DARE - Earnings call transcript Q1 2022

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Welcome to the conference call hosted by Dare Bioscience to review the company's financial results for the year ended March 31, 2022, and to provide a general business update. This call is being recorded. My name is Delfin, and I'll be your operator today. With us today are Ms. Sabrina Martucci Johnson, Dare's President and Chief Executive Officer; Mr. Strategy Ms. Chief Dare's Fair, Officer; and John Lisa Chief Financial Officer. Walters-Hoffert, Dare's Ms. proceed. Johnson, please

Sabrina Martucci Johnson

Bioscience. and Thank Business Results Dare Financial you. Update welcome for our Good afternoon, to First Quarter XXXX Call and

first Our milestones XXXX. quarter last plan anticipated in use business for view and time March, to our strategy today review and call results, developments highlight since is discuss our to our the our objectives and

you differ Federal that within we Laws today's these and of uncertainties, will fact Litigation during known to begin, made be of Before pursuant reliance statements call of I'd that Reform risks statements. this statements statements statements and include are statements. Harbor anticipated unknown not the should made the are considered should on not or remind implied from meaning Safe provisions Securities forward-looking due like which materially those forward-looking Act the Private Any events to by discussion Actual undue place historical could you to XXXX. of forward-looking Securities results or

new XXXX. on call, XXst, reflect out that I qualified which statements to law. point no includes XX, this except for Dare the update the as May forward-looking in the statements Form as including of time-sensitive call entirety ended statements undertakes information the developments only by obligation content report SEC their would or filings, today, year that is after required also December of current any information to this Forward-looking like cautionary company's our filed XX-K XXXX. by is annual in March are XX, on XXXX, to

on lacking that the focused good upcoming broad for a belief to initiate is year. use health partners, prioritizing this the and you also to and do in the calls And XACIATO the and is with we we've study our Phase convenient not but advisory Phase this women update phosphate an that stakeholders, will today. know, choices, we Xb The typically that squarely for commercialization sexual in clindamycin with health. women's We'll NIH It disorder, achieved Sildenafil Dare milestones look their from effective Bayer, anticipate. year. collaboration cream, support including therapeutic date collaboration gel, We to our the our provide And clinical with you targeted we these programs and readouts Ovaprene vaginal commercialize later two arousal X%. anticipated our As solely update is study, X that with set the milestones clinical clinical families, women's course, for the only launch many other collaborator, shareholders. of Organon to female or and on of

two, commercialization before we're already for for to we into of take and want objectives a do how. agreements However, we have two the terms we entering most minutes achieved, our articulate collaboration the of the to in clearly strategic why that light in programs, few advanced

building value. and health few business to to unique started together company create recognized are that and providing like We and before a financial somewhat few take a I'd opportunity. to Specifically, minutes our this updates, we review therapeutic factors to a compelling women's because our strategy about a category approach portfolio

improve and life be can that persistent exist. of not unmet First, are can are a but that products women's outcomes threatening, where number needs convenience therefore and to continue altering in Indications health life compelling.

not customizing oral with indication many or ingredient, her addressed such persistent opportunity. has believe development risk, for meaningful active opportunity that biology, or of the be sexual as can these first yet delivered API, a different APIs delivery pharmaceutical needs vaginal well-characterized commercial still is an but in for addressed because a by category cases, in one line expected route unmet female of we Use unique and disorder. with for such mitigate arousal in her way, Second, first women, as to been have well-characterized or that in versus cost, can Sildenafil a time

entered with do internal not developed in into companies transactions creates to often companies footprint acquisition. commercial in their opportunity but transactions, also just in have Third, and tend these and robust a the footprint not gap Bayer licenses women's in Dare product that in women's agreement those the effort as focused health. women's companies category, development evidenced licensing date, the with a companies by to thus, through health the the other portfolios health health, commensurate the executed. This commercial Organon And an grow women's other have with for has and

three one capital commercialization independent million in our one collaborative programs. such our Creating of going is a successful portfolio with foundation factors, product preclinical Bayer has and research one years with not foundation others different programs grant a pipeline have diverse one that four into we the grants FDA or a different result for routes for approved candidate to agreement of target SBIR product modest that one entered public, APIs outcome delivery one the for the since and product collaborations, product and investigational of of of programs, five of quite of two these a and As candidates an deployment candidates outcome potential utilize of of a leveraging seven or and so product relatively indications, Organon our NIH our have done NIH strategy. nearly candidates $XX been different and with assembled for

women treatment and candidate, women, indication an both represents of each a strategy personalize of that drug convenience both overall terms options for the the unique and in to women. biology opportunity Our for selecting vehicle also the for delivery involves

cream, implant, vaginal portfolio includes injectable. capsule a Our an rings, hydrogel, proprietary a soft current drug gel a and delivered and via viscous

three to development single a of non-dilutive to the with the for have overall FDA's new product We includes regulatory portfolio. the for cost therefore XACIATO, those and for for well just the many XXX(b)(X) evaluating via acquiring pivotal also strategies funding commercialization develop portfolio opportunities potential with approval Organon Ovaprene. program enter years have we and after regulatory approval when those we XXX(b)(X) those Bayer and utilize candidates has well-characterized those shorten been, obtain with and was pathway. expect that collaborations the current such case potential in study. that products, we a The factors APIs attained that marketing time clinical programs to XACIATO our and including Our rights or numerous path just established Since consider as development as today as factors the into as which U.S. impact already the FDA for to to that funding, ultimately

need, talk terms perceived cases, for the areas product commercial attractive to in or category optionality successful. of advocates In that to providers In approved of to unmet identify we need. high women, persistent with women's we potential We be if and evaluate healthcare which therapies would needs. health some to that terms within process, start unmet potential option have a the indication or a approved therapies identify we unmet through product take is to it are candidate, as the sufficiently the first and giving Once have indication. The that cases, potential an need. market to how first be for them. but are lens not in using collaborator, the us achieve no area the address convenient development therapies an revenues the FDA of to profile line women exist, each we a other we product for must effective is create there target In

us many to product portfolio until collaborator, in portfolio, fund and and no target as commercial advanced. to launch the the our have we the to has commercialization. advance we ultimately to the portion through our profiles manner, put allow designed to that's to focus access we accelerate in potential achieve to we allow When in or successfully women's assemble collaborations a their collaborate current and that select to with a ourselves achieve add expertise acquiring well-positioned has and with the data of achieve and acquired demonstrate model built strategy. payment cash profile, need program to been and commercialize the our collaborators This candidate it cases, modest approved, we target a assets, of if we development amount potential candidates its us or will shareholders. of generated leverage we contemplates candidates the we for financial or a that efficient of commercial third-party line portfolio seven believe unmet us defers an an the Most that's to that well-characterized product and meet or portfolio development to the on FDA time, health. Dare features, the licensed the commercial commercialization candidate Organon a into our execute to as peak model development provide and intended to development product we we via has women we potential by and the have we our the And under have with and necessary believe clear least a Our in been XACIATO APIs the upfront one to indication. to Dare flexibility we a identified will our a cash characteristics, all that commitment the in to best highest approach to outcomes successfully approved, sales or candidates consideration, are capital the consideration and candidates greatest prospective believe licensing give in is to with Bayer. and because us product large development. opportunity milestone directly to product features that accretive have on in are enter a have first based position seek if date or enabled a Ultimately, and stakeholders, obligations proof-of-concept needs did believe And product for approach Because eight women, for the payments, category first in

and our create value to and innovation such in to expertise the development such portfolio on elected advance its contingent and executing business best enter a address in the To own. our to advanced on categories and identifying Dare funds our current value believe accelerating strategy category. our market a we and avenue through our assets differentiated potential with the to the and in development turn most for generate women's into out attempting needs, these on to through John through manner the efforts. to women's for and therapeutic line Opportunities unmet over external case solutions rather commercialization greater or collaborations via is portfolio use we've of In innovative commercialize and collaborations efficient I'll time date, company Ovaprene, suited a identifying shareholders. high demonstrate the developing our cost and of dynamics collaborate first and resources agreements, candidates for conduct shareholders to XACIATO now approval the launch FDA ultimately are products model our to stage to health, portfolio commercialization organizations of involves with the stage larger or market our established XACIATO that in update. for commercialization salesforces the license our late and ongoing programs in to summary, health and it than the Given needs areas to first best

John Fair

the Antitrust transaction that of women from provide royalties to tiered of potential The Organon's to in and license with to our closing in and condition. critically to Under eligible this will position payments can microbiome Organon the product which approximately Closing start from sales. overgrowth XACIATO. of customary most to is Dare women by strong to expertise million ensure U.S. our The women health, bacterial the Organon receive as transaction under upon innovations our is Thank on to worldwide capabilities option. will approved market to up women's XX lead common natural health. we reaches well the $XX Hart-Scott-Rodino QX XACIATO million and upsets FDA the across shares important I to of commercial believe cause XACIATO this is vaginal expected a impacted double-digit XXXX. of million symptoms $XXX in will balance of and the a the Organon needed estimated most women's expected bring net Sabrina. of bacteria, to of to QX commercialize is other an Through of U.S. will commitment you, its And is XXXX, affect in subject discharge. be unique vaginosis milestone capabilities as with commercially and U.S. in Bacterial Act payment and vaginitis based in odor access the advanced results vaginosis and transaction and condition commercial first to that be close cash XACIATO XACIATO, review receive Organon and Improvements avail in conditions. agreement is

the XXXX. our Bayer, the our license what and the the are Human while the Ovaprene, X novel candidate pivotal a we commercialization year have seek Dare Dare rights initiate are this commercialize study right by monthly we control XXXX in the of to in and full we duration, adequate. study rights Phase initiate that process. currently XX of We expect per to subjects the pending single the to we FDA access Bayer's of size pivotal agreement and IDE are IDE Ovaprene commencement we a at resources National of and agreement CRADA on with over the commercialize approved making Phase Development, an to and or license NICHD, U.S. completion exclusive NIH, onto Eunice National Health, together be has and with the submission with will to Dare. development FDA's retains study, pivotal a approximately initiated in place. to the regulatory in support use we payment FDA is extensive Kennedy Under the Shriver Moving of terms hours of of commercial in Ovaprene pivotal XXX study least approval advisory to contraceptive clinical which week, our pivotal order expect following Ovaprene study for capacity Based for of for study, preparing approval Health Institute XX X IDE, manufacturing Bayer must be early Ovaprene. U.S. whose X review to $XX Under Ovaprene, has Bayer obtain approval completing hormone-free under months necessary Phase in to with million communications Institute the to part pre-market FDA. Ovaprene the In targeting the of sample process

receive Thereafter, Dare potentially commercial royalties addition will in to milestone $XXX double-digit payments, to be net entitled tiered totaling on million sales.

or approved to version of our dysfunction, attain arousal sufficient physiological there Turning investigational product are by address to inability Sildenafil FSAD. a our currently characterized female to It's or attention sexual cream. condition, erectile during her genital maintain disorder, no sexual FSAD is therapeutics. which FDA the arousal activity for

in continue We FSAD enroll potential a for treatment Xb Phase the sites evaluating country. to RESPOND across clinical study, as women at cream the Sildenafil

to sizing. Our study analysis planned interim power has a evaluate protocol and trial calculations

We designed we healthy clinical postmenopausal study higher and collect results relief the our consecutive versions label data. approximately on that study in from will months analysis for safety, in Phase women IVR, conduct the by two the of we subsidiary to study doing X positive expect being in DARE-HRTX, hormone will as announced of conducted in take or anticipated period symptom bio-identical Phase advantage study of usability, start And line open the to data The so. deliver announced first new of top timing lower is This to XX-day top provide a this progesterone Australian roughly after therapy guidance in DARE-HRTX year from of three trial. of of our This study evaluate is We also April financial PK continuously use. which acceptability, of our benefits evaluated DARE-HRTX and intravaginal X/X will X estradiol Australia regimen. clinical ring, DARE-HRTX. and the versions study XX XXXX. XXXX, a a of over Phase the part line and same of unique over dose

is for these DARE-VVAX. in or to would history brief survivors million to hormone during expect XXXX. for formulation investigational X.X in the for or breast vulvar an breast postmenopausal to and vaginal cancer be at or common of diagnosis top is cancer atrophy, fourth We the administration addressing like for provide history provide a a Phase proprietary study cancer of most finally, and report between VVA X/X XX%. approach women. treat breast receptor than the of, breast of could positive update estimated type of our tamoxifen line to VVA, a option receptor from XX% as are be cancer. cancer VVA, We an prevalence on option data is survivors. of to with the a we'll quarter non-hormonal women it have risk vaginal important And DARE-VVAX -- positive women and More considered the breast U.S. breast Hormone

As interventions. to Australia in clinical treatment many survivorship of half the readouts. standard for candidates of X/X look We study quarter of based of launch, and XXXX. very you call line over Phase Lisa. study initiated top turn terms this expect these program. for third extremely women excited cancer report XXXX, during second XXXX keeping to are from estrogen data X/X not Thus, updated with we for in about, data DARE-VVAX also atrophy product Phase we we in And the X a now the start, study And ideal breast will we're that, which I one two three which on to milestones anticipated about pivotal excited one forward Phase vaginal

Lisa Walters-Hoffert

I which Thank quarter results thanks like the first financial as XXst, to for quarter or refer all summarize the John. of for XXXX, I now will to XXXX. current the Dare's And you would of quarter us today. you, joining to March ended

product advance and assemble monetize in business As you know, of to a novel health. Dare's women's is candidates model portfolio

or costs, overhead, and our expenses corporate result, R&D, development, research maintenance and portfolio, activities. of acquisition and a As consist

to and or tend year. predictable administrative expenses somewhat be general G&A, are, our throughout the While

Our clinical, advancing vary expenses related with activities and R&D preclinical, will our manufacturing, portfolio regulatory our to candidates. of other

and XXXX, approximately G&A expenses in the were regulatory costs Ovaprene. greater manufacturing period Sildenafil than $X.X X% approximately and $X.X primarily million related were and same clinical our RESPOND million. were current study the The related and to expenses first activities the the Xb So approximately activities for R&D XXXX, expenses quarter's and reflect they to Phase quarter our of R&D ongoing cream

million was approximately so for proceeds approximately Our May in equivalents. cash loss end million through XX, XXXX of under our and quarter, We the approximately ended stock current the the quarter we $XX.X of net cash sales from April X $X.X comprehensive XX, March million. Subsequent to in $X.X with from additional ATM. received

In addition, upon Organon expect as under agreement a XACIATO, receive John transaction currently cash the mentioned, just which the occur million from this $XX we in closing will payment license the quarter. of Dare for to

Dare well based a cash and the million fourth $XXX to be addition, XACIATO future of available million $X.X become first expected to the entitled as of as the commercial U.S. quarter XXXX. receive double-digit to In tiered is the on commercially of payment XACIATO up sales. of payments milestone net in U.S., potential in will in sale upon royalties

seeking to XX, May to approximately before, had endeavor in have Dare we build collaborative, said and stock of we closing, and As candidates opportunistic of our outstanding. be the shareholder XX.X capital as creative, value. necessary million advance In shares common will

March XX our our our in and Form We on to call XXXX. the filed well XX-Q risk away. financial would which capital of it to so the quarter as investors like XX, December this our was report take our afternoon, I liquidity more turn ended now Delfin, financials XXXX, review as operator, for annual XX, which on and also to condition, year XXXX, resources Form March was today, over filed discussion the and the our encourage of ended so factors detailed for XX-K

Operator

you, Thank the for call. Lisa. conference Thank you attending

Please will first We conduct Our question the question-and-answer Partners. Instructions] from Jallah now is session. Zegbah ROTH [Operator ahead. Capital of go

Zegbah Jallah

strategy. on my the for thorough really taking thanks company Thanks for and and the Hello. the background questions

here one me So, just the for first about XACIATO. is

kind can As process? you where update on launch with manufacturing plans, part of are commercial you the the of us

Sabrina Martucci Johnson

comments. and questions call for Definitely. on thanks for the And the Yeah. for being your thanks Yeah. and

So, had anticipated timeframe. underway. support those earliest the available as to be as at activities the so the manufacturing definitely guided in we would launch previously, are summer we had And commercial commercial supplies

is on And fourth for so collaboration where in aligned based where on we're the that, with. a with launch that working the quarter. timing is Organon that's That's that

the we And launch for second they the closely year. we to Organon the that support as working So, later that expect to on transaction are with obviously, in prepare quarter. this close

Zegbah Jallah

for on FDA confirm you those might then, the Sabrina. follow-up guys commented know And just sample or next you be still I had if waiting discuss then, regarding And that to what those. just is the John are? size Thanks please Can to steps. the okayed clarify here necessary. And are wanted Ovaprene

Sabrina Martucci Johnson

Ovaprene. Yeah. Great questions about

process, FDA, the with of many IND is accustomed to than IDE different bit so, with us a are And the process. what little an

the that is and So, the with to we of in actually our the outcome for Ovaprene, pre-pivotal study that in Bayer. on process instance, the case IDE of study, did, which part predicated collaboration led

successful, transitioning really happened going before and so then, up in can information that to to sure set actually all -- is address approval even FDA get IDE is their And for process you IDE the study PMA. be that a called that they that to to ultimately and questions IDE to IDE a need all allow IDE process, meet the you pivotal discussions to to support the IDE pre-submission, to with have that pre-submission, what's include the phase. you collaborative your that actually the make So have to you expectations

And we so that process initiated this the earlier that's year.

per subjects so XXX cycles, more XX have turns add to on to pivotal up question, size your it yeah, XX therefore, John out the shared them of if feedback months cycles, year. basically study, that in expectation is than XX a point, which month, women the menstrual the cycle, terms so -- all you that in of the time And out one around

communication the and expectations the their study. discussions for cycles, XX that on is pivotal it's the with FDA So, based

starting so we The way IDE so, process about the that. the did with is. us important And what's

collaboration with we mentioned, have the as NIH, also John well As a Bayer. with as

part be this ultimately IDE, in doing getting discussion going some pivotal the on so, they're that we'd really execute the the their to as the input, against like to significantly speak on wanted about because the be clarification process be be based be we that both And study. working FDA feedback it to us earlier study whole study and be going sites share what and contraceptive starting to they're with going to process running from and really that ensure IDE approval ultimate NIH And from successful allows back, have. to of to the our so of us terms conduct. preparation in have Bayer then to discussion with with study, It one collaborators ensure in go that otherwise as starting FDA and NIH, to commercialization to experience start and the and Bayer the NIH are in they we're collaboration that support that NIH, with sites able we're trial to interested to work with than excited we clinical planning that to and the network pivotal now the support to might lot the able identify a allows do normally of and in

all picture gives then clarity And process FDA. little up to a kind the So, have give into process the we're perspective importantly, set which really we we that updates design, obviously appreciate, more on Because sure on successful as us the feeds more to execute proceeds, of pivotal of study. as more background, making a the as and to also, with some understand you start pivotal of manufacturing study we giving look critical kind that can is study could. timing hopefully really can forward for the targeting as big of and just sites year. this on But that quickly against we that design, supply the as this

Zegbah Jallah

X coming the last balances checking here, one a Sabrina. And study folks the are is, cash with with up, spend. and way a Perfect. Phase lot part on NIH costs. Thanks the of help what the Then those market could agreement, know, CRADA it folks are obligation kind they some of about, be. And the of as offset agreement, might financial I the curious of really

wonder so, taking be your into to what to just And And study? might as we my thanks again Phase obligation it can relates terms then questions. financial clear if -- for the X you Ovaprene as put

Sabrina Martucci Johnson

for Absolutely. Thank you that.

landscape that, to. of have So, paying that it's kind market in we sector these honestly, we're I today's attention is companies frankly, really all markets the obviously, really, to and are close have something think have that are right, requirements And collaborations this capital of like the general. the where context infrastructure in which of manageable and in that have, we really, the to kind grateful

mentioned start million quarter. G&A to million some first I'll give Lisa $X.X So, with, just perspective, quarter, for as just the $X.X -- for the

So that gives you some perspective.

an our approved not for product, a about, that flexibility ability all And having hand, to the cash the $XX year, manageable, very -- talked Lisa the the particularly balance million Our And then on fixed top million quarter. that right? cost G&A that is monies that, given of for So, But first $XX about of that, the Part and expected also what the from question importantly in terms really have the XACIATO. we just are you on in now. is situation of secure us obviously, to balance non-dilutive mention, the to that Organon a funding, FDA with endure cash market a what is launch, commercial Ovaprene. closing to and come of it's sale for that are on around the we in do sense addition to just under touched to wherever we dealing right have the our position portfolio. hard is us where and strategically kind the of worked gives feels also cash made And to has creates in puts good lot too. almost

of conduct study Dare's those $X.X So talked -- there's part NIH, is for specifically essentially a for to the activities account, the resources right? stuff. funds can that's the paid Ovaprene that like million importantly sharing that this and into has so with is are like for the because that about, working portion the start escrow the basically preparing have to which cost trial of protocol, entered cost of the the already that all in, that NIH, I an study been a already collaboration year resources pivotal startup So, NIH, well, of those of $X which that ensuring we gone good various clinical the has finalizing million, sites, the the utilizing they with commencement of

have our burn. flexibility lot a we So, of with

readouts on the we've do required have talking both the programs data overall portfolio which are and in year, well-positioned start. we but X, of about the pivotal lower. for hand hit milestones, which so We hand, conducted capital of on one of this year, can subsidiary minimizes costs Phase been and she all the Australia, to we're advancing, expenses that because a yes, The studies our this that We're being in beyond. other really for the the two are that have

So, thank appreciate great question. to you the definitely And sensitivity we for asking that.

Operator

Thank question H.C. ahead, you. next Please sir. And from Douglas our go is Wainwright. with Tsao

Douglas Tsao

without enrollment would've you Sabrina, standpoint, the think for having you've maybe that NIH the Thanks an or I'm study. Ovaprene network how much basis on just I'm from executing afternoon. you done do just standalone referenced, the a to curious, ultimately Good accelerate taking your operational versus access what questions. will for curious it?

Sabrina Martucci Johnson

on get different than -- contraceptive their their and group NIH the they as or than something see that be would particularly doing Frankly, like Bayer, institutions. trials trials group across right, Dare is contraception the because nice companies to more of Obstetricians conference it's our week, clinical is than to the own, last had in these that just even and so, of to our that does are a and participates and bring Thank that number this like organizations opportunity a kind their in individual That's drive on why of clinical funding And of and partner the College I they lot home, just -- collaborating collaborations meetings, it our Gynecologists, money connect you. Yeah. and the American question of value more that great with Because collaborators. the that we like like ACOG some more we because network different specifically. trials timely of NIH with table. a it's a the

a share. coordinated not able that that share NIH And are so certain an with perspective, having an individual can insights from big picture us, way then NIH -- to insights NIH would collaborator through that the the and there in be

insight what for So, insights us is really operational the be as effective Phase that very shown be, do I we can and things. during in execution Dare XACIATO that with as we that think effective is those we've trial allowed kind to certainly on navigate strategy around helpful. can XXXX and information having But X have it's of and COVID, our can trial the be effective

strategy. of to guide and terms So, a different for with instance, they've trials, been they've with rates able site they're at sense that a of proprietary. but in share us to around big a and nothing what level dropout inappropriate level picture rates our seen able across us They give anything talk to and enrollment perspective us, high expectations, at have don't

point, level. if wouldn't has that that of Doug, sites, helpful. same your individually And those all been operating So, to we with at the were have we it's insights really

Douglas Tsao

I just question the A another the then of capital bit may. around little a prior maybe question, broader if markets. to And follow-up just

beyond mean you year product Does right some have if that have to that of not I environment you candidates than it about perhaps a of even advance? of might sure capital affect have three-year make ago, how hurdle have a am have A sense. you And in number might obviously you more the a what Does assets that situation you make we'd behind programs evaluate conservative data? and see? you higher of have sort thought. thought Does a them. number You what current sort should would sort of lead

Sabrina Martucci Johnson

like way every Yeah. landscape? to commercialization at to program Where supportive product? going stand say that Is whether absolutely be based generate after, to before, where to wanted do push what Are capital does And I our day, make was be go and it these capital programs sense. we had XXX of strategy does had means would And which be we Every the the COVID X for go of way to What So, when make up? efficient. today? competitive accretive of with secure mean, capital. effectively program Are quickly is and that years day we started, from what on mean literally program to up? looking we to ago thoughtful the do XACIATO new that we on a what this is right? the we times seems we've this is go real-time, do and that that? year information hand to still that you're with programs is in to doesn't deploy information in I move able data environment. create truly to stand decisions around to to new day exactly had it Does capital Phase always Is trial. the one we it best weren't What XXXX, on It holding the decisions And I one to with slower, that based execute talking challenging still best value. that back about things real-time. right? now. the a tried And inexpensive. that We make and day, But doing that that truly still ahead is shareholder means, we have or decided differentiated? which flushed navigated this in

data have data Phase you decided generate X that HRTX paused that a year. that that ultimately advance that, to X for sense product Phase quickly a it program our move proof-of-concept we is like program We and also on and makes that because can

that think were what in Sildenafil to the would about we uncertain but COVID starting such program Xb. the didn't alignment trial worried We the You reached remember, Phase start right FDA that we was an year that on had take, with may environment.

So, a a be as portfolio more of a we've little might rich had ways have that in portfolio of that without constrained And maybe have to that pivot, do the is we ability to company we this of that beauty the real-time. having kind to do.

to shareholders, measures non-dilutive for deploy creating hand to without we it doing be and on we that to value. We our pivot, but have maybe with still of funding whenever responsibly things, against an can but can assets, it way a can. doing creating capital capital the still responsibly in be value, where opportunity advancing leg still that And the favorable having as aren't our we other take displaying

grants We have different the from have we NIH. received four received now different of now programs four --

of We those exception advance preclinical our cost NIH funded of Ovaprene. are the we pre-pivotal to have help $XX have grants with Ovaprene, directed of a NIH study, our the primarily programs where our at programs foundation Those million. the grant for and almost external and collaboration

sometimes, then could pedal the as of environment, yes, look have different all execute best we at it a And at we maybe every we we those look to grants. flexibility not to prioritizing fast at a that particular We programs look it opportunity three capital the are against we but to not We the that in environment. have in metal, for value create way. tools. So, Doug, as in against responsibly think at environment look suited potentially at and the

Douglas Tsao

you super Great. Thank That's Okay. so helpful. much.

Sabrina Martucci Johnson

Yeah.

Operator

sir. go with our next ahead, Please question Thank Kumar Raja, Brookline Capital you. And is Markets.

Kumaraguru Raja

Thanks for my question. taking

you able closer cleared, in the Are forward to Ovaprene. one of clinical to you on quickly that, and And are filing? the this with once you more terms are end ready start pre-submission of the getting collaboration? trials? how we IDE the move to guys So, are Where is IDE

Sabrina Martucci Johnson

question. Yeah. Great

with pivotal it's FDA that is that process on plan really with, and terms is too that the give of is than been process say about aligns the IDE FDA. working -- about process Other our our much study. what in don't been your question, of matters proceeding. the with discussions part ongoing we've discussions to the a We -- the the second detail process, to typically commence So,

very And so the activities and you the commence serious, sites commence process the been NIH to when can't the have enrollment that. approved. we when IDE and on aligned plans obviously, much talking more just is with on that is with like with that until we'd The

with without start study on have aligned we that. that, line wanted with were the to a protocol. making time their with that clarity the with the of that, the in that very And sure the support clarity sites working that what pivotal on have pivotal -- your from point, could and doing was was expectations with that planning input first on item with the that an we would So, do NIH, protocol of to for FDA FDA start FDA list, been the that on and the our the now so much with getting is PMA is one and to with aligned the on process can't you the reasons protocol we the work that we collaborator ultimate terms

get But it's later talking target So, support we've have with year, for and pivotal year. terms on the we'll on to guide working this in but sites with study. already study been talking NIH this to the the them start and that with collaboratively more ready to specifics, of

Kumaraguru Raja

like much payer interaction, you XACIATO with Okay. involvement with that? about having of how now care to all right to guys those of activities, regard pre-commercialization And or Organon are thinking pricing, is regard taking

Sabrina Martucci Johnson

Yeah.

It's so for are. like was closely value both to table And and at discussions with things participant working Dare our because things. ability. expertise partner terms in strategies that it to the Organon execute, collaborations a they to table product. will that's will with that. plan are and to responsible really But partnership with Organon what agreement these participating be Bayer all the to -- wonderful these not and for are gained expertise to to as and execute Bayer, that the around our be of to on all They on input, of but them, financial activities to really Organon's collaborative that, going quite and process, Organon insights collaborators. under of truly and give can our also deploy the this is against They it's our that in Organon, and with comfortably uncover commercialization are those So, capabilities our there. have want Organon's an insights and they Dare Ultimately, how Those the really picked we've say Organon all allowing that's of value we their have value because And plan of table. a we about it. execute XACIATO. is a their I our we're seat having why a nice the wonderful at get seat we brings

Kumaraguru Raja

And more injectable this one grant for long-acting on hormonal contraception. from on NICHD the work recent

Sabrina Martucci Johnson

Yeah.

Kumaraguru Raja

these when So, do get funded? what you these data studies? from line have is And the think of will terms in when time you

Sabrina Martucci Johnson

question. Great Yeah.

to tool is times us mentioned as So, wonderful and I a to useful, to are great mix, really ready against like particular is now, our right? grant -- put dollars, really grant particular this that. XX-month. needed, beyond sufficient that, from that And really we or so have funding is as it's NIH trying And to the a for X as It's is back will continue the we insights contraceptive move advanced to grant differentiated, X that sure also we're touched for to are this preferences, and is get months be preclinical NIH, us the it actually likely be of brand going XX-month make we our two the getting contraceptive in third to the NIH, in injections preclinical SBIR able Ovaprene today, like is to all we're few strong. injectable a to those grant program as six-month can deliver made a but grant collaboration. around method making advance, that gives it's to up We where particularly XX program going particular we're that is dollars the always being we this the a optionality six was understanding be this ADARE DARE-LARCX opening non-dilutive gear implant, the really whether make product commercially user designing just to the on on and received allow program that Phase months contraceptive most get innovation and are a And a duration developed development. lot our and This to programs, as of couple upfront more interested to action of so get per in as positioned that opportunity it's and women one Phase and there year, from well the this really points fall commercialization, It's a in comments, contraceptive stages preclinical differentiated to sure six-month into or us preparing. I a sure via or to a clear hormonal in an beyond. a

helpful So, very, this from away. is of intended to a to gather can very, and influential go be getting we're that very ready perspective in right data some that those market discussions, and

Kumaraguru Raja

Great. Thanks so much.

Sabrina Martucci Johnson

Thank Awesome. you.

Operator

you. on will turn over Thank remarks. queue. I for the closing the the There no more with are to questions Johnson And that, call back Ms.

Sabrina Martucci Johnson

of regarding activities seek of stages we the our set forward that time We updates contraception, quarter our prescription been as to XXXX value With differentiated important launch And to market all as various for product discussed, therapies health. commitment of we and fourth recent and seven drive all objectives our expand we've candidates healthcare and taking in areas we've and on approved afternoon with today, updated under as prioritize we expected discussing our providers sexual this in outcomes, candidates vaginal to diverse the for year. bring women's look the treatment against and development have shareholders. commercially health XACIATO to fertility, to you the keeping our wellbeing, thank about hear the FDA improve our launch. progress options of that women, and portfolio, primarily in stakeholders, for you one Organon ongoing well to the development, Well, the Great. sincerely Dare's milestones and this

keeping for to you this We thank look afternoon. forward taking So, time the you updated.

Operator

for everyone you Thank call. your conference today's concludes this And participation.

You may all disconnect. now

Daré Bioscience (DARE) 13 May 222022 Q1 Earnings call transcript