RLMD - Earnings call transcript Q2 2021 | Relmada Therapeutics, Inc.

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Operator

Thank you for standing by. This is the conference operator. Welcome to the Relmada Therapeutics Second Quarter 2021 Earnings Call. [Operator Instructions]. I would now like to turn the conference over to Mr. Advisors. LifeSci from McCarthy Tim Please go ahead.

Timothy McCarthy

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

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

Sergio Traversa

today's will and opportunity candidate on to comprehensive always, I'm market an XXXX I call, as pleased highlight depression for compelling substantial afternoon, for Tim. upcoming you, On product and milestones. of development to product this our adjunctive everyone. treatment the candidate the welcome update Quarter provide lead Second Call. Relmada's Good Thank and REL-XXXX, for review to program the Conference

indication. in the Following acquisition reiterating With I begin of shared or rights the line Ence, review the over last evaluating the will Accounting to human Compliance by potential active overview XX oxycodone turn then study, the results control. milligrams brief of this, psilocybin Officer will news and development provide call I as abuse Chief the commercial a and our derivate I'll a to recent that, for a of to financials. HAP of and neurodegenerative for versus significant week Chuck novel program our REL-XXXX top from

As many the of isomer esmethadone, REL-XXXX right-side you known know, of is that dextro methadone. already is racemic as also or

work this While the conducted a there a FDA relevant Agency, statement data lack from including clinical published opioid effect, Enforcement support it adjunctive the an for drug guidance for as REL-XXXX or Application, the active treatment and done MDD. is Drug NDA, as package CNS per DEA, supporting considerable very of Drug for New data our is existing clear to for we commonly comprehensive

the FDA the results any Importantly, The abuse guidance dose. were taking XXXX the for therapeutic REL-XXXX doses the global endpoint and the dose with those endpoints. the REL-XXXX, results significant consistent which confirmed drug again line similarly rating statistically statistically the oxycodone primary overall showed desire of those is maximum doses, XX in which of with evaluated versus are in XXX X specifically, the the and secondary difference demonstrated all Notably, tolerated for highly placebo differences Xx was of scores that They versus manner demonstrated results a potential followed for were highly our endpoints, the potential. liking was proposed highly results at the unscheduled, IV designed all is meaningful milligrams. or for between REL-XXXX oxycodone was evidence control statistically significant users significant Top of drugs demonstrated the of of More of abuse consistent recreation and opioid Scheduled Schedule included study primary that drugs. the a approved difference that active milligrams on of V. that and the no assessment

important liability NDA results for of addressed are in The have establishing as abuse overall approval to [indiscernible]. believe the potential concern a of REL-XXXX. active by that opioid that the data inform secondary study the FDA's residual also is that We further they results FDA and the view for any endpoint strengthened future separation the scheduled human clear control regarding new from risk collective these

in joined Dr. session. program safety is placebo Scientific drugs approved, note to be pivotal I participants. novel -- of the XXX will National those to across the the Gorodetzky RELIANCE that both comparable many from sister well long-term in Abuse which study, we RELIANCE, Q&A better Dr. includes or Institute RELIANCE per were by In regard on provide V placebo-controlled X-arm, now which to by Gorodetzky participants of also today of Drug rollover With available I II, as as of Charles have are Research which will to REL-XXXX, It update will the the IV. for study either REL-XXXX Schedule during Addiction participants Director like for again to X I and Former include HAP an Phase pivotal answer comparison any is would study Center. the ongoing questions XX been study enrolled that consists addition, or achieved unscheduled, the each open-label sets. the the Schedule that, RELIANCE-OLS, study III results that FDA as in

filing minimum MDD, already arms, existing placebo of to treatment studies antidepressant as milligrams for depressive and XX designed standard endpoints are first RELIANCE-OLS, the safety of part these and and half next participants, is study at secondary safety reminder, disorder, also the planned. to treatment long-term the include Both antidepressant in label X NDA of participants year. the evaluate top are is X be up adjunctive a change expected in REL-XXXX, are both Key endpoint therapy. for an open with as at who the study, a RELIANCE Impression top long-term on X MADRS score includes this II primary XX. X enrolling I at REL-XXXX tried and day of Global Data XX. which will change severity change As from or day MADRS day The and data ongoing progressing of Clinical line in unsuccessfully package. have major in and CGIs, score RELIANCE the

of In the monotherapy addition, dosing we as for to III have MDD. use REL-XXXX started a evaluate in RELIANCE

most II. conclusion significantly We between consist to reminder, diagnosed and the the planned are ongoing the a prior study with and monotherapy is RELIANCE anticipate who As depression RELIANCE study standard different of the trial and are will clinical of I completing study The individuals not this therapy. antidepressant this taking MDD population. currently

an one assessed which planning effective control second an for is has established positive ongoing. study. in REL-XXXX history potential our on, intravenous and versus as abuse Moving This human ketamine,

passing recruitment, of the side We antidepressant safety results of by any months Based potential a enable profile, suffer profile efficacy favorable of potential agents switching be date, has do therapy and I Adjunctive line including MDD year or and when the suffer call in to not without are Moreover, patients broadly to adjunctive therapeutic of approved in treatment indication. FDA the them the the all currently a neurodegenerative there clinical his sustained on of will of next based options respond commercial acquisition approximately oral Chuck, and first treatment current Phase this require its all are current generated then antidepressant crucial million to wanted of I treatment help development novel of recent moment FDA-approved significant are limited to therapeutic for drugs Chuck significant, for other couple the data study antidepressant be option they and to all individuals X for have the XX% respond and well first and expect a showed to end our X, of but patients. statistically the with more can requiring potential and precise top antidepressant not effect to significant and change it's because touch first SSRIs of speed program rights X those MDD I'm take side do are REL-XXXX the of financials, Over X are collective only to the II the over they the who enough. and from of on effective the these other on new to XXXX. this for XX XX% a adjunctive believe the antipsychotics. time of oral positive treatment these we and weeks reaffirm withdrawal up and with yours. challenges, that to not results the Traditional in and U.S. effects. the currently, timing novel mechanism the now approximately Depression options take antidepressants. review common, the Despite that tolerability effects. action rapid presents. show to patients that options quarter for to on is disorder. the many need major psilocybin derivate will depressive a for results REL-XXXX MDD MDD. And of

Charles Ence

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

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

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

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

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

For XX, the share diluted short-term June and equivalents a basic the million share $XXX.X compared net June per and of XX, period or to XXXX, $X.XX X million net cash compared diluted $X.XX XXXX, On we company per in XXXX. million XX, of $XX.X XXXX. million basic comparable $XX.X to or and investments on of December a of months the $XXX.X approximately had cash, recorded loss ended loss

XXXX. that the expect the of data progress. most I readouts to for us hand first Sergio will on his remarks recent through continue position anticipate back through the cash further the at Sergio? multiple call to now will We we least half support this strong

Sergio Traversa

Last and Asia derivative to and ex to psilocybin territories, from and announced our expand outside studies development REL-XXXX. leverages potential REL-XXXX rights you Arbormentis program bear all agreement you, U.S. of with and focused will program the Europe. particular, our of commercial development we Thank At at our psychiatry. month, time, recently expertise into lack this and another is further Chuck. too with including program, same of acquisition for but track the we competitive the of complementary this the importantly, date the is disorders, distinct we'll of study confirm but focus program development share we REL-XXXX and that expands to us, pipeline on can cannot about psychiatry. our to and neurodegenerative share remains summary, body for the program, were which from much what in and of in with reasons, results In the extensive is This derisked mechanism work on the core indicating and was HAP/oxycodone neuroplasticity, the depression the indication by literature, abuse time, that consistent have on

a over and long-term the readouts potential have next multiple acquisition commercial data the program. rights added another development Looking and key to derivative ahead, XX we psilocybin and months growth anticipate driver with of

questions. also sheet. participants our executing and partners clinical Relmada able calls. being their any important a noted, my an get now possible. to please Chuck hard in extend it dedication and for our educated effort to in I continued work a mission. is sincere strong initiatives the for thanks the question In to for I by to is it our And are operator, therapy for to credible can supported open abuse to and up? to for clinic would like that to as opportunity, like Gorodetzky would narcotics We the balance up closing, trials robust the can in be and their very remain to there is thank addressed authority R&D call so expeditiously team -- regarding to if and -- clinical grateful one study participate And you on. REL-XXXX the a Importantly, and these the as open Gorodetzky Dr. involved advancing field also Gorodetzky answer. well-recognized of the We'd be Dr. Dr. this And great as to

Operator

Instructions]. [Operator

Marc first from Leerink. question comes Goodman SVB from Your

Marc Goodman

of -- study. who Sergio, your is, people a And had of OUS? there, Phase everything off RELIANCE were with just the just ask no division there changes I'm changes where the can having remind And a -- kind give there's again COVID are curious versus the setbacks just you a at kind program? I there. beginning same us us impact just down in your signed reason curious, recently break planned? it's bunch so some that checking as working there's making just of we've it's the second, sense because just sites companies. III working obviously, you of kind couple And XX U.S. you mean are in FDA the forward moving other box, is And I, of doing clinical of had is I at studies with on how And you with of out so at the sometimes whether FDA. sure on

Sergio Traversa

The first part XX all the are your U.S. Well, Marc. you, Thank easy. sites in of question, it's the

we are a company. So U.S.

Switzerland, with We have high-end and Italy, nothing except very nothing of some operation, outside universities, believe no -- I collaboration the in U.S., like too.

development, How in large Well, for U.S. going? the we ago. but all study -- the few are started so months is is And the a sites the It a program.

now potential We have abuse are actually running finished human X different clinical the we that study. trials with

So it's III, -- there that monotherapy started just a is is then then long-term recruiting. safety and the X it is Phase there

from or about not COVID. will did feedback feel, on timing. about impact the more We right, any major of the any But precise you're of asking COVID. impact We major complaints be the -- the sites the

Now the last quiet. been few pretty months has

of bit resurge. is Now a little there a

weeks, done they the they don't remotely A once so operator really or them happens. remotely, we or that any FDA, -- not is that major week What study, hospital. the normal on work actually in question don't most know They -- other we with these the specifics expect they way question a visits did a from straight So from no is have no the Acadia have know we to no, COVID. go the and in we'll are. course business. I X believe the lot you hospital. both best the for from issue One perspective, X major Axsome. can is months. or approach the X MADRS. go topics your that, done now any programs, readers the they the -- the of the like and what must that the go related division. interviews of particular specific believe next psychiatry our And be we patient be impact to But have -- delays, don't like are not do And like all the X. what more X, in I the specific any general I raised only the to in, might and answer it's don't the beyond our the answer we be maybe of believe No, one the mentioned really Taking FDA. question delay

So did we not I any this or have issue far. mean, NDA of not topic we Clearly, did so an yet. file

when file So we everything. we it We'll cannot NDA. exclude know the

pretty clearly I helping is to a has an issue. is FDA, say, us thing need how benign would been develop in there they product. more the this recognize far, One than So

I been answered extremely satisfactory hope your way. they've cooperative. all I So questions

Operator

next Your from Andrea from Goldman Sachs. question Tan comes

Andrea Tan

for on set. to one you a regarding look more filing III? discussions that be the maybe And this nature if include FDA data color you. with considered registrational data Can are you Sergio, you wondering initial within could the the your provide package? Just of RELIANCE thinking the would

Sergio Traversa

we Thanks, I the a one will very -- to And at will enough. is FDA line is this -- because soon be provide have yet on they abuse any the yes, and data on monotherapy. be will little fresh. this soft for that them The the as data, top to monotherapy, not something have FDA. there look have they the data, is don't we reportable Yes. Andrea, And we question. are the clearly, as

the aggressive have we But would registration HAP -- bit it go have about FDA directly to So and now doing Phase and studies. little starting we trials. to the the animal claim have to be a III we study,

preclinical package population the strong. package pretty and is -- the becoming special the So

we yes, and but to So a from only there have bit expand early do would I give directly answer to be it question a your answer. the answer, The you patients, trial. make is cannot a number difference a because different of monotherapy that but it's registration chance something to too I don't may the the yet straight

some soon can as what on everybody update get what we we and do. will cannot We certainty as we

Operator

from next comes Tsai Your from Andrew Jefferies. question

Andrew Tsai

Okay. Great. Maybe Chuck. a question for

the drug X-factor to the methadone it out analysis. understanding eventual down any Our or scheduling there, of boil will is

liability Or them, seen So relates please. follow-up, evidence are And other And equally relates I was those X weighted? And to as day, of the about some strength data wondering a these I they? if I can the the then it about abuse factors? the, are and guess, then for to factors. end it esmethadone carry What factors as have you you've talk of of the more at does the weight? study talk

Sergio Traversa

Chuck, it's Gorodetzky. all yours. Chuck

Charles Gorodetzky

far the factors you before in in a most on me, the I It's data run this I good liability deal point predictive summarized. Sergio the seen we've what don't have could of but that is to eight probably the at of single of as front looks would they positive, kind very And drug very, abuse the weight be. on predict the this analysis think that put so the gets liable abuse study preliminary market, to that study.

I at one of and think have. study a -- think FDA was good if of liability -- or of like looks would this one recommendations. and no whole drug the very has we of or methodology. keys IV any, all at of done looks deal their is in which because no weight very well But consistent on. low-level specific on treaty look the difficult will abuse follows a positive. was a statistical I They most that analysis either they very V. data Its certainly the all like be with international that will put the like will data scheduling, very that scheduling, obligations a done. So that factors And This The low, look there's recent picture. They that

Andrew Tsai

dose I I a got response to positive," for dose scheduling? of I a Makes favorable highest sense. there to but on your meaning a drug think the shown, so it a know precedents question of favorable "shallow guess, And is, XX my want a ended I it's and abuse about, if I show does second DEA has don't knowledge, just are up know, where, mean, VAS this liability getting the scheduling? guess, to ultimately is that wrong drug positive know common, kind I

Charles Gorodetzky

so antimigraine the and slight oxycodone, there's be significantly show the examples yes, again, think was there certainly control irritable X Schedule here drug that still a that in far and liking. placebo from are seems scheduled even drug it that and is some positive a recommended or Viberzi drug like Handling very above as mean the different bowel dose may within some unscheduled antiepileptics or were and wound in even be even placebo which to significant with still opioids IV. examples difference up where the very did And again low. differences from nonspecific but within very even show I I either doses the for a only Xx somewhat indeed might down show and therapeutic at from

So absolutely I potential, scheduling. it still necessarily for think with low not that there being are but consistent certainly abuse low very be X a very precedents and

Operator

from Joon is from Truist Your Securities. next question Lee

Joon Lee

arms does Where early we you on in And enrollment study, report some I can in then love design programs? would on really used RELIANCE terms So ongoing of you us that before II, for year, the color do the in you from Are you III that line RELIANCE first I second to the doses data correct? and what and getting And what next quarter, half and the Are III to expect a mean? RELIANCE or remind year? RELIANCE top Phase II? next of data that's first RELIANCE study of quarter the is, that. track data are hear

Sergio Traversa

Andrea. a too to because the the make I the them the come have of that answer, answered, I more I'll it Thank to sites. same going, but of as me a clearly sense more And prepared say early is clear call. recruiting. would you, answered data It's point because the to maybe recruitment number is number bit front in we're how Joon. similar Well, the Yes, way way, I in answer

December. XX sites sites sites in very and the XXX. in have XX XXX up and started running late on we first XX active, XXX, already in one So

So XXX is probably smaller.

So have started we a it's also smaller and recently. normal number, size to very

I not So of part the some many, XXX. sites Consider up are vast a but of this running. their site, on good and mean that that majority the and share, XXX

-- we reach the enrolling see safety that say the we number the number XXX switch everybody, mode of when of that or with that because not will it a that long-term is can before XXX, reason automatically maximize on patients. to the maximize top in would the new FDA of comment patients finishes process that in patients patients monotherapy, enroll is they And the I in the trial. XXX. study open including to site and value So they will The still and that is the be right, outcome the finished make major the to of the how also thinking to, are and the

And antidepressant. are adjunctive study, more as treatment much more especially that Andrea. expand new a a are than it exactly something add registration is currently may it the than patients antidepressant that The the and of are same. on But patient mentioned, number a current earlier the is an protocol. naive will difference clearly, with believe willing to but It's that to It as the is antidepressant start and population. treatment. the there only that not to I patients finished to of on recruitment faster patients that we make So patients not or -- we are be is the reason

is but with recruitment. it's -- speed not the of the the answer related of related to on it's satisfactory. my patients I hope number So

on will We update this.

Joon Lee

you still in Got your dose? consider possible useful to you it. that -- want is then And it's higher really Or dose a view, milligrams? for might a higher do think as XX not monotherapy,

Sergio Traversa

or No, we animal the Yes. is patient the milligrams, early and effect. II reduce the in probably the it's to of is studies Thanks, XX milligrams terms placebo reason It's less and we from milligrams effect. effect, Phase XX of that difference the dose. It's the -- launch product at placebo is dose. look harm, side population. the efficacy in same it's just data from different very the optimal reason of Joon. same or not the all in to real tolerability and the terms because The XX XX the very with less not safety

can So two the terms arms believe the we arms the have. And effect, don't the efficacy would is could in the of that using only placebo only XX, XX, number minimal we the have have we of effect not or improved adding of that but increased increase placebo have drug.

XX real that's use of they and All So the it board. across is the trials, XX. reason choosing

Operator

from is Olson next Your Jay Oppenheimer. from question

Jay Olson

separate seen reports Congrats diagnosis studies the differences could. on any clinical seen your pandemic? patients you And question, a the enrolled progress. baseline Have of any versus I published you previous increasing for of had rates in if And MDD the have during between MDD characteristics trials? then I

Sergio Traversa

question. -- the depression. that we of reporting increase the just diagnosed have I for very for think the Jay. -- publish call somebody something patients on Well, big Yes. we been The thanks, spoke in number Thanks on

but that hard an somewhere. I And show XXX%, read increase so it's that -- yes, there are believe, out to number up that's to that like there reports is

the the In see the patient related I they of terms profile with we pandemia, the nature of don't depression don't really are -- enrolled.

I when that's would so And pass.

We have not. don't pandemia exclusion criteria that believe for inclusion with related and and are they I or

I must could to give jobs on how profile probably the the impact these effect, patients And assume the economic depressed you an has don't and with be more it crisis -- some actually would some it enrolled. don't and on profile specific are -- to not love that But see the patient but a like show know I of depression, the pandemia answer, be, than change how I patients and believe then virus read able job-related they itself, -- that relation the so virus-related there between COVID more or that have patient I the been that if the of and depressed the brain, an some there has a effect I impact. be but manifestation all symptoms. So in post-COVID really pandemia. do changed there I believe

Jay Olson

about then what Okay. NMDA talk the and MDD? other differences could MDD? And Great. in between both prefer provide appear cause the in efficacy And GABAA mechanism onset to of rapid since would you mechanisms versus physician to one a

Sergio Traversa

a Yes. kind opposite the is end is other good towards of one question. going same and Yes. one also Well, direction, the I right. the activator side, from That's but an an believe inhibitor. very

true that in physicians the efficacy and so a the of mechanism we believe the depression to of pretty FDA -- drug safety, GABAA believe improve have that over is that want it keep and is will take if long a but stable for NMDA while efficacy looking then is terms Hope can it's being opposite. chronic also time over you data a prefer -- the at this increase different the answered the then question? terms So you does efficacy NMDA I And the is strongly just illness, time in your to the available. what biggest or Probably difference or the in time. that the that the mechanism. tends Probably

Jay Olson

Perfect. Yes.

Operator

Yatin Suneja question from Your Guggenheim from next is Securities.

Eddie Hickman

Yatin. for Eddie is This on

what the on [Technical RELIANCE more modeling specifically of the here? powered give Difficulty]. effect be arm, how what you placebo sort a can of us little placebo you are -- trial how So are sense is some a could And

Sergio Traversa

could of like XX but Eddie, I know first question. only the your hear it's if I just don't seconds me,

Eddie Hickman

now? better me hear you Can

Sergio Traversa

much better, better. much Yes,

Eddie Hickman

Yes.

Sergio Traversa

asking question the the about You're power.

Eddie Hickman

Yes. Yes.

Sergio Traversa

be I'll happy do that. to Sure. Great.

size assume remember it So the data, has around got X.X, as I with that the approved. it effect something Prozac and was Phase II size, that definitely about work fluoxetine -- X.X, effect an X.X. I you

has. we effect what an have size Clearly, although REL-XXXX of -- So was Xx take didn't of extremely drug, Phase so don't we we fluoxetine want believe the -- effective to we -- much kind want II the to risk. in too

from reasons. size we effect from So across conservative III the clearly, only wanted -- having very Phase of using, you of of make it clearly X material a and should of -- in II Rule loss Phase arms we the board. makes a instead you to a of adjusted assuming size difference. for the can loss thumb for Phase this so like program the be make effect that X of even conservative. XX% variety can when size, the be about But in example, Phase be is to lose go effect assumption III Phase expert II, III modulated But coming -- some versus

-- in had in So we that we we'll about we II. the assume Phase effect half assumption, that statistically the size have

So That X.X conservative. to relatively be X.XX should to X.X.

Eddie Hickman

of antidepressants? naive then there period And of their I study, the certain washout patients? last said, on are Or like Okay. treatment a these monotherapy is before sort

Sergio Traversa

the there are washout Yes. considerable are But I can they -- to do trial. they how much the is before into get I of to mostly they I believe of don't exact before a time they they can believe the remember have pass into allowed get naive. amount time trial.

it fluoxetine, As now that my on known, not a working withdrawal but significant they effect. when known you know, was is was it pretty well have SSRIs time I

have depressed, to a gets want you the from to thing into withdrawal last is patient do only is not SSRIs. the that effect So

I when an or give months offline. it's like that before the it. they remember. it's -- you not believe or It's antidepressant have to months exact But not week X X. can a I So that taking I X something be clean, like, to number believe don't get or I

Operator

would conclude remarks. for Traversa Sergio the does to to conference like back the turn This any question-and-answer over session. closing I

Sergio Traversa

thank on Well, you for joining operator. us you, Thank the call all today.

progress REL-XXXX with and are pleased It and continues We clinical recent -- program. advance. have pleased with to our the been are we pleased we share you to development

We the keep clinical you joining Thank you, XXXX. results us the again, on enjoy lie the the call, we'll of and the and rest updated important are of that through on activity us, and for day. catalysts ahead about of you. remainder excited Thank

Operator

Thank This you. conference Thank for does the you participating. conclude for today.

You may now disconnect.

Relmada Therapeutics (RLMD) 11 Aug 212021 Q2 Earnings call transcript