Daré Bioscience (DARE) 14 Nov 242024 Q3 Earnings call transcript

Welcome to the conference call hosted by Daré Bioscience to review the company's third quarter financial results and to provide a general business update. This call is being recorded. My name is Deidre, and I will be your operator today.

With us today from Daré are Sabrina Martucci Johnson, President and Chief Executive Officer; and MarDee Haring-Layton, Chief Accounting Officer. Ms. proceed. please Haring-Layton,

and welcome Business and XX, Daré Financial quarter Bioscience Today, our expectations Good and pipeline Call to for and portfolio. results third our Update will September developments the Results and we for afternoon, review the discuss Quarter XXXX. ended

forward-looking made or statements during differ this of statements Reform risks historical include call safe anticipated Actual Private securities like uncertainties. known that are by implied are laws, to facts will not made should that results of harbor the the to be within statements. those Act pursuant today's unknown due you would statements could statements Litigation events or meaning the provisions these Any materially from which Securities of and considered I discussion and to remind forward-looking XXXX. of federal

on You statements. forward-looking should undue place not reliance

ended time-sensitive including or includes was call, like SEC as statements out no content XX-Q for any in the Forward-looking information qualified that to are quarter company's XX, obligation entirety by in would required our statements law. the update also is new as Form today. of statements I current call this today, Daré November to this of forward-looking reflect to undertakes developments September only cautionary XXXX, after filings, XX, point their the information XXXX. filed which that by except

I will now over turn it Sabrina. to

call joining for Thank the today. you, you thank and

we $XX XX in last a in have just We of that cover, the updates number announced days. million regarding to nondilutive funding including over the

you taking through forward we So look very much to them.

the development pain, across women's and and publicly remain well-being women review, disease traded menopause. fertility, clinical contraception, to And products health, is through of sexual the pharmaceutical focused company believe for regulatory pelvic disruptive only solely advancing to Daré dedicated development, and ultimately health we infectious market. health, on broadly, product We

products the leveraging gaps. and the pharmaceutical outcomes and certain by of that need is understood, that to pharmacology innovative Our about therapeutic lives improve women addressing women basic treatments to focus and science existing health accelerate is active marketed in boldly and commitment by ingredients want

And advantage. the women, of and We positions for the product competitive already high-impact, portfolio candidates have our health which broadest potentially that medium long is and improve concept. have pipeline many of first-in-category well well-being robust we believe believe to demonstrated of this a we the short, us And term. of proof

successful our hold allows product to regulatory interactions base. and portfolio us Our us from across XXXX has And allowed and conduct learnings clinical broad X clinical to to in knowledge across trials XXXX date alone. is what candidates integrate X and FDA this XX

cases worldwide Health papillomavirus for ARPA-H, well-being to announcement continue Advanced increased We treatment for related by award all evidenced recent or cervical women, excited including cervical announcement health Agency of and are the as or the the for which receive infection. of Projects investigational Health, caused selected HPV-related Women's diseases. DARE-HPV, the cancer were $XX attention of is their on for innovative our under we program by an the to be Sprint awardees human about to Essentially, that ARPA-H and Research by HPV the million

time expand provide clinical Daré the of accelerate aid in Bill and to funding this number novel will identification nonhormonal study Ovaprene grant announced ongoing just to to we the that Foundation development activities development in million up to sites And week, $XX.X Melinda an from line. support & allow product intravaginal the Gates the pivotal will also contraceptive candidates, to of the and

first-in-category candidates, earlier, as by all do to we market value And our a development want advancing accelerate seek we Daré's opportunity of innovative treatments on this continue I stakeholders. mentioned execute to represent need. of for to We as our women late-stage bring that, to and of mission all deliver which and

our addition is and the which Sildefanil continued a is III with bacterial our and gel Ovaprene phosphate the sexual in vaginosis in treatment clindamycin the older, lining aged to for available XACIATO, the prescription the X%, in which commercialization arousal first females Phase our vaginal on III by focused sites first-in-category disorder. FDA collaborator, Cream across emerge our that Organon, at constructive also continued XX study on ongoing Phase with by female program development the to interactions and nationwide, Phase from In advance is portfolio III candidates to U.S., we enrollment FDA-approved of for X.X% continued product

treatments despite program are forward this into prevalence, before, discussed disorder. Phase arousal sexual we've its for there And high to III. advancing FDA-approved As female look currently no we

conducting Additionally, of we preparation is for from $X study in I DARE-PTBX, Phase a will II million activities a today. and Phase of cover which study are supported briefly I all a grant DARE-VVAX clinical which by NICHD, of

yesterday in portfolio, announcement equity Capital the established the Lincoln $XX award financing second quarter, the royalty million track our the in and Lincoln in meaningful in milestones million Daré we $XX.X with announced Park for put $XX Park, $XX strategic Fund, and October, ARPA-H the million the nondilutive LLC, or across XXXX. on in we secured progress arrangement October, The along grant with from line million

going MarDee, over development today. We do, Officer, before portfolio financial that will the I quarter to Accounting number results. turn our first But updates to to provide our review of that it third Chief have a to I'm I on end back

refer which for quarter. third XX, thanks, like I I Sabrina, ended joining to now will Thanks, us summarize would for the results everyone, Daré's as financial September today. quarter to and XXXX, the

in R&D the portfolio the of address the and or expenses. health, meaningful to differentiated Daré's development and strategy of required overhead, includes advance ongoing needs women's unmet we've assemble then long and an is to near and research clinical product advance As and maintenance advances corporate The portfolio term. to identified of regulatory candidates and over build our portfolio investment acquisition Sabrina costs, monetize and business that portfolio's mentioned, value

of I'm to compared expenses quarter which services general commercial to QX a and and primarily administrative XXXX, $X million, expenses. due third is professional decrease the QX XXXX, XX% sorry, expenses approximately our to reduced readiness compared reduced increase were During --

Our approximately R&D portfolio, preclinical, to entire from expenses, million activities compared clinical, for the XX% other $X.X to were period based across quarter, on is our regulatory manufacturing, period decrease QX which vary XXXX. a and third which

R&D previously will this we expenses continue full guided our our expenses. year R&D As year, less to anticipate we be XXXX than XXXX

common was for XX. We million X.X the comprehensive November the outstanding as of loss and equivalents third approximately cash cash of quarter Our approximately and with $X.X ended approximately in third $XX.X had million million. quarter stock shares

and be entered of with the Park which to if will Park, the we right arrangement line common an the to our in at under declared in October, period discretion the to the pursuant SEC date conditions into Park equity the sell not and statement the up issued are and In over on purchase been to limitations prospectus connection is by registration that may $XX purchase covering that XX-month may obligated Such commencing Lincoln any, to the of stock, be final and certain Park, but resale time other and have Lincoln time purchase our a sole agreement to is sales is Lincoln of filed our subject million stock. effective we therewith agreement Lincoln obligation satisfied. shares from to common have a occur by

to achievement also for an DARE-HPV ARPA-H's of high-risk of agency Biden the of in which development an White In management our our consortium was approximately XX-month activities February Health preliminary with Sprint announced for a is U.S. October, evaluate selection to period by a Health milestone-based including the study $XX our sub-award Research. of XXXX of II of result in and in DARE-HPV an on receive and of was research objectives subject relating sub-award Phase specified are major Department the by HPV Health, program, entered we safety Initiative we and first and of which advancement over infection awardee clinical within into to payments Human Lady First women. as the firm agreement commencement House the of of deliverable million the efficacy to funding clearance a Services, The entitled agreement to ARPA-H, under Women's up the Women's Jill

addition, of this fund intended share expect related later, a Sabrina novel will foundation about year, with agreement of identification brand a we we a to additional the to and candidate, into contraceptive study. $X.X entered mentioned, up study approximately more sites development add and intravaginal and pivotal nonhormonal In the Ovaprene $XX.X grant I ongoing of to we product receive to accelerate million, clinical announced the as activities which approximately to yesterday for that to million

capital annual December our on to our for more XXXX, XX, discussion resources filed investors being for Form risk XXXX. year creative, XX-K to factors needed filed well as ended These which represent our We and shareholder build nondilutive the XX, was encourage condition, and value. meet September detailed our XX-Q and agreements XXXX, the commitment quarter financial and capital the review to seeking afternoon, Form this our our in liquidity, funding collaborative March as financials, opportunistic the ended we objectives which XX, of to

like now Sabrina. the to over call turn to would I back

on milestones. to a Thanks, those MarDee. candidates, late-stage the and, do asset, want focus, Ovaprene. I our to date provide on Sildefanil XACIATO. with update and how I XXXX mentioned importantly, on to with an as through our accomplishments But upfront, going talk perspective I'm now anticipated some Cream frame on-market And first,

reminder, from is It's in I portfolio. X% the treatment emerge So XACIATO, product indicated, of and mentioned age years a our first older. XX our vaginosis gel, bacterial vaginal of phosphate for FDA-approved upfront, female as to clindamycin the as

available time in gel it's as that And year, limiting And place. of time, goal single-dose first be a may the our agreement by retention spent it's at colorless States. through you commercialization known time with leakage formulated As day. with Organon, United and of became this any increasing vaginal vaginal of across in applied recall, can of XXXX, quarter the XACIATO prescription the

been Organon's year We've this of with first pleased launch. progress in

both health to the experience patients total sales towards And continued team a prescriptions the for for of entrant increases in October, of team friction-less providers. and see opportunity in ensure novel and month-over-month XACIATO, to fulfillment new continues As to the in steady options work with go-to-market Organon enhancements the line a women's category. branded

to through And Organon's on at successful launch coverage additional the build wins. continues team achieved access

edits drug for Texas they with access prior example, the had a to X.X recent list step provides an patients. For no additional auths addition preferred million that or required. And Medicaid to

sales that area. continue health exist in needs to therapeutic focused on affirm treat who unmet this value remains strong and belief clinicians Organon's vaginosis And bacterial providing to team clinical women's proposition who XACIATO's their

I'll now turn to Sildefanil Cream.

for program for Sildefanil our upfront, including, as continued I arousal As the a respect to development. take sexual FDA proposed constructive on treatment Cream development with Phase disorder, III forward endpoints we importantly, to mentioned with have the interactions efficacy the into female

and this be FDA's feedback, disorder of As candidate treatment study look the planned Phase have we've relevant as providing several been Phase on of III III We they women. collaboration available. we pivotal meantime, the study the times, our first on for towards ever that updates study. mentioned updates well the making arousal strategy to designs a the as plans, Phase forward would as III therapeutic In any in become progress operational

ingredient know, marketed you has under meaning first. administration, in in -- form launched. any women, And ever for are was need treatment dysfunction name And treatments erectile it's that for successful sildefanil of FDA-approved of I for prescription form don't disorder undoubtedly products remind currently there active men. brand the to potential the of most arousal tablet be you, no the sexual As to the is the Cream in Sildefanil the Viagra oral one currently

U.S. of research suggested And market the no in million experience sexual women approximately or low XX arousal. symptoms

development available. look program updates are to forward additional we providing the on they So as

U.S. the our terms Ovaprene, the rights on intravaginal agreement an wanted the the a to advancement investigational contraceptive. of of update Phase Ovaprene, with under are Bayer. for provide commercial which III And study of license novel In is monthly hormone-free

And opportunity. hormone-free are by So nonhormonal currently contraceptives no market monthly the FDA. there represents a contraception significant commercial approved

products the disruptive the important a or has be option do for Ovaprene to to in potential who category not control women cannot prefer so. and So contraceptive birth use an product hormone-based

Ovaprene. research, candidates women market are alone for on U.S. XX Based potential approximately in the million

and Working the of in XX with patient III and of or months in the followed pivotal Phase as Ovaprene Ovaprene recall, Eunice And cycles Shriver or collaborator of or commenced Bayer, Institute Health Child study NIH, of Development, the women National may NICHD clinical Human Kennedy over National the at December XX enrollment Institute study use. XXXX. commercial collaborators Health, our are you we

than and United Recruitment campaign advertising across sites supported more the at March the launched for a of States, is that proceeding central in that's study this by currently little XX year. a

quarter, subset interest that As campaign. from have response we the that we trial that considerable the central of most last particular in been translating in ongoing to and discussed successful the continue participants women sites total the see to substudy into advertising are study

enrollment So or to of our of XXXX. XXX the use, participants that anticipate complete half rate, based the end current target by months, which second we full on half number XX the study is the average of women approximately X quarter months of product of complete of the will approximately

that we just expect to yesterday, grant agreement the year to accelerate additional the the sites, expect study. add and grant we we're we announced going this With funds receive to under study

communications that a to application date would required FDA. to registration premarket single the the the study FDA, the we with submission if approval just successful, support believe Based be with on

DARE-HPV We were and mentioned So now the mentioned to our receive that at MarDee DARE-HPV. selected start award on for to $XX the program. million we of of the the call announcement

treatment innovative investigational HPV-related diseases. I it's cervical for mentioned, As an

caused cervical die cervical each And XXX,XXX are treated estimated I can't HPV are year. worldwide XXXX. in that unsettling, an essentially despite unfortunately, estimated in the by women an United will in And enough the HPV for women infection. which cancer And States, more precancer are vaccination, advancements cervical fantastic, stress even cases still cancer from X,XXX and screening all

the reach is recommended associated an cervical therefore, and removes precancers risk surgery, they patients common of of with fertility birth that which for with until and And since cervix. stage most the the monitored is last treatment are surgery Today, not concerns. sexual preterm part dysfunction, is increased

infection risk In cervix HPV HPV at women for the puts long-lasting them of will cancer. their infection U.S., about on develop with XX% that cervical

approved HPV-related intervention clinically to managed that the infections, potential change And Their HPV leverages have as the first as the really how of like at known could is has program FDA-approved category, cervical be pharmaceutical cervical they're could lesions are DARE-HPV HPV-related well both understood. first reflective that So earlier-stage cervical Daré. pharmaceutical well development been the to ingredients active but treat to diseases and we It's that today. late-stage treat around in paradigm viral of infections. so type it advance other

I soft and proprietary gel lopinavir is DARE-HPV the with Specifically, treatment very to be investigational diseases. of HPV-related an mentioned, fixed-dose formulation vaginal insert ritonavir in first-in-category as cervical potential, a for

Women's of a received supported placebo-controlled We look for forward IND to as Sprint conducting activities FDA clearance necessary in to all the of application funding for II randomized million of infection we will high-risk HPV with And double-blind study women. enable an for that $XX be an of Phase submission clinical ARPA-H Health awardee. to DARE-HPV the

to We first-in-category hormone-free of alternative updates proprietary DARE-VVAX also other a severe activities it's therapies which estrogen-based a FDA-cleared preparation provide wanted being X sexual II conducting clinical formulation DARE-VVAX developed of in is our to is on pain tamoxifen our intravaginal administration. to use. And product that for as on moderate based opportunities. of for trial for intercourse. our And treatment during we're IND of the Phase dyspareunia, for

IND And that's application clinical study. of for I XX continuously deliver supported of by our designed ring mentioned FDA DARE-PTBX, $X conducting as grant a submission to front, We're NICHD. to for birth. an from bioidentical necessary Phase up enable the activities that's preterm a days progesterone intravaginal I million the prevention to And over

progesterone also phase That IVF luteal of PK as will serve safety investigated be intervaginal study an for Phase and to part support support ring regimen. also this I to for

just grant Gates & the I did want bit Melinda announced little And Foundation. a we share to Bill from the more finally, about

will the to need the ] that such or suitable addition important and derisk In pregnancy. in unplanned contraceptive for Ovaprene a for development clinical acceptable activities trial, [ novel prefer of the the to support product grant who settings support could country intravaginal women and low- for a also to women middle-income avoid be nonhormonal

in development health. novel forward candidates with We right fulfill differentiated innovations particular, move extensive in proven to in needs women's to of like product that we're the advance that nonhormonal product contraceptive these ability the given space, believe development experience organization our and our programs unmet

that So grant term payments, in an MarDee agreement. approximately is payment during receive, typical, are XX $X.X under then XXXX, we'll as the outlined, grant as achievement approximately and period of million of the the initial specified and upon our development additional agreement certain contingent agreement, reporting milestones of grant months in

So ARPA-H similar for which XX-month period, over a to disbursement. million This $XX.X the is $XX is that period. disbursement also award, million also XX-month a

we potential collaborating some women decades, agencies, candidates with forward continue and to summary, many of deliver to for of work as XACIATO leading portfolio product as for Bayer treatments Organon as in health and to well-being progress look well we in possible. the as companies, disruptive providing to So the of including potentially most and these funding Ovaprene, more for candidates women to commercialize our updates first-in-category and advance as

I'd now over for call the to turn Q&A. like operator to the

Catherine From the with Trading. of Instructions] Novack [Operator Jones line

Congrats Congrats study. expand on all being to the the enrollment progress. Ovaprene accelerate able in or on especially

be So read? XQ then this the on 'XX. wanted still interim something by I expecting? this from Or interim we're interim end learn how readout? much touch of can we Is safety? or potential interim looking to potential the Just the for what just look should efficacy from we And an

Catherine, great question. that's a Yes.

really through on the the all, So of to all sites, nice excited that. sites to thanks got. thank we sites able network. add are really to the first you NICHD's Right It's we're congratulations the for be additional some addition trial of clinical study. the for a And now contraceptive funding asking. And to do nondilutive

some opportunity to be to as to of with give sites great and going add additional the go be well, program. the the with to to it's even product outside faster able them right, really experience that So

about So thrilled that. we're

partway important important of place of for having that getting and this critical mark an halfway us that and definitely study, time in at of terms through kind subjects in to data. In terms enrollment milestone look the it's

not they're or everyone active the for people no open label. As just That's reasons, any trial this ethical at may considerations look study, in product. There's a continue right, may the placebo as And contraceptive as like have getting that is recall, all standard it. for of does We course the throughout opportunities safety other this study, that control. evaluating well interesting monitoring create in do to to board, safety. data

for In terms reviewed as at how will what monitoring commercialization the collaborator this on that's think with and are as be well that really of through safety closely exactly time what Bayer and information handled, and be will that made as, charter be we publicly with the something that we may program. well as board our data working available obviously,

the contraceptive that lot XX-month contraceptive And is better, time. reason rates just ultimate say or that that study, is a get of and to XX-cycle I right, data indicate this a over there's

So the things what around think how of to in about of be sort handled disclosure have that. to going we that's look one would terms of we're any at and

to that. an Bayer. collaborator, commercialization more discussion and our so So ongoing It's active with come on

as So we on we will give that more get updates closer.

sildefanil. information? are comes have III? can what's do need still one -- And Or when you along? then Phase move by little outstanding you to you in interaction? it us towards anything to Can you this a share progress Do they let that bit more need they additional if else about from you your order FDA more operational what on know you And Great. mean just

More Yes. question. great

much very That's your is, they're the discussions end second we in of FDA. progress actually -- our discussions been all course. of taking all, Phase important focused importantly, end have, of picture, the for of mean, of NDA to the of Really an kind of around what on right, need first focused and on part always step So question of at a FDA part with with operational the I II. going the back Phase II, submission, big terms do

the when no has this, first-in-category one like development circumstance pursuing you're a a first-in-category because before. of fantastic for is which in opportunity this done But product

a what's the so to right, important And III of monitor, on program, for is demonstrate. what Phase lot be really important to focus a appropriate endpoints, should the what's

What of safety around So what's before really III and that a that program registration. in Phase of efficacy expectation Phase conversation does from III to that III of expectations what and does to shared like, that's detail focus we've the be are program? and terms is Phase the trials lot that the And the then look right? required. support what to But going exactly the entail

where focus So that's the been. has really

population, And see everyone improvement, rich. There's to the Phase learning in II was where a they data want for of the is patient experience it see so improvement. terms endpoints, where -- the they

so all And really it's through that. just going

FDA frankly, get just So and have likely than it's just interactions, these it's anything, day not to And time. to every the more call conversation. a

So of and sort goes how back processed it's terms forth. very of in communication

going through and getting really answering So aligning. just that, questions, feedback,

that the III. We've as been we expectations important making been very has us constructive. the place with but front, I much it's on and alignment sure also get for understand how our constructive with to how the wanting shareholders in FDA to they and can to But collaborating Phase great it is ready there's where very to us go, us pleased up very been be said

working where really we for we're can that's so So know that trying to importantly, around towards. we all expectations and what those success, ensure, we're communicate clearly

then of as ready to that, alignment, operational really go. terms as it's reach around making that we sure In readiness, soon we're

want we you work supply not to So drug as have control, that that manufacture with, that so things in we the making we can to we that work know we're sure such sure CRO sure sites where something. making do making go want to with, we the waiting that

such that the go. we protocol that we're and on for aligned make we we've that can are control initiate know to so completely that that having everyone been operationally ready within to then process all is those doing is are our Phase things, the all So right, sure waiting that III that are we

we've always in is that place. make Obviously, we sure financial that MarDee that well we're of we've structures the to about for in some why to that considerations, have talked think also about terms as which put tried of ready

makes on progress. hearing share them. some to That the it. Congrats when Definitely looking all sense. of Got those able to forward updates you're

Our the next comes with Douglas from of Wainwright. line question Tsao H.C.

Hello?

Mr. Douglas I unmuted. Tsao, think is your microphone

All right.

Our of comes line from from Capital next question Kemp the Brookline Dolliver Markets.

definitely mute. not on I'm

So a couple questions, if of may. I

and With you're Ovaprene interim obviously, it wouldn't the -- potential stop look, at would the be trial trial this a point you where early.

So what doing specific from that follow actions analysis? might

great it's a Yes, question.

So monitoring really what DSM the with is is charged obviously safety.

routine. that's discussion it. can this That's One a label. it's is open look And there's question. So as been great why obviously around

Obviously, kind take can in -- in safety that anything, of efficacy to have you're -- no until cycles look So got don't one far study a frankly, enough in value or doing patients there's and look. perspective. you've enough to you the order at

this one beyond at where that It's can specific I time. say there And anything those one that can. isn't so of situations

months, the less of there than And is sort there studied been and any point partway the time methods. knowledge, least right, certain looking X study. And to these time for at of that reason my need is isn't that's ever that is it You cycles period, really product, -- at number through, least, right? contraceptive at the a also important

an sort And about. why milestone. to are going And right? we've when time that's It's there, of something be us so has we that important for thought point been

at in well that how for you. know literature given I there getting ] think better. a Pro we we said Like always question studies and had can I we look X months, terms frame. the about and about clear be between that wish there changes time information are have contraceptive very then Index that in the we I XX and of what what to in [ what upfront, over do with things

also that our commercialization and So does particularly for considerations partner, Bayer. raise

follow So more to get closer. we as

point well. one we will important that's DSM Importantly, that safety at assessments also as our an doing obviously and be

Okay. great. the just trial that That's on for stay moment. And particular

So you now. have XX sites

do many going funding you have You're to additional available. add? to How some sites additional intend

to clinical followed. in XX study have Yes, that's that patients been the and trial great contraceptive are would have we under continuing clear, to And the too, a network all sites sites of just there's obviously question. the be And under involved NIH. be have these active total

a so the a We that, translate study on from than study in the are terms efforts today, and of quite the recruitment half, as been they've focusing the than participants. little of August have from in how XX, patient women sites I the now interest exceptional on more more really little mentioned call of into kind reiterated

So we want research to study. covers with the in be sites that really with NIH collaborative thoughtful together under agreement the our resources we the those have that

sites. think focused we as sites why forward-looking we're of group that's so recruitment, about And really on XX-plus that CCTN through that

to to that which, had we've sites really meaningful the enrollers and given funding study and active, have many for of of can us a are will how many additional handful efficient this sites add a really study been a allow The just how impact. have size likely

do So about super excited to being that's why able we're it.

closely sites sildefanil with study. our are of all the outside in with worked We've us network, CCTN network. that sites the working be with that us Contraceptive the XACIATO of clinical our in honored They been -- NIH. to But community-based and really Clinical were Trial to had studies. Network it other we've And have happy fantastic they've add CCTN the study, our that works also been allows with on experience

to a they've get excited very Ovaprene So because as work so. well do on them of we're been to some with also to chance very anxious

to and get requirements you FDA and about to time think and sildefanil last certainly alignment funding. once my just the And having the relates Great. question frame operational potential with

to soon think just most So get trial? funding, you you do were as gating here, you'd of initiate we think to the able being factor next how say, be if month, if funding the

weeks, that and who Yes, another operational really, work like think -- still -- the things some weeks, but sites, mean, as as that do want we them around done of great even take you if -- several can't to we upfront things question. contracting I about but not we're though operation know can there's we start-up, with. days, much we've study we

IRB. You the final have can't protocol do you through going until

So that things will fast we those are those can. go as as

But cannot there things have the we do those of until is some start-up study traditional that protocol. final we

your and site well. study to start-up couple realistically, funding, that then can that, few initiations as traditional a point, it's protocol months, often with just a activities on take to So those

is a start next So year possible?

the always FDA, that Absolutely. get things and study final that Yes, operational it's then point, IRB, like [indiscernible]. the the to Once we then have But your obviously, absolutely. contracts, protocol just to aligned really start-up, importantly. think the yes, money, with site down it's about Yes. then

from question Douglas with Tsao H.C. Next Wainwright.

Can time? this you me hear

Yes, yes.

Okay. able just trial? in new these do have be enrollment by ultimately sense And outside addition And Ovaprene percentage and will How you types the a do anticipate of study the of you sort might network? total come sites? there patients added the sort of CCTN from the different of Sabrina, them sites. of what going of of of be these will that sort the to study of being quickly terms curious I'm in enroll

more great Yes, question.

like we've past had the would in nice study track to I we've sites are the a that with alluded with. as are identified from the question of to we to experiences record that add Kemp, So these sites last have kind in great and that

done study. vaginosis both well as our the Some bacterial of study as sildefanil them have

of into with We've them studies. before. them like those But before. X contracted is them Some we've that just with worked what of did translates

that would are out be different there to going know. we -- like to we than efficiencies very were if So we that brand-new going sites be don't

this get going again, not to going days. our to sites right? process. quickly get is is that, quickly is But weeks, expectation up our those as possible. It's expectation this still really it's work weeks, we're to through So It's as and

So to are year they quick going I've as through year, who We're now in been that with right? we and as to quickly with. of time end use the want new to this work possible know them, work going the the we

in of terms as looking demographics into diversity of study. And study bring well different enrolling subjects, do great are we women around country is parts the objectives we're in in we going to And the at hitting participate the in study. question that to ensure also to we're also terms the types that of are your some allowing different always as of it well, the in want

opportunity thoughtful some think, regard us well give we to in as kind additional, does want also be very leveraging. of I it that that and So about

into in in the like participants. study, then the to these translating have translating, what of us well And for performed terms contribute of these the again are, sites could in that subjects are terms historically again, they interest sildefanil study, very of proportion

just the trivial Contraceptive And that's have sites the particular of them by others And better been Clinical great some this Trial study. not and than for Network way. are

criteria eligibility and sort interest to, what come so in us sites participant. of the in into can that a be we're down -- is the can how shown interested study have they've that meets there. selecting the it's studies past going translating very And the very someone that's run, including efficient who's for to is study And past be in contraceptive

they that that can that a to a And diversity also study, think along make of make they in we're sites. well, terms make great if of contribution. still meaningful so a the diversity in participants. And we just study do the far overall in contribution meaningful meaningful would study they be They can't the not and can --

complete mention you of thoughts on curious just that of the And be need of That's sort helpful. I'm program? for how how some did much to funding sildefanil amount upfront Sabrina, -- that the to the the -- you needed program. would about begin to

the is this particular as with the having million well of related the FDA as about direct of the we're estimating, each been an I on study, mean would costs sort $XX conversations individual CRO, I study. all it's -- and study, based the we've say of to Yes. external

in X So that's you the total, if together. $XX add million

is $XX to So there's we not us so sure an expectation an that we we certainly think But to important XX about. $XX want before number, is for make particular trial would million, had started. million and a

condition, for participating. Now it's to expectation -- a a are that, study shorter the this -- not -- it's obviously, a life-threatening is the is period who and having women it's said it's, not going fairly it's be

just short in you you a completing how time can literally it's you So upfront need that terms around period creative start enrolling right, be much before people. and of keep because you of there, can

able feel want to I going to $XX all we're confident is the But to don't of even the that are thing those confident, is continue through need study the the understand that million, that we're not women very But to study. things to million. look going $XX all very feel make at So we'd time. be we there is we important that think sure an individual we if upfront, and

Sabrina would the turn to remarks. concludes session. the Martucci or over like That back call for any Johnson to additional question-and-answer I closing

for the our all recent this of and provide to for Daré's women. choices stakeholders for and our commitment of advancing therapies use drive by ongoing all thank updates Well, hear hence, new identifying afternoon Thanks. and value outcome to you ease and, to time additional about taking potential

And to leverage that make of funding our value being while innovation lot for also support able last commercial we accelerate the our everywhere, the to of As of well women nondilutive collaborators, and over we driving with for just including you believe great continue all Daré heard progress. today, we month, stakeholders. to positioned unique brought a we're model, in

look we and updated keeping forward So progress, to listening today. thank for our we you on you

Ladies and conference call. concludes gentlemen, this today's

now disconnect. You may