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Dare Bioscience (DARE)

Participants
Sabrina Martucci Johnson President and Chief Executive Officer
Lisa Walters-Hoffert Chief Financial Officer
John Fair Chief Strategy Officer
Zegbeh Jallah ROTH Capital Partners
Joanne Lee Maxim Group
Douglas Tsao H.C. Wainwright
Call transcript
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Operator

Welcome to the conference call hosted by Daré Bioscience to review the Company's Financial Results for the Year Ended December 31, 2020, and to provide a general business update. This call is being recorded. My name is Sarah, and I will be your operator today. With us today are Sabrina Martucci Johnson, Daré's President and Chief Executive Officer; John Fair, Daré's Chief Strategy Officer; and Lisa Walters-Hoffert, Daré's Chief Financial Officer. Ms. proceed. please Johnson,

Sabrina Martucci Johnson

afternoon and Good to XXXX our Thank update and call results business for financial you. welcome Daré Bioscience.

is since in Our discuss and milestones time today to XXXX. year’s developments last plan for financial to notable highlight achievements and our November call anticipated last use the review results,

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

of entirety statements our quarterly company's Report I'd and the qualified XX-K Forward-looking content out are our Form point on on by in Form to filings, the including also SEC XX-Q. reports in that Annual the statements cautionary that forward-looking obligation includes like their required law. today, call only this except new after undertakes call, to of this March as information by Daré is reflect to current XXXX. time-sensitive statements information XX, any as no update or developments

women's leader innovation life focused a you we're in wellbeing improving health and know is Daré women. As the on and of squarely

We to have clinical in and commercial this and agreement Ovaprene allows that and first contraceptive for product partnership Bayer first for all Affairs benefit health, us XXXX. commercialization the XXX candidates meaningful for XXXX, the opportunity ended in Regulatory health, commercialization net line for study. believe X also we availability commercial corporate the new partnership plus rights. believe January our products on opportunity advancing by to during can achieved tiered We have with of broader women. for only sales, women opportunity, selecting accelerate capital is support million commercial strategy December we be our in in unique to But validates category first up from menopause. milestone posed payments, and with first programs completion and two in the Phase of year milestone, that by portfolio XX the commercial announcing Bayer’s is four royalties in Daré potential started to objectives. development, provide year with products a portfolio first important in creation vaginal stage first million of we Despite challenges with and value not expertise Our category of to in double-digit sexual the that contraception Then, prescription the Ovaprene clinical

XXXX. Specifically positive DARE-BVX set across study of X DARE-BVX first treatment NDA our The XXXX we announced topline meaningful bacterial the of Phase portfolio the objectives positioning for for data for vaginosis, the in in stage portfolio, submission. Daré advances from the

to who to you XXXX, are of new those Daré, an interesting time for know So get to it's us.

today's more here as look XXXX, programs announced I not of positive The just these just mentioned, key cream call. DARE-BVX three in and potential XXXX. more target we three highlights We'll objectives Sildenafil study I following, announced additional are approval two development and But programs, stage enable for an portfolio clinical each as the action the prior thermography X the to Our and study Ovaprene, of readouts X that different the readouts Phase during us which detail across three filing in well. XXXX. clinical Phase but encompass forward two in XXXX already programs clinical both pre-pivotal XXXX. NDA portfolio mentioned, in in include And the cover

commercialization new and topline PDUFA the application NDA For DARE-BVX, strategic study Investigational Phase action X clinical and submission; cream, the potential study. and data; potential the DARE-HRTX X Drug of the submission, Sildenafil commencement exemption data DARE-BVX Phase setting agreement. Ovaprene and initiation drug topline clinical the BV clinical Phase

million X in in basis documents, which to protocol well that at are of basis. primary guidance So the have vaginal on assessment disease with treatment to odor line, curative the of rates clindamycin XX potential announced lower per outcomes surgical to the in cure as intent of women and an XXXX. investigational clinical vaginal for vaginosis bacterial prescription the those to a is for up to XX% disease. study post it's have and XX% have FDA symptoms birth, in estimated discharge importantly DARE-BVX first and modified We Bacterial studies hydrogel causes population. U.S. vaginosis. age, X% these which XX is efficacy branded recurrence population, preterm infection prescription start current demonstrated treat treatment women products of care range compared health very bacterial with infection rates reproductive including disruptive DARE-BVX improved on XX% for clinical The of to the XX% infections, risks modified inflammatory and rates most as It to thermosetting pelvic treatment. branded XX% current symptomatic phosphate administration formulated the potential successful women end our Those in vaginosis, and demonstrated and XX% of is XQ sexually per DARE-BVX the the to both of that of range, rates DARE-BVX. the products her completion DARE-BVX I'm vaginal within estimated bioadhesive affecting going the XX% current transmitted product DARE-BVX to a cure first intent of provide novel for shown vaginal treat including vaginal linked with best-in-class says as months protocol improved in products common the Phase study a single patient

Phase vaginal for both products study, clinical in have marketed basis. the delivered demonstrated and population X a values treatment DARE-BVX modified by of those cure oral mentioned protocol FDA currently to vaginosis intent been and on bacterial better the per than treat a our I As rate approved

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date. Drug data, we're we working quarter. is NDA toward candidates of the important an regulatory the to review fast be for vaginosis. product in which goal U.S. PDUFA time the Administration, granted designation is the the to Food submission, And a lead of U.S. NDA product these second track line and believe to FDA disease at infectious a option XXXX submission advance priority FDA positioned allow the qualified Given for bacterial the planned for approval the DARE-BVX is to by request The treatment first could DARE-BVX and The

in prior we be June XX XXXX, XXXX. of would that in XXXX, XXXX. review filing July a of market is date XXXX submitted support means FDA approved granted just the the allow if that for and notified December underway. by of acceptability robust action XX, to the granted Specifically, would priority of as approval whether by is as are introduction DARE NDA of to And long discussions other be would activities review and PDUFA XXXX. XX Ongoing BV-X priority commercialization if strategic

shortly detail the in how process. now to to commercialization the in talk Sildenafil and strategy John insights we strategic cream will our additional discuss to and provide in maximum DARE-BVX XXXX, shareholders in So we to announce value this approach greater going about our collaboration intend X.X%. the U.S. for will seek capture I'm on finalize for

have pro pre- a to has home XX of estimated physiological namely disorders, Xb in be in formulation to The localized we arousal instruments first potential cream distress XX, FSAD outcome topline be the weeks study next over us study a so And treatment. in be dysfunction rest we sexual sufficient in women a that U.S. for arousal evaluating suffered cream sexual FSAD. of readout the the first on period. is measure disorder in FSAD large for far is for March low advance eligible clinical primary XXXX. of Sildenafil or general to FDA over efficacy symptoms estimated both experiencing FSAD Commencing response XX and the women, FSAD various And viable products category to with the data the need so with provide XXXX. topline readout of be cream Sildenafil by and the even women investigational of we the cream men. without FSAD, more at screen now to Women in approved approved Xb On with though arousal it successful, So option. most exists Sildenafil our data cream working FSAD will of as Patient long and female to research the million by in edge the a as as several peri-menopausal female experience. U.S. targeted exciting general market dysfunction that no world. and sildenafil, active erectile women to updates characterized positions a Nonetheless, our is for administration address ingredient reduction sexual commenced following end focused will year inability an too during at or treat and sensations for compared types and erectile in analogous women today study a actively respond used maintain If in sexual achievement unmet Phase to topical progress the the towards development cutting or that FDA and if of activity. the months, condition target. represents distress non-drug is dysfunction Phase placebo treatment Sildenafil sexual the to end clinical with potential an option of on use significant potential potential announced Viagra intervention not treatment the the women's FSAD it attain to to of market FSAD the the cream a to arousal with FSAD suffering is FSAD. of reported both from health improvement run no placebo seeking will is treat treatment evaluate endpoint, or

this with looking very progress We year keeping updated you program. much to forward that on are our

talk to investigational contraceptive. monthly going about hormone is novel I’m Next our free Ovaprene Ovaprene. intervaginal

terms the program, agreement submission. upcoming data currently into under As positive ongoing the a XXXX. regulatory is and involved January for Daré the our on interactions support already that trial People the in XXXX agreement in and Daré is FDA Bayer to we with Bayer the often pivotal partnership heels with announcement mentioned, entered of of in ask responsible how given of the pivotal commercial them pre with

under may Daré full of terms you time equivalents recall, the agreement, as this up at point to While, provides support. for two the advisory

to meetings of the the manufacturing, concept commercialization interactions treatment have Unlike and that's vaginosis, with a as and vaginosis, activities had the per with up of today. bacterial clinicians week way planning. Thus, to such represents before device franchise, preparation Ovaprene that partners. available with where like to required and Bayer support intrauterine launch successful the and areas Thus work Ovaprene bacterial very the contraceptive familiar are launch a franchise to vaginal approval, amount FDA in as so The Mirena of successfully already one-time product familiarity critical similar plus any these undertake times they pre-launch. billion completion dollar releasing turn that study is ready functional which to So per our today. ensure pre-commercialization first underway hormone disruptive medical affairs preparation that that we teams regulatory, multiple of the another advisory to hours are reduces revenue Bayer's Daré. work meet include clinical, pending week that put across XX unlike pivotal are

a U.S. contraceptive terms the the quarter is that pivotal that path pivotal XXXX. on is of steps registration, initiating study for IDE next fourth of study submission requirement the to commencing in In the clinical FDA to This for for a FDA planned

technology planned the to XX-day touch used the up for and on months the clearance containing quarter an months completion DARE-HRTX announced enrollment readout was the we prior the read that quarter the the Pending to Bob data developed month a in delivery commencement by Medical the potential confirm as offers of in estradiol of and On XX expect of Dr. Dr. and Phase outcomes. the in it's I'm DARE-HRTX. [genital] DARE-HRTXis [ph] or and and X X and drug seem a to investigational is enabling data are Phase for March we Daré clinical Hospital going symptoms will to we important convenience Ovaprene, the women's when a over out for improve least six at syndrome delivery study with clinical IVR it to with School. treatment end XX, alignment on of Massachusetts the Langer of used We to versatile The of XXXX. study's pivotal And General platform associated our the by from six Harvard period now commencement. with Bill study menopause. vasomotor designing IDE, bioidentical system XXXX. of progesterone study Australia bioidentical evaluate MIT the in topline urinary believe and Crawley designed XXXX in the and unique second health drug intervaginal ring first IVR FDA from

luteal being progesterone the prevention fertilization same DARE-FRTX ring XX-day vaginal and birth developed bioidentical broader period of to an vitro a regimen. preterm phase our fact, part deliver utilizes technology the is of support In program over in is for and or IVF

ability You support of Kennedy IVR clinical active receive we of may evaluate The DARE the grant of by Development of in Eunice up DARE-FRTX development DARE-HRTX grant awarded and of including the million that objective our Health dual release to activities a two XXXX just division trial eligible X.X recall for technology supporting completed the to to and XXXX. Institute development total achieve may well is as NIH enrollment National preclinical of funding at its Child the DARE-FRTX targeting that the in of release Shriver that ability Human X continued in to a as X Phase different for the Phase to objectives rates. different drugs where we two we're is that HRT-X be

securing incentive it to R&D efficient R&D in funding the will program. receive the capital to conducting study similar about example Australia's back of discuss of incentives Lisa in non-dilutive talked Daré activities Phase through subsidiary an the approach just eligible through tax to future shortly an to that payments is as our cash Australia I As X grant be makes form us tax

DARE-BVX turn year study this to plan upfront. Phase we just commence X mentioned my I want over I to I colleagues, before that to Finally the that mention it

clinical women the one DARE-BVX of risk our is X vulva breast vaginal study vaginal in atrophy Phase with positive or formulation proprietary So investigational of or to With we We as now and update. for to back going treat I'm incentive a turn at hormone development provide in receptor of that every half tamoxifen plan payment the the administration cancer. second XX.X% commence in and over to eligible that tax business corporate a spent leverage it XXXX of John to of currently Australia partnership where cash to company. to to dollar plan VVA

John Fair

exciting the the We're move DARE-BVX you, for an to of submission bacterial Thank step introduction for of us entering as time important will Sabrina. treatment closer product new vaginosis. NDA one this the

pharmaceutical are adding We continue as interest as activity candidate new their be we strategic of the from healthcare seeing product and portfolio. companies large interested impressed to in with differentiated the as level well emerging a product specialty in to manufacturers broad

look strategy we execution a commercialization As of we’ve definitive following DARE-BVX in the past, the to our forward communicated announcing for agreement.

we're start which believe by it's parallel providing partnering in about on timing, often the can process. best we interests derisks to DARE-BVX some to believe discussions because I with our to we our program. asked adds However, I and that reiterate continue value in context regulatory our wanted our to advance discussions

a executed before in parallel able was the that and the force the We indication. we to mitigates for successful. with because a or Bayer of NTI today direct it with of believe with a have vaginosis tenable for which the required we responsibility much to would positioned an DARE-BVX believe straightforward the DARE-BVX in are clinician the are commercialization. some number new market complete be of commercialization We contract work a the role a definitive to profile to traditional of the similar bacterial flexibility awareness reduction has execute Being in of commercialization women's and organization, product driven a size out where commercial efforts of fact we is can therapeutic softening play that to the healthcare end required optionality And in health to our that than target about Ovaprene multiple as strategies, development that brand Bayer involvement months on portfolio ago. forms from complete providers we us viable a deal all of broadly XX we year. reasons a of are sales more in of structures of the to means considerable the products think the we have partnership we collaboration commercialization license, contemplate. the commercialization for what by make commercialization And that also scale appreciable agreement reach to type The field have structure for of

resources sales provider time with implementation like driven pandemic, achieve entirely a their almost over. can continue COVID-XX of and with even remote this accommodate virtual greater that's by and to expense. much With more with representatives detailing, full Doctors believe workflow and the a the quickly, reduced adjusted and the pandemic we fewer organizations ours visits virtual scale is have will after efficiency

is All and greater commercialization all proposition the of DARE-BVX taken optionality partnership patients suited value best this the of compelling the together the are Phase study provides DARE-BVX table. options pick to that our for on structure believe shareholders. In summary, the from DARE-BVX, for we and given for X us data

want reiterate continues relationship Turning both some we Ovaprene. the briefly additive partnership, to to of to value the Bayer I with made our companies. comments be Bayer believe for Sabrina about

IDE filing in both plan of efforts the months, ranging a coming this our work pivotal in medical from only externally to Our number and are that planning, stronger of later of year the collaboration this synergistically grow and two we preparation planning. will trial and enrollment Regulatory operating anticipate manufacturing We clinical for streams, brand as pre-commercialization affairs Affairs, in includes XXXX. organizations the which internally across the coordinate key

the the words in Finally, of say ecosystem. few health the a I broader to women's brand wanted about Daré strength

variety side products continue to new the differentiated elevated side and Daré, from into continue been and stakeholders We to us this deliver to active our to and be the help have brand for to real is fronts seek continue value What's pipeline. of has both number partnering been and will of through about that a to on category. success new our drive a development on into develop and has year translated into interest and Daré the the that

advance. really excited keeping Daré are turn you to and look that on exploration what we I With call think the is embark for will we to collaboration, growth phase discussions So forward to and Lisa. updated over next the as

Lisa Walters-Hoffert

all you, entire assemble, to joining novel summarize results of John. year. would a past business for efforts Daré's financial our to for candidates today. advance thank XXXX. to incredible team over XX, Sabrina December now in for the excitement ended monetize like year and women's Daré you the Thank model share health. I their us product and grateful I John's and is portfolio And I'm

result, activities milestones, As other our acquisition expenses a including research consist clinical and to our costs candidates and necessary portfolio through corporate development to the and maintenance of overhead, generate regulatory approval. and data advance

were Daré's expenses For or the and R&D $X.X were million; expenses were December research general year $XX,XXX licensed ended development expenses and million. XX, XXXX, administrative approximately approximately and approximately $XX.X

and personnel of costs primarily as DARE-BVX to grant by DARE-LARCX. R&D addition study, Ovaprene related Bill the Melinda supported development Foundation. you team, and our program preclinical R&D In the for DARE-LARCX Gates to know from X And is the reflect expenses costs of activities the Phase years activities our the

the for year loss comprehensive approximately $XX.X was million. Our

and with just Total described, exercise $XX.X of year approximately in I sales year, $X.X loan license financing proceeds. year activities from rebate. the were as was Australian cash We the the financing and of million Reflecting cash represented XXXX payment, fee from approximately net well stock, cash cash warrants grants, proceeds million. cash ended a the as and during $XX.X the and During the activities million approximately equivalents. incentive cash received R&D

million from XX.X program X approximately facility, our Following under sales between of warrant to $XX.X Equity approximately stock Daré January year of exercises XX,XXX consisting approximately of March cash common and $XXX,XXX of program ATM and million, from XX, funding. net in fees received end XXXX, approximately additional Line

In XX, SEC subject explore $XX of flexibility our registration could replace file once without SX late shelf XXXX. by meaning a to could adds and that the activities, shares existing us these XXXX March the restrictions being January, existing rules. approximately exceeded common form that yesterday, that the XX.X imposed use and million, SX Daré million float as statement baby stock public of Following we self float exceeds A of million. $XX outstanding public were tremendous our registration in intend three financing effective which over financing can with the us the not registration variety available We years, will statement be enable to options SEC new shelf were to form allowing to explore time. us or that over next used to different options shelf

As attempt in we manner the we so enhances in and done have value. past, protects will that to a do shareholder

to my In the efficiently. are during there worth of few to and us our serve should they highlighting commitments given agreements, addition a XXXX costs our development coming comments, reduce manage resources and help arrangements cash collectively year that

attractive recognize been for grant of funding have an and grants source rejection expenses. and funding statement of development we research grants; operations in non-dilutive First, our a Daré as to

we received Melinda an related our expenses DARE-LARCX Ovaprene, and grant Foundation. Kennedy monies recognized of X.X R&D have Institute to offset XXXX, Bill and and as funding DARE-FRTX. we National of the Shriver Eunice to grant To-date, Health Development, Child Gates million Human and During the from

continue grant the allowable continue to funding we additional and to explore expenses, our will grants to apply for use We existing and to for intend in future.

well. expenses in with our our These XXXX of XXXX cost eligible connection based mentioned, programs. to provide helps staff credit in additional expense on development a are in as incentive for Australia's for expected Currently, based for arrangements and study. cash DARE-HRTX related of up our program, to tax agreements as received during program XX.X% to XXX,XXX eligible efficiencies cash and of decisions [indiscernible] XXXX companies And during R&D the commitments research finally, we their the well applied to we resources for expenses. development the quarter certain $XXX,XXX as time approximately which of terms under rate activities as in receive had Sabrina of eligible refundable clinical the and provide Second, allows incurred reductions on first

needs. a option we capital M&A variety product cash to working exercises, continue to to equity, raise of for fees. have explore candidates our sale our grants the advance and satisfy inception, raised non-dilutive warrant will capital We ways our of through and to transaction, and license Since

COVID-XX. We of creative in about we endeavor value as capital be efficient highly to such opportunistic seeking need be to will to our capital. the we build A advance use candidates in and and the word

at We to impact and to time. predict many uncertainties factors the responses, to the detailed we monitor rates the and of many and rates impact this to including We liquidity on on business. aspects and continuing reasonable our and unable the condition, our with accuracy pandemic investors our our the governmental in potential its surrounding full the efficacy any financial are filed pandemic, capital are Due and company be financial which review business XX-K encourage our with more of discussion financials and will resources risk SEC. the vaccination

typically you file a as luck our hour it down. today, we have half but the before earnings XX-K, an know, Website SEC as call was our about Now, will

as and operator an for would to file we that keep will soon eye over turn the out like to now we So call can. as I the Q&A. XX-K

Operator

comes Capital ROTH line you Partners. conference the Our [Operator the Jallah with from question Instructions] attending Zegbeh call. for first Thank of

Zegbeh Jallah

of guys, Hi, for a programs all thanks the updates, different are lot ongoing.

So the of it's nice really what kind to each on update is know of them.

of just starting expect kind to approval with say year if the March? just an were was would we the priority you for it's get review, first in DARE-BVX, curious, one not So

Sabrina Martucci Johnson

Sabrina. this great. Yes, is And

review six review from day Yes, file you the because month the XXXb(X) pathway. question. allows So a great this is priority

be the the So file. from first day PDUFA would we to If the quarter. you towards it's end then not of review, yes, expect priority the

Zegbeh Jallah

of mentioned the really positives as terms you the involved. Sabrina. of the able do and in products, can remote market then be a more love virtual And Perfect. that, Thanks a of I John as well lot being to partnership, established guys know

launch? looking so, was We're cash terms prioritize priority. just someone not wondering, And kind that or to balance, I can of of cash, is going upfront really the for in that you a just handle boosting your are

Sabrina Martucci Johnson

exceptional an question. really is That

to really asset, for the let our me how look that matters partnership is shareholders is right? frankly, looking at to access at end and, maximize so We the accretive you the we Because there beginning the And to that and to best what try women? gets What Daré is going this it. what articulate are what partnership best potential right. to and isn't, the that's

there what that looking in we're best number So And is balance that structure? to of things partnership a equation. are

whose give And successfully that positioned to best position for picture, and looking we're the the its attention our clinicians into best achieve beyond does how positioned product it the whose to who objectives So Daré in DARE-BVX it target is to big to best message value commercialize and that deserves success. that. to order deliver

think, should a about asset how think you what its saw We each merits. I Ovaprene so sense own this. And on we of take with give you

with to recent talked category in absolutely billion critical brand was about So a we as has, today, contraceptive the that have program dollar it we created into days, Ovaprene, that company partner. launched brand that to a successfully and as category, the felt only that new built

off the to right have that program sense And was any that that involvement made do to for with hand so it thing we didn't it feel program, to with Bayer. it us to

particular about and that DARE-BVX, all for optionality gives trade this that us think about how you partnerships, call, mentioned. more reason lot a communicated off program and think reasons and on we John we how the lot this I for we about As a think of

be? So you we did end? with with it there do was your fortunate So just gives a of off, excited we possibilities just do at upfront? make take Ovaprene, are are us very take as That to money you do who the programs can the more be that lot And we'll on by trade all as people the side possibly product back that? like and Ovaprene, big is and look as excited Or to you And partnership advancing the do who's want to going about. like about optionality. landscape that Ovaprene,

front cons the near directly role term where certain structured about process We're with and of translates I way a your also we I just Bayer perspective ability we towards value know all versus that how our the on enough that non-dilutively, you hopefully how did partnerships all gave the under in as of of that play some that. because into having that So But funding I also the all less, the of dollars come flows. like this of pros into can't. absolutely deal cash could to deal and us talked weighing end answer in are well. I not weighing And translates question that

to clarity posted, these as today that mentioned, updated. hopefully towards keep as regulatory definitely we some progressing, is our the we're is So, get stay that for John the finding it discussions so definitely progressing, will in that, in keep interest process to outcome best not NDA parallel our got And you our shareholders. rush and as conversations going best are and the we people process

Zegbeh Jallah

as evolvement in I quick on be might be been curious color And to as driving said Sabrina. of It some thanks because well, pre-commercial for that here, I some pipeline additional for Thanks of Ovaprene clarity what the just supporting just the rest And activities of has the payment, next the well. of IDE, even the of you are had terms one what timing was happening, of helpful that. timing then, regarding that could your of as kind just milestone the underway. on think that another

Sabrina Martucci Johnson

more Two questions. great

to moving the right Ovaprene sights hopeful pandemic a had program. XXXX. get terms the you -- Ovaprene, the who've beginning remember in that our been IDE process, in so while, faster, We as COVID going faster So early those with getting of Daré following before at that were of on the of the for may you we

with be a with COVID required opportunity well. was actually to about we Ovaprene the that that it also allows pathway as pathway. the manufacturing to and you the for that regulatory have a PMA. the pre-submission do things would is goes which get talk non-clinical that through With There CDRH CDRH work don't always almost FDA the during pandemic pathway, opportunities unlimited and allows knew also It's meetings things. and It

one And was some in towards for forward the the data the and what was those Bayer's recalibrated always which all so XXXX, same we to looking at factors, right, time in of of we kind have the program, process. objectives, regulatory of light balancing ours as timeline were while

the It's are time we've of a And types so more pivotal those any planning the all what studies that little of the activities, studies bit is that challenging for work, trial, spent start are of process during different, had close luxury that we've period safety that had different of stopped just this been advisors know, of going through our We've actually wanting terms environment number particularly the their in activities, in manufacturing that required as the a study non-clinical I PMA when to and doing over kind that it's nonetheless, talks, very you're COVID regulatory the this had -- some and are than NDA. you particularly guided mentioned. funded an filing midst stuff. particular of they the we pre-pivotal from collaborators studies NIH, been pandemic, who at have study contraceptive used all a heard studies. of have because contraceptive that not of right But

all those on we for other things. So focused reasons,

in that XX the timeline is this payments payment then, XXXX milestone of it, looking question study. the of the the pivotal So filing milestone readout that really the driving that is from end to the in think which aligns Bayer, your asking what and And what's at for I and how with million year. getting you're

of exactly to is, is have been months, months. my free not alignment the months of is comments, IDE able contraceptive part products have finalize will until XX our devices pivotal in mentioned I XX Hormone -- vaginal discussions cleared products the typically the been be FDA, kind have the data with what but been required. six they studies, monthly of be duration As finalizing X, on

So months, six months or months to discussions slightly contraceptive same six even XX go be very down contraceptive don't at from outcomes see at with months going potentially at months. are the XX between going though to on that of predictive you're what these are We the XX FDA XX rates know clinical duration. products better and at

of milestone what final pivotal contract a study is So in Whether a contraceptive or whether to due the on or whatever the the long months certain of to that timeframe. needs data depend is, not as start based we've ultimate triggers position required will is month next is as what to out the payment six that end to submitted study we that ultimate going pivotal on six we XXXX. XX be is, payment by aligned read because FDA, package the it's the we the the that year, be study

payable contract, haven't the We in treatment SEC are request the redacted of completion the it's that's in filing disclosed all details the time on on study. the a certain but after the confidential with

completion, contraceptive it's completion would So when if there, timing not effect is but happen. XXXX not six months that right XXXX, the is the that that's if in

Zegbeh Jallah

a maybe position for then the come How step? could -- one your just And for then, should context data? how Thanks we more interpret the next additional for readout some from out? in you subsequent put it to HRTX perhaps the detail in me, on, good even does hoping data And you as put when the of just wanted see the get Sabrina. for what [Technical to Difficulty] last details are

Sabrina Martucci Johnson

in this questions. Yes. queue to And the move I'll on then, you've awesome the after question next had let one,

come second so quarter. data answer see this Phase your at excited And right, it's that the HRTX, day to looking so I'm XX point, data is PK we're to On release data, we're the and we've get to over So objectives. looking to these. our period met at really in going to drug X,

sheep. are ring As great been technologies, this because human ring can already work you in full has vaginal factor for model recall, for sheep. you Sheep may vaginal done a use form the in

this we've sheep. in demonstrated So already

an to adverse was done similar to women, also if to and that importantly, there's obviously, now this events do is what vaginally see this So in any unexpected. are sheep, in opportunity

not doses those terms rings. where consider And progesterone HRT same interesting to would going effects. we're look the progesterone nice to we confirmation we're at at doses, also of to that And of going to two look looking up we same So but on it's we're for have what because FRTX Phase and the the it's that the sheep. any those look estradiol. going the at for then, doses, in the why are million that NIH the of also saw to in actives support of program, are we some the X of the is both same for look data vaginal progesterone funding really PK progesterone we to for, all which is and program, we're X.X some And going same the the the that

So at like. data it's those peek early actually PK kind of a what look nice, might

obviously, to decide Phase that X, to also with step would for the it we which us program. be And X, we're NIH proceed with can data, helps we collaborating plan for program So how Phase want have for Phase X into the where the that then, FRTX. we progress it next HRTX once

Operator

question Group. next with the Jason McCarthy line Maxim Our of from comes

Joanne Lee

on Lee your the the on call Joanne congratulations questions progress this the Hi, and in for for is Jason McCarthy. Thanks taking quarter.

if you of previous a FDA meeting which it's announcement the for the PDUFA plan the regarding on there's the you the guys FDA? been do heard? in date? all was were any on with the the what and question, if DARE-BVX, the of first we announced and results study. I responses having submission guess I saw planned obviously was pre-NDA not, looking we're some recent the put in discussions for Or with to forward quarter Or fourth line you of earlier a sort the just my with I is asset, submission For NDA data QX. wondering great understand BVX

Sabrina Martucci Johnson

absolutely. Yes,

into definitely reminder, previously probably thanks should guided and on I'd guided had have way helpful a FDA, would have. really risk Ovaprene because that on to done we NDA a discussions discussions it pre-NDA obviously to So mitigate are any our with submission, pre comments pre today's sponsor neglected meetings of do with call we have those everything NDA Well, with FDA. We but of for Hopefully we your We've discussions. the right and can the that to you some to the mention then, consideration like as have that engage I can the to you guidance them. NDA. FDA. the about, and you have previously the Ovaprene DARE-BVX. with an you take advice we on that program, and that from We And absolutely lot advantage make even a Sildenafil opportunity you've prepare sure gathered similarly to opportunities and ask program find anything FDA's the take suggestions to questions had

we NDA exactly as of do yes, exact is But where we NDA and communication company disclose is FDA critical important with events and in those So, a filing we timing never strategy. something our part pre process. of are the that that and the a that absolutely

Joanne Lee

helpful. Great. That you. Thank was

sort the of So surrounding end there's shifting of the the exciting of asset focus FSAD us year, future was Xb assuming the year a initiated that for activities you the current Phase just program, the steps lot study results what but I company the onto to through study BVX Sildenafil of earlier walk market? completion been Could hear to this cream to the it nice this positive. briefly get of at are following are the some this

Sabrina Martucci Johnson

use talking hoped way that word to about when I'm excited describe it a to is really have asking about very because excited for you I that it, the better been like thank product, But we And product. Yes. about trial. hate the had study. with This to last to year And really to this right that was had the last year uncertainties starting year. all just the we start was we felt that another one start enable not

were of going a with the XXXX. and unmet interesting at chomping we this we to primary It's get the such end So alignment it significant an endpoint FDA reached such at need. that the We the had on the because study bit is announced program.

we So something to getting this going. looking were forward is definitely

a the are foundation to design and on the expectations you kind entire What XXXX the excited. FDA. very out your What what are who FDA there's that X that Xb It leaves And of part Phase to the like? you laying lot was is discussions a look with end may to recall guidance So which sponsor with -- because the at to sponsor a those their of the open document we're align Phase of to like? discuss our the time what start to point does of document. and does involved question the really may the there, look guidance program open

So expect what next. terms we in of

designed is as use of primary the alignment Xb came work to our Phase our what with also endpoint, best as But content Phase this to X. FDA likely take study looks validity a this endpoints primary endpoint and into that So would of the in was out content part that forward the number very works. of include good exploratory exploratory secondary a validity

aspect to we take important is it a be picked the the So be one primary, program. forward may may what Phase of an Xb as endpoint, picking it right is into Phase different one the the X

Phase a whether that disorder, is look currently terms to be will the designed consideration then, the XX document Xb. does arousal FDA And what the versus XX will that weeks duration Phase the clear Phase really around have really female hypoactive in guidance was with in sexual is not It's in which stipulate an continue So X the disorder CNS important of standard the weeks' like, that Xb. desire for that condition. we

with right have need Phase that discussed is two X. to But study going So be already area of discussion. that guidance weeks certainly for the Phase FDA would the an And XX now, we X. says we

leveraging the is And XXX(b)X program, different Sildenafil a safety in is oral for administration. of this men this while Sildenafil, vaginal it's So indications. because we're

will Phase the two X be trials. So expectation

X, end after FDA next on with and going. step So and on of would the hoping meeting that align be success, get then have Xb the Phase to Phase Phase that, X the based for the

Joanne Lee

Thank Okay. taking in really for quarter. the and, any We're hear details excited you much again, question. coming the so for additional those updates to

Operator

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

Douglas Tsao

just curious. I'm

when sort along sort to With Have we taken the terms approaches of different given hormone in thought you X. assets. far partner you terms want would When those? development, you you how replacement of Phase of therapy in initial into want or when look your products at of portfolio, going to take

Sabrina Martucci Johnson

that, of true. question. companies of for that his kind Because always Doug, and very on comments John, talked in asking it the fact with right discussions, about he much touched kind some in where we're that of is thank you

as So as portfolio, mentioned he across partnership That's know, our kind at you create the right? the we active your business, question. in we too should all to times, and of our between and opportunities back-end be, on in everywhere we front-end are we partner discussions, in

depends program appetite really on it kind for and do. the development. depends on So investment And of it in we the

opportunities the that the Daré under as we So we as is we quickly the attractive to exciting we of did as form and reasons such and lot that were while right creative now we because to assemble is leveraging for out fragmented. her. terms assembled market were category are there. XXX(b)X being super able products did first pathway, to them have as a a of innovation and portfolio we a able one lot of There's and just how you're There by doing still delivering

health. But over of that hasn't So there entities can very you commercial on outcomes news And been and improve and last are happening. weeks. watch invest convenient, matters threatening, excited and of and in that we've more Merck in couple not commitment there's are life see so make Organon, to nice but women's it much more really much indications there's And altering. that these more as the to life development to been the

U.S. particular this constantly we are shareholders, with will we outside the our think absolutely program that it advantage something the makes And in of opportunity. definitely take makes exploring sense sense of it's for collaborators Doug, for and when it we U.S. So and potential

Douglas Tsao

to multi-product far, that at company. so And sort I And I just question. on your activity partnership things certain when program-by-program there's as mean, a look a for follow sort that of you, up been has basis different of have there's that because think engaged you in fit bucket? some development And into fit ever sort collaboration, I could that partnership stage buckets. maybe earlier a just discussions, in bit of little

Sabrina Martucci Johnson

be kinds absolutely. we're of opportunities. very time. we do. very explore all our portfolio, Absolutely. what in way, And our conversations. different are And and It's those able have like like they No, doing. conversations, all And I because the proud all a by beliefs, some you it's said, you're of health have what does we we're have kinds We kinds need in premier we portfolio so mean, all We facilitate it asset, conversations. that of to of partnering of the active more different, stage we're so to women's development

Operator

are to now will call closing I Ms. Martucci There turn you. Thank Sabrina for the Johnson further back no remarks. questions.

Sabrina Martucci Johnson

the update time to Well, pandemic the our our company to environment. XXXX afternoon thank of you value and driving operating and share all hear our goals in that and of all and all options spite any for our this great improving of for taking stakeholders women transpired questions Daré commitment chance for outcomes the then and during to our everything under

its demonstrate value driving XXXX direct in capital ways team, our the investment shareholders programs is And namely our our and to to our grateful the thankfully, that And a touched and to of programs. we So portfolio and can resources variety feature us business of and the mentioned which women's Doug programs of simultaneously we the ahead, as XXXX our on potential. And support, in across time indications and of advance are diversity as efficient made really of that that kind exemplary numerous possible. that enables our achievements stages the core Lisa our health that against manner. look and our milestones development model is his plans a questions

you environment our XXXX look that in we've that discussed our clinical we so even of five and different and this forward so, challenging objectives demonstrated today key progress a And programs updated indications year. and keeping on we to stage against across the

much for So so time thank you your today.

Operator

concludes Thank you conference for gentlemen, Ladies your and participation. call. this today's

You may now disconnect.