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Dare Bioscience (DARE)

Participants
Sabrina Martucci Johnson CEO
Lisa Walters-Hoffert CFO
Rachael Yang ROTH Capital Partners
Jason McCarthy Maxim Group
Brian Marckx Zacks Investments Research
Call transcript
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Operator

Welcome to the conference call hosted by Daré Bioscience to provide Financial Results for the Quarter Ended March 31, 2019, and a General Business Update. This call is being recorded. My name is Stellando [ph], and I'll be your operator today. With us today is Sabrina Martucci Johnson, Daré's Chief Executive Officer and Lisa Walters-Hoffert, Daré's Chief Financial Officer. Miss Johnson, please proceed.

Sabrina Martucci Johnson

you. thank Great, financial Bioscience. our business call update Welcome results Daré for to and It's to and the first have a to pleasure opportunity XXXX XXXX. results, our in quarter and talk company milestones highlights upcoming and XXX our about

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

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

and company except XX, call, current vaginal as as is developments areas reflect health, required squarely of to health, in that entirety Forward-looking our which of the update for law. on annual the ended XXXX, improving information focused sensitive by was women, cautionary statements this statements fertility. point XX-K any our March I'd statements on and like this out of the December wellbeing filed contraception, Form time XXXX, to undertakes in of by for call ended qualified the the XXXX. is today, including only no that May Daré Form also report XX, XX-Q SEC forward-looking report to the or year biopharmaceutical primarily a on obligation new content sexual XX, are includes filings, their quarter company's after life today. in quarterly the Daré and information

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bio-identical menopause. enter fourth ring HRT X DARE-HRTX, intravaginal Hormone is candidate following study or combination clinical year Therapy progesterone, Replacement this Phase expected clinical and Our to for bio-identical a stage estradiol

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cost-efficient in expenses we XX product, XX% study candidates in will women We we portfolio in Australia. clinical be of our to as persistent a do need the category today women's has addressing unmet commence therapy Our conducting cash the subsidiary Australia in incurred yet our intention as of this stage first discuss believe leverage well approximately our for candidate a each We research existing year. and DARE-HRTX preclinical potential not health. as deliver rebate that the first-line or a opportunity to study is over in in the its believe Phase in X of Australia can

call again, to to the turn the review want summarize Lisa to I financials. Before milestones, upcoming I the over

Lisa Walters-Hoffert

update for Thank call. summarize of first for participating results the I to like XXXX. you on now quarter all you, Sabrina, thank would this Daré's and

development Daré's in advance inflection to candidates activities product be value to been milestones. continue activities noted, through will and previously our have As and clinical research primary

development financials of consists product maintaining and such, general expense, As and expenses. overhead related our or primarily and candidates corporate costs our acquiring to research

During million million. Daré's and XXXX for ended Development $X.X administrative XX, the our general expenses quarter $X.X March and and were expenses Research

costs primarily to X.X% related were and DARE-BVX expenses for and the to extent, activities the and a lesser Cream development Sildenafil attributable R&D Our Ovaprene to DARE-HRTX.

pursuant first quarter million $X.X of air shares. million stock and shares shares during with outstanding in $X.X related was of expenses of completed approximately proceeds of cash purchase stock our offering agreements license our ended for deferred million X.XX common for increased quarter, million. in of million stock to the proceeds common fees and to We warrants million. the of quarter and $XX approximately April, point million, we XXXX, net debt. of The addition, $X.X no about offering XXX,XXX we representing In due underwritten shares $X comprehensive to In the our approximately million of public common gross first XX.X approximately outstanding, loss DARE-BVX $X.X our an to recognize common sold aggregate approximately

a execute believe from programs operations of first just the at next will on We grant of through complete $XXX,XXX, the our landscape year XXXX public other the to I quite the has to a put NIH solely size. available transactions The XX, we Given note like into fund an S-X that and be plans development group are Form the Sabrina companies planned under expense, together our XXXX. position quarter underwritten of described. would comprised seen existing equally to development with the Daré Ovaprene proceeds participated approximately us of offering. for in and completed shelf of our for was that offering, financing registration the shares the cash March with common and we've offering statement, sufficient clinical who our pleased to or investors pleased offering in

additional strategic forward, candidates we explore While partnerships, and equity. are but We in including execute will these to now agreements, to our we so need of on funding, efficient, capital believe as to I options we turn access to like the would the foundation intend clinical move capital. over not issuance we multiple and limited call back operations doing to collaboration Sabrina. grant for planned

Sabrina Martucci Johnson

first Lisa. interest in to forward up to candidates. is Daré Sildenafil as to unmet we for in excited the And women's as We category with portfolio and ultimately breast cancer value we the product drive setting hormone strategic Vaginosis, programs which from believe addressing a as you well Bacterial in positioned and the value we well population. IVR maintenance are in level and potential persistent to that we on to health Tamoxifen a and of in believe for from program our atrophy of and a Ovaprene milestones women. of as the significant Great. efforts. vaginal keeping each hormone you, positive Together, XXXX is and and our Vaginal regulatory relates encouraged the constitute our product our look need expected be portfolio receptor long-term investors programs, our capture the these and it clinical differentiated positioned partnering XXXX and Thank health, Cream most deliver when well year arguably for for from replacement transformational and and updated to with our pregnancy has DARE-BVX activity programs women's health both women's short and are

Test Cream in of and this into at second-half of in our primary Phase expect expect first Phase a announcing additional XXXX. beginning XXXX and start the Completing the trial, specifically category advancing our to the line Ovaprene multiple with XXXX. on clinical at-home the portion mentioned our top three regulatory for and and the steady preparing and milestones Vaginosis end trial we deliver of for development, against of study, X I DARE-FRTX Bacterial DARE-VVAX call, for content FDA programs which year validity program DARE-BVX the before XXXX study from potential position Xb for in us in Post-Coital readout clinical Sildenafil the endpoint Phase X As we alone, can the with DARE-HRTX engaging

who will lines We Q&A. over now will the, for turn the it Operator, to the open

Operator

Our conference. Rahimi Yasmeen line first question comes from for the of attending Thank you instructions] with the Capital. ROTH [Operator

line Your is open.

Rachael Yang

my taking This you Yasmeen. Thank for questions. your for Hi. on Rachael is progress. Congratulations Okay. Yang

Sabrina Martucci Johnson

you. Thank

Rachael Yang

a bacteriologic show clinic? the clinical the between and DARE-BVX care In are the by bacteriologic clinical percent of therapeutic of the the clinical physicians for more what proof-of-concept XX% in is and and care XX%, used the really results care versus care measure difference meaningful studies care, a and

Sabrina Martucci Johnson

Thank that's you great Yes, Sabrina. question. for This that. a is

and are point, points the So, in the puts used the clinicians to are actually way their you FDA and that to managing at for that real out in clinical evaluated of think are patients your all treatment, improvements, endpoints being the world about Vaginosis they treatment how guidelines that that that and nuisance presence looking discharge, or when are Bacterial changes for the programs clinical and be signs really the clinical are as as care, the include endpoints cells and she of of present in as experiences of at basically such looking eradication which of both that in disorder, the -- in odor care the symptoms Vaginosis. pH type that well elimination can the and symptoms Bacterial specific

morphology, and bacterial a secondary Nugent experience are clinical So, bacteria improvement signs as at look actual endpoints are improvement symptoms at that. of and well that in a elimination studies, looks types then proportion, what at cares into score and the on that both the of improvement take score. looks and their you in as then therapeutic in And bacteriologic of the Nugent the bacteriologic care of Bacteriologic care present signs women at guidance looking a account based of and Bacterial assessment FDA what used care, therapeutic therapeutic is if looking and those proportion care for Vaginosis a those a context care you based meaning, condition, and of at the get as on care an that symptoms. rates basically really clinical

recognize most FDA is the what a and clinical the care meaningful and is from women to both perspective. so, that And clinicians healthcare

looking primary endpoint signs really be symptoms, primary at the the as your well. that that and So, would It's improvement and that's our and program in endpoint. clinical

Rachael Yang

much. so you thank Okay,

Sabrina Martucci Johnson

Yes.

Rachael Yang

microbiome birth. in for has are the shown risks women women, affect recent can both changes research and the associated healthy preterm Vaginosis that Bacterial pregnant So, with and

potential ranging and over wide study? DARE-BVX So, use for the criteria inclusion of affected thinking your exclusion the this upcoming how pivotal has

Sabrina Martucci Johnson

Yes, great that's question. a

a in ACOG your look are you you at the would for that that Vaginosis, recent by saying the think Dimes, like typically data criteria today about highlights think Bacterial of women Conference these of is back and what the presented conditions focused I March talked more and the far-reaching for what meet -- importance some this, very and that So, we treating and the the as basically sometimes nuisance symptoms than really of I like study understanding Bacterial with really was primary signs is like we what effects are like opposed to the get Vaginosis, feels her women on experiencing that step outcomes and taking just nuisance important condition. a goal of

hopes so, awareness are birth, the to as is because thrilled it to the and really preterm the to think between it's the about difficult the be. effectively, And just can importance rates see for the physicians we out link manage presentation that Vaginosis where condition managing today, everyone of Bacterial because building really effectively. And the it are we there treatments unfortunately, very they cure are really with

the a obviously the you exposure, really but of also kind be terms may favorable limits in because that a is vaginally any one-time hopeful really on-demand really obviously is like and something this are we so, has And benefit far-reaching that's delivered administration to which very have population product and in with studying. that of benefit convenience, potential systemic both any a it

Rachael Yang

you. Okay, Thank you much. so great. Thank

Sabrina Martucci Johnson

you bet. Yes, Yes.

Rachael Yang

it's DARE-BVX? on example, Phase also proof-of-concept? there doses, proof-of-concept upcoming to like for be what be you will be timeline quarter? design now endpoint to the length the fourth planned finally, and quarter For you be provide third the those X trial any closer color whether trial, are Can going the will down trial the like the the going differences similar to to and can or major between to the very some And

Sabrina Martucci Johnson

definitely. Yes,

terms guidance endpoint the nicely documented requirements out the trial that what minimum design, and are. out FDA XXXX in So, very a of really the lays put

those. certainly We will pursue

your therapeutics, -- back case with she criteria Vaginosis, care then of you called of XX. the versus signs to determine you care placebo look the test That you seven into day establish in of criteria. group or what's condition requirements, is test Bacterial placebo, symptoms administer and on and DARE-BVX then where you and met And women a of group that's those women visit, this what the at so, comes proportion statistically and endpoint or based should meets primary the have either placebo the you for visit, then in that active

secondary follow you women back same XX the a visit, to and As for endpoint, day assessment. that of out also will kind in will come sure do XX another to

clinical measures. at the that are to to care And secondary therapeutic bacteriologic so, endpoint you'll look continued and care out also outcome care and day then XX XX, secondary

indication. So guidance that the treatment on that's for in. what's use therefore your really the FDA required And really likes what minimum design study

has indicated this that that of we the are to timing later year, year. us have fourth quarter starting we looking are looking at we the actually the trial the one in reasons I this mentioned, of that As starting and

and of the potential expressed program, that to about partners of talk FDA for an that and interesting the already we and timing in as key be an one think interest that's leaders enhancements some explore interesting the them us with an it's the opportunity opinion might reasons commercial highlight really have and trial very what as attributes for DARE-BVX perspective program. beyond unique well is that us the works required might So, basic given design from features very really well really to who is

we to about of that closer a start we guidance little at more study, like provide get the what the as So, initiating look will time. that might

Rachael Yang

once and much, on again progress. your so you Thank great. congratulations Okay,

Sabrina Martucci Johnson

Thank you you. Thank very much.

Operator

you. Thank

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

line Your is open.

Jason McCarthy

taking progress quarter. this question, for the Hey, on thanks and the congrats

Sabrina Martucci Johnson

you. Thank

Jason McCarthy

an So, I us you would like to post-coital what size a look for Ovaprene the if of at, what are could look data need? to kind sort trial we study, what might endpoints see approaching Then, the see idea could give pivotal trial like? from and like of a you as you

Sabrina Martucci Johnson

you great a thank question that's Yes, for that. and

it's Ovaprene, like types the a the well The think the that of product device the acting reviewing consideration -- safety we as will this it's that analogous combination for agency leave the review products as with hormonal other in given used products has reviewing. that in that spermiostatic pivotal more a it's thing of is the with important agent. Ovaprene agency about as first device of side determined FDA So, really accustomed product a look because mind side the non-hormonal likely much of the product, non-hormonal nature, release drug influence barrier typically is because what opposed component would locally its terms the on that like. to of FDA to as keep study to the a should at really to division size that's product because the to trial And of

if PCT and to So, will be with device an step of our that engaging trial, step to commence clear, FDA the is to the in a the us be next that important around file investigational design study. pivotal pivotal agency really exemption terms successful, the next with step the is also clinical the of and

FDA surrogate the that most have we division similar FDA. that FDA opposed that pathway to can sense once product even division a approvals Caya so the think in a on it's product However, the at a it's diaphragm, the expected design. to contraceptive by done device of you and at method, really be what is to that is may the been it's through advance nonetheless, through look specifically, products. good like recently-approved of give which reviewed moment reviews the we of in Ovaprene, based as the on a of that look is It we that And for can meaning the in recent to that demand which we believe used terms month, stage us look pivotal but diaphragm, given go of it's peri-coital most s for

typically on based often six duration, And one They the six the women to rates to division, dropout six one effectiveness to that it XXX are prior so, over in XXX at those on course contraceptive at rates about so based of XXX pivotal that study, that are make that it's where that pregnancy get subjects XXX contraceptive enrolling they're point by about closer months, typically typical to device and time often had in out study. of they've six reviews months. months studies, looking maybe months out or completers you're

on So would about current like, for that's thinking the the on 'XX, that in a run today, the expectation start 'XX look based expectations. talked would position we would in pivotal be file our us what plans and putting about should to study preliminary in XXXX through our XXXX, our and approval in based an be timeline

Jason McCarthy

right, All much. you thank very

Sabrina Martucci Johnson

you, thank question. Yes, great

Operator

of Instructions] next from Brian question Our comes Research. with Marckx line [Operator the Zacks Investments

Your line is open.

Brian Marckx

Sabrina and Hi, Lisa.

feasibility Regarding topical November you announced study… in start believe the thermographic of a Sildenafil, I

Sabrina Martucci Johnson

Yes.

Brian Marckx

you if that it status learn to can wondering is talk the hope about you I'm that, from it? what -- of exactly and

Sabrina Martucci Johnson

that's a Yes, great question.

sexual in Sildenafil. a response different or dysfunction to the into into So, based the vaginal at blood been thermography in the it studies used using specifically really sexual is basically another drug completed of It's tissue, that a been way assess flow the as XA looking And that's camera tissues. it's changes used without flow at dysfunction we've body intervention tissue, any to used studies sexual look what to a a one for to a heat, has temperature than already been vaginal but on in in as way a approach tissue.

profile did -- similar great to effect oral oral probe, and remember for flow while effect study, not in from same was Viagra at the the troubling tissue our women show blood that to what may was a vaginal Viagra our tissue. also the done women, looking You with evaluated flow a demonstrated increased that the profile And when candidates vaginal from blood side to oral side that pursue that general Sildenafil, through flow it's it Viagra cream with changes probe. blood went to increase vaginal a

blood robustly but to we allow time at and can in already course have flow. thermography change actually temperature a look that in approach doing different done till to change little more that So, study, you that that. is a therefore That

So, like pursue thermography whether actually exploring we could investigational you were interested drug. with in something an

loaded temperature with changes. to it's fears pilot you see to ability a not the self, it So are detect really drug know, just study

in We've been actually at actually conducting an ongoing healthy women. is study it's that study, So, and one site, ongoing. it's

see might So, these I insightful to whether to really women some arousal opportunity for Sildenafil with like it relates not thermography have are an findings disorder, cream. us said it's as

in know, progresses, people definitely that updated, that but of ongoing keep hopeful will as we might you We out at come still and that that's certainly time. this great have some point learnings that,

Brian Marckx

endpoint upcoming this -- this related is the in potentially an study? Sabrina, to potentially does

Sabrina Martucci Johnson

No, question. it not. does great Yes,

great assessment. So, it's a laboratory

Phase to women the studies the up frankly about the lab the So to of are study thermography participate camera, in Xb think setting. intrusive if it's it and product a assess more with of Phase that, really in a like have you in-house meant for do set kind and in performance them much special X the natural a special programs you quite to

where of And were so, analogous as their is home they some their erectile and to response that able at on rigidity they general of around man kind opposed product ability the very they studies the taking to that have in setting thermography types home dysfunction, deal at it to of reporting and to the actually using want. looked

best we of going very studies I regard, and and use opposed X, more to of outside be Xb an the think of that actually as to tool study, that And symptom, their ask these the asking. validity and we're the we're the very make is content in we're women help improvement in really in a with to to their understand bothersome hone bothersome study that they right environment. home sure on most response, partners Our in little our most the setting drug that symptoms it similar questions international to that get to use maybe is that now interesting the potential the Phase questions can doing clinical understand thermography Phase that outside as in product the and capturing natural will arousal about a us how women to bit designed her where genital are works

in Xb answered about erectile product. this very an and dysfunction will to Phase So, the the at approach you looked analogous the the understand be X their studies, studies drug, and experience many experience to have Phase much questions using women's using on we the entireness that questionnaire-based

Brian Marckx

Sabrina. Okay. Thanks,

Sabrina Martucci Johnson

great Yes, no, question.

Operator

I time. back I'm showing over no like to further the would at now for call turn to remarks. questions Sabrina closing this

Sabrina Martucci Johnson

Well, hearing afternoon thank for much our you the so progress, time We your all keeping updated look and and Great. interest. you definitely of updates. to our you forward for on thank you this taking

Operator

for the thank conference. you today's in concludes gentlemen, participating and call. That Ladies

disconnect. wonderful Everyone have You may a day. now