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Dare Bioscience (DARE)

Participants
Sabrina Martucci Johnson President and Chief Executive Officer
John Fair Chief Strategy Officer
Lisa Walters-Hoffert Chief Financial Officer
Zegbeh Jallah ROTH Capital Partners
Chris Bialas 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 Quarter Ended March 31, 2021, and to provide a General Business Update. This call is being recorded. My name is Ryan, and I’ll 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 financial Good Bioscience. to first our Thank and and business XXXX results Daré update quarter you. welcome call for

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

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

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

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

since health, sexual stage first selecting today line to four clinical XXXX women across we could in Our the programs in And the menopause. objectives for value summary to and meaningful the and XXXX. products to start new us, and alone, the will commercial in portfolio a are momentum meaningful who of with opportunity. XXXX those stage story potential portfolio, year for be the the believe was and have XXXX are prove remarks end candidates. have to potential to I’m going to product meaningful – them appreciate really will hearing you Daré I’m contraception year by year. and many strategy to of us most accelerate of set health, call and this going is the important that of advancing first-in-category to this advances these We and milestone the of repeated. there currently call new XXXX address This development the also milestones for availability prescription of creation vaginal Daré have areas be a for reach likely the my candidates

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I'm talk about contraceptive Now, in the Ovaprene to to transition going category.

of next contraceptive, stage last Bayer intravaginal pivotal collaboration a is entered our recall, And the advisory working with for hormone-free per right put Ovaprene with terms the agreement the often hours likely commercial is you So program level the up to novel now. in provides monthly of partnership to two that's we of recall, study. investigational way which to Bayer involvement support under prepare support, XX advisory that program. with year. in up since time, as as a agreement, may full-time or Bayer for Bayer's week on People January of ask you'll equivalents clinical And been about we've contraceptive into of the development, another

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this file to the is IDE plan year. current Ovaprene our of for fourth in So the quarter

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in potential technology different offers intravaginal versatile different a delivery can women's the convenience. active health deliver which unique our with platform drug at system rates, So ring to drugs improve

release dual active Phase the indications as the conducting objectives, application IVR call Langer as technology General which ability we're in MIT that developed X to the is multiple ability Medical of by is enrollment is exemplified we we targeted. an objective bioidentical expect clinically the programs The year, that across And of comes the report in complete. today. Harvard investigational day release the this drugs from advancing its Phase Crawley technology progesterone Hospital to menopause. two are it what the Now this that the together vasomotor evaluate containing from bioidentical announced as Dr. X in study to to two estradiol XX intravaginal achieve and Australia testing first this the The was rates genitourinary Earlier of DARE-HRTX, well of with IVR this DARE-HRTX different by general, quarter. Massachusetts and technology data associated Bob top-line Bill delivered of different syndrome is at we we're as Dr. School. And is we for treatment the ring and and

the progesterone IVF as prevention ring same the intravaginal luteal preterm broader in that's of of developed alone as an platform is regimen. period. which an deliver a And as application over of DARE-FRTX, is second for XX-day phase well part fertilization birth, bioidentical support technology being Our to vitro investigational or

we're to preclinical XXXX we recall receive eligible And Shriver by that to we Eunice of the National Health may a were total Human of may You DARE-FRTX. support including for to granted the is finally, trial since mention X just planning up for Development, to NIH commence over little colleagues, and we year. in clinical that grant Child in XXXX. million to $X.X this turn Phase our to it to that I development, X Phase in award before an a And my activities I bit about the Kennedy study, continued the support that funding division approximately DARE-VVAX targeting the development Institute are want which

VVA hormone breast vaginal to women with, vaginal and non-hormonal to often So important atrophy a positive administration DARE-VVAX approach or receptor or option in investigational for is is for treatment an of Tamoxifen cancer be addressing cancer. effective regimen. the outcome It breast formulation vulva our at VVA. for risk of could proprietary an VVA treat

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John Fair

quarter, submission Sabrina. NDA you, for exciting we later entering Thank are for first time this an plan With our DARE-BVX.

will awareness on spoken is new, potentially clinician prescription for clinical this our rates more we've and broad before than category effective that delivered our believe more cure March is definitive are parallel with vaginally there potential currently the and to the deliver to what and bacterial available. based advancing a we with that It's a one-time best announce of to DARE-BVX We convenient option a belief call, and this we positioned often our believe vaginosis the we are strategy persistent As product the stakeholders, condition. in healthcare execute in regulatory for category agreement and discussions during diagnosis well believe providers and ready commercialization the be addition developments our partnership serious treat of end routinely diagnose is the that noted commercialization who a year. bacterial to and treatment welcomed plan that vaginosis, the

out all to DARE-BVXs as by on As how in and discussed active doing full likely lot plays and eligible are of the go-to-market payments, with thing to gives in a of license differentiated where commercialization market Daré us more to a commercialization. from the of strategy exploring a last role right in our has call, partners most relates we patients we are product stakeholders, the be U.S. to reign we no if in and patients, product where a we profile receive regulatory way through the other would interest but where options Daré the actively optionality And of we to addition go-to outside key sure exploring for the have milestones to commercialization U.S., make scenario we in Daré These options get planning identify the the options effective potential into royalty hands role success.

both Lisa will keep that, partnership for update. look financial And to continuing progress So to for our U.S. you ex-U.S. and I to the opportunities. we over it forward a turn of apprised with

Lisa Walters-Hoffert

the XX, March John. to summarize call everybody, today. thanks and for joining would results like quarter Thanks, I financial XXXX. Hey Daré's ended now for our

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

corporate milestones, our acquisition our As R&D portfolio activities result, expenses to a research approval. or candidates development clinical maintenance and costs regulatory through and including and advance overhead, consists and of

And DARE-HRTX. in DARE-BVX, Daré's and same million. activities and $X.X approximately costs, quarter affairs the were expenses For and were expenses XX, in $X.X related The increases the regulatory the to general Ovaprene in related million. administrative development XXXX development increase to and reflects research period R&D Sildenafil to expenses quarter’s Cream, ended primarily related compared approximately XXXX, other March clinical,

quarter loss the comprehensive million. for approximately Our was $X.X

and with from stock cash the from program, proceeds $XX.X activities and April sales approximately of exercise. million sales XXXX, We million received ATM cash $X.X represented ended cash from of common under in the Between proceeds net common Daré warrant first During our and of our equivalent. million approximately stock. of net proceeds quarter quarter approximately financing and May line $X.X XX, equity were cash additional X net

XXXX, activities, outstanding. had stock we of of these common approximately shares Following and million XX.X as May XX,

During we there our XXXX, a manage to to two seek capital efficiently the I'd will to And like balance areas, to cash access of and continue in resources manner. highlight. thoughtful were

funding funding an a and The have grants. been statement non-dilutive first rejection of our expense. operations is as R&D in attractive the recognize we of Daré, for grant Grants source to

expenses to our We existing allowable explore to and use grant will to and to grants for continue intend funding. additional for apply

a to of SX our statement. our our SX. company is existing options Second intend shelf explore registration for We using variety financing

addition the is program currently that place ATM In SVB Leerink. in with to

financial XX, creative to in our seeking Lastly, and I risk to Form and that operator discussion in we will XX-Q and would turn Form more XX, investors quarter on ended we as the March our well resources candidates. December on opportunistic the the now XX-K be capital condition, call endeavor of our the as XXXX build value filed and year for liquidity annual was factors XX, detailed XXXX. like that We our Q&A. encourage ended report to to the to capital financials XXXX, advance our review our today, filed over for to need we the for March

Operator

from from Zegbeh comes of Partners. Instructions] line the our question [Operator Capital first And ROTH Jallah

Zegbeh Jallah

Thanks have clinical believe four you for exciting. the update. Can't really almost programs,

think a questions. just few I

this and terms can is? the as non-systemic, clarity on for just some imposition think one of, the first you just on in market wondering was, some I how you line want the antibiotics being you kind of used, folks with commonly how your have but was drug you imagine and mentioned if elaborate provide the is big The positioned perhaps being how guys just to proceed starting you market opportunity, things of DARE-BVX, I this

Sabrina Martucci Johnson

give you the for me Thank differentiating on perspective some DARE-BVX of really the on it. the factors And and question. specifically, great market a and let product. with some That's Yes.

XX% million noted, system and XX%, So as are and States women about look XX% XX the with United seeking I – treatment. are in actively to the on you in are data that healthcare there the depending bacterial vaginosis at

be are after. condition. highly those definitely immediate population a So It's patient going recurrent would the one target that

So recurrent XX% recurrent the episode women patients women to XX% least have and highly one for representative tends months and the very had disease of of treated treatment. and of have last condition that be XX in at so who are seeking

as So Particularly, a possible, for patient treatment with you're systemic dealing with avoid medical dealing and are the right? Just But as that's to for society today. group. landscape antibiotics wanting rates clinicians many the today cure products market you're And that You're are we there, vaginal the that a it's to exposure notes patients I and to XX%. something important a really right? recurrent, available prefer whenever XX% as vaginal antibiotics mentioned mentioned, an condition. when and

really cure is look XX% on of methods if basis. to you currently is And XX% XX%, vaginal just approved that but of intent to marketed preferred. XX% the vaginal per the protocol. that So the XX% rates methods, vaginal And treat to at FDA

right the heard cure they're you of standalone data, against there, we standout that in pack, saw. the as our just terms So rates

XX%, looking the of protocol at XX XX% basis, XX% instead on products, X to vaginal XX% to to day per if intent modified to the you're basis, compared that we're XX%, seeing the – or a saw of that treat on we XX%, XX% XX%. to we and So saw

really in of product stands ability to cure. demonstrate the terms So the out a

it's it that's clear and and in we seeing And it why we're So foremost, a importantly, it's rate also convenient. cure bio-adhesive place. vaginal do. really gel, is super that the that's a very likely single first but meaning It's administration, stays

in So marketplace, terms in of going be those to important factors. differentiating two the are

in was saw how rate diaries about perception more population received study. well. share and also they the positive very about to the well the publications, product just in cure to X excited a looked And study. the to patient these it the rates, by some findings electronic very patient day as response of had also the You in but XX. really in their We at response We the were

So opportunities very for we're patients where right with And to really excited what to from anything that I want it the their that for try available prescribe them patients team treatments today. one and optimistic are different about very add to they're that? and to about see other providing this the to it. missed and is clinicians experience product going We're you

John Fair

product currently exist I I add, that who just dose. solves would product this the look are vaginosis. you mean, lot of for at problems women if the one-time the bacterial really a We're in profile, it convenient for experiencing delivering

a or still the it providers resonates. have was really demonstrates highest heavily We and as population payers, kind this an clinical in clinical When study to the The a of cure rates. profile example, done pretreated highest cure rates. we this revealed

we excited are were very excited. guide, very but about to over want we the don't So We opportunity.

Sabrina Martucci Johnson

more Perfect. we'll And And maybe question. move then on. one

Zegbeh Jallah

Yes, yes, definitely.

out, just I what up me about to looking for figure should think the that's shortly. be for in DARE-HRTX one is other the try coming to readout we

Sabrina Martucci Johnson

question. great a asking. Thank That’s for Okay. you

HRTX we're about things just I'm XX-day this So and back which it, a ring. to program, couple other program the so it's vaginal step indulge a take which a going on is, me, excited is share why about

But of delivering symptoms the and recommending recommends hormone from hormones of there her the syndrome vasomotor are of a benefits possible. that it's Society Menopause XX the really So leave estradiol together, days, genitourinary a they're treatment, suffering if the who non-oral in for menopause and are and North menopause which it because place are route as women two a therapy. administrating of whenever progesterone number it's for therapy, hormone American you're to designed which

for so And convenient product administering the recommendations those in the way really is knowledge, and to first it's product her. that's following this a our

it's vaginal. So

that So lowest one and days, of what it's of effective possible time which hormones. non-oral hopefully dose and every the the with hormones the it's together, both two one also of And XX recommend. is they

as designed of expect what So Phase it's in should really a a from PK-study. you terms study X, it's the

we're comparing well. do up how a that levels assessments have trial, But safety and looking the the have holds to as comparative we products so acceptability of and demonstrate hormones, those appropriate we PK sense did So we the in can get we're also the against some of X. Phase to the in that products

So obviously safety this some you and the in also how in but hear to findings, the PK findings we excepted as study report should about any is the the important, of expect which technology. and women sense foremost data, the first study

Zegbeh Jallah

the on Thanks and progress. congrats

Sabrina Martucci Johnson

Thank you.

Operator

we from question, Doug have Wainwright. next come the Tsao H.C. And from

Chris Bialas

Bialas everyone, got on here quick is Hi ones. Doug. I Chris for two

The NDA. BVX about is one first the

there's So a and aware the standard on on your the I'm compared that the prior sure in review agency backlog could And of huge does affect reviews? you do prior approval pre-approval puts NDA how you – inspections. sorry ahead think to potentially the the queue you're some

Sabrina Martucci Johnson

interesting Yes, really question.

I division, say FDA. it's a infectious disease will right we at condition. This interesting, disease been infectious So dealing serious the are with because the is

working apply really that's have the need make priority we're fast And those disease have we has area designed an designations product where and really to help fact, sponsors qualified in timely more are unmet are and track. been In designation, infectious the that you also with interactions to serious as agency. noted identified to possible for review. able an And it to there

busyness with timely can like date, program to found have hope. agency, I haven't So to one the as the Developing interactions to date, responsive with. we the working the this and of absolutely busyness all only would we a be speak of and specific specifically division with of we're the agency with potential at that pandemic sort the and any during dealing they're global a felt implications

least we that from we've know everything know, perspective, obviously, as that experienced then to at They need ready. from what that can not sometimes do we always those inspections, the your And be haven't we're right. to felt come, date, So we but don't a seen And do they necessary you to what's haven't doing product. opt for to manufacturing depending manufacturer, on to obviously date. to can't deem

have, if designations it's it necessary, of other to So they for it how to of an as given we as for if and do the terms a have some well instance. relevant so program this, do becomes agency in approach some like optionality that

Chris Bialas

you one for What, quick any, you. And are this gating one on track the for events said just submission? Got if Ovaprene submission for about you're the then IDE, XQ.

Sabrina Martucci Johnson

great question Another today.

originally associated So as back for events, IDE had unique take it looking FDA, really advantage world with where for to at number where reasons, – device have bit filing remember is Ovaprene, review interactions it's sponsor preparation they you where for bit with your you lead the sponsor, to division it's one get is SEDAR, the division IDE. the pre-IND provide what a a the Ovaprene, year. in of the your little we that with so And primarily chooses us which Ovaprene the if get of a you obviously, with an an are and the step for agency created opportunity happens kind of the opportunities of And than a of shot. some may some little different actually and for a opportunity a meeting of of last kind been with take

So interaction the you're allowed with more a have agency. to little

of even have that the may how your on the that was may so have pivotal felt But to the we road down implications could been necessary. or for or definitely, process maybe IDE took have advantage so PMA the that point, otherwise looks. study could been do have wouldn't relevant relevant we And we for work

comfortable you’re demonstrating of is last this as well. hopefully though effectiveness in felt related year our well study a for a the women have where pregnant, get running bacterial right? those based trial And the and so probably opening on of you then you contraceptive of a year. plans, as really use to vaginosis. we’re Even the that who a We felt though submission pregnancy related the activities your have to to enroll that felt risk enroll was And XXXX. Even we taken women of on little product, clearly kind starting for nonclinical are best this was support as And willing started world factors really time of to up very to comfortable a mindset number activities interactions manufacturing and different. obviously Sildenafil contraceptive, those as the study at we do submission. Contraception’s timing that

all So for lines. was everything those those of along timed reasons,

the based timed backwards filing plans given IDE it quarter. and given submission of do we kind came start support working is we that up we of a And to IDE from and so on to how the then wanted the the work could how the time fourth XXXX that’s to

nonclinical some a end readout looking that it’s up leading importantly at the it’s by writing, most XXXX having manufacturing, of was which start, all data XXXX. it’s So of activities, to it’s

timeline. got So that we that’s to how

Chris Bialas

Awesome. color. Thanks so the much for

Sabrina Martucci Johnson

Yeah, absolutely.

Operator

comes the Seneroy [ph] And question the that do Brookline. Shivendu of line from on we next from line have

Unidentified Analyst

Xb results you [ph] future Sildenafil from for for end of in am FSAD, Phase I about including cream at of With assuming the for RESPOND some plans, study your update. of color product? line with the Kumar please calling Thanks the are plans Could regards Subhendu XXXX commercialization to the the in for expectations. provide Brookline.

Sabrina Martucci Johnson

definitely quite the we’re Yes. that Thanks enthusiastic category PD-X we’re Viagra and some should which in a one needs this inhibitor, have it’s that’s using given for the asking utility about in It’s that unmet given program. and that condition. about same the in here, active

different in designed allow Phase and demonstrate Xb efficacy is the terms number is to a to to steps, the product of designed evaluate also next us of endpoints. of So really

approved this So with there the are mentioned no on treatments. because forward are FDA we as I the FDA front, first sponsor up moving been I’ve against working indication, this

planning of and us for that endpoints also designing exploratory and obviously a allows there. program X result, number a primary pre-declared around the so as have become Phase from to basis the these so – Xb a with very secondary a endpoint, collaborative And process been Phase the the data really it’s going FDA that forward can but the declared

FDA is be X. disorder arousal study. forward what Phase lens us study study much into for to take this in The But this week very guidance Phase guidance for is sexual a what’s going X. itself a required XX on of to So providing documents some female give

In terms of take endpoint provide duration And X. forward could be also the same, could input be one we’ll then study. of we into the of exploratory Phase into some that

X. which insights So that into previously, female is for the the time. for nice are says this how document XX currently indication, more But and which different other need and study looks week have some weeks psychological guidance indications more XX of from studied have sexual been some we’ll dysfunction that Phase

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to thank more definitely follow So for that, you the on question. but

Unidentified Analyst

helpful. Thank very much. you so That’s

advantages our as trial compared one organizing Just U.S. I’m VVA question, of curious Australia of more to the just in

Sabrina Martucci Johnson

Yes.

So thanks for asking as that well.

just this touched which interesting that some in trial we call, is really proceed provides on the but in Australia some briefly you ours. opportunities other programs with Australia clinical calls, with like mentioned we’ve So in can

we actives. you which regulatory know, across leverage pretty dealing means well pathway we well-known are XXX(b)(X) with heavily our As portfolio, that understood,

the a category if opportunities. and for create the studies them run can it either novel that novel that without you applying nonclinical and human clinical indications We’re going run of means clinical in means, the in U.S. But an required in in actually additional forms what submission dosage Australia, just paperwork program equivalent program are a often or time to to you’re these first IND

doing in just offers a it advantages the IND the a work part human parallel, lot your So and it advantages. from an parallel offers actually United perspective, from which of then data would of run for your that IND And in of program that becomes things get it other also mean allows you to human also that expediting, time study X. advancing you’re that submission, the or perspective. in supportive cost of actually before IND you’re some submission. needed States that But so can into Therefore, be Phase

kind subsidiary we right rebates research little just give a let Australia have We a chat we now cash get in rebate and that Lisa a I’ll to that when having structure, you from in sense of the there. subsidiary Australia bit, do of

Lisa Walters-Hoffert

certain for echoing programs what conducting an But are has And government the tax study. advantages all, a Yes. and certain activities. incentive first clinical of the Sabrina in in for Australia, bit cash just general R&D the little a program said, of place expenses lower

expense we be maximum year can can to but of we a refund on of that’s So apply – kind during portion up year. the to for course the have the rebate. end a the at we XX.X% of it that track, And expenses the of current basically a

we can. trial Sabrina if then lot ability because earlier it cash being the the there, regulatory the bit some said, a little also issues sense and start our as lower, So to really earlier, a cost of some of makes studies do that a to of the of little

Sabrina Martucci Johnson

Yes.

that strategy the you’ll Phase is So whenever in whenever Australia. run makes It to it see our we sense. can X’s

potential FRTX, U.S. million fund to from to have $X.X Phase in grant we the the with NIH Now the X the nice up

paid is that, really get we when those will otherwise, we grants. and attractive a required absolutely the that for, it’s for Australia in But us. do So funding non-dilutive U.S. option as like under

Unidentified Analyst

Sounds great. questions. my for so taking you much Thank

Sabrina Martucci Johnson

Thank you.

Operator

And at you. this time Thank there other questions. are no

So to to turn I it Sabrina. back would like

Sabrina Martucci Johnson

to taking Great. stakeholders. options hear and value time this Well, our of ongoing recent the our drive all our commitment improve strategies thank women and thank afternoon for you. the Daré’s and for updates all to you to And about for outcomes health

developments each them. as your number So and with I’d other meaningful All potential of XXXX year hearing, is a a across independent to to moment summarize for a in Daré. of portfolio closing, the like take

year result we’re So to sexual strategic that an in PDUFA so goal Sildenafil With vaginosis which into a intending health submit we’re disorder. DARE-BVX, FDA female is for our and announced a approval program, this NDA, and with could by arousal have – date, bacterial which programs, commercialization sexual enter cream, hopefully agreement, end.

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cancer. very breast out seeking clinical study approach a vaginal X starting hormone just And atrophy, forward to with including discussing, Phase are for then women non-hormonal looking that. we as So program positive receptor an keep that we eye with women DARE-VVAX to for were much

XXXX So look for today. watch Thank forward the against you year. throughout objectives we as this for again on our And updated your to these year. you well that keeping important time progress

Operator

And this does call. today’s conclude

You may now disconnect.