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Dare Bioscience (DARE)

Participants
Sabrina Martucci Johnson President and CEO
John Fair Chief Strategy Officer
Lisa Walters-Hoffert Chief Financial Officer
Rachel Yang ROTH Capital
Jason Kolbert Dawson James.
Sally Yanchus Brookline Capital
Jim Molloy Alliance Global
Nathan Weinstein Aegis Capital
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 Quarter Ended March 31, 2020, and to provide a general business update. This call is being recorded. My name is Victor, 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

welcome call and financial and results Thank Daré to Bioscience. update for business you, our

We forward milestones highlighting the beyond. are results recent quarter looking development to discussion and anticipated for and first XXXX our and

Litigation we Safe will forward-looking securities Harbor the discussion laws, provisions Before that are made of Securities the include I'd of remind statements like you Reform begin, pursuant XXXX. today's meaning which within Act federal of to to Private the

statements from of this forward-looking these during call or and not and known be or that made unknown implied to fact statements considered uncertainties. historical are statements. events Any should could those by results Actual due risks differ statements materially anticipated

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

the filings, for which company's report cautionary statements ended which Forward-looking is XX-Q XXXX. are XX, filed ended March statements in XX, XX, for including XXXX the Form our XX-K Annual And by SEC Report the on year filed on today. XXXX, December quarterly qualified in was entirety March Form our the on quarter their

statements obligation information call required update to call, by XX, I'd this content XXXX. in today, is time-sensitive undertakes as as information that or that Daré developments no the after like point current forward-looking May new out any only also to except includes reflect of to this law.

contraception, the So as of you sexual fertility. and health, wellbeing life squarely improving women, know, biopharmaceutical of in on a Daré areas vaginal is health, focused primarily the company and

the be and accelerate health by selecting candidates Our believe that product availability new women's potential first-in-category strategy in and value of to creation is have prescription first-line. to advancing products we

our business as as clinical well regulatory our COVID-XX the pandemic discuss On our operation, we last impact milestone. general and anticipated on of call the

quickly believe we circumstances. changes in react to we business As to the uniqueness allow our use model of discussed

we X trial necessary treatment remain objectives regulatory achieve And since namely, development our conduct for to and we and the on results clinical regulatory maintain on this activities we of the clinical have to of of remain for discuss, report vaginosis. to topline Phase DARE-BVX and case bacterial product then, tract track year the

to in the XX estimated U.S. condition alone. impact A million over

We prior our respect Cream confirming are to guidance program. Sildenafil our also with

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We Cream the FDA female has potential erectile to the female believe arousal our sexual approved men. first dysfunction dysfunction analogous Sildenafil most disorder. option candidate be disorder sexual The for in treatment to

finally, potential monthly results category cream trial And pivotal continue agreement are to for a the clinical license U.S. in novel we our commercial with a Bayer. contraceptive topline of with first be free under rights reporting hormone investigational to plan and in anticipate XXXX our product

investment women's that believe enable programs We this it the ways and indications variety and that of direct stages across diversity our health to resources challenging our and advance in environment. the portfolio us enable the in to of programs our us development our

timelines for Of as pandemic the course candidates. disrupt development to costs we as our the to in spread to product the potential increase put and business, our potential recognize its that slow COVID-XX place and well have anticipated restrictions the

And therefore evolving the closely we rapidly continue monitor circumstances. to

remain we However regulatory top-line we've timelines clinical on currently, track on milestones results study the deliver and discussed. to

on such capital established. financing our we that our believe as aligns at-the-market and how line business and allocation flexibility recently when strategies by value. supports shareholder and equity the model raise afforded and with our enhancing We with program we capital Together optionality the provide

health of a products of of structures clinical women's the the assets health Further, manner. can staff provided in health capital we we in that dedicated acceleration this expertise expect reproductive clinical our the week pricing decisions agreement development with development and under announced with efficient support

this Phase a spend plans X And year. our step DARE-BVX review next program. time and Sildenafil Ovaprene data the for readouts Cream to to now our with the little more like study We'd and

our provide into additional decisions. partnership also insights health with We'll

and financial in as activities on our first partnering vaginosis. quarter As results. update DARE-BVX I'll an well general for start bacterial with

is a treatment X% of it's phosphate one-time containing being and for DARE-BVX developed the as administration thermosetting clindamycin vaginal BV. hydrogel novel bioadhesive

condition As affect U.S. million I mentioned more a the highly estimated XX alone. in prevalent women to than

an administration in we've seven test proof-of-concept reported, investigator valuable of that clinical occurred cure that at As a previously data study the to a days of from after demonstrated of of initiated study rate DARE-BVX. visit XX% single subjects cure fourteen the

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drug development ensure approval. the frequent to and A to support collection receives designation is drugs plan the discuss Fast appropriate eligible of that our FDA drug with for Track needed meetings data

and communication clinical such criteria are frequent priority a review written FDA and from things about as proposed trial and More for accelerated met. if eligibility design a approval relevant

potential need. designation a are Track and which current treatment serious for inadequate this that address options DARE-BVX DARE-BVX's validates it is unmet Fast infection to BV underscores Our for medical

indicated XXXX. expect Phase enrollment As in X top-line DARE-BVX trials.gov, we end data in of read posting to with in an by clinical we've on July our anticipated out recent commence study of clinical our the

X on document include we've the the a with and discussions treatment Based Phase endpoint had on the control study recent for assess the placebo the enrollment as as the study. primary to FDA, guidance the will resolution of XX to and from days visits defined occur developing drugs BV signs FDA's clinical visit BV, the care after cure clinical symptoms of test as and specified in add baseline XX

Phase women XXX conducted and X a new and successful, approximately file in study studies application drug are XXXX. the to X we intend the Phase non parallel single to for DARE-BVX be with clinical this If in

alignment now on patient endpoints. announced to Cream. instruments efficacy design pro outcomes reached I'll the the used the Sildenafil the reported or novel XXXX we study with important to Phase December then and be Xb of measure primary about FDA talk We achievement in

X.X% name So to treatment for the currently the for ingredient has product analogous a a in first oral sexual FSAD. Sildenafil be of Sildenafil dysfunction FSAD the female in men. and in dysfunction the erectile the arousal Cream is or active men Viagra tablet the brand dysfunction marketed potential sexual to disorder FDA female under disorder administration most approved is for erectile

administration, local medications ingredient is which means active men. in Sildenafil, genital a cream the locally active flow in erectile thereby improve formulation, It's for a utilizing vaginal that's same formulation applied the our is the formulation designed Cream, arousal topical response and increase blood to of to dysfunction pathway tissue. delivered Sildenafil that's the

effective way oral Sildenafil particularly same the delivery associated for an achieve to arousal oral is formulation oral not While men, response with are women and optimal the in effects side the therefore challenging for women.

acting arousal deliver and with been the observed With issues to formulations the locally, improvement of offer fast response blood potential benefits oral to the in general in applied flow that can be sexual design the formulation. cream the increased the without Sildenafil systemic a

Market their market seeking U.S. improve of XX women dysfunction are ages sexual are in suggests million to research believe XX% the and are symptoms approximately XX% of or them bigger low experienced a and the FSAD condition. We no that the solution in big than to XX as U.S. is of the arousal market. XX or erectile women distressed

complete To XX. put the an treatment market to dysfunction of prevalence about increasing estimated men at age FDA XX% of at to for approved FSAD opportunity be erectile the context, age X% XX is in

study Cream in will FSAD agreed-upon primary genital experience. arousal utilize and measure The planned endpoint achievement the distress of Pro instruments women the improvement efficacy the to in that response Phase sensation reduction that of Sildenafil Xb namely with localized of

Over will activities, and a study submission. conducting the to startup preparing focus efforts on as activities Phase clinical as preparing NDA other electronic such future the other well initiate as next diary to Xb support months that non our

to and studies run weeks period. dosing following Xb Cream setting evaluate over Sildenafil Phase placebo study by versus placebo their designed home in both drug The non subjects in of XX a

of topline mentioned study I expect report As of before XXXX. end the the results to we

investigational of pregnancy. prevention talk contraceptive I'll product. the Ovaprene monthly about now, briefly the clinical be first hormonal approved could Ovaprene. an free vaginal hormone it contraceptive is And If for currently development non monthly in

under Earlier Bayer which contraceptive Daré this commercialize agreement Ovaprene exclusively billion States. year, can dollar the of the Bayer, the in United announced license the franchise Mirena marketers and

the of of million included Upon which payable us a sole discretion satisfaction to agreement certain trial Bayer's of by conditions payment the Ovaprene. Bayer, following the completion in on pivotal $XX

Bayer in Ovaprene providing million net agreement commercial in royalties payments we're is development sales eligible also double regulatory the capacity. the by and experts up license receive advisory supporting plus for to process $XXX to digits. an our in tiered on milestone internal Under

These information can More with Exchange terms found regulatory already filings planning about implementation and the to the as work Ovaprene Commission. stream. as value resources our be have clinical and manufacturing, added the pre-commercialization of the the the planning of agreement well at Securities

in confirmation validation of market is in Bayer built strategy the health the contraceptive is contraceptive broader they excess a licensing to potential billion. hormonal brand first with and company have are monthly committed non believe innovation of agreement We Ovaprene's family our to of a market women's bringing the and Bayer product. only to $X as

or next activities the of plan exemption to and pivotal several safety an FDA's application the year other clinical the a the and clinical and intend regulatory investigational program. study initiate continue manufacturing months effectiveness pending to the IDE, to plan contraceptive of Over we Ovaprene file and advance non we this We Ovaprene. device for IDE to review clearance

XXXX this support We report this in as expect study Europe we other XXXX U.S., we worldwide. projected. data believe the approvals successful, still marketing even If to and countries of in in and can top-line study Ovaprene commence

to update. the business turn provide a over I'll partnership John corporate to now and call

John Fair

Bayer Thanks To global robust up connectivity to and relationship Bayer remarks implemented effective we've by framework team. Sabrina. pleased really made on our concerning a of with with we're their management facilitating with announce follow the communication Sabrina alliance some

Framework clinical the States. for their the to in development, regulatory enables United manufacturing us on and expertise and align leverage Ovaprene launch potential internal strategy planning

range of the Bayer insights is world real across contraceptive functional leader commercial been area a planning expertise mentioned, current wide time marketing. sales invaluable. and including Their in have and Sabrina As

event the for with We Daré. Ovaprene contraceptive and Ovaprene agreement technology a for of commercialization believe is our the Bayer validating for

our been broader partners profile strategy on with against raised number and and subsequent continue relationship for actively a on tailwind execute us our to portfolio of we health engage has collaborations our which potential transactions. has and fronts with Our across in Bayer women's great engage as a follow-on

transactions aggressive licensing model. out to with For those familiar pipeline efficient ensure those you the our of is for of know the differentiated one that and core imperatives moving you development assets to company along cost a story an are and a our of time assets in and have manner. continuum Daré partnerships to keep we And

organization an research Decisions, clinical women's To help that a full development with or advance announced and contract end programs. CRO service diagnostic to specializing we us our Health alliance portfolio research health

in manner. with The pricing clinical women's in expertise our key along clinical development is agreement products the with development opportunity the to a in health efficient staff programs structure resource accelerate and the expected have of dedicated

active in is NICHD, the Health trials our that for a conducted They've the contraception or aligned a the NIH. and portfolio. unit coordinating is Center with therapeutic of XX of National Decisions over Institutes are they're and number clinical of areas Health clinical across statistical which

working have successful Decisions on clinical study PCT the bacterial prior test on we study plan post coital Phase and them clinical of the currently including with X worked Ovaprene, we're or Health And with in vaginosis. successfully DARE-BVX studies

their with our I expertise and enable Health key health pricing combined mentioned, clinical investigators with with us When dedicated pipeline. we community clinical to the and in alliance network, our includes Health resources this programs relationships As agreement expect structure. Decisions new the to women's Decision accelerate robust

and clinical women's enable relationship partnering with to to regulatory high against and of unmet our will level solutions to need us in that continue our and we've several execute Health portfolio maintain strengthen it's address we our our the provide persistent Decisions deliver in and milestones new ability In do upon incumbent strategy, that over health. believe us on order the seen past meaningful to new interest to months to

And to that, it I'll for update. with over Lisa turn financial a

Lisa Walters-Hoffert

in joining women's XX, portfolio for monetize Daré would you of all candidates advance a product to financial summarized thanks and John, for and I Thanks now health. to of novel model today. XXXX. quarter business is results the ended us Daré's assemble, to like March

generate As clinical and and related and overhead, and corporate development fall advance clinical, work to a efficacy into result our and milestones. expenses research tend regulatory costs preclinical three and and to non-clinical acquisition expenses to our through categories; maintenance data portfolio, candidates safety

XX, approximately $X.X For were were and the general quarter expenses were approximately ended $X.X million, and XXXX licensed $XX,XXX expenses development March administrative research million. expenses Daré's and

During included this hormone that's for activities activities the our July pivotal of and regulatory pregnancy contraceptive activities for costs in vaginal acquired DARE-VVAX, replacement on as other program related XXXX candidate of our the DARE-FRTX, that personnel work the or development DARE-HRTX Ovaprene mentioned, the quarter our we and on to to team. R&D therapy microchip November and and research the the other tamoxifen work and maintenance space related prepare initiation Phase for X vaginal rings, one study DARE-BVX two of to Sabrina of

$X.X comprehensive ended XXXX proceeds Our March financing million proceeds for the provided under option cash of million. $X.X by stock quarter three approximately was to of sale XX, and net our exercises. warrant and Net from was quarter the loss and from activities ATM consisted approximately the

the equivalents. cash approximately first in quarter ended $X We cash and million with

our additional to requirements capital programs XX months. our needs, to our our working satisfy stage need access programs will later capital advance liquidity next three We other to the over particularly

have Since and transactions, of cash options and public and private our of we license grants cash, equity fees. non-diluted offerings M&A raised securities, inception, the for our placements exercise warrants through

to seeking endeavor the be will be of capital. opportunistic creative use We such to and in in efficient and capital

of took costs Ovaprene, award approximately further development certain our to in strengthen we which quarter receipt grant of has from third we of XXX,XXX April the for On and the steps of end applied Xst, position. the received. cash the a to notice announced of since NIH funding Subsequent toward been of $XXX,XXX

purchase to under $XX the the satisfaction net XX of by the Capital of raised timing with be the for of approximately our a stock million up sales this in potential sale period over of to $X month conditions On we a to us stock agreement May and of amount additional million sales subject under April Lincoln common We and XXrd, Park ATM. through of fees from cash with announced in purchase shares such our of limitations month XX of any controlled the and Fund agreement.

a purchase recently filed have S-X an statement perspectives this related may you to we registration and As seen agreement.

as million outstanding. have these XX.X stock shares of of Following activities we all common of May XX, approximately

condition, of COVID-XX potentially are terms we monitor including to as its our associated ability our raise impact Sabrina clinical capital potential continuing affect to when on In pandemic, our mentioned, to operation planned of the financial restrictions additional and needed. trials, adversely our the results business,

are accuracy various and impact many predict severity rapidly we company evolving business to and and the including any time. and at governmental restrictions duration around circumstances the on full and this its financial uncertainties Due easing of pandemic unable our implementation reasonable to with the

our and our that liquidity, factors resources and related detailed to risk financials filed investors statements review XXQ to financial filed the financial was encourage audited discussion in our our was risk capital factors and and in XX, and March that of XXXX. included the notes the our on today more also XXk We also review condition,

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

Operator

first Thank line ROTH you. from come [Operator And from question of Rahimi Yasmeen Capital. our will Instructions]

You may begin.

Rachel Yang

Thank our Yasmeen. for Rachel on questions. is you This Hi. Yang for taking

questions. two So

costs faster clinical partnership to what can provide you. clinical on with I've color follow-up. partner? discounts of you First a by working do much trial Decisions and allows you the your in some your how receive Thank program move you types Health And with

Sabrina Martucci Johnson

And you question. is you. for that this Sabrina. Yes. Thank Thank

partnership excited that allow address. program us the of about kind really fact that on and advance cost-efficient John you part in because structures and that One key provides noted the are also I both two And the arrangement. hit it's pricing type efficiencies of of manner, it to we're going I'll really our that the which to a benefits. being of us time really As in

examples So efficiencies. time some of terms in

and includes As to John programs. be -- dedicated the noted, that assigned Daré part of team agreement a our is will this

have be well worked successful way with the our We with teams. other with on post them By test the DARE- study. working program on BVX to continue able as our Ovaprene as to will already opportunity programs and work to them We'll we continue partnership. coital advance that this we as under

what us that so continues And a is team means with that very seamless to way. work in

not And officially really of mode, Ovaprene trigger us with relationship do tomorrow, studies you beginning not a in to we're example, that contract there's them organization activities sooner. we research for engage real gives things an might at those conversations that we're those and in ready that able so So it pull now until we signed startup starting the formally instance that but to can literally certain normal about significantly you study as like having have conversations time when right we be the can your be really efficiency. that clinical

it's it's ability Daré to like that's engage family. them really team an So the the and of team extension dedicated the and with

in efficiencies terms forms. pricing to under variety structures structure pricing can to there's terms partnership nice receive we the a of allow the in of come And some that structures, of how in us really optionality

to things of the terms and and when shareholders like our but benefit because just confidential against our the in Decisions We and clinical preferred terms pricing how are are the with more of to have of to pursue the us terms trial in terms deploy both the capital how of course, terms often of suffice in really reasons we programs. in benefit we those disclosed details say structures that very represents partner, for can programs that a shareholders for a we're structured structure in it haven't payments Health pricing favorable of designed a it but obviously, timing also of that us

Rachel Yang

Thank you. very That's helpful.

second on share you. up us is personnel following of partnership our included? does And can partnership, expertise? the their you with what sites trials sort many Thank And of are types involved and question the how the

Sabrina Martucci Johnson

Sure. Yes.

clinical Decisions is of great reason us focused in and a health, capabilities. very So Health was to in expertise the such women's one their for terms contemplate that's partnership the research

sites part network of that network it's kind contraceptive and As John NIH trials alluded -- and the to, of large associated that of clinical that. the is of That are in in trials health supported that's that clinical They've of part health. number they're part research division. they're of studies relationship partnership. But involved XX in the through being just broadly women's not but women's broadly conduct contraception includes

structured contraception relationship areas in that's so as vaginal such sure BVX specifically therapeutic general well with the as as expertise where areas clearly our includes that have program, And for we've the gynecologic fertility them and they health. and health,

that great demonstrate really areas we're clinical design a so, as staff, in as efficient and acumen and all functional outcome And trial, the so runs the leads statistics already effective those that of project where And and of the terms it conduct different of of in leveraging gamut success the manager your kind and all you an clinical and and parameters. really dedicated the staff and they've well receive need for of relationships. it areas that monitors as area we includes

capacity we group run that the clinical represents So all a effectively really functional to it's need trial that a

Rachel Yang

progress. for much And That's so on congrats very details. the you Thank the Okay. helpful.

Sabrina Martucci Johnson

much. so you Thank

Operator

will next line And of Jason from Kolbert question James. from you. come Dawson our Thank

may You begin.

Jason Kolbert

what's timeline on do easy on going Hi in not is which guys. preserving balance COVID. your sheet with with thing an to a Congratulations

Sabrina Martucci Johnson

you. Thank

Jason Kolbert

Yes.

like I clinically. how could you a You're kind maybe maintain that feel you and have of little that If this CRO do bit just us contracting can Why you to of it these been that with don't I what a very particular been a timelines? chaos. just know? piece like about tell puzzle, understand I guess taken in elective mean, confident it's procedures I'd as to you've welcome. seems able

Sabrina Martucci Johnson

can't, a we that's Yes, One for really are question. there I luck. that is credit things wish could play. -- is Jason. Thank take couple That a that's you. great we and And

patients the as provider are and clinicians mentioned, it of very you and is the with right, and luck condition odor a And vaginosis for the company diagnosed terms of as trial actively really or bothersome procedures but still have they're that our elective telemedicine a As enough this of provider treated critical us health discharge that bacterial seeing actively very, clinical that vaginal for would are are program. not is can, year not it, in can as affected. terms appropriately see effects this The bothersome a urgent healthcare is data most readout condition are doing possible, condition be vaginosis exam things whenever as women bacterial COVID them. where seeing in much only in and women they a with for are care the and a is the that today side a to world needs vaginal very

patients. that both see They're patients are study and -- really in closely of board Decisions Ovaprene and terms the based I had in had, of your some which Health with to the on communicated with efficiencies we've of their had Everyone ability they're that conduct with seeing that study can the we obviously because light be a about and have some environment to so as mentioned you the whether bacterial track study, been really vaginosis to relationship to conversations condition. So still very the to the as believes with our sites started have would the started but conversations we all also timeline time everyone that the we with on them real and continue we the identified we've study for across that we COVID point in seeing provides, they had enrollment working talking and identified program our relationship for obviously we and of all with with vaginosis Decisions it's the July as the on this sites Health obviously bacterial that the into delays study. begin -- still

critically circumstance, is So, really in look as And it women able to in that planned light where keep sildenafil. in pertains programs at of the can little is clinicians obviously it our at important. little and the relationship of look two condition a We the helps with certain Ovaprene, things and are one their we or COVID where and certain been and which sildenafil favor. the Health activities both necessary of bit activities Decisions of timelines terms similarly, to if bit factors and see to and our in how this had a do to sequencing maybe a recalibrate programs on right, with going working our we've it's their is still Ovaprene

is those sildenafil of things ahead and advantage can engage delayed other that doing mentioned right go and like to way. those that we are regulatory both we like diary non-clinical -- need things And out of filings to even can and startup this that I ultimate get we happen now for in them subjects. can be are enroll there activities with aren't that time take now program of or needed activities that going right before can for the One we we impacted the the to electronic be then

on track. times then we us the allowed flexibility for to of those factors stay just lead our really had as So that built and a for well timelines combination that

Jason Kolbert

of lot sense. a Makes Okay.

Sabrina Martucci Johnson

you question. for the thank asking But

Jason Kolbert

volatility that significant both at of things have a and market a just just I when wild that's I directions COVID there the been one high-volume increase in translated of swings the follow-up see that result And in Sure. days. is as is, in a very some look

with days you're how now. able fair? on for is of sheet and those So Is balance preserve that's ATM taking my high-volume to the that assumption you're those advantage the that

Sabrina Martucci Johnson

Yes.

preserve place we've a the in those As and activities us in days. your to it and very point that value, Lisa on bring to do But is… preserve give ATM it's way great pricing to reported, shares in some to that a point market that in manner shareholder for had efficient in the can the the quarter optionality us your way capital

Jason Kolbert

of price. exists Well, without stock in advantage take market to the the volatility that fundamental the hurting

of a kind as it's a So no-brainer tool.

Sabrina Martucci Johnson

Yes, you nailed it.

Jason Kolbert

Yes. short good investors with mean of I look take stock seeing truly to business of on, placing fundamental when institutional volatility we're of sense. kind the I good, what's going just at advantage makes

update. very you Talk soon. So thank the you appreciate much. Really

Sabrina Martucci Johnson

It’s thank so your Thanks comments. Jason, appreciated. much. really for you

Operator

you. of And Sally our the comes question Thank from line Brookline from Capital. next Yanchus

may You begin.

Sally Yanchus

Hi, Sabrina, hi, Lisa. call. $X.X I One, rest of a enjoying do Thanks to expenses million couple wonder, quarter questions. about the just remain this expect R&D the for A year? your you for

Sabrina Martucci Johnson

Lisa But let helpful about I I'll for we're and people that. Yes. understand. the learning address to just high level think to listening it's Daré

flow. and is Our vary. a lumpy, Lisa and which as R&D expenses ebb ebb flow of term uses way them activities really will very much the probably and great to describe as kind program

a instance, this that all in for the filing it's program the NDA obviously is not we've through DARE-BVX year. million happening $XX guided, for So spend all

it Some last of happened year.

of year. Some next it's happening

going make in lines that we filing XXXX. mentioned not to I either. to As look be it's straight And

be Over line. straight this going is what course you know if we year said the

it us there's no that high So flow and and great level might guide be. to going to way for ebb than is other

Lisa Walters-Hoffert

Yes. And add study -- just DARE-BVX I that. would just Sally, clearly to would the is and in start July. I to our But goal

based have but Sabrina of other kind the not preclinical line, cash and So we be start on and as activities on some we the and turn also off certain environments. a we will actively said, available it's can there clinical market once expenses, because straight enrolling

So that. thank asking for -- but you

Sally Yanchus

be many just Okay. And patients I Ovaprene will have I'm another enrolled? curious question on how the trial.

Sabrina Martucci Johnson

Yes.

as a the may different familiar, with little again be bit who it's for quick Ovaprene, division with just a review. high device not hormonal because product. combination for the Ovaprene So that's regulated leading FDA Ovaprene product. a the level those It's background And is but than of

with typically typically products, at looking X,XXX support a product the know hormonal subjects yes, you So so you're registration. or exposed to to and

division On device it's XXX around subjects. the typically

of makes big so yes, so, in terms which difference spend. obviously And a time difference, and

program. the with that So helpful

I submission this subjects, able we guidance is as and year. on working completed how very, many the we're exactly FDA be for process and is to to Once are IDE differently. that clearance process of treat mentioned so, that to that we but on expect very planned in going FDA don't that give And it that for specific we division the on have the of norm the

Sally Yanchus

this type So product I'm control? with curious a what be the will of placebo

Sabrina Martucci Johnson

Yes.

for is why reasons way, I'm for there this ethical sure no not it studies do contraceptive that So work placebo but whatever they arm.

rates you the And pregnancy there's in So look months trial product to duration. -- of studies. at everyone get there contraceptive course the over typically XX six and duration their either

So you're to study But at pregnancy everyone drug. your looking is rates. exposed

Sally Yanchus

All right. much. very thank Well, you Okay. helpful. Very

Sabrina Martucci Johnson

Yes. Thank you.

Sally Yanchus

good progress. on congratulations And

Lisa Walters-Hoffert

Thank you much. very

Operator

come Thank Alliance question from Jim our line of you. from Global. next Molloy the And will

may You begin.

Jim Molloy

for the bacterial speaks -- vaginosis. market I guys. sort New for on Is I news? England or question. guess I Hi, impacts Medicine taking came on Thanks a have quick Can just the walk of how came through that That's BVI? to know old you this Lactin-V had studies just it out to of Journal out the prevent of my question recurrence in today.

Sabrina Martucci Johnson

out on I asking and today. of top for that Yes. because that, thanks just Jim, being for Yes. came thanks question

bacterial vaginosis managing condition. again indulge me we condition with vaginosis. dealing there's think second -- One about and is things think the acute So if a the take for who think on women back you infection. the with the just two a step about When treating are you really bacterial about

and obviously and has want the get she you preterm with effects also as and discharge, control efficiently the it's the side infection I really birth associated under to as it acute when of that nuisance possible. infertility. Because quickly but as odor mentioned So

infection to important get under an it's So control.

one, And That's right? what doing, that infection under want is get that's the DARE-BVX Xb. you in cure was at to targeted rate control seen investigator-initiated that So quickly. where phase XX% the

mid-XXs. infection. important given today right FDA XX prevent and super following the approaches care now So also at the to rates seeing to comparison about we're which really antibiotic standard publication with approved non recurrence is its to slow The looking of the came out of that or excited are cure

three women condition the are of condition and get So per symptoms who or these the get bouts most several more. have this so year, women bothersome also the who often unfortunately

have So those recurrent are infection. women who

And so, as infection she the when trying acutely a bad bout. quickly are possible rid as has to get only you not of

reduce is the You're also product, very that's approach or rate And of lactobacilli exciting that occurrence of a an delay and and the the product time increase was category. do. reported probiotic approach that's in to also think important kind trying the we what to the looking

John Fair

we're would the Yes. we say, underlying is complimentary is prevent would think just and -- future think, sense in that John. that it's infection resolve the just product it to something this this say I DARE-BVX then to treating I And recurrence. can I

Jim Molloy

So boat I'll lifts that. our rising I with agree would think, tide

John Fair

Absolutely.

Sabrina Martucci Johnson

you. Thank

Operator

question line our will from And Capital. you. next come the Aegis Nathan Thank of from Weinstein

begin. may You

Nathan Weinstein

sort of taking Lisa question. historically evolved Thank and give question a that you could over your my Sabrina, have and condition for on the thoughts could time? has John. I Cream indication. on Hi, awareness and opine evolve us Maybe just of on Sildenafil the big how picture how FSAD

Sabrina Martucci Johnson

Great that call that a it. opinion work actually Kingsberg can awareness that around it's too, have key for about about talking we're just obviously talking you the a our leaders. great because yesterday about condition, the Sheryl question. just of And had with very the the We timing question program. Dr. with And one condition comfort and people of passionate

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lot more continue and general definitely a That there's awareness that in we belief so, the grow as And is going creates clinical conversations and our the condition. about through to this enhance program development. about and condition. awareness to And more advance

do that during market. to advent did market pharmaceutical the came development of once a on erectile they So of with follow new expect trajectory we very kind really treatments awareness and it their dysfunction similar the both

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Nathan Weinstein

you Thank so Great. much.

Sabrina Martucci Johnson

you. Thank

Operator

showing And over this you. any I'm questions further like it turn time. Thank back Sabrina to for remarks. closing to at I any not

Sabrina Martucci Johnson

for We appreciate everyone time you just maybe thank And summarize. the to it. taking Well, this Great. afternoon.

to we're with partnership productive that, and contraceptive Bayer partnership the Our and our work with programs, Ovaprene about reproductive is looking to really a into talked and and we we talked we manner new clinical a is category. well. to the we to development to with its with innovation health both through accelerate nice program bringing the adjunct that forward a that relationship as the Health development off help cost-efficient advance as the as And mentioned great about our start Bayer time going clinical that expectation as Decisions us and to of long

grateful term our the And our to Cream continue Ovaprene. efforts on year commitment to to and we'll the and study overall our with other X now. to importantly their we we on to we look And of clinical our year. to Phase team the the alluded particularly non on focus support both we and to continue remain mission as to activities DARE-BVX expected addition, And that we'll data program you startup this near In our the of topline and for study work the entire before Daré objective end discussed necessary dedication for forward progress. shareholders Sildenafil updated keeping conduct

and So keeping with informed. forward you thank look to that, we you

Operator

and conference for gentlemen you today's Thank this participating. call. concludes Ladies

may You disconnect. now