RLMD - Earnings call transcript Q3 2021 | Relmada Therapeutics, Inc.

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Operator

Greetings and welcome Relmada Therapeutics Inc.

Third Quarter 2021 Earnings Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. to conference like host, to now McCarthy. Tim would turn over the your I

Tim McCarthy

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

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

Sergio Traversa

for Thank have our to today, everyone. And you pleased Ence. afternoon also candidate compelling that today's you, the for call, is on I welcome comprehensive review Tim, call. CFO of the product am disorder program we third conference call and adjunctive Chuck the to provide REL-XXXX Shenouda, update Relmada’s lead treatment of depression product I an to on top and quarter and XXXX good on candidate development opportunity or On market the highlight Maged our this for monotherapy And will upcoming milestones. major substantial MDD;

each Maged study, Chief assessing will a With the Following readouts the expect at of first have we or REL-XXXX will potential second we next further HAP abuse this, results that, in from by Institute brief then ketamine. this I shortly, but to Shenouda, we that financials. year. elaborate over Conference in I quarter the top-line last intravenous data our next to for Education XXXX, review human I each that point Neuroscience on Financial of the Officer I will of quarter will versus summary, highlighting overview presented one the turn in recently begin call year the a of data will week. provide

third that, Following is from III study I update X for in the that like monotherapy which studies, sister on RELIANCE MDD studies. and from These therapy. and to ongoing placebo-controlled expected MDD who are for would prior are is important quarter development To The of not now anticipated results I X to and RELIANCE top-line second adjunctive randomize quarters antidepressant taking to RELIANCE be respectively. XXX last Phase data the with we the currently the completed monotherapy in I reiterate begin to RELIANCE With II III, conclusion expect of will top-line RELIANCE arm, and II standard quarter, we pivotal registrational In regulatory aims REL-XXXX individuals with III, anticipate second provided XXXX, this, I month. RELIANCE the the trial. the Phase of the patients we depression diagnosed two fourth which momentarily. XXXX, discuss ongoing

Importantly, X III a monotherapy. study is conducting a approval time potential may the the of meaningfully RELIANCE Phase reduce for MDD as REL-XXXX

today. is potential in In well the addition, adjunctive approval support two based treatment, as a a on for a pre-clinical this REL-XXXX confirmed TQT need support seeking generated The will study sufficient in safety cardiac to monotherapy, FDA REL-XXXX. conduct for data time not order With that of has years a be to that does potential what cardiac confirmed regulatory human as that in known regulatory submission study safety an also at been Relmada FDA required not submission as carcinogenicity REL-XXXX. understanding conduct to to

confirm to the of as As profile to cardiac data safety would provided Phase the the program REL-XXXX. data generated as be be adequate to-date well from and X evaluate the

XX provide an of ongoing I which and each per II participants across now XXX will I update well as per on, study. Moving the sites, include study RELIANCE of studies, RELIANCE would

Data CGIS. Clinical RELIANCE are have which second development change to II As evaluate endpoints the and expected to reminder, endpoints The a XX, progressing MDD X mg Both study response package. Both in part participants remains the score and this REL-XXXX. enrolling had is next at arms, from adjunctive RELIANCE designed participants a well in be X for and of meaning key rollover two a planned. of from antidepressant at MADRS NDA are protocol secondary participants. the in that include program open-label the The X RELIANCE-OLS, both three ongoing and own severity RELIANCE as day long-term are studies filing inadequate as change year. MADRS as safety top-line and novo with score as XX and study XX an up includes participants is treatment of day who data changing Impression pivotal safety open-label placebo and trial day to being at both I standard half de of also therapies. for long-term I to in antidepressant REL-XXXX include score RELIANCE-OLS and clinical the II standard of the enrolling Global with would unchanged RELIANCE the a primary addition

we confident look RELIANCE sites score targeted the key more in sufficient studies to improved. As note ahead it the our catalysts degrees demonstrate clinical we powered the we earlier, desired to and highly MADRS to program, than are important is outlined are I that that

II data Our significant, demonstrated points improving while per REL-XXXX Phase the placebo trial. in score

history effective positive second Based XXXX. study an the control intravenous our results we versus on, an is current first study ongoing. ketamine, of top-line and REL-XXXX HAP this evaluating Moving in established quarter of on the from recruitment which rate has as expect

reminder, an the mg we in As first active announced third top-line REL-XXXX from positive our as results HAP study, control. a quarter, oxycodone XX versus evaluating

two data on our last go calls, too in these here. discussed won’t we length into As detail investor much I

between However, recreational I will Notably, manner results dose. the endpoint dose and significant versus FDA reiterate maximum proposed the evaluated designed XXX doses oxycodone that of and three which abuse assessment REL-XXXX the Xx demonstrated therapeutic the confirmed primary followed REL-XXXX, milligrams opioid guidelines difference of active difference is the for the a all active milligrams. a was potential the this on tolerated was users showed of in that statistically highly XX XXXX of in control drug that is statistically significant study highly control the the drugs. Top-line

potential. meaningful endpoints, the evidence abuse taking endpoints primary desire As of those no any of consistent secondary such with again were as demonstrated drug the the of

three CNS in the Importantly, which are antidepressant of with to I XX profile of side-effects suffer XX% than also four, these efficacy. affect over antidepressant their to Education the to the and for patients Furthermore, from are pass are patients respond needed six only adjunctive which review option for recent at their difference need go long-term in can and held Current these REL-XXXX the first to a significant results to all which consistent a antipsychotics, MDD XX% then therapeutic serious discussions. oral we classes have monotherapy recently treatment seen respond potential the would believe disorder financials. do REL-XXXX Maged make poster HAP on will ability treatment. call stable a a Institute not been ahead, I presentation current standards treatment of deeds to reaffirm for Please results will not major side-effects. and as study presents. wanted options do have new take at are or weeks four, on five and Neuroscience have the I or cause the depression can treatment. Conference. any that touch individuals with Over the Maged. that is and their clinical new to now available care current often even of take to show adjunctive treatment and to option limited a FDA-approved the drug that potential It there we million moment schedule. the evident is has

Maged Shenouda

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

Total cost, period to broader associated third $X.X general as to period administrative primarily in quarter to primarily program clinical quarter compensation increase The to and ended approximately execution compared was in was XX, XXXX, due compared of stock-based ended million comparable expense September of for The REL-XXXX. and approximately the the million development XXXX. for the for million with related of increase personnel XXXX. and second a consulting $XX For the the XX, $X.X for services. September as was increase costs expense research $XX.X total increase million, an XXXX comparable was an

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

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

personnel the million, of in services. $XX.X million and cost, For September for to to XXXX, $XX.X as was increase nine primarily administrative stock-based was consulting XX, comparable general compared months due compensation increase approximately expense and XXXX. The the ended period

the recorded per or $X.XX months in period basic For a to basic share, XX, our and on of million, $XX.X XXXX. approximately ended XX, over $XX.X of I diluted the XXXX, December recent loss On a and compared will nine share net Sergio? and comparable of company we of net or September Sergio and XXXX, loss million XXXX. diluted million $X.XX $XX.X September hand for further cash to which million remarks call investments compares the short-term on now $XXX.X most back cash had equivalents XX, the progress. to per

Sergio Traversa

including Thank eight mean, a post-op Earlier week, presented of this Phase the analysis the posters resulting with Congress I month, trial. new at posters in data from our X NEI you, three heads from Maged. last we total

the questionnaire depression may on for benefits well of potentially patients patients data analysis just the the treated REL-XXXX with that of implications scores have anxiety, REL-XXXX working post-op from meaningful the showed sleep scale social and function suggest improvement. ability improvement of symptom ability. from motivation, These such signaling REL-XXXX the dissociative SDQ, may cognition, beyond extend with First, scales of its MSED in

to And meaningful experiencing included of Dissociative which dissociative is NMDA Scale clinically it used in other symptoms treatment. MDD REL-XXXX The beneficial patients in success Scores, that suggests its patients after affected be prior post-op second antagonists such exempt but Clinical only a analysis to the may to showed It generating the from the state of Abnormal docs. it treatment. be have REL-XXXX Administered States improvement psychiatric may dissociative measure symptoms by poster not

in antidepressants in trial risk. program study, some results REL-XXXX and REL-XXXX showed RELIANCE year. assessing II intravenous developer on each has lacking monotherapy not one risk. In by fourth followed we To expect trial the quarter, with expect standard lipid data metabolism respectively. patients that top-line key XXXX, the track the with REL-XXXX reiterate, in in increase A like of the ketamine in quarters abnormalities Finally, results and we quarter quarter second care significantly top-line post-op summary, III cardiovascular analysis this in did we of and catalyst MDD an RELIANCE top-line next at current remains half second potentially shown adjunctive from expect data from of I from the the third versus first – RELIANCE

to hard to In noted, remain like grateful executing work Relmada the in strong in operator, as my their and REL-XXXX Importantly, advancing their believe, questions. up on to to possible. our call are clinical you the thanks as and therapy robust this sincere Maged the the will for mission. I clinical trials team expeditiously by extend for open initiatives R&D dedication important supported up? can now please our clinic for involved participants as continued partners the would efforts balance a closing, open I sheet. also I we to And

Operator

Andrew is [Operator Tsai with Please Instructions] Our question proceed. from first Jefferies.

Andrew Tsai

for I medium it study. noticed on the notice means noticed the the Thanks abuse questions. secondary little guys additional increased Congress, I XX. for I Great. my taking shared state at oxycodone secondary endpoints, endpoints help Okay. can at for you scores at that while a the also the esmethadone NEI liability is some

were it’s time, kind felt did you question guess, you So, same about I of who was my I like – interesting. at of that. ever out talk just who the What maybe thought not that But what it’s outliers I was VAS scored score were, the or I like then, part second find CNS that high. like, exactly you of is, because wondering if I exactly feeling them of in but terms Thanks. they feeling confirm definitely can the high and higher? mood guess, euphoric were And effects. the that, score to anything make what they

Sergio Traversa

therapeutic summarize question. details the I old the and that all difference the both secondary data They are dataset dose week, difference massive that we six CNS can be from – at the point just slight would that there. consistent endpoints. Well, these Andrew, with expected primary very was inconsistent mood, would published presented the publication product some out they we primary are – of none there the the for thank very that even at is any we as on be the Look, NEI But is marginal the of for shows would between they affect placebo, you, confirm say the times and that from that endpoints. last data dose. especially

on who straight reach just a we the they second question it’s subject answer are. the reach So – so study we complete confirmation. not we out, did cannot – out the after your don’t know On they is to the the really

who So, the some the – questionnaire in the asked study. the various why what questioning of it’s hands we we did is we and look But they limited that so outlier. is set that, they noticed the were or in at the the privacy. been that of in outliers. question site, outliers majority without And the have There are knowing vast – number a has single-digit

feeling liking subjects there particular anxiety from We likeability like and a that that rather drug felt a of single show – could have was was totally reason So but have any don’t number, with bets. over we that that XX% exact subjects. something digit – number to whatever the speculate positive set that antidepressant That suspect been a confirm of that fact in likeability not the for antidepressant any it see a score designed – massive dose they and symptoms was subjects an not some high. to only these the cannot and and score that though we with single-digit as of I’d was a because one taking benefits. not number symptoms it we say, This extensive study significantly. in the them was that’s though third. psychological the may only it of signal, patients it We across first can – different effects, I the can but There psychiatric, rapid-acting in – these was patients made was subjects remember not and of

your I So, questions. I hope answered

Andrew Tsai

Yes. knowledge than more I Very think.

Sergio Traversa

is. It Right. It is.

Andrew Tsai

Thank you.

Sergio Traversa

Well, these X I look, to Phase questions. the forward will answer look all data. ketamine

Andrew Tsai

the of one have X depression Phase in is, Right. first QX. I And studies, the Phase hypothetical did speaking monotherapy X data question

rate your say on question not maybe effects, which XX studies? I guess, it doesn’t would why So, efficacy, rapid next hypothetically, date adjunct show show a Phase to that it I hit negative day then, be to doesn’t if be it X should happen the or

Sergio Traversa

Well, know could hope X what happen, we have only Phase way data data first And seen we we that drug the outlined. X. we have that confirmed Phase is we the that that

there is that So very, signal. is efficacy strong it doubt a no very

show confirmed repeated treatment is to potentially it fails signal that even and So synergy that some as efficacy not or a form only and monotherapy in current be or the reason existing in could if the NMDA. there one is of between

to the as that not well some I we you that doesn’t But, as that’s So the this, going difference case, that adjunctive me would not – maybe not it work versus treatment I if there a domestically that treatment that’s monotherapy take honest, ask believe taking by too is believe that be monotherapy. reason be would one because drugs can a would case. chance to there well don’t monotherapy directly to reiterate, adjunctive but correlate the the that read we adjunctive that the I work in the as in not two to

Andrew Tsai

Thank I X Thanks. us one you. of us the are would minimum can the question, adjunct studies? to you versus And endpoint quickly what can see? remind minimum just XX, MDD study, last which the you – to then Very placebo be like just similar these more Great. is you separation that very the So, kind would monotherapy guess, primary assumptions time? day for Phase remind

Sergio Traversa

to versus designed more placebo. can X, – it exactly adjunctive two one all the Phase two with is for of same straight And a the plan delta I same MADRS a point monotherapy. detect the score the is in three the This give you statistical Yes. answer. The

statistically statistic significant. points we the way delta, So, hit be three been designed, studies. has the will That’s the if the all two study

that a delta Now factors the two two to that is as potentially or looking the of products, lot rule points, get approval, that, clinically meaningful in are at is in of I it an [Indiscernible] meaningful. approval. reason is the – But other should be even of the that have an rule everything, Professor published monotherapy with efficacy, point adjunctive like FDA that deserve could not points looking but like point terms clinically of approval for guidance, delta a believe depression thumb Therefore, is number because thumb the There the same, potential X.X approval. we it’s is should doing approved at something are getting course. becomes it deserve two correspondent should of it the we not all saying what therapy for or or are treatment resistant that not to an

ask we delta. eight point So,

So that’s sites. patients, Phase wanted is more a We it more lot liability, and conservative. of be t X we more room know that

we we that show So, left something But it. in we be of with have the some X, it Phase it the one-fourth will way go would significant. seen statistically if be for still is still room doesn’t like efficacy we –

Andrew Tsai

Perfect. Sergio. you, Thank Okay.

Sergio Traversa

you, Andrew. Thank

Operator

from proceed. question Suneja is next Partners. Guggenheim Our Yatin with Please

Yatin Suneja

guys. good Maged, question. to hear my voice. your Hey taking you Thank for

a for me. couple Just

Maged Shenouda

Likewise.

Yatin Suneja

separation And you label the study then, are one to that you regard you on has all understand, then With been couple like then, file? X, going Can hoping sense ketamine to that, Are So placebo strategy in this just study X? us type ketamine studies just be? question think Just about happened And help do Phase that a to three And was you you then, get? to get how the the complete with make but a to exactly trying going the is are you which first understand earlier the and to the doing RADIANCE Phase your FDA? of to a III being us RELIANCE. and questions in to terms get it doing. filing which a conversation of between study? the are the arm can led upgraded now what X, Phase on not you what of sure in you did help differently

Sergio Traversa

Okay. insights. Well, questions and for all the thank Yatin, first you, those

a program traditional that we that’s uphold and the not pivotal was XX of does proposal moving for conversation So not Phase making that the this actually that a study. with we XX, has we the that the FDA waited the have in question so and the sense have days, monotherapy the become what Well, signal change did. study in filing first plus, we did with FDA or XX send usually what anything the X the the a

didn’t until So, we from end again waited we the of hear then, August and FDA. anything

the a make we it difference. was same. the was product not The So, exactly really lot There X. Phase of

outpatients. in the has X. what study things instead HAP change the problem. that to And think comfortable on shows one So July could carcinogenicity all question lipid that the that FDA there tolerability with the that no an two years like is now and from patients, changed and to Phase safety The been have somewhat things, the was is of was in make FDA or of Two issue then, us the the with that, TQT drug. study the FDA believe XXX abuse the feedback expand the a the do trial we

FDA we that we or we believe together and comfortable, efficacy in all as efficacy data data is we the have data have monotherapy, don’t adjunctives. took single a So, some is the do that very relatively is safety there no that any could not risk well, comfortable, put said, know drug you shows that monotherapy different but from has that although the these any

illness that the Phase it X. Then and about relatively but to in are And We the we we was in and that had and very initially saw abuse we then then, also X thought they proceed works. data so, comfortable. positive the some FDA reason the Phase

why it moved so, Phase that’s study. filing – regarding we make X a to we And

was… question second The

Yatin Suneja

study placebo time between and It differences was ketamine sure on at this the make this and the the to ketamine, study like the separate? the arm past

Sergio Traversa

the qualification is the our thought placebo control. unsuccessful it not the very as did all were No, the yes, had no, But the work part ketamine – study that’s ketamine, of almost half ketamine. that failed bioavailability a we in poor – study. they were first simply of all our reason the our patients We taking was – they and was taking

So, at would we a with ketamine. what & And this, using of study And Johnson are rich the ketamine in look. kind Johnson that gone product. not we an now intravenous look has

XX So, report, infusion a it’s kind that’s works number that as I standard I mean, million believe and a control. of certainly

there data, the – that nicely, control has no if and been the And regulatory, looking correct? So, is doubt track. the forward the work. progressing will study Look, we have fast

rolling have not and Phase we we kind all are we available X Probably believe file file the other, do away together. that too we to one the like the file And file other. the Phase the a the So for if the we not they month Probably, NDA. for whatever you are rolling of efficacy far to will II planning from a rolling and to clearly have with maybe will study RELIANCE studies the the NDA is standard III, and pre-clinical module decided that the NDA, X wait then the really I and do one CMC. do – will final like is usually for the there package, plan

standard want So enough to FDA review and more time CMC the we preclinical. the to have

we us won’t filing. do the will they if would there to more, have FDA, delay So anything the We that time. like is

Yatin Suneja

P&L? the in Got it. Maybe so rise help mean, R&D. steep for Can I one with question us maybe Maged. you

should how model non-cash to year year? that how this can trying in then, of the this was you. we the get then there? And sense Thank and Just next much next in – half XQ a

Maged Shenouda

Yes. Yes.

and funding for So, non-cash would SG&A for thanks the the $XX.X line remainder for pointing but just XX-Q year, quarter, am with have going operations was which expect we you and to continue the not the line XX least relates say, guidance, are $X.X at question to I file the believe for to that, we with million components expenses question, R&D With million of our that to certainly, months. ability and regard Yatin. regard R&D the we to of to And tomorrow I the sort morning. to forward ongoing sufficient we meet for giving our

Yatin Suneja

so much. Thank it. Got you

Maged Shenouda

Sure.

Operator

proceed. Our next Truist question Please comes Securities. from with Lee Joon

Joon Lee

Hi, included and And fact this thanks up ask. TRD I ask thought also the updates reported just ideation suicide your patients, the that you I for given for TRD another as it’s Did questions. come would have data thought a follow-up. I your question I taking see to Phase study. for trial? company for any that have X, in our And

Sergio Traversa

Yes. you that come. these Joon. Thank you, could – it wouldn’t Thank questions

at ideation our Of reduce on ketamine of and form we that know only was release suicidal ideation not released the is and study. – a antagonist, has suicidality We days seen straight We course, the answer so, running nasal do the for look another believe ago. our competitor as we more if working is at the are to suicidal few there and reduction. in a ideation look is supposed data the you that trial not been there that press that NMDA the attributes, are they they no, that any any what nothing in than of have that,

is ideation antagonist to supposed they NMDA be specifically syndicated suicide. for So, are for reduced specifically there

process issue, one is year of black it box development because taken – a and And the, Now, the suicidality. And you and it Look than a is right? program in launch it’s on. that – we if an was do of increase when a showed out it side-effect, the XHXA remember, of is observatory. I you have less way under fifth this, surge

– specialists. a are high right into there yes, But we said, – dose speculative. silo be and if are that different these with look action. these depression. So don’t not With was as we it’s know, – it’s When And, of it’s We mentioned, one. you mechanism all such with so a few drug abusive, take of really IV totally speculative. look it’s spoke patients this could so, XHXA versus a

So, how enjoy. – not they trip, they they the something don’t want to have it’s the and right, cycles that to call, take

for [Indiscernible] resistant and you take heavily have in-clinic than a of an it’s are you dose That’s you more treatment. are treatment If confused. totally you depression, depressed, few minutes, why massive

in and that would are acute may But way that. suicidality. right if Basically, during it’s early phase. you issues too just into you start So, of I thoroughly are after much the some read too you on not confusion, moments depressed speculate. the believe And I to it’s working, have and

Joon Lee

But saw study? a sucidality being an also monitored your weeks, patient you was for two in-patient X that but by Phase no

Sergio Traversa

Yes.

no, issues have We suicidality. no with

Joon Lee

Okay.

Sergio Traversa

expect. don’t We

Joon Lee

was what within and is, And stats is say why but the say And dosing the of as days really by then, during which any dosing. we and days trial X symptom day of using were opposed But showing how like the dosing seven include last academic is circles posters during X physician follow-up think intrigued just day question the stat not period? to at day circle scale I the FDQ which was was speculated do last later, later used? it’s significance of you period versus FDQ the the that or FDT,

Sergio Traversa

answer I first question Yes. the first.

there, – they go home and and in a we as terms had the bit patient when to a when report when fact so questions they – symptoms feeling questionnaire and to and kind in second of MADRS Sorry, realized and control. you’d are went quicker lot they and then, self-administered The day they from anything to question at taking actually the the the that come the they patients more is depressant home without time PGI, are are XX little they slower of ask the first. react the better clinicians the

XX there it’s of and slower the we course, and – is – so, because – is SDQ it’s was PGI better patients of some not to to that at to So, had X. than usual get are a used not the symptoms compared having MADRS response the The they that reported patient believe reason day there really to time day need reporting is depression from just that. before

the sorry, And –question.

Joon Lee

Oh, the by SDQ? metric at they used no. it that academic physicians pure how of Is is it the use? the

Sergio Traversa

was Eminence published it in believe I Well, Academic.

do MADRS. From all another believe correctly only know FDA previous at approved. found somewhat don’t for with MADRS that support So, but they the likely, the something. consider I do But will it’s – It on right, wrong, I everything, CGI conversation FDA, the they look similar. the MADRS based and a believe I what means these most antidepressants

the try into of don’t you that would you if with okay are MADRS, with take and different to think Right, be we CGI. endpoints it course, play. – so the So, okay

We – are FDQ you the correlated. – correlated. but playing, strictly said, the not they is not are strictly

So it there. meaning has some

be results good get from – You to the MADRS. have

Joon Lee

you Thank Yes, you. much. thank so

Sergio Traversa

hope answered. I I

Joon Lee

every good. pretty that’s Thank to next And yes, quarter data you. next other forward Yes, – year. looking

Sergio Traversa

you. Thank

Operator

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

Andrea Tan

the first Sergio, run on comments for results the the submission. for just a Thanks NDA second to use support trial one, the need plans monotherapy you your Would indication? question. follow-up RELIANCE or for a to would that on rolling approval taking III picture from

Sergio Traversa

enough to to afternoon, question. good going would it’s study it’s would these the the underneath. If work. that If be studies Yes, I this. say think one, have study, then an that are all the monotherapy way, our Andrea. upon positive, I By do be don’t get would three opinion, only so, believe a good – The positive indication commented we FDA

to at So have least run another one we as will monotherapy. a

that’s thinking. current So, our

Andrea Tan

just seeing could Got commercial in approved? then, I comment on in II that particular, of reflecting with it. RELIANCE And the REL-XXXX do play dynamics the this enrollment readouts. any way trials see you that’s are if in timing those were you delaying and you what And one could if

Sergio Traversa

as trial. a simple the Look, quality Yes, little do longer complete why of this the you to mean, more the it adjunctive. takes is

have with of patients be – lot pay the quality want a the really lot attention the We lot first. – to a we of of we of

failure that would patient patient, want not don’t patients And pretty definitely, the But not. not but know, treatment. of be needs will mean, depressed respond disorder And screening but selection, that’s anything have XX%. is we or have I a is so, or we to that an personality that antidepressant there appropriate from an does rate for selection sure not high not the about and be

of is not So, patients that’s enrolled, two one because not qualified. out

but very we sure of exclusion being focused enroll inclusion focus have also is and we enrolling that on very criteria So, safety on course, don’t everybody. stringent mostly easy. And

we lot criteria for in is up what the as is. patients of and but monotherapy but The it want not ramp exclusion study, adjunctive, want effects what But, an can because and very to drug that’s faster, bit it are the you program, little want the do. the – is would supposedly more the and a to time. just you very, September inclusion reflect takes conclude the the that that’s the a If it we more selection study We do quickly, our that see same as industry. is patient

Andrea Tan

Sergio. it. Got Thanks,

Sergio Traversa

Thank you, Andrea.

Operator

proceed. with comes Our Olson Jay from question Please next Oppenheimer.

Jay Olson

Maybe follow-up own Hey, TRD to for the Arbormentis? an us the in recent give see program psilocybin for that results congrats from of Do you can on on just questions. thanks TRD. progress competitors’ and status you Pathways read across your psilocybin maybe compound? the to on And study from COMPASS in that update any the taking current

Sergio Traversa

sure. no. prospects the much forms you. different on go to works Look, siding. of our that you, silo base any Nice the pretty if Yes. is to The from correlations, Thank silo siding competitor Sure, is Jay. every there the the on hear other answer program

an We are to is end expertise high diseases and so, our similar we rates agonist results psychiatry effect of regarding to much DDNF effect anything at not similar the of and a on neurodegenerative to depressant pretty leverage antagonist. doing the NMDA the and neuroplastic want neuroplastic castrate, in an now

from use lower that to our that to get science So, and whatever you neuroplastogenic and effect – of we what effect. that hired competition the scientist not they psychiatry. neurodegenerative the the with do – in like get the we to that enormously diseases is And leverage compared base but want works to dose need to [Indiscernible] believe that of have our actually it’s scientist, a

So we neurodegenerative psychiatry for lower not chronic diseases. with and and treatment go much for dose

So, that’s – synthetically produce is the I straight easiest are much, and other to not not talk working answer do. compound or between on don’t it - The we Believe it is, doing, what status, are manufacturing. too no the the we the if what certainly there is correlation but. companies know, Maged,

chemist. own generated proprietary designed and have a We with our synthetic freedom

compared would agrees, especially, especially safety the FDA for is of low a so, are to two dose. working about other like data parts, to are dealing the we pretty the at we siding, through easy one dose molecule, package use now siding silo to of manufacturing and players. that’s with the settle, sorry, FDA, And And problem going leverage we if the because on very low right the silo is sizable course, we that would one silo like all the we siding, safety the

definitely next if we so, the FDA we in second then the program face REL-XXXX. theoretically completed probably massive be half – of and And of this sometime theoretically Honestly, year. agrees, busy very can the manufacturing will dealing with then straight to go safety are in

is is siding not So silo going, it instruction. the but

are is believe. the program So REL-XXXX if chemical the – – see to And data, of a siding second the on the sort focus Phase things on X of to in FDA be sometimes Phase silo siding, But second half is skip, it’s derivatives then we manufacturing next preclinical of and the X that plan agree we well. part the will focusing do we the be as to silo things we if will is to entity. do to And FDA done. the the up able new year to as focus could when whether

that’s a full development. fledged So

are from siding more than I now. So, could. we – some But believe earliest we the siding very I – we the through doing the we silo will but in hope silo vitro as start and start that will have answers animal it’s you. we studies synthesizing now

Jay Olson

your Thank X just Can on great. That’s comment you about when trials? what forms super and Phase you that studying maybe thinking are particular that’s of helpful. follow-up. very one Yes, much neurodegeneration you initiate you

Sergio Traversa

try. me Let

a we say, focusing nerves diseases try on so me of yes, - there is the acute nerves. damage where I damage. – without of some Let would are

and right, doses – nerve, the it limited and way is up there we we the that recovery if or measure of and - silo the the the So to damage is could recovery. very safe recovery up potentially, if of a the speed speed at of are are siding especially using,

Jay Olson

update that. wouldn’t So, more than

Sergio Traversa

so. FDA, with be should discuss that’s agreement we to to will that we, How of the we what are we But the want with be want plan. are We or much would there discussing sure pretty do. in

So, reduced more that. attempting nerve improve and damage and improved recovery injury of for acute to the so,

Jay Olson

Great. That’s super helpful.

Sergio Traversa

- – of it course, indication be the for can it’s one important but an can acute happen That’s it nerve it, damage, I yes.

Jay Olson

spinal cord or stroke? the Okay. It’s injury not in only

Sergio Traversa

close have get spinal And injury. cord and that. XX never cord injury, been No. Spinal involved to ago I years not

Jay Olson

Okay.

additional Alright. Thank Okay. I much. the appreciate so Great. you color.

Sergio Traversa

Thank you, Jay.

Operator

at there for to Traversa this time Ladies remarks. questions and you. call turn like gentlemen, back I’d to closing Thank further no Sergio and are the any

Sergio Traversa

us Thank operator and all you of today. thank you, for on well, the joining call

with advance. you and the on We readouts are ahead the will clinical to activity months. updated important our XXXX clinical lie in coming pleased keep many excited progress are in share and to we program recent REL-XXXX you development the and W about continued of us that catalysts

your where – – we believe be a Next I is know we a of good potentially or can a enjoy rest believe all be have and lot you on drug would you. not. very day. do Thank that we the helping again drug And for – really and call the year do have joining at do will if people. it we the drug of Thank a

Operator

This concludes today’s conference.

this disconnect now your time. participation. your lines for very may You Thank you at much

Relmada Therapeutics (RLMD) 12 Nov 212021 Q3 Earnings call transcript