And because simple And look, study

is after is there what effect the -- a rapid there XX-plus effect have of X So sustain. and months XX we and months. a patient this is responded percent -- the seen the that And clear

And loss confirmed time. no safety drug the and has of So the safely that there is is efficacy extremely well tolerated. over

in a mix. in really experience. very the So a key the learning adjunctive is not significant of difference answer In real-world and make not study difference. these monotherapy. -- it's there It like is The the was are a the a really XX-month question to the

somebody it very separate they to that -- them. doesn't do be would medication, it's XX somebody we take or don't know take So if them, monotherapy from adjunctive unfair stop in because months people

there come be mean de would and that work patients or that X at let's makes pretty reliable put they XXX, this not real it the There is It's and in extremely either subset work well information. overall it novo Relmada, way So because look population spike be Phase I way. drug no it's no didn't we that It's of studies. experience. a us well. really consistent, the patients a that would world comfortable the XXX difference over III from the would is that

Cedric, to anything do you want my to add remarks.

Cedric O'Gorman

that rapid placebo-controlled just think open or well looking said our de this -- confirm ideal who the all, there's I isn't to onset that improvement as trials it in you gets said novo when the you're it's consistent at at you to on controlled in. group because what the study label the trajectory as with look efficacy

a of there's lot and common they're -- lot So and don't subjects, on. that you of medications a

So it's bag. seen treatment remission quickly observed also setting, label open consistently better quite do rates trajectory with thing in we've But in the high the as really a controlled the one response and that mixed is trials. patients whatever is and consistent

Operator

Jefferies. question next Your Tsai, from comes Andrew

Unknown Analyst

What lot just Phase questions. are sort can high power of similarities the X study you seeing of matter a Andrew. for were And on to ] Are successful show just a quick studies you programs? of III elaborate on X separation placebo? of speaking, integrity that. for studies couple for say a Zenah those you between question of [ Cedric, is run. in confidence how operationally could the X Phase Axon studies terms if versus each And to XXXX, similar with We are how your This and III had

Sergio Traversa

our and the run Yes. Zenah just different with very, trial drugs. question, both -- Thanks, ]. answer would trial, your trials, runs very on to to right, and should like try that. answer running are but Cedric maybe [ I these Axon the Axon last comparison very, Maybe Cedric The

I don't want much to you reliable the So compare be how know Cedric, answer? programs. try And would do X to to

Cedric O'Gorman

-- and that subject the And high-quality I anybody to think possible. I major X a very run protocol, strive down the development much the disorder, space, comes particularly selection. who's in that as No, that selection Yes. depressive think program Sure. things: really to in drug site

matter sites best you then to which there the you response. And And aims those tight so know for to in have doesn't research with to work to the very a it are the course, want of of sites, placebo that for, who sponsor always efficient protocol want you reduce MDD conducting trials. depression sponsor. work are clinical that that us same And work known

are depressive knowledge So there and because you the these major best would be in familiarity that sites expect would disorder.

process to makes -- of avoiding that minimize And eligibility a or you're just that a avoiding selection well enrolling response. sure should professional that prone or the patients. doing you getting I that And have an from then patient you're be very who may might carefully to recruiting high subject say, confirmed right you're having have everything patients process with you're diagnosis MDD and placebo as subjects,

revealed the our powering, yet. that to across that pleased the And subjects say actually letting So the I you in very that haven't have the into how do with rigorous program. I'm statistical on we trial. processes eligibility question And

to So to XXX if to take or placebo you Phase consider controlled I the and mean MADRS. XXX, on XX you if it improvement the points were was -- where would II data, and XX be about reasonable

figure we're probably powering it subjects we mentioned the could beginning. approximately how because Sergio are You targeting XXX at as out

So bit hope helps an there answer I to that your little with question. a

Sergio Traversa

and versus score to is add in for point? According the enough clinically literature, just one history considered a placebo I MADRS difference Can points X.X the KOLs quick and approval. X, meaningful

may file So these according statistical will in that parameters. imagine to you the -- plan we

is difference good I Hope question. So properly and from set answer for to enough will be meaningful a your that the up MADRS statistics clinically detect placebo approval.

Operator

next Suneja, comes Your Guggenheim. question from [Operator Yatin Instructions]

Maddalena Delma Caiati

for is This Yatin. Delma

just psilocybin you, a ask a have I you program. there have Are to these wanted for the and I on the use filed already if planning I trial few any to to trigger expected you sources Phase are IND psychedelic the of how doses So there? questions many experience?

Sergio Traversa

the answered I Sergio here. first Sorry, -- it's

to because repeat if one then you don't well. of I you second very couldn't first question, the part mind hear The the

haven't we the no, filed IND. So

the planning prepare start the we [indiscernible] I believe to I on next year. to the but single are IND relatively filed We do are soon, Phase process in be and QX will dose

let's now. second the you So months Can please X from X, say, repeat part?

Maddalena Delma Caiati

asking experience? how these Yes, planning you a if -- if And sure. is trigger many any of dose I was expected to doses have there? just you're psychedelic

Sergio Traversa

And that and real tolerated haven't How other well will will No, of know exact finalized discuss the toxicity you we dose are that. literature we a single many use the is can and regimen in because they ongoing, I are it the using history milligrams from not programs we what and share in But doses? XX toxicity. dose the with dose-limiting psilocybin what be XX, will IND. in that is X/XX is the from

-- dose when be assumption So not be term. your way, psych. are not it's is psycho dose well or limiting to tolerated psychological, when symptoms start the will is trying toxic we using you putting this in feel you drug will have the we a general fair psychosomatic determine to that affecting -- to in the start But toxicity, that

developing So extended that low-dose, non-psychedelic. a we release are is

be So the the toxicity we assume the milligrams is, it below exactly know X will that but what dose-limited daily. will We effect. psychedelic X, don't dose be

Operator

questions proceed. Please this There time. at no are further

Sergio Traversa

REL-XXXX, for our work grateful the remain you. do thank we to the look forward progress remain programs. We that derivative months on to an and drug Relmada have dedication the to pipeline And novel about executing are reporting summary, ahead. psilocybin team of Look, hard the Well, their and I excited mission. confident and in with the we in in do we approvable our potential continued

development. involved promising we'll reconnect and to advancement the trials to everyone, thanks soon. a sincere lot of for to REL-XXXX their Thanks the investigational patients in my extend clinical to in the this like partners would participation medicine I and

Operator

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

Relmada Therapeutics (RLMD) 8 Nov 232023 Q3 Earnings call transcript