Recent VERU transcripts
Associated VERU filings
Samuel Fisch | Director, Investor Relations |
Mitchell Steiner | Chairman, President and Chief Executive Officer |
Michele Greco | Chief Financial Officer and Chief Administrative Officer |
Christopher Howerton | Jefferies |
Brandon Folkes | Cantor Fitzgerald |
Leland Gershell | Oppenheimer & Co. |
Kumar Raja | Brookline Capital Markets |
Yi Chen | H.C. Wainwright |
Operator Good morning, ladies and gentlemen, and welcome to the Veru Inc.'s Investor Relation Conference Call. All participants will be in listen-only mode. [Operator Instructions] After this morning's discussion, there will be an opportunity to ask questions. Please note that this event is being recorded. I would now turn the conference over to Mr. Director Relations. Inc's Veru Fisch, of Investor Sam Please go ahead.
on call may morning. The forward-looking conference made statements Good be this statements.
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do least COVID-XX at systemic breast including patients multicenter, Phase X IV Phase label sabizabulin in in cancer failed in or negative taxane. fulvestrant seek HERX in promising For metastatic the open second AR breast open X/X and COVID-XX, positive, of Phase line hospitalized controlled cancer, that use With trial sabizabulin IIb in metastatic Phase in this and that cancer positive, risk a plus positive, ER questions. now label And clinical double if inhibitor; multinational, expect abemaciclib call negative milligrams after enobosarm II And will Operator? a an an two we have a are line emergency Phase metastatic ER label alone agent; positive, the nonsteroidal combination chemotherapies, plus breast HERX plus study after placebo at II in ARDS. in an we ER in failing combination blocking we CDK metastatic failing open study I results enobosarm an indication. study, an to III triple for setting AI breast blind, a third in completed setting ARTEST that, AR to randomized the high for cancer patients Trodelvy metastatic confirm who III sabizabulin, observe in authorization trial, open palbociclib Trodelvy
Jefferies. first the Howerton Chris [Operator from Instructions]. question And comes with
Congratulations on broad progress very here. the
And fully kind operational of expression commercialization? The impetus formulation the sabizabulin, may then more It additional the what clinical up potential was like with ready more could second go is of two and, to give form. team. I mentioned be diagnostic. to first have for the color what a for work You and reformulate I respect us the have the that question drug? a AR me, that levels you terms for required to course, for to a the little guess related questions just bioavailability in sounds guess upcoming dosage I trials of companion to
with not, learn expectation or I I presentation we learn we to there So, of what of that – the some the cut-off will be will the is guess, And ASCO that enobosarm program, expression? if for respect development so, that? AR will guess, at feature if
on is the The first question reformulation.
study. cheapest you in into give you And in patients you know, start development, with Ib. you pack a to it you that capsule, is and take drug way what As Phase that's do typically drug and the the this their
to-be-marketed careful doesn't – approved. It I lawyers got but so the we've be the mad that that when form what – to is say because the done form we've So, I've got get to-be-marketed would means in commercial III, Phase to use use that that your you have to if approved. the that form is you form your form. that And so marketed, be have typically, it's we the mean
PK out no excipients Ib/II, that allowed work. and Serendipitously, your in we turns the study for bioavailability. answer question, there's in to formulation and oral the Phase further better it for the when the III excipient So, Phase they did put created the the
milligram go? XX XX means the answer raised milligrams is And equivalent the be dose. the some And XX milligrams Phase the to in milligram XX question example, diarrhea that, it disappear. It the grade grade And so, of did dose in the it that's maybe The where that that may for X. is, X, the stays that other responsible didn't we're gut. for seeing, Ib/II, the
one we fewer setting, III effects the benefit that is of So, that that in absorbed. see was reformulation side potential the may Phase to related may, drug be not residual
So, we don't do work. any have additional
one Trodelvy for cancer we're we're the in that in in the will the III in only milligram it against have this for be the going X we're negative triple week, has form that is form. COVID-XX, going III that and version prostate, in using using Phase sabizabulin with to-be-marketed Phase We start which the breast it Trodelvy. using, study also the and combination not And to
get be some you somebody so truly you'll would are meeting often, find targeted better we're ASCO activity every that imagine, happen, to expression exciting to And for a And be June activity Second have targeted they you a has as marker. something that. data in because, what targeted or where question the it say because, support level AR there has to do marker, This marker. to the with to marker. is is for But happen biomarker through a considered to is a this going expression. presenting
expressed, androgen thing that's an more activity being least And result wouldn't of enobosarm present. is case, at the activity. with expect we So, the all better is, the you second the in if be, this anti-tumor from that. not receptor should the And see that marker
tumor support radiographic as be particularly to presentation, – going relates the clinical is is target we're expect to rates, benefit data it the goes truly is all survival, in ASCO so, that, at ASCO reason would AR progression And why if presenting objective as you working. enobosarm free paper responses, the responses, to it tumor
in done. done, don't be becomes immunohistochemistry, a could so, good not to have, that the a for to our it's that But that can likely is active a we robust are can to women able One the means easily want critical thing because of which can us have that the the enobosarm, women most that, response complicated, bottleneck. identify that will that the so across we be in companion in be because blow companion you be that be that don't sense to diagnostic. control. deck be we And favor, can to so a stack world, complicated it going we're that respond putting away done actually we want hopefully, to its diagnostic And
the that's intent. So,
And we're not diagnostic so, a companion company.
And do us for to that's make so, something sense. wheelhouse doesn't the in not
in they're characterized, And us we companion an we be by of the are because we that the over they breast diagnosed, going can estrogen guys – in progesterone companion it they companies, time. diagnostic, to same parallel, meaning the companies some that BRCAX. announce diagnostics. expression, But once work the And both and doing that look done a automatically cancer a receptor, say in laboratories she's molecularly woman for when diagnostic also having for do able discussions therapeutics, is you're cases is let cancers and these know is drugs available over and so, BRCAX them with opportunity those HERX one are the the do to – receptor, this and hell what they've at the those with so will
receptor of of androgen breast the available. the group in is can oh, select molecular by way, the And characterizations cancer. says So, the report enobosarm very initial added be that –
it. – ask we'll You than because be for that available that better for marketing only can't then the a one
population ASCO the learning our seeing those off, correlations because be us just you'll So, cut patients. and this the you'll yes, for be patient we're stuff. that all at excited meeting, enrich Again, helps the
huge that's women of women, those, number women we targeted question your of AR number to memory, Now, those And market. do your you've population half so eligible even in you still of the our may much reduced are somebody had positive. that, the well, if that patients you of reducing be last be patients going XX% will AR is, population. a of really for Refresh are ask if the that
to to Now, you're compared X% and BRCAX, BRCAX XX%. at
in a So, works good from time majority a I the the that make patients would of standpoint sense. having drug think number of of
to I that look presentation forward ASCO. at
Cantor from Folkes next question with the And Fitzgerald. comes Brandon
now. urgency well just is degree business? Congratulations firstly, on and well to your all capitalized you're Maybe, what the progress. female of continues do sell to Obviously, condom the
missed secondly, combination registration And II there? but be Phase if that So, the just starts enobosarm I sorry, next color study? this, any then quarter, study this on will a
Your first question is health with business. of company kind we female the are where
we're more a it and And allows product. So, way a one have to me as thing do, you prescription another would changed business any that result, important more sector like imagine, on like you make US you record is to we're like that's marketing comment. and XXX growth. looks prescription again, looks to record let a we're your is, receiving we a product can – we've from a people, as selling public we trajectory is sales heading that And had math realize year. prescription business, in, high a as growth – other selling And is This are us And last the profits, because spend these the the and margins not is the again. business XX the of year announced, people on force We which numbers, using year eating it's almost that it from money a or we marketing because no see year. selling.
reinvested our of money So, that can essentially, be all into projects.
of run that's all is these strong. why our projects able we're And cash so, to and
to multiple that opportunities us in I to do these dollar this with goal invest able foundation, be so, platform and to be multi-billion shareholders shots wonderful. the is able to this want And have on to think
company it blessed sale. it's excited a takes that flip to very very of pressure trying look doing doing and team do well well possible to when that this. it's has the and been it's do we're because fire growing, a so, not monetize growing. strategy we're off is alternative said, the to it's to of is, when business And able With side a for lot time The your it you're the and best
February, deal get for did resources company don't take have going. in have Interestingly, in any in successful it that want can resources the fundraiser You to to comes in best that a put health to get. the we position also back enough we're deal a you we by doing the that that female that bank the keep because we
I the this for or in best the best, and best ourselves we've strain at any put not – in position the monetize So, to think price ourselves time put in driver's we're seat. best, shareholders
we So, And explore can to stressed we're that's continue lot there's this I activity you not in way we time moving the for from and to that we're options. best a money because a with the what all kinds have do going and standpoint, is, shareholders. tell of of forward, we're because
As it which it – relates indication is your is to enobosarm's second second actually indication. question, second the
lot So, a therapies. you have with There's things to the can combination you of do therapy. do a combination FDA said
make that safety combination in the First to there's sure therapies. is
that's separate really program. a so, And
pretreated heavily to And failed line activity, X/X the enobosarm FDA's and the treated receptor XX% see monotherapy on decided we based estrogen third have thing that, so, easiest inhibitors, in data. we that agents women CDK blocking preclinical is We good have the failed setting, that response, data. a do we
earlier line III. nice with to Phase good it setting. go to a be second move we're So, wouldn't boy, But, ARTEST in in
women palbociclib of less patients the into cancer the crowded that a CDK literally positive line are do or not first treated targeted the crowded because that CDK receptor So X/X of and AI with overnight, So, But, trying been proven. There's a told fact of coming whether getting after they're crowded they it's agent, breast looking an this X/X XX% initially, ER inhibitors, with because space. non-steroidal if do to almost that therapy, majority something estrogen fail? the we a what is lot means has space become were get predominantly is you and space. in drugs which after fulvestrant, are of has that for inhibitor,
second that to setting, thinking II thinking study. in as need in information II is it us a trial. Phase doing, Phase we're the to So, III it We're the of we registration line the confirm Phase a not of we're provide a
Congrats the all again on progress.
next from Gershell the question comes with And Leland Oppenheimer.
on the comprehensive for all update Thanks your plans.
clarification. a quick question, a just Just really
included So, the CDK the restricted keeping to going be correct? X/X with in exploratory arm the be no will X/X Phase had you ARTEST that only for study II? combination Or to well? that you as Your in will ARTEST, exploratory be contemplated is inhibitor that III CDK Phase longer
no. No,
So, every we you so of add another hurdle. III, it's as additional arm, the that simpler, time the III then And Phase exploratory easier. moved Phase an we know, the becomes arm statistical out
just So, which these it estrogen monotherapy clean, [Technical do agent, make blocking the women was enobosarm Difficulty]. idea another that versus failed
diarrhea, us line stuff. It's a And so, against. pre-chemo all pretty it's looks And up women these have would a side no effect setting, loss good an these and endocrine exhausted therapy. it's looks things. chemotherapy. third of control vomiting, good. that go not to and profile like for all It hair And There's our and
going the And do blocking specifically is so, They of look – example, be. us and for profile that to to move agent. of CDK to If therapy great palbociclib a thinking. X/X like spot ribociclib. safety asked you for do you can't if combination X/X going the because one you we inhibitor. CDK estrogen CDK was say things kind do X/X agency our right? receptor name feel you Because earlier, can the a But makes if combination to I'm to That therapy, that's just an we're want that inhibitor sense, inhibitors, for different than, has at in
and palbo to why its first is and is market. of leader the safety much one was is it so, of profile because because used so reasons And the
standard is up another go we're blocking the Phase and setting in against first II can if then why enobosarm that's you line the the with earlier. enobosarm in come estrogen very used palbo were a So, Phase God, in plus second specific, being the receptor in And in ademaciclib agent. going of to time XX% moving is what's combination which – now, my and imagine II we're right since line, which in program,
lot program confirming because line we'll think separate III. third for credit that programs, Phase earlier. good data II program your a kind get of I III just Phase And in very setting, they're Phase to go So, at Phase a for of II then, point, you're
build just essentially, more into some indications you're going But when And cancer, estrogen indications drug. game we'll the than the be we've of then is going announce for the only in there, androgen to how the able to explore done have what the an which program. after prevalent we're and other there'll be go enobosarm is the the later. we breadth to depth receptor that increased cases, breast receptor, we'll in So, we continue to
And get there? of follow sense. makes Any then pattern thoughts maintenance? any up, thoughts of then a an down it, treatment initial at period through those the of on of enobosarm, type maintenance who kind just can kind the patients That on use with stay to they sort may tolerability line, and
trial in the about in are about or talking you're So talking real life? you
No, Real no, no. world.
real the the radiographic to using progress. world, stay they we're endpoint, In on survival since progression the until then patient free as gets
tamoxifen the inhibitor if So, the five five an So, an different patient because it. it's endocrine used or chemotherapy be maintenance induction by followed the used it is How's benefiting for as stable than being be for aromatase it as long being from three chemotherapy patient therapy. for years? fortunate, years or alongside to any would like treatment won't we're
for any studies. patients the in similar almost it cancer. on They'll we a it to – are cytostatic kinase lung And tyrosine to it's do continue of maintenance until to take don't while have drugs so, inhibitors the some even where like
from next the And Brookline with Raja comes Markets. Kumar Capital question
care trials results? how to to And regions, regard factors like the this? in going compared day, to the think impact driving and is you III looks to with do the standard XX XX-day of in you're variability a With that regard with COVID-XX endpoint different Congratulations. are given the Phase also, going what the
It's with to effect guess, a has and result? question geography first The potential on do very good question. recruitment, I
United have in we up. And States, several we're opening so, from still sites standpoint, the US that that in
are You checkerboard, a areas fine fine. know it is some like where not look areas and some become it's almost weird,
that at if it rate day though you we're cases out a even getting And of so, you still still was between and we're have death is look US, and XX,XXX significant. it, the thinking XX,XXX it in a
II we're to given don't that And so, advantage the US. that's how long go. of But position the in take going I know Phase to in
instead picked reasons ICU that Now, of days and we to death. one measure, you fake the of we're mortality. going why pick mortality? because mortality Why – picked did picked all a we stuff can't you which We
if Is respiratory because If a are some a And sickest can variables care, needed because is bed oxygen. WHO that patient days So, other they whether is pretty of couldn't or patients with dies, failure going get medicine respiratory has these of people to a standard There's a count failure or because of in go other these because greater, X patient hospitalized good it into sicker the Since it in they by score the COVID-XX working of they pretty studies. is we're were that your definition, after patients. is determine hospital it easily. many you patients? that respiratory failure, death not. endpoint endpoints the that too use
– as and enough course, we region Mexico, countries I and geographic FDA mentioned, in those and that okay. of Colombia, but and contributes, look and again, at how if even are the hospitals, into we'll be by will think So, we go think other good way, locations, make Argentina each Brazil, always like you it the we
have up in back to Europe. We
As surge. you through to is another about Europe go know,
need to. we sure if backups making trial we by year-end. fill We're aggressive have and this to do we so, And going be incredibly
each because, contribution at I at the point, of the to so, be the of end going we're at and fine geographies, look in the And their but end different think will to we study. terms answer final geography
study be we've beyond the XX. picked if almost not XX want well, And our endpoint, much that out to As or XX every in good boy, information of if a see the it can. that. a But, look we most FDA XX to because capture as that not you're days days would nice at done patients days, versus days. it we we at was looking doing is to was benefit capture by turns oh whether you to learned XX what were XX boy picked days. And going we as It have them day it contemporarily, mortality relates study
so, is previous study, And XX safety really window. our in day what was our
it a XX and longer but XX he XX and the patient to day capture for capture they're them past endpoint XX, respiratory day and is then you is to alive death in want dies little So, he's placebo you if bit able keep idea the at is, failure days in an and day or the group, that.
And so, it will more will is I data robust. think mortality what it do
question Chen The Yi Wainwright. comes from with next H.C.
time Just groups? to for in be to sabizabulin formulation of their clarify, first is the X this used XX milligrams, patient respective milligram dose
Yeah.
study those before, given than study forms. And we XX that that and we those and the prostate the blood in were for learned But Phase the with then formulations at on in picked PK looked Phase reviewed did compared we it'll we've to-be-marketed So, PK II agreed to those it the levels the the Phase which to the the for bridged a study agency dose first formulations IIIs bioavailability doses the we milligram acceptable, be II. data, Phase was was what showed went in in the better agency XXX% that the based what dose formulations. time were III where
what the but Phase we're is be the the yeah, consistent time is, the those we going did using with first level it's drug answer in we the to are going to drug levels be and So, formulations, know what IIs.
the milligram milligram milligram to for the XX to prostate. and is X milligram the XX So, the use COVID-XX XX we be Phase that similar will dose similar in the Ib/II
the trend My with second to trial year? going expenses throughout multiple is, question how are operating initiations the
the first of I question. lost part your please. Say again, it
initiations? operating How trend to expenses with going are trial multiple the
Michelle, question? you want to answer that
increased for indicated expenses that this We've our drug period.
Let me those numbers just pull there.
months all at R&D just these They're going a trials over we year million continue will Steiner and we the quarter this that increase. year. to Again, We're from Dr. on went from to on million. Our $X.X over to add to $X.X calendar $X.X this being $XX.X those continue – that million. increase added were going $X.X six as went call on quarter, for million million. last expense the continue to to going And to
going So to continue increase. they're slowly to
Thank the for this like to Dr. our turn Ladies concludes over Steiner question-and-answer back gentlemen, to session. closing I'd and any you. conference Mitchell remarks.
look investors' I updating next us the I Thank call. you today's again. you. on call. appreciate you you Thank joining all on our forward to at progress
replay conference beginning internationally. digital will Eastern X-XXX-XXX-XXXX The May the Time call in approximately be dialing XX, Thank you. today, and of US available X-XXX-XXX-XXXX the by noon
you You'll access has and be which Thank replay code, your attending the for conference record now name enter be joining. Please when concluded. The prompted to discussion. XXXXXXXX. will company today's
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