Samuel Fisch | Director, IR |
Michele Greco | CFO & Chief Administrative Officer |
Mitchell Steiner | Chairman, President & CEO |
Brandon Folkes | Cantor Fitzgerald & Co. |
Christopher Howerton | Jefferies |
Yi Chen | H.C. Wainwright & Co. |
Kumaraguru Raja | Brookline Capital Markets |
Alexandra Heller | Oppenheimer |
Good morning, ladies and gentlemen, and welcome to Veru Inc. Investors Conference Call. [Operator Instructions]. I'd now like to turn the conference call over to Mr. Sam Fisch, Veru Inc.'s Director of Investor Relations. ahead. go Please
statements forward-looking The this call conference Good made be statements. may morning. on
may not and developments may intentions Forward-looking may or statements but are actual and include, statements are SEC results suggested forward-looking Such forward-looking in differ cause in actual contained and included and company's operations, or like filings. and statements to objectives, XX-K that projected, uncertainties, product those turn business, call statements. our our portfolio. results Steiner, Mitchell of to President. necessarily from the Chairman, any Dr. plans, Veru expectations to risks now its and CEO differ or known are significantly regarding subject materially conference Risks finances development XX-Q unknown to the to, Inc.'s limited over I'd and
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Finally, The we're global in fact is COVID-XX enrolling pandemic. trial a long sabizabulin ARDS. still evaluate hospitalized with patients Phase that We're X for middle COVID a a clinical to war. the high-risk will in of be
have over and we although this drugs is of still evidence for that now, witnessed vaccines need to win have effective war. bottom we effective line over. the We The
use promising we to emergency steadfast observed in authorization we study, continue the for confirm be-- completed of be the X clinical results to to X study. to seek Phase have indication. have the our in execution We clinical expect Phase this If
drug of of trial clinical large of products COVID flow late news away. have In going candidate summary, clinical steady, a committed. is for milestones data. a trial achieving global clinical we We positive and expect premium indications, are stream not we stage market reports portfolio
shareholder call We business, if With the open have the commercial to rapidly we I'll a to enhances growing partnership are possibility now based it that, open a us options. Operator? affords pharmaceutical And strategic questions. of which value.
[Operator Instructions].
question first Fitzgerald. from Brandon Folkes comes from Cantor Our
all Congratulations month Veru do transformed have fair going on company, on. into the an having firstly, just a you oncology progress. Maybe
COVID thinking sell sold, the-- the program FCX lines, you fund what, of the data? you business given any And So and urgency the once see company whether do about funds? you along you have may any just those to those streamline the sense in change to reinvest then
areas we are ourselves first clearly have is, company, given we're Phase there's with and no transformed that that Xbs doubt question oncology two on in track the the into cancers and markets. So large the that an with Xs Phase now major the
very, good it's feel about been business, these looking So not very we're we're in the options, we're interesting that rise. FCX also-- but options-- that. with strategic interestingly, we most the strategic But for
So the keyword that you was urgency. used
it's real So look, in because, urgency million no generated $XX the there's last...
Nine months.
to Nine fund growth, months. all we that we say And stay the of if amount on with bringing trials. our track same of clinical in money we're essentially need
so And at in add $XXX that $XXX burning look $XXX receivable, the million, we've way, million, the bank, million our you number, not $XXX the at to got whatever you look million, so accounts cash. we're we we and if raised cash it almost if through
very what do with that a to in to interesting asset. we're position seat So want the in see we're we driver the
business. always sell be both There the mean doesn't strategic things way, and I allow value So shareholders' shareholders our that do that the by get of other can can option think-- can and the to best we world. enhance
on ball, and So which not to the through and we're eye push oncology execute the no that, it's side. off is to continue urgency, taking working our
I As after or we're said question, it to we fund relates report to your to second COVID-XX, prepared positive when relating results. not whether it and
remarks, drug that in supply. clinical resources and we we the mentioned have I the my prepared have as trial So supply,
and a need study see. funding, If interval. on, we multiple of it's will be of treatment, have do of a that. we're going and and can again position so that population dose, the production dependent though and to to the begin-- to losing very we for not we're going that able U.S. only it's have even that need external the to I So because or level at the going With COVID-XX, I of scale-up beat lot run the think a a in drug a for we at XX-day do to trials you on including treatments mean, we're to we're X you different to because without sabizabulin get be the ready X-day funds are milligram we world. successful increase begun data, a said, interesting
that there's with quickly scale to just step the provide will quote so like the of the as as including U.S. in try Merck situation resources the we for available would can. that So flexibility recently we will to spread be to up required the be drug drug a ideal the government lot But outside saw and the masses,
need that we'll direction to of are so do because, fact win this just some a as the corner. continue vaccine are doesn't-- said, and also we're of X. the that only with not given I guys, that And so drug. to the in in environment have looks great. that we where move resources It the we going turned we're up. we is a I'm conferences to this the and stock to hearing Everything that drugs We discussion But not and thing again. Phase was already care had have we've the COVID realizing they're quarter-- taken I get canceled it starting opening do right think fatigued people positive now that whole with that to this that going the and data
think the dramatically do funding move as in I change for with positive that step people data. will So
comes Wainwright. Next Chen H.C. question from Yi from
speed? is, way enrollment the has The question Delta the-- variant affected any in first the
Yes.
what-- the yes, you me So why. answer you tell is so I'll and tell let
started what's week the hospitalization can't working a and from we we rates now, he's just happening I-- this on got because, we the I these a because getting And him to of when And kind because incredibly person ago, disappeared. me, crickets enrollment contribution have back and trial the we looks, United go of that Difficulty] it's at of Difficulty] of States's emergency-- slaughtered. these we've to COVID-XX [Technical that and the in saying when looks opened death call X, reason ICUs excuse So said Phase the can I look and I is see drug phone a this trial, thing. clinical [Technical you still each call like each it we're lived the
the up see that it's newspaper the gone you So pick to way. other and just have
there Difficulty]. variant the the yes, in the us U.S. variant [Technical in and out been Brazilian So delta the is America, has Delta Delta is variant there. helping South definitely ex-U.S., The already Brazil
hit hard. South America has been extremely
coming. variant ago that across the they're sites in ready like those we look from did countries you that, so ago. the getting on Delta to know X And hearing to we're continue top the that And We're Delta of is X months or months world then variant.
seeing happened So United and happening what the States the they're States. in in United
taken way like release of outside the to the is pulling brought outside drug the to-- coronavirus it. makes that, new cell and as of the and microtubules and it's nucleus that the by And the And released, it works are works viruses, the the urgency. have to viruses mentioned highway the before, an that from So the replicate. to again, and a where I once the to extreme can works interrupting virus our through then microtubules cell into be surface bring interrupting microtubules, required had on which for are the virus sabizabulin it responsible
bus care be going not don't we to So to it's in move car highway gone, out. able a the or green car a or truck, or whether is blue a and you're freely
So of have the our antibody we're vaccine major to that specific that's a very strength I an like not we're the or to so comfortable be going And-- think going issue compound. against a variant.
these variant matter. or some it So coming not that through, or Lambda other whether are variants variant Delta should of
replicate us Phase good have we I spectrum product. an so if that again, if broad type puts to-- the effective to think And of X results, in footing
regardless correct? COVID-XX unvaccinated. patients then are that same got among And whether perform sabizabulin the Got also, Is they those that vaccinated it. or should
a fairness, more you it and to we're vaccinated, the to staying fairness, middle tend a this in very this is again, we're it's-- if speak, you're But good mild so because in very, Yes. have close outcome. question, in war, of to
this that breakthrough. And so the are the ones this the really pandemic. that yes, of is the particular seeing are of you're brunt unvaccinated strange in happening are what's And part
these if it you're to going the variant, though because situation, get are people that quickly, get are to lot even it, same and unvaccinated, going bit. it's then and to we're whole but Delta age, you're And filled you're starting the show of still, so hearing the didn't And that people young that didn't age still up older the they half the a are vaccinated. About of get get vaccinated. with ICUs comorbidities
people we So X. there's that going our is to trial, to with more confirm are going clinical clinical our we support-- to importantly, be but help to can plenty of trial trials going try what saw replicate in Phase clinical through
So that's variant. Delta what the I about say would
for enrollment the it. Got X the trials? prostate Phase this slow cancer Does down
have seen that. I it's made comment we before, mean, metastatic, cancer-- had spreading. with cancer, not No, that I Interestingly, patients, cancer this it's and
see scared. the bit are their had half so Xb is did the when scans. into few have the we first And we did coming and the Phase about X people get a little to we ongoing got hospital What Phase in nervous a that patients
people with that got actually in there a they a an of-- but rare more we we instance. enrolled, when already trial scanner they're and but CT delay MRI, of on stayed a track. Most that looked here little kind was the was So
tell if little now, smack on terms target, we're not in is and enrollment. so Phase of that sabizabulin a I open target enrolling, and you ahead X And can of
problem. then inbound getting COVID-XX, we're get calls. about calling our of was your far, question have the a U.S. nobody in sites changed no us, dramatically. there's couldn't-- crickets. seen before, like And to point said, for not that's returning interest nobody that So we lot We was before back was it I But
to terms we're enrollment. line finish And that in will so get this the of us hoping
comes Brookline Raja Markets. question Kumar The next from from Capital
the administered. for of see upticking how difference in on based also completion the of either dosing recent by the So COVID-XX any end efficacy year the the that does trial, regard with cases? by being or orally the in you enrollment drug route, the is take to And of nasogastric into consideration terms do
Right.
So nasal-- I'm answering the second first. question
the So we you're asking in problems capsule finding or administering the sabizabulin are setting. a being that in drug some ICU COVID-XX
they like using administered either nasogastric tube. be are looks the can orally It
yeah. So,
exactly. yes, Yes,
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it's we-- a problem administering orally because the capsule, NG in and so tube. an capsule a either through or with it's powder had And we've no
So fine. been that's
quiet relates our uptick your to a we other we'd As in the it meeting filled year-end the by then thing get this and words, and goals. said question U.S. about In
in must X not admit because nervous after to But numbers, and because the just start I daily U.S. the picking was certain weeks win nervous have component are the average the up, now hospitalizations it have cases we a So a I gone-- on XXX,XXX picking U.S. were mean we're we getting deaths up. look new way. anymore has at will
just-- a it's the predict and unvaccinated now patient, now, can gotten And it's to the not-- fourth playbook. going so the than to I patient entering wave, we've vaccinate to what's other point that happen, is we mean, of the kind always following
more reach because we're uptick So goal. that I say to would the cases our likely of in
regard talk with also, pharmaceutical to that little And with as you what's talked Europe, to And enobosarm, bit about partnerships. sabizabulin regard as well front? happening in a
should bit on we like it? little partnership that? color maybe Europe? how like a think of about So Would it just be Or for
sure. Yes,
cancer know, programs a So position becomes, cancer And we're will going as in then Phase you are in be prostate relationships, And the X, decrease X. both global fortunate back that question if in and in be to say the of piecemeal because the would that how we're a to our of Phase we're breast viewing the the it you opportunity envelope partner. the partnerships. you value for
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pharma that are the have feels good data to going to of programs. best some think value couple value. see medium-sized X some promise but get constant with pharma with can that shareholders label. biggest data thinking discussions to open like in me, our Phase that's to going we and us the good if the it's I And-- we're And it, all across Phase to X we're large Phase data small pharma is the and X way We or of because
thanks resources have have We our our resources, support, because to shareholders' the business. we and base of the
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Chris from Howerton comes question Jefferies. Next from
I me. for guess just two
to great might would to second on First, us be expectations I on for that program. that provide know curious contraception, if the a of about. that currently? see perhaps to the like to color driving the what And is growth helpful I'm trends the there half what continued into guess, could going you is expect that is year, obviously, the little FCX, growth seasonality as some for you the
for it, one second when we in prostate expect X I So that's maybe missed just I question, ongoing then guess, the but the I'm the And wondering study portion cancer? question. Phase might
Great.
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is growing. Happy business the So to report.
completed, X asked years. ongoing The Phase the of with X. had it's second The that you ongoing but to still question do have are Phase couple we Xb, beyond a patients
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the X the would Phase prostate data, end of portion towards I look So cancer the study sabizabulin for the of say year.
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design. I the think very solid about we X feel Phase
years, these XX think we is the that patients that the receptor failing months that's got trial we're change of androgen have good. And information But us design. are agent, with Phase I some I in is Phase Xb, doesn't our told help the targeted months, now you in and X Phase the X.X and average, also to that would patients and reason on stuff. alternative the X because design we've if continuing pretty heading PFS understanding providing and use then an into months X X that assumptions kind
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to drug that have the patients for we providing responding. So are keep
firm and on Phase I So solid no, for assumptions think the X. we're
The Instructions]. Oppenheimer. from Heller next Alexandra question [Operator comes from
on the landscape also for how strategic us Congrats for quarter. you existing asset? into the your and cancer sensitive treatment VERU-XXX fitting plans see you prostrate the Can then the resistant walk through hormone
Yes.
we've the with androgen is nobody landscape surgical the living were is-- that the longer, to the instances, way these longer. go. VERU-XXX, therapy. allowing castration, finding and this last inhibitors, castration new and field the we that deprivation is in And and the compound are of And chemotherapy evolved that interestingly, out medical lines the what on years. for So targeted beauty current patients receptor is has such the the base some to side this to you're PARP over XX, sit in able that castration medical how of learned is wants watch And live androgen drugs are patients agents XX all
on what And now, of So get chronic a when could we triple that involved went we've the that, for you is time. therapy. to with advantage double ADT something takes whole from that. be XX with they're ADT, And us truly learned. months or
give the what that drug, of levels away, So the is ELIGARD testosterone castrated then yes, that antagonist days, off then the down right and away, thought when and and you and medicines, a turns right that the We also high. have are always-- such have we that agonist X if ideal. study their worked. is put that's learned? had on and you having weeks one. you about high have lowers injection, those as we you mean, LUPRON, it [indiscernible] of patient and as chance the you in leuprolide, landscape of events. and had it that kinds if the the FSH, showed castration X along XX learned in but this LUPRON out of to it levels be came I type And for cardiovascular gets event pretty X not they testosterone And-- were shut another comes cardiovascular important now which It's had a LUPRON, what you've
So first would and the GnRH that I was approved. would never have argue the discovered agonist probably been that LUPRON antagonist
to So this antagonists. GnRH I think definitely is moving field
medical second of standard. GnRH flavors antagonist, the you challenge versus is disrupt become care care part do standard Now do of you the how medical how the now in the
a was the it X-month now well. didn't of right GnRH care makes antagonist month their X away, a was get imaging standard are to add depot good because using and and not not Decroralics it comes kind see do then doctor it every because the months X the to that People it we sense, patient And every patient and to it So did in well do LUPRON. in right know castrate to to is come drug. as of
So and the were problem is standard so people of didn't it about of worried ELIGARD LUPRON And-- care. month care. depots standard X the it. the froms and are But X of fit
was is don't or then important kind really become you get GnRH substitutable important that could compliance when for agent. X be the day, and And is of you the castrated. X because had well you reason at choice the a preferred the for compliance of you end month easily a depot, this this feel antagonist, So agent if is because
of develop flashes. gynecomastia in you change and loss muscle become-- hot mass body You and fat lose composition and with diabetes the libido, you and your
way to for holiday. you're looking drug So get constant a a
with and or break the their feel because compliant so that may then they good control, going agents to patient was targeted to as were some control if comes kids, And their they have whatever. patient then back on spread expensive And tumor weekend they up, in to want in not own more when get it's the testosterone be androgen the they drugs and to than or want going is cause to receptopr IV castration, the chemo.
prostate you be-- it disease, should start is not be develops given sensitive, would every we that And advanced three drug the So first that buck hormone every the X VERU-XXX. us drugs, months, of with metastatic it's think that's strategy the it cancer be given care. because the patient standard the our would when for should be months, it foundation, potentially that
it, same but see will will So same the comfortable the at we knowing the the patient doctors usually the come patient usually time patient. will be time, that providing at they back image
not care. product that you're the gets because of change. get the changing based urologists of the and So a on standard administered get physician and the the medicine, doesn't percentage they AWP, they paid And also so
strategy is And our so and critical. compliance
today. ADT shows Now unusual patient the other thing that data get monotherapy a that's it's the that changed to also is for
have pill hormone that medicines. load if why reason and the and taking to to of day. thing to X these other so sensitive that's another with some you have it with can make it almost comes worry less there's they patient simple somebody about decrease that coupled so even disease, is certainly And they things other And try want every the
going it's to think very do I interesting. be So
and leuprolide. that is and for be pricing the that's quiet, deprivation thing, worldwide packaged price androgen based ADT about on other $X.X is leuprolide. strategically, The will therapy antagonists GnRH market not billion, for are generic
so market not And of that double, that. really move And the to just needle. we if need the much is triple get don't market probably to
go we to is we could regional of this us. and really attractive option think and a product hold and for is of medical you're really is where Difficulty] of urologists this for to sense. Europe, about So cancer. the in foundation. we license-- kind sabizabulin Asia patients partners in maybe as attractive you the receptor ourselves a and on it's lot product androgen And have that That's targeted oncologists this [Technical ADT product have way would regional on the going U.S. know, because a And fail and prostate make call agent
So it, Alex. that's how we're thinking about
Ladies gentlemen, back to like this any call would Dr. the question-and-answer remarks. closing concludes for I our turn Mitchell to conference session. over Steiner and
look forward all I updating call, joining next to all for on progress appreciate on our Thank call. you joining our investors today. today's and I us of you in you us
X-XXX-XXX-XXXX The beginning digital internationally. replay X-XXX-XXX-XXXX the dialing by Eastern available in today, of August U.S. the approximately and time will XX, noon conference call be
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