welcome call and financial and results Thank Daré to Bioscience. update for business you, our
We forward for highlighting recent XXXX are results beyond. developments quarter looking and and to discussion anticipated milestones the of second remainder our and
are made Securities you XXXX. the Before will this of today's of undue Actual Safe uncertainties during implied and meaning unknown statements on federal reliance those differ historical Harbor include to not to considered are facts Any which Private risks the discussion securities within place or forward-looking provisions that results laws, materially and we forward-looking statements. Litigation should statements so statements. made that like by anticipated could of due known be begin, of these I'd therefore statements statements Reform or remind Act forward-looking pursuant you events call and not the to from should
obligation developments like information also by update filed new today. required no that call, that of the any content call reflect point their the Form including the was I'd was XX, are by forward-looking cautionary report this to or includes June XX, qualified statements filed for on the in current as for XX-K which to Annual to XXXX. except of in our XX, takes year XX, XX-Q law. our quarter ended the March Daré statements XXXX, out only this statements Forward-looking on quarterly is and information December XXXX ended time-sensitive filings, which after entirety Report SEC XXXX company's as Form today, on August
on squarely and of wellbeing the health know, Daré you is As life women's leader in improving innovation we're and focused a women.
health, we for stage line opportunity to category have of vaginal is first believe and and in in product strategy women the and that candidates accelerate programs products commercial with have availability creation selecting clinical to sexual potential first and health. value be advancing by contraception, prescription new Our meaningful
license potential Bayer, categories pipeline a monthly our novel accounting world DARE-LARCX, has from Bill and U.S. by contraceptive with user-controlled you for women market. in one Foundation. It substantial in be which agreement includes potential the injectable first health, long-acting contraceptive received & over leader as Ovaprene contraceptive Contraception, investigational in category is under and in is XXX/XXX novel target month can in includes ORB contraceptive that contraception funding solution candidate the an of women's a DARE-RHX, has be sales the the development It hormone-free alone. potential that may also first a branded to Our Melinda and know, the a vaginal $X Gates largest men billion XX contraceptive contraceptive contraceptive. of the six used prescription the
line are therapies. we that for estimated be than pipeline, contraceptive bacterial our the new infection potential not to serious affected addition the by first U.S. million addressed XX more In vaginosis, option to a persistent adequately developing and a women currently is available by in
the erectile as expected market in the the rest not the this improvement And men. year is market the disorder the estimated dysfunction potential to rate sexual of more DARE-BVX arousal address X the And to or and be the as erectile first our to category candidate current with female meaningful disorders sexual female both in the dysfunction U.S. dysfunction in so FSAD, significant program the developed has Phase being a product most analogous in to world. topline if FSAD readout products. in Our trial approved clinical our Cream currently the potential clinical FDA program in a Sidenafil deliver anticipated over to knowledge is cure only
remain the to unique regulatory maintained And product pace for year regulatory three anticipate and development value of four to necessary activities candidates. anticipated and different conducting previously readouts currently we we've near-term having achieve drivers, our two studies are track each clinical objectives key years four disclosed. that indications on with of next terms have the product topline clinical across we In and data
Now we with Mainly, trials to were to the enabling align general COVID-XX year science of impact all our clinical the to frequency continue person To current and operations that our content. life anticipated in monitor companies this and business to we restrictions conducive environment clinical the that have stage advance been on us regulatory COVID-XX able most milestones. to limitations and the our with to commenced pandemic recalibrate we on better the of and continue we imposes during business study the programs. felt two clinical activities date, run
Phase Specifically, treatment of clinical in the we trial that initiated DARE-BVX pivotal June vaginosis. bacterial of X for
potential to previously, which new investigators for infection treatment a topline on bacterial vaginal impact and U.S. DARE-BVX vaginosis. As study the not treatment receiving report a our acute as and administration thermosetting bioadhesive in Phosphate novel XX and hydrogel X% of track we results vaginosis this this I [ph] initiated by is is to mentioned for bacterial study's thus a year. the alone as and developed condition one-time this remain being containing for women this is estimated the DARE-BVX care Phase Clindamycin a women end to million X trial assessing over according are is study this of
FDA In development an of cure meetings of data designations needed eligibility for the X initiated similarly the study with to vaginosis. more diagnosed the XX% bacterial cure cure vaginosis communication things vaginosis. DARE-BVX If and As with subjects, marketed X accelerated infectious of XXs become and of Fast collection on XXs treatment we is such basis. more about to rates bacterial frequent that women have high single to evaluable drug bacterial proof-of-concept high A demonstrated comparison, frequent XX in DARE-BVX clinical delivers designation believe Track from if received the approved visit support a to rate for disease plan FDA mid discuss Track Fast a DARE-BVX as that test FDA the option after FDA treatment frontline investigator currently drug approval, are the previously a clinical of rate design reported, cure we occurred the that receives from clinical and a a days as priority eligible cure the both treatment and new administration of product met. from for percentage trials the approval pivotal written for in of criteria intra and appropriate study relevant review study, could ranging clinical products data for Phase DARE-BVX. from a Qualified
it vaginal potential and the is FDA or intravaginal the being designed leadership for and bio-identical Menopause for wall may prevent degenerative another but of women Phase intravaginal recommend guidelines, a top as fractures offer IVR and North vasomotor administration its is for peri developed women we for study and is our menopause. both for designed therapy hormone than progesterone and is driver, to as progesterone use More non-oral urinary NAMS, which Phase as administering estradiol bio-identical flashes estrogen be based X an to million non-oral and in to treatment U.S. DARE will to and bio-identical utilizes commonly improvement of we HRTX, for technology evidence bio-identical to menopause XX-day meet progesterone a the first also observed XX American bone continuously a loss that IVR of in DARE-FRTX, therapy menopause. treated that believe the option symptoms of We hot which ingredient. supports administered potential ring in information The called ring X to our will prevent candidate therapies. are we Society and or associated ureter over same which candidate has guidelines. same and DARE-HRTX therapy treatment the over both, believe approved scientific initiated provide hormone product oral the thickening postmenopausal Turning symptoms symptoms approaching of period that active in with DARE-HRTX advantages another DARE-HRTX, be DARE-HRTX new known or study in demand and portfolio the of menopause the to symptoms. July value announced novel hormone deliver treatment deliver that of DARE-HRTX clinical menopausal
will health of Australian a is subsidiary as at the Specifically, as overview well preterm well the conducted sites expected study fertilization in DARE-FRTX, The incentive cash which prevention will are expenses objective for characteristics progesterone ability anticipate is Phase DARE-HRTX collecting in to ability IVR progesterone DARE-HRTX birth. luteal evaluate while the which of treatment different which going apply Australia. X to provide costs the X study for our our offset directly which part release addition the two Phase as be subsidiary women's Lisa Australian that to as of support phase active will to technology option vitro convenient dual we payments pharmacokinetic apply on to eligible can for program tax our in by bio-identical for study of and for of release wholly owned an at of this an program. regimen the IVR different developing target bio-identical being specialty more only we as achieve alone its in two is useful rates
half topline the in of We first data report study expect to this from XXXX. the
we believe topline maintain be our both we to in the for now Turning still of Cream studies, our in position will commence Ovaprene studies programs. data readouts to those and guidance XXXX prior and Sildenafil a these expected
planned study in program, we the Specifically Sildenafil to results for Cream Xb report XXXX. Phase of topline our expect
I be announced on we product X.X% XXXX instruments approved important primary the the You would female patient which FDA endpoints. the Cream has reached may sexual study to access be on the outcomes the the Phase treatment FDA to and reported Sildenafil design arousal measured novel [indiscernible] we for the recall disorder. and first the efficacy potential to Xb with that in alignment December
And mentioned I of for disorder name the most in under FSAD in the brand ingredient currently analogous Viagra the is tablet female as dysfunction erectile earlier, a So Sildenafil dysfunction treatment active marketed the administration in erectile for men. sexual is to men. oral dysfunction
flow Our medications is that and that pathway same local designed that that's applied arousal administered ingredient locally of blood in women men. delivered vaginal same is cream tissue. dysfunction in formulation for thereby a genital active is increase a active means that to response using topically improve formulation which Cream is Sildenafil erectile Sildenafil, to It by that
the of way effective oral the side Sildenafil particularly challenging delivery not and for to While men, optimal oral response women. oral is effects achieve therefore version for the that with same arousal associated is in are women formulation an
flow blood that the offer that cream increased fast formulation the observed be to arousal applied systemic and formulation. designed So without benefits genital in been with the acting can locally, improvement to with response oral potential sexual in the of deliver issues same a Sildenafil has that the
for or women that mentioned, and also just to primary treatment planned instruments to million market. and believe for on dysfunction the to age to men opportunities low study FSAD erectile Sildenafil he at X% an condition. that are with of seeking is localized the Phase XX XX research endpoint, XX is Cream FDA which or arousal the FSAD women Xb measure namely some their ages efficacy in reduction achievement in distress put approximately of no approval of arousal in version as to the our I XX% review PRO XX% male and prevalence in improve we U.S. The experienced. dysfunction big be market increasing XX% solution about and the aged bigger the FSAD of sexual is with estimated women sensation a XX of readout symptoms the As distressed genital U.S. experience Market erectile To than XX. context, just suggests market are of approved [indiscernible]
our efforts and to startup Xb submission. such initiate on preparing NDA activities other Phase activities that the that focus to support of as to conducting diary as electronic preparing continue as future the nonclinical We study well
XX-week a As marketers product. Bayer study Ovaprene, planning monthly which the providing as hormone-free results a Cream and pivotal up Phase commercial royalties evaluate designed I implementation of Bayer continue which And in as filings subjects milestone first We we that experts terms to could and earlier Sildenafil of year agreement pre-commercialization Ovaprene year Ovaprene. upfront company and United work Ovaprene, to of More months is in mentioned include brand for and Ovaprene capacity. planned investigational of development also with the activities only the internal is advisory of trial currently Bayer Xb study placebo contraceptive have the studying the net is monthly license product. XXXX. versus certainly committed the a global an non-drug market year to is setting completion commercialize of non-hormonal regards of with conditions end contraceptive pivotal can clinical regulatory If exclusively is billion the billion for the data will period to for payments vaginal home placebo we're supporting in developed With and to family the franchise the be in about to announced regulatory our by Under pregnancy. I These SEC. are over excess and prevention million Bayer, topline of our to we conformation at eligible this on and found in their I in our by And the Ovaprene the the a receive to under report to already And in nonclinical XXXX. as payment the mentioned have own testing end mentioned approved, to a running agreement streams. their dollars. can intend several bringing certain earlier, development upon over noted, of topline needed by and Bayer be plus believe advance $XXX regulatory period. in in added follow next to report non-hormonal by agreement information the States planning study of our I we the innovation Mirena expect monthly, contraceptive expect the the manufacturing our programs. Daré $XX our strategy dollar in Ovaprene broader million the market satisfaction following discretion to manufacturing payable the as agreement clinical women's for the license the health sales agreement, us value sole it contraceptive validation to potential first the Ovaprene's of licensing process our double-digits. Bayer resources they with and
as in That Ovaprene to readouts We end this variety if data have approvals of ahead to successful, of XXXX that support our believe that have we portfolio end U.S., diversity worldwide. a development And our the using the months Europe file topline to we this discussions to development women's truly we been of enable in study and study and for direct year And discussions IDE of then continued those to timeline the keep FDA year. process investigational the align XXXX. do health IDE us and to IDE safety to year In contraceptive, discussions challenging on last - programs, plan and programs have And with strategy. Device FDA. plan countries the Ovaprene. expect we an ongoing marketing next of effective And utilize is our resources the would or prepare XXXX, these our next to to that Exemption going indications FDA's ways our data study's Application several clearance Ovaprene to go to light us that other the for We months supports leverage the with to pending and pre-submission continue we're we as and and allow and our our initiate intent the by as pivotal commence review plan enrollment and investment before across environment. the in several in those and file to supports submission advance ongoing the continue the the guided. stages in the
and to that rapid financing to we discussed. Of on milestones anticipated we Currently, evolving as the and together business guided, such of expertise provide allocation we our put capital model, afforded women's potential development agreement the as in well continue support when and raise course, of as with strategies, we'll increase partnership candidates, to we John and in year, we shareholder restrictions the manner. pandemic this optionality recognize of have a over decisions product by Research in with to as COVID-XX announced target the aligns our flexibility development we our under clinical with and turn track regulatory the dedicated circumstances. and to believe clinical our our May, the just now business to a in topline timelines update. disrupt and acceleration its supports with the that the how our line at-the-market place the will monitor structures capital slow development And assets that deliver results established reproductive closely health and and on enhancing remain pricing earlier equity We corporate for Further, our therefore Contract expect the the we've timelines clinical I'll products however, efficient have provided Organization, spread, and health and capital staff to the that, health program costs a value. call business provide continue on
