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Dare Bioscience (DARE)

Participants
Sabrina Martucci Johnson President, Chief Executive Officer
John Fair Chief Business Officer
Lisa Walters-Hoffert Chief Financial Officer
Rachael Yang ROTH Capital Partners
Joanne Lee Maxim Group
Jason McCarthy Maxim Group
Jason Kolbert Dawson James
Jim Molloy Alliance Global Partners
Brian Marckx Zacks Investment Research
Nathan Weinstein Aegis Capital
Call transcript
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Operator

Welcome to the conference call hosted by Daré Bioscience to review financial results for the quarter ending September 30, 2019 and to provide a general business update. This call is being recorded. My name is Sarah and I will be your operator today. With us are Sabrina Martucci Johnson, Daré's President and Chief Executive Officer, John Fair, Chief Business Development Officer and Lisa Walters-Hoffert, Daré's Chief Financial Officer.

Ms. proceed. please Johnson,

Sabrina Martucci Johnson

and welcome call and have financial and of quarter results opportunity milestones and Thank the for Daré to Bioscience. update remainder results third our for talk and to company It's business highlights to upcoming XXXX. you XXXX about our our a the pleasure

to forward-looking provisions laws, would meaning considered of the are forward-looking the statements. I begin, you fact which I historical Litigation of within made to remind Reform should Harbor call statements that not XXXX. made federal statements securities the today's Private Securities Before Any be of like that discussion of during are pursuant will Safe include Act the this statements

by uncertainties. due risks these and unknown Actual known statements from results or events implied differ to and could materially or those anticipated

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

December statements was cautionary the the our Report entirety November September on are Form filings, which the XX, Quarterly quarter XX-Q statements XX. ended for on in ended XXXX their qualified for including Forward-looking company's SEC Report on Annual XX, XXXX, by XX-K Form filed and our in the year

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

life improving of Daré and well-being is contraception, health a sexual the women, and health, fertility. primarily biopharmaceutical on focused the vaginal squarely of in areas company

value women's product in of program to delivering premier deliver of the candidates inflection health innovation on and advancing continue our key by vision our milestones. points becoming We on to meaningful accelerator

our clinical drug we very merger important to earlier and of add innovative updates definitive review delivery candidate our an to study updates, to contraception. will we truly pre-pivotal Ovaprene with agreement will results the late-stage of and and the development and progress On the Biotech some can recent and portfolio X.X% with in XXXX. spend therapeutic announced exciting of potential to Sildenafil hormone-free monthly Cream, our review areas technology the contraceptive game platform balance including upcoming two our changing call, you we vaginal today's expect XXXX milestones of bring this week, DARÉ-BVX that assets, discussing the Microchips multiple these After we the time

Let's with Ovaprene. start

with stage application, the pleased device for into an clinical the a filing Ovaprene to or with our trial, We what extremely you top step clinical clinical pivotal results postcoital to sets are and believe the trial. study. be advancing pre-pivotal able exemption single product line for be findings IDE product important investigational our test will this toward we a expectations which the is in line There share are of

contraceptive are deliver the innovating the that What investors in a can few points a For prescription share actively the Daré that this means are is new story, alone. U.S. valued than value. market market company at more to ours significant that is billion like area in for $X

of value. X% market $XXX branded the in total million every equals An that prescription prescription independent analysis estimates contraceptive roughly

$X a her via to between able like stage share top fully free to billion for women suit NuvaRing, available example, digit controlled $XXX lifestyle So product monthly hormone there life and convenient Merck's options and can sales. that hormone garner line designed to that Currently any dosing. monthly women highly high effective effective, million is aren't are single contraceptive market deliver and of

vaginal $XXX million and of Ovaprene led NuvaRing truly be has hormones. contraceptive free disruptive effectiveness use a us products us to hormone unmet with of a persistent to and and monthly clear contraceptive. be could the over that need the to effective product new to associated option This in without the identify a an convenience and the Ovaprene potential which range hormonal encouraged viable global once-per-month in but same opportunity technology. monthly of XXXX Merck's has sales It offer had eventually

gain, is of to there hormonal hormones very number women meaning birth are that seeking able these significant cases, We to also Ovaprene changes alternatives women why early weight are method of review current our as in are PCT control be that avoided, line you to or with because are classic so can be important, believe are control. hormones their users are condition they who and top today some findings effects hormones we of they will since adopters associated existing an they we of be not the with a interested on mood could anticipate contraceptives. We side product, of hormonal Ovaprene because primary contraindicated, is call. excited the take nausea In unwilling but including birth medical the which believe to use

motile Ovaprene contraceptive observed, These in regular like The post-intercourse sperm begin, high-powered surrogate device the fewer device surrogate results a women samples a effective effectiveness more of terms is numerous conception. considered trained a pregnancy. clinical for likely are for ovulation which of preventing be taking the the a challenge designed each mucus from thus effectiveness. or clinicians for involves the To then of cervical by microscope the a trial the in in to subject's postcoital marker is time terms analyzed the to a progressively a are vulnerable PCT to It determine sperm via samples contraceptive number utilizing during predicted is test most samples.

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normal enrolled Ovaprene most the in like of a in utilizing revealed results ovulation for X.XX per PCT and time study during mean top women had Ovaprene were taken women motile cycles, the field ovulation, Ovaprene. samples progressively device device progressively Ovaprene of the power challenging contraceptive all median The their Importantly, had that motile a frame sperm. line the for with sperm a peak high zero cycles

motile use of pills, the typical that XX% products studies pregnancy cycles. that To vaginal clinical that of cross in such earlier. demonstrated hormonal PCT in canal their size rates contraceptive contraceptive like in was and Ovaprene went vaginal reaching from in this preventing the cervical put typical effectiveness motile ring, evaluating discussed women Other that to in no all the use cervical of over a methods the similar six nearly perspective, effectiveness at effective on study, progressively to sperm the sperm pivotal we range demonstrate means XX% studies patches similar rates XXX% ring mucus month to as period, monthly and NuvaRing all

the and that premarket Health, designated the U.S. study with the Administration, and to from approval process. communicated, filing an Drug previously a for have Radiological this has Food used countries we review FDA's we Center to been of Devices be other contraceptive IDE and will of Ovaprene As data division the support the clearance to Pending plan XXXX. study initiate States, a study Europe of worldwide. safety and to in half we the United of IDE, pivotal effectiveness and If of FDA expect the support in marketing Ovaprene successful, approval that review second under Ovaprene

on edge Ovaprene news update give another another you working our to week, platform. of to agreement now, important In potentially the with acquire Right this may technology that also to we access Biotech, detailing the believe company seen what an have that drug-delivery. will at outstanding addition to game-changing and is innovative have share the exciting is we drug-delivery Microchips you us biotechnology news cutting

and has Pace, healthcare and by Intersouth refine The Gates Michael Cima including the enable release technology further to long-acting of by agent platform program Dr. Bill investment development up supported Pharmaceuticals. developed system Partners been to investors, Polaris women their Langer $XX.X by to Venture Teva device, Melinda active contraceptive researchers, particular received from this renowned The Dr. designed million was user-controlled has fertility and MS funding controlling to of Partners, and in Robert regulation implantable venture and the the in contraceptive the grant customize funding leading develop and disabling contraceptive by Foundation the and enabling MIT remotely.

Officer, will technology. more our Development provide insight into Business little a Chief John Fair, I ask the to

John Fair

when to combined eligible of the Gates value of in cost up its resources is will ongoing XXXX, of into believe We Sabrina. additional product stage it million. truly any in of is currently landscape It's for funding else women's received grant it an doesn't to with approximately on preclinical Foundation fully for translate you will with in compete development total Thank will from the technology already that current $XX.X through the creation bring this developing there the and we candidate stage amounts us highly $X.X important to technologies current the immediate cover development and the which nothing from funding for in Daré. preclinical development its draw This new is program to-date, or like and activities complementary funded million are acquisition receive health.

The and the by for drug hermetically-sealed indication intended by completely The be a that remove, The in on numerous implant be desired months is for device. via achieve to doses iteration return therapeutic therapeutic be its contraceptive the the a is dose patient device predetermined be each deliver to self-contained remote wireless effect. store a device to years delivered precisely-timed, patient a to the over rapid to or is technology schedule microchip-based disabled designed and easy fertility. final implant and importantly is to that controlled can

resume for amount great a to contraceptive an user-controlled of innovation upon of the new desires the contraception it and implant the to exciting should date. be her our technology to We based on and addition convenient that return think future is It's needs a at ability of believe discretion akin to The on functionality her tremendous fertility, promise as able holds has to of that portfolio. protection off a user. giving allow the the some long-acting being we or a turned her of form

to over back turn Sabrina. will I that, With

Sabrina Martucci Johnson

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the not compared the extension will symptoms treatment differentiated To study which anticipate are study, to duration be treatment support with study vaginal support DARÉ-BVX XX provide evaluated is otherwise treatment proposition, with commissioned days in the treatment evaluate extension post metronidazole and subjects BV cure will if both a Phase important in we additional clinical that XX option data with DARÉ-BVX no which to dosing will an and data receive the payors. as or We plan gel as value of will resolved. sustained that to X additional response during but conduct receive also of subjects a DARÉ-BVX provide to

sexual excited am option sildenafil, update approved, the Sildenafil program erectile male the Sildenafil to on condition active a is to sexual persistent drug, agreement I a difficulty. distress arousal Female Cream, Finally, could same approved disorder our interpersonal I X.X% dysfunction in first Cream an which maintain treatment be primarily attain provide the If or FSAD Viagra. refer it, women. arousal general for in inability by ingredient FDA FSAD, incorporates or or or resulting during characterized recurrent to sufficient activity frequently as

with of brand and is pathway existing to and provide in observed the XXX(b)(X) Cream profile in with arousal avoiding the to of FSAD As data the women utilize with marketing is Cream plan Viagra oral blood We in dysfunction and flow in blood the insufficient response to established while flow the sildenafil. Sildenafil general female genital systemic U.S. the formulations increase of improvements FDA's associated genitalia. safety approval leverage erectile to to designed side effects Sildenafil obtain men, sildenafil

for of regarding program for Xb third sildenafil we content studies or we this C we Phase subsequent quarter non-interventional trial the last development Type for specific intentional from a a design measures of received reported our study candidate. conducted overall FDA clinical meeting FDA the of During of had XXXX, meeting Based guidance Sildenafil the that and outcomes to year, support product PRO the on patient with Cream. clinical intended the the validity study,

The relevant well are in target was these validity in Xb use since to which which year, their setting the trial was Phase the of our general designed identify XXXX, and and home PRO to arousal are want important in and that would subjects which study content completed Phase third assess demonstrate quarter Cream as the we to symptoms in our systems will X studies. cream Sildenafil this population our most placebo as

the Now trial be timing of receive Xb clinical which to end we of to that Phase FDA that FDA influenced by of the the trial. for the are guidance we In have results, XXXX. Xb will initiation additional guidance, of we conducting activities expect Phase those prior anticipation the startup

or the work a using Cream from a support clinical as will findings to assess human to to on placebo Cream such component might study. women. This will we clinical the of Phase study when for healthy blood XX also differences Cream reported Sildenafil that endpoint arousal primary perform of flow findings measures in overall in surrogate statistically minutes arousal. within and performed have Sildenafil thermography self-reported demonstrated we the Sildenafil showed Sildenafil pharmacodynamics a response general six a addition, that of a In placebo quantifiable study the genital women significant continue because be compared recently application. and general program Cream additional increase and between the positive XX meaningful to Xb The is non-clinical statistically valuable of be This required and temperature, significant of elicits to self-reported for demonstrated of

not mentioned the discuss, first-line therapy to we Before our believe solution Lisa health, those or each I to our potential I and call in those address on become portfolio, has candidate women's need well mandate unmet over Walters-Hoffert, did our would reiterate to either as in as persistent today turn first-in-category both we that here a delivers the CFO, to or like

financials. call will our over Lisa to I the to turn now review

Lisa Walters-Hoffert

financial I on results Sabrina quarter this call. like to XXXX. update summarize the for for ending now all third you participating thanks would to Thanks and Daré's of

expected been portfolio and approval. noted, product to continue development our primary operations candidates be of and to research are previously Daré's As have and development ultimately to advance clinical regulatory through

expenses research During $X.X advance clinical candidates and expenses milestones. expenses the approximately in and Daré's and to our portfolio included accruals research the million for Most or of XX, discussed, were the expense for Phase other to development and programs X the and DARÉ-BVX, general XXXX, and quarter million general our quarter. buckets fee costs. Sabrina Ovaprene $X approximately the clinical advance development overhead, into towards activities of initiation licensing PCT were study the ended just of expenses trial the that our for personnel prepare September corporate administrative R&D fell of form maintenance and our these to

Our quarter XX.X our common common third approximately quarter comprehensive of purchase cash loss the approximately stock million, shares $X.X million. the debt. We ended $X.X warrants for X.X outstanding shares and and million no of was million to approximately with

more Monday an November Microchips close fully Daré. Daré that to Microchips on XX, with past of merger as this it merger footnote subsidiary the closes, XX-Q merger on our before will and wholly-owned announced mentioned, of in agreement filed of into disclosed a is plan Tuesday, Sabrina XXXX. become entered Biotech if As XX or whereby and This expected

Microchips million plus to closing, shares addition cash team exciting of At of the issue cash payment at Microchips Pharmaceuticals. seasoned expenses. equivalents time to in Sabrina and and Polaris common development those and has Venture Partners cash just be expect the our Partners, to and transaction-related liabilities Intersouth Pace, include $X.X of platform, and Gates we a the after Microchips acquiring cash approximately stockholders issue stock and of of million consideration mentioned, which, its a In shares will to MS complement as Daré $X.X three Teva closing, equivalents with Foundation approximately relationship technology an the cash own million of

add investor healthcare these to base. We our to thrilled funds are fundamental

as product development, funding, payments. has the addition, as regulatory of contingent and pay to Daré future agreed for royalty milestones commercial tiered specified well achievement In consideration

of become such million with payments consideration option stock this at paid contingent of NASDAQ to will our in XXXX. compliance shares end may through common cash, the We And expect be our of $X.X payable that or subject less than rules.

our we our a and operations our capital discussion in encourage have to Again, investors we Microchips XXXX. November file that liquidity filed also condition. be going to our the continues Tuesday detailed the sufficient merger and on through fund to concern with Daré definitive In XX-Q will not more resources as review planned XX-Q, noted to and our our agreement with recently existing relating financial resources SEC our

I would call to like to back now turn the Sabrina.

Sabrina Martucci Johnson

Thank you Lisa.

a in we and strategic pivotal to from I as our Xb portfolio value capture that transformational we into encouraged view partners and are women's potential positioned particularly and continue initiation X want DARÉ-BVX to to planned number health assets study Sildenafil one as or late and stage and to add initiation we we Ovaprene Cream conversations continue well our go create we readout, XXXX year we more indicated productive continue mid Phase interest and product with programs. to our Daré study also of for are the by initiation. Phase So of have of XXXX believe with that have the candidates, study companies the for

continue partnerships the such, our and discussed, opportunities context in timing drive have value for will the shareholders. of we we we to As greatest collaboration evaluate those will of believe what

our believe women for level most long interest short and earlier for stage drive investors term from and partners we from our both strategic the our us programs assets Importantly, portfolio well to position as significant to well. of in potential that the or value in late importantly mid stage

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

Operator

Instructions]. [Operator

Our comes Rahimi Yasmeen Partners. from Capital with first the line ROTH question of

is line open. Your now

Rachael Yang

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

within type how well you assets assets? us acquisition walk What So of through first, can current you you do your pipeline? of fit believe determine

Sabrina Martucci Johnson

clarity and you the Thank Yes. question that to some that. give opportunity on for

to think to we minimal assets more they and as have to about four criteria hit meet really a portfolio, as our number ideally on Microchips than of that even So add the those.

clearly today. So meaningful they have add not viability to unmet first is assets that needs to addressing need, addressed have the have and so because address means is commercial what's to currently and that to really that persistent they us foremost, be interesting that a

concept and concept. of love ideally Second, even existing data proof that has program we human proof a and of

ways systemic, so that that we that regulatory very, pathway, take sometimes is, leverage from meaning delivering your that that look other are unique a enhance very and risk, oral an category that often to in programs interesting avoiding that fourth have us know female delivery. Third, meaning interesting her for programs drug an are for ties and opportunity biology really which of really XXX(b)(X) are by outcome of unique into in convenience to advantages we products pathway we our importance can sometimes areas reduces

and the as provided like relationship with of to both and as to and of team and have a foundation has their funded, the development that comments, Lisa had And technology to personally really is have those a a kudos are at funded. example for next beyond in that went that is so Melinda important take incredible four and have Microchips that relationships now But thrilled an on noted that, program that and that really really support above program John Gates formed that, of hit are this, that the to the forward wonderful opportunity criteria. with opportunity Bill the program are to phases Microchips, all Foundation a kind a the we beyond, they an obviously company

from doesn't here So we away is a activities programs that other take other have plus. it and

they And on exchange investors really that to our hand theirs to it a that's Daré boy, to that cake shares going opportunity on investors really icing have are to now to for wonderful and us is, that able to cash well. be was as exciting the for in be be able like issue

question. So hopefully that answers your

Rachael Yang

negotiation? a of which us are the follow-up. financing designs up plan how in you you X Phase Ovaprene on the have That's trial and components through to program And and stone very so Can helpful. you much. Thank I are set walk which

Sabrina Martucci Johnson

Yes.

So thanks for that opportunity.

into comments the before think kind some I will I in highlight entered use remarks Q&A. I my to of we of made closing that opportunity

the and done I to fortunate that a we health, in the portfolio persistent have think products truly it build very preeminent very, to are need. women's speaks unmet address work we So

to We a have program potential of potentially have been interest it of disruptive companies have or in the programs conversations very interest one such that the a in opportunity certainly Ovaprene given indicated contraceptive strategic with our productive number more of technology a very, to is category. fortunate has partners with and be

as I and such the to we are collaboration of But of the the the context partnerships opportunities also we around make partnerships mentioned, to shareholders. continue going evaluate in of a what decision really these greatest and timing value our type drive believe will for

So updated to and forward that keeping we the have you on our interest on our that we on look across portfolio. progress

do what they six process to it an development of in one their, the with that that development done to our robustly is Typically, and opportunity, As an have what been FDA, is from months to IDE engage pivotal program, been really their as that program. of We obviously pivotal other have Daré's have pertains opportunity the that the they six required up know end around FDA evaluating through to months. really opportunity, about filing filing and duration division gone typically same our subjects first at XXX clinical IDE in that it's completers clinical around study, first in the programs. products

products. So that's what's happened other with

that of diaphragm condom division been That's product. the a spermicide, first FDA very hormone-free has so the interesting. a gone brand-new Ovaprene on-demand. through why on-demand, product. It's and exciting once-a-month, so of is on-demand, Everything else it's category a a that's Obviously,

providing to forward forward these FDA we interactions having looking really as with move are and we guidance clarity program. So on that and now the

Rachael Yang

much Thank your and on congrats Great. so you progress.

Sabrina Martucci Johnson

you. Thank

Lisa Walters-Hoffert

Thank you.

Operator

you. Thank

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

now is line Your open.

Joanne Lee

Jason. Joanne for on This taking Thanks guys. Lee, Hi the for question. is

I you implant fully Biotech, funded? if pathway over of further go then ongoing And Microchips on some the of understand could on contraceptive wondering the acquisition I to details being is guidance approval? its some which the Regarding was program,

Sabrina Martucci Johnson

Yes.

have proof the still stage kind preclinical really products the like a like areas concept One concept of of technology of the profiles preclinical proof we stage. The study device is to itself areas and there within design through contraceptive in So which the been two for human a things really obviously that development that I has of and and program the program, this technology is activities. in is and like through development show focus technology at the been the in of stage optimizing say that. around development core release is, the

So preclinical and what for think are as development into about preparing would clinical that any, you do you often doing typically to any as kind are go in you studies. program at phase human

really program. stage in includes be animal would as this design the at work So that as that work done well development the

are a As well she as it's like also to to we great research technology like use those how to design to make really would sure opportunity understand do market with achieving this all women a objectives.

these So development. of a that hopefully next about thinking are gives you sense of how phases we

more to to there your trying questions. am was remember I if

Lisa Walters-Hoffert

did funding. Yes. And about the ask you

we has the press in call granted million $XX.X funding available $XX they million. in to been was and So Approximately had, announced it our $XX.X million, release and there so Q, issued date. to that up

did operations another received fund Sabrina program is XXXX. a into great about their for million, there is which with that it So funding what's nice as opportunity come was which will noted, Daré. if so $X.X existing

Sabrina Martucci Johnson

those female And really of that to fund next animal including phases activity work.

Jason McCarthy

Okay. health was you FDA's contraceptives little more all am question. extended to like just another the Agile's actually I views on may the a is if specifically February, don't in to contraceptives, an just the the ago, aware, unexpected. call bring which really and wanted Can products they market? approval PDUFA think way with are guys. the got willingness jump your This hormonal hour I be bit discuss on I Jason. to just too. till Hi into I and women's or efforts you

Sabrina Martucci Johnson

us I question. to and you to gives also the little business It's us frankly a talk talk an giving Yes. field Daré. opportunity great a about bit for think about the Thank at opportunity our it model

on going, talked we portfolio So or about you hard the talking have or I whether worked to didn't Sildenafil and we true One achieve we Cream I of have but of Ovaprene and designed portfolio about have you kind can couple built constantly tiered are Microchips of milestones probably targets we being, an a while think clinical for as as we we our this our keep as BVX you or and mention is operational investors, very, it's the very we objectives. about am and the program, worked I to have all and interesting our portfolio. call, portfolio are regulatory also, hitting kind should it's I across events data, design. n Because

think 's interesting structure. is So portfolio in I a

But they question persistent interest for the women. our products clearly defined to strongly about unmet speak that interested women address program. can approving absolutely to approving in specific products products And for sildenafil ensuring needs. I and and their your are FDA that to believe women have We in

last As we meeting a you had Type know C year.

ongoing feel year. having are why is which we with the We will clarity we discussions obviously go into have as agency we the

is So definitely to new women. interest and with market sponsors there enthusiasm for products working to bring

exactly say, second areas could willingness. I there have where lean be don't that risk to marginally from no the we category right. a persistent our to tended portfolio and be there a need, will equivalent So is meaning to or very a other company that design even a is as clear in program, product unmet we that for perspective, again doubt towards considered

one-time BVX, administration of clindamycin. So

a is cream. clear it's cream, and while This bioadhesive. gel. while other not one-time is another It's even So creams there there's a a clindamycin

first month look once a If hormone free contraceptive. ever it's the you Ovaprene, at

arousal look the the where first you sildenafil, developed category approved. for there it's product at else is If nothing disorder in being

way agency are with with the where as and definitely to mean category category that have your be in And the have there there that the slam when someone may means right, benefits looking to they you to a product enough certain always as while as where a similar for perception isn't quite that, risks, not nothing there is to outweigh differentiated. opposed offering else looking type of work do that I your available a are at is something at they any the agency end, conversation a and the dunk, in imply anything a it's

built it end successful that them will rooting are that product we think I we because their interesting hopefully, and be nice the are that's because to But we is some context that interactions. at really don't FDA want available Agile an why it we our and our for gives how Daré see be for to how for there armamentarium today. and looking do addition us, XXX% portfolio So important and

Jason McCarthy

Great. Thank Sabrina. Okay. you

Sabrina Martucci Johnson

Yes.

Operator

comes next you. with Thank the Kolbert line Dawson from James. of question our Jason

Your line open. is now

Jason Kolbert

the what that much. so Thanks you to areas. questions would on Most the guys. I Lisa, been about two you spent focus million answered. in have $X.X my is, Hi One quarter. talked fact But like of

what cash. You other same, cash ended with in a the Plus financing. acquisition, a runway the million me being things Help your understand, all like $X.X essentially is finance, non-dilutive today? looks

Lisa Walters-Hoffert

quarterly We out $X.X guidance have specific on we Yes. as And question. don't provide year. annual runway that's described. an net did because through excess don't basis. we Sabrina of the the the basis going million for development November you But on thanks that funds, go pointed can use. $X.X the that even of XXXX preclinical a or million activities, research But say ongoing We to next to and then we of acquired, the Microchips some and that, cover though

acquiring be them. will We

I more now. of wish could I as say I So as specific, can that's much kind but be right

Sabrina Martucci Johnson

you with have much at we that efficient value spend we our drive on how I what are we try of question add Yes. spend a because that focus and for for again very our things well asking think little company to are investors, And it one to really as bodes I Jason capital think of inflection. the thank can would incredibly proud you we if I things how and that, is and look accomplished

events. of in So goes we the regulatory to and milestones clinical we bring most we grant funding And can. money leverage wherever

So we the for the incredibly which by thankful NIH funded the Ovaprene program. is of program this the for to are that point essentially really NIH, support

very overhead can terms at continue as opportunity to So capital NIH we we as Foundation funding Ovaprene historically creative non-dilutive the using that forward we are much expect are incredibly we will have like can the have in strategy we as can it's capital forward-looking burn and creative showed I when in as Microchips, Gates to of we with achieve that I mindful is are as look much minded in continue and that had and same company that capital and opportunity to of as as that around possible think be funding spends sort we and equity how forward around can us value. you that really as driving going that low we we a sources going be from think are you what very, see efficiency that what culture is we

Jason Kolbert

and that's Good. think comes element think the And you I I through I that that of and made. important an acquisition get that

development proof individually proof what BD status, understand we will, programs concept those sildenafil? little kind the and of concept are business coming I talk you where the of is in interest about on of So you kind And on three next of up that. of level BVX, just bit Ovaprene, if linkage a and between Can the of catalyst, particular? and

Sabrina Martucci Johnson

on back will been can't I and validating see better continue across the Yes. frankly level interest really there in to enough interest we and We is could, incredibly bold, of that programs. and portfolio the just it to just programs if I our BIO-Europe. have the it from fortunate that has came in all I the stress how put

these We doing of kinds partnering meetings, and are I. John always

in is three level which portfolio we got of value now we that so at we point. And interest. interest are interesting have are to an right excited the that each programs, point, And super level your of about because, of having inflection

studies to can the which with of efficiently, NDA methods, XXXX, program. PCT how Ovaprene how that and are goes the just we of contraceptive, robust around lots milestone in your out point, for having filing. to quickly of to the and our BVX effective being partner hormone-free contraceptive Ovaprene how in an But studies the data Phase is level clinical of is predictive have we same program going the X the given effectiveness the our study first and and field the deliver I reported, that that it potential BVX obviously PCT has potential a X highly kind for obviously. these our and want sildenafil a monthly mean is data clearly program and interest and get commercial important kind through reported readout Phase that of

at For stage a coming have right that interesting XXXX. up we program that of development really that's a in milestone

the in and those than study program are Sildenafil with success of through the they is female are an motivated. and and Cream can't and erectile started is really, version which Once program first that incredible enough. potential getting milestone I demonstrating planning product discussions just important our important are clarity milestone and we general FDA is her through sensations XXXX. Phase quarter, study. dysfunction disorder get emphasize provides actually that's a more that's sexual as And that as the running for getting for Sildenafil women of of the Cream, an hopefully with outcomes for event these discussions with Phase the there on Xb reported Xb we FDA against company continuing that really last through getting that as be will we patient And Xb study, with which are treatment that year the Phase X for program Phase arousal that this through the for are me This for just erectile arousal distressed arousal disorder, dysfunction. There that

Jason Kolbert

to really to of large would level progress. got be deal come specialty the a pharmas some high. all have of interest really, pharma on even really the together. the I believe It's to interesting and that It have be among see exciting. BD Congratulations

Sabrina Martucci Johnson

you. Thank

John Fair

Thank you.

Sabrina Martucci Johnson

the same. feel We

we So that said, have. have it's like interest to kind I very of validating the

Operator

Thank you.

Partners. with Alliance Our next question comes from the line Global of Jim Molloy

now Your line open. is

Jim Molloy

for an additional Does Thanks for to be for capital? Melinda Melinda that cover comes about a and little up additional following that for quick the Or it? there Microchips, Bill and talk key on the to will the extent on a catalyst a cash question the are had I what And in next question. additional get my that the and need Foundation from there you and option the guys. is taking a Bill little capital? in cash costs the Could Gates bit. Hi potential kick Foundation? Gates the

Sabrina Martucci Johnson

question. Great Great.

So collaboration and mentioned and as that, Lisa the that has all will already has Gates funding of the level $XX.X Melinda Not Bill of received. reinforce million. Foundation, I been the been

answer. in think that's So yes I

but of already funding As we can't agreement. to-date Obviously she ongoing grant certainly of the that's current fits has the looks about into kind this that to Implants $XX that part is of to planning highly what there noted, in in stage million for come just most million contraceptive like fertility. a been in technologies and speak gives future interested super method. by $X.X programs her family about the the effective and disruptive contraceptive method that are opportunity foundation allow far effective has ability the supporting her the control truly the that contraceptive

sufficient success, getting to ongoing and that funding upon of appropriate program. kind through continuing into funding to look for look can secure is the that then get obviously, that that feel forward of point. next to next forward come to So very next we that we and will that grant described relationship we really year in that phase current And really as activities and good really to including this phases the

Jim Molloy

My apologies. Right.

website looks grant, can see on little that relationships? deal not. about Microchips' a their had mean Of back current course, or you the come I from Teva a to the I And talk guess ago, it like Or day. is a in will while that Is with in that $X.X something see I they from but the ongoing? will left addition we million that's if on in

Sabrina Martucci Johnson

Yes.

a one a great an one work stable kind really of I are mentioned of is outside the we over of periods spend know of on, field lot technology to the on field. this effort promise, the contraceptive upfront, because as So of is long The utility really release and actually that that has can interesting contraceptive doing in there time are environments. and and time that kind drugs

the areas. it's as there are a kind to program place stage But work about therapeutic absolutely think other of first this So great indications. and do of on

our had and support the as shares. also Daré program the clearly in involved and now some you was an getting some point, one for investor are program, noted they at Teva, of So

So program. the focused kind development therapeutic like at women's particularly an are for I that implant think like those on to And agnostic we but to here health continue to we very support opportunities collaborations are think as is other other of there obviously Daré gender. the ongoing of areas, about this

put an in men or in can implant You women.

about are just we so at capital all development kind of around general hopefully opportunities partnering, we appropriately are And gave answers Daré, in from these non-dilutive we partnering bring. certainly the business here and that

for we technology look where this will look of well. also areas utility and absolutely partnering opportunities have as kind could those other So at

Jim Molloy

the I will trial you are top data? looking last then BVX, have make the that to start in When get X for line One queue. hop XXXX. that question, in data you back do by One clear XXXX your Phase to for you

Sabrina Martucci Johnson

XXXX start associated Really, in lot that timeline that and plan the relatively It's short actually right supports now, of simply a the we study. activities already doing the a year. plans having are, are to in the are is startup that the us and trial data is what

pivotal the XX mentioned, just should that XX NDA that's day that XX that XX. to filing. extension visit XX, not to the I which study days. part out that I talked to phase, primary clear I the for that's pivotal we need about, the goes that be endpoint is But study, day So, another as

short you in lot to is readout a the start So the when XXXX you leeway as a to guess, can how study in the the There study can given of know, is, you data on start XXXX. have study.

Jim Molloy

questions. you the Thank Great. for taking

Sabrina Martucci Johnson

Yes.

You bet.

Operator

Thank you.

Brian the of Research. next from Investment Zacks comes line question with Our Marckx

now line Your is open.

Brian Marckx

the that any I can signoffs whether on is patient start that wondered regulatory you need or before Sabrina, or BVX, congrats all And you site on everybody. there study? Hi progress.

Sabrina Martucci Johnson

Yes.

So great questions.

had work of company a as things we the that the we had own as in do that So because been file mentioned IND, our program, prior had one was initiated. the that investigator past

have a we file IND. to So Daré

clearance. So about timeline process talked IND reflects filing the the obviously the and in we an step and program important of that that that's

and an are this treatment. one And to a a the then obviously study this patient is have yes, investigational like in thing particularly an where they an infection in going they and active study get important consents

to product So study our studies part this operationally, worry a what placebo, when around of you they really we setting successfully patients manage else, a going that's don't give to infection. be time have your because something if you to expectations will are to you comfort want these and is or them if like appropriate about something can in running big placebo randomized worry, that to over you randomized give placebo are

And piece and so a operationally, of consent those discussions is it. important

women we those before protocol as that to for at kind look take you at have does are to And one now them get considerations they and is the are instance, to part keep starting look so up literally that make that, able study, going going to and activities in treatment. of roll you comfortable get obviously be you them that all the and to right have of going sure

piece big it right studies. been have is And the of fortunately, enrolling BV sites. a there other But

disease in studies they have to over to that have a that placebo to sure experience really you good infectious make We time, the randomized were a stay going are to they if want have but have get and to States be United and type sites good with the of these kind sense really have need that treatment control women where who of in placebo.

asking for about thanks So that.

Brian Marckx

then the BVX, appreciate that to portion thing, the you run detailed that a, Or is certain portion are on that some do will to of Relative a that you extension also that those something going the is And You announce? are I the announce? that, certainty be will of conduct you Yes. to of results extension it? it, that study are answer. determined? you

Sabrina Martucci Johnson

Yes. Thanks clarifying asking that question. for

with It's study. is work done conduct now, with based have something we looked work payors, intent right to done at So and the the extension were that have we on we have program. potential What really commercial helps to interesting program. the see some this on that partners, of them differentiate earlier done might be questions to be right, for for with, partners potential the

we you this readouts, on that we and to to have are think back program if did continue to clearer kind when program different going will So we when of things starting. clinical clearer guidance, Ovaprene, as progresses, provide as are with

now, our that on given Q. is the the partners, of you and it given significant for we well. detailed some right provide But component to study potential low plans guidance when relationship upside again but But payors the data we able extension payor, study in nice and to exactly around terms forward and I the has clear the is, refer information cost really expect to look get program how cost. inexpensive as that that in can would being it It clinical this certainly of incremental

Brian Marckx

Great. you. Thank Okay.

Sabrina Martucci Johnson

Yes.

Lisa Walters-Hoffert

Brian. Thanks

Operator

you. Thank

Our Maloney [ph] of next from Suzanne comes line Catalysts the question Partners. with

is line Your open. now

Unidentified Analyst

ADVA have congratulations and successful I postcoital was you completion Hi. successfully different license share Thanks to have fees pay guys I of I study? fees you that to the the and was so the much kick that trying enthusiasm curious Ovaprene completed your licensing whether of the in for any update on the for the asset. keep now to track study. the postcoital

Sabrina Martucci Johnson

Yes.

specific we events We are agreement so not that given level, treatment SEC the don't haven't competitive file is timing for We that reasons, events to and question, milestone guidance. our request when of with confidential level that disclosed. those the we give of the milestone typically what specific for thanks

specificity aggregate commercial, the we process, in be. the what important what be we I in can -- and front is, both have company in me it look give in investors to So to it's understand milestones, admit people right and for think point trigger look milestone might interested the might that up What for around we disclosed of don't never this might disclose it under however understand really level clinical at and is but position, quickly, I payment a we it what have program to did in of it's because I like. a that I have

Lisa Walters-Hoffert

$XX I million. think about it's

Sabrina Martucci Johnson

about -- Yes. It's

Lisa Walters-Hoffert

it because sorry. the gets -- am them all clinical, to together between in and $XX we here. to am million yes. and regulatory I this I commercial going jump down About lump to tried you and break

Sabrina Martucci Johnson

of people, guess, for Even us. I all

Lisa Walters-Hoffert

Yes.

Sabrina Martucci Johnson

Yes.

million million. it's $XX So about $XX to

Lisa Walters-Hoffert

Right.

Sabrina Martucci Johnson

reasons, disclosure And that's the again for only competitive that's given. clinical. we Of have

Unidentified Analyst

And my Okay. been and other questions all asked have answered.

that had the So was only left. one I

Lisa Walters-Hoffert

you. Thank

Sabrina Martucci Johnson

Thank you.

Unidentified Analyst

Thank you.

Operator

you. Thank

of comes with the Aegis Weinstein from last line Capital. Our question Nathan

line Your now is open.

Nathan Weinstein

before. good questions Hi. taking some question my for asked Thanks were definitely there and

I looking market. was at ask And women's so on the level, actually to was what a health hoping macro

the ESG-focused In the guys have of terms investment interest particular, general then is in how Thank over this funds activity whether time And from investment growing? in seen, you in greater seen market have space? you you.

Sabrina Martucci Johnson

the sure I am of question. not I part understood last the

Nathan Weinstein

ESG?

Sabrina Martucci Johnson

you could sorry Can it. make you to repeat Nathan? repeat, it? repeat I you am But

Nathan Weinstein

Yes. Can you hear now? me

Sabrina Martucci Johnson

Yes. Thank you.

could you you. that repeat awesome. would Thank be it, If

Nathan Weinstein

Yes.

question So with you whether over part the investment space guys from the was, seen in funds ESG-focused interest time, in of the have you last greater general?

Sabrina Martucci Johnson

ESG, this to And just make properly. thinking are sure define we about Nathan,

Nathan Weinstein

-- social So ESG be would environmental,

Sabrina Martucci Johnson

thought that Got it. what you We that's referring to. Yes. were

that I that's a really funds this. are looking at but conference or And and to for that focus CEO, not sector category female SOCAP, a only interesting a for conference the female funds opportunity an fit September, investor's some traded a in totally that Board Francisco health because impact people have of think are often very the front is in other go boxes that majority things we a representation aspects to that they our interesting of Daré interesting company, mandate. don't given publicly So environment visibility that and for them. it It's an healthcare the are investors capital at because impact are had in a typically neatly these and women's But And some get often Daré there is as intriguing interesting because we of are it's That was it's women's opportunity kind feels in funds buckets good the of in tick to in San investors really health as understand company investment they interesting more interesting the that that of fact, and which to is did a an doing. things like attend that. focused, invest interesting appealing receives as to and which looking we like into social I company understand us. little work

really those So get starting circles in as that well. to pleased we are some notice we

thanks that question. So for asking

Nathan Weinstein

Yes. the for perspective. Thanks

Sabrina Martucci Johnson

Yes.

Operator

to Ms. for back session. you. call Thank remarks. closing question-and-answer will today's now This I Johnson over concludes Martucci Sabrina turn the

Sabrina Martucci Johnson

and this Well, year appreciate thank to keeping questions really really more opportunities, for us we next our afternoon you. our to think but upcoming the to And strategies, I because are little everyone's partnering got provide today advance time portfolio, opportunity our particularly looking our only year thoughtful we clarity our there as we want I that clinical this go our around hopefully a that into forward as regulatory in well. updated programs, are and absolutely on And not you with progress. mind, great

all. you thank So

Operator

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

now may You disconnect.