My name is Joanne, and I will be your conference operator today. At this time, I would like to welcome everyone to the Daré Bioscience, Incorporated Q2 2022 conference call. All lines have been placed on mute to minimize background noise. After the speaker's remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press star. Ms. Johnson, you may begin your conference.
Wonderful. Thank you. Good afternoon, and welcome to our second quarter 2022 financial results and business update call for Daré Bioscience. Our plan today is to review our second quarter results, discuss developments since our last call in May, and use the time to review our business strategy and highlight our objectives and milestones anticipated for the rest of 2022. Before we begin, I would like to remind you that today's discussion will include forward-looking statements within the meaning of the Federal Securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical fact should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties.
You should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our annual report on Form 10-K for the year ended December 31, 2021, which was filed on March 31st, 2022, and our quarterly report on Form 10-Q for the quarter ended June 30th, 2022, which was filed today. I would also like to point out that the content of this call includes time-sensitive information that is current only as of today, August 9th, 2022. Daré undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. As you know, Daré is solely and squarely focused in women's health.
It is our belief that prioritizing women's health is not only good for the many women lacking effective or convenient therapeutic choices, but also for a broad set of stakeholders, including their families and partners and of course, our shareholders. We work to accelerate innovative, differentiated product options in contraception, vaginal health, sexual health, and fertility that expand treatment options where none exist, that enhance outcomes where current standard of care has meaningful shortcomings, and that improve ease of use for women where a more compelling form factor can drive adoption. Why? Because these are compelling markets impacting millions of women, and we have seen that innovation in these areas has led to commercially successful brands. Let's look at contraception. There are 73 million women in the U.S. ages 15 to 49. The first monthly intravaginal ring contraceptive NuvaRing peaked at $900 million annual revenue.
The first hormone-releasing intrauterine system contraceptive, Mirena, peaked at $1.2 billion. What about menopause? There are 47 million new entrants to the menopause and postmenopause market each year. The first estrogen hormone therapy, Premarin, peaked at $2 billion in annual revenue. How about arousal problems? There are 10 million women estimated to have arousal problems significant enough to seek treatment. Now, while we can't point to the success of the first arousal product for women yet, since there is no FDA-approved product for female sexual arousal disorder, the first product for the analogous male condition, erectile dysfunction, Viagra, peaked at $2 billion in annual sales. Novel products that provide new features and flexibility have the potential to become meaningful brands. What are the next big ideas in women's health?
At Daré, we believe these are the four novel contraceptive candidates or potential candidates in our portfolio. The first hormone-free monthly contraceptive candidate, Ovaprene. First six- to 12-month injectable, DARE-204/DARE-214. First long-acting reversible contraceptive system, DARE-LARC1, and the hormone-free contraceptive target for men and women, DARE-RH1. We believe it's the three vaginal health programs in our portfolio. Our FDA-approved product, XACIATO, clindamycin phosphate vaginal gel 2% treatment for bacterial vaginosis in a single-dose vaginal administration. Our product candidate, DARE-HRT1, the first hormone therapy, bioidentical estradiol and progesterone monthly intravaginal ring, and our product candidate, DARE-VVA1, the first hormone-free vaginal atrophy therapy for women with hormone receptor-positive breast cancer.
We believe it's a sexual health product candidate in our portfolio, the first topical cream with the same active ingredient as Viagra being evaluated as potential first in category treatment for female sexual arousal disorder or FSAD. The pregnancy management product candidates in our portfolio, DARE-FRT1 and DARE-PTB1, IVR, designed to release bioidentical progesterone over 14 days. Yes, it's our belief that prioritizing women's health is good for the many women lacking effective or convenient therapeutic choices and good for a broad set of stakeholders, including their families and partners and yes, of course, our shareholders. It's our belief that the programs in our portfolio represent a compelling opportunity overall, given that strategic partners are looking for meaningful market potential for differentiated products. Providers are looking for first-line and first-in-category product opportunities to address unmet patient needs.
Investors are looking for a diverse pipeline with independent outcomes to mitigate risk and enhance the overall commercial opportunity. Women will continue to seek innovative options to help them navigate their needs and preference over the course of a lifetime. The Daré portfolio is built on these core principles, meaningful market opportunities, product candidates for women with first line or first in category potential, and a highly diversified pipeline that often leverages well-known and well-characterized active pharmaceutical ingredients or API. A great example of the execution of these core principles can be found in our FDA-approved product, XACIATO. In the case of XACIATO, use of a well-characterized API mitigated the development risk, the time, and cost as compared to new molecular entities. As with XACIATO, that 505(b)(2) regulatory pathway that's possible for non-new molecular entities is planned for most of our development candidates.
Why is that important? Well, 505(b)(2) candidates have a 23% probability of success of advancing from phase I to approval and a 67% likelihood of success advancing from phase III to approval versus just 6% and 38% respectively for new molecular entities. Let's talk about multiple delivery platforms. Persistent unmet needs require creative new approaches designed for her. Novel delivery platforms allow us to configure the most relevant API for the condition in a dosage form and delivery duration that has an opportunity to improve outcomes. This can lead to first in category products while using that well-characterized API that allows us to use that 505(b)(2) regulatory pathway. The commercial value in women's health has been evidenced by differentiated brands and recent transactions in the category.
Anyone following the category knows that women are often the most frequent consumers of healthcare. They manage 80% of the healthcare dollars in the household. Recent transformational pharma transactions are a good reminder of the global opportunity for differentiated women's health brands. We continue to drive our portfolio forward to deliver value as evidenced by our anticipated milestones. The milestones we expect our programs to achieve in 2022 alone include a product launch, a phase III initiation, and two data readouts will be the focus of our call today. Specifically, in terms of the milestone, XACIATO, the clindamycin phosphate vaginal gel 2% for bacterial vaginosis. We have that commercial launch planned and targeted for the fourth quarter of this year, so more on that to follow. Ovaprene, our hormone-free monthly contraceptive.
We're going to talk about the IDE approval process and the pivotal phase III study commencement that's planned for the fourth quarter of this year. DARE-VVA1, our vaginal atrophy program for treatment for women with breast cancer. That's one of the phase I/II study top line data readouts anticipated this year for the fourth quarter. DARE-HRT1, the hormone therapy for the treatment of menopausal symptoms. That phase I/II study top line data is anticipated fourth quarter this year. Sildenafil Cream, 3.6%, our female sexual arousal disorder program. The phase II-B study top line data target data announcement is pending an interim analysis for study sizing, which is planned for this year.
Shortly, I'll turn the call over to John to provide an update on the collaboration with Organon to commercialize XACIATO and the launch targeted for later this year, as well as to provide an update on various of the anticipated program milestones this year. First, I want to address some questions we've received regarding Ovaprene, and particularly to provide some perspective on our IDE-related discussions with the FDA. As I mentioned, we're targeting commencement this year of what we expect to be the single pivotal phase III study necessary to support a premarket approval or PMA submission to the FDA. In order to initiate the pivotal phase III study, we must have an FDA-approved IDE in place. We initiated the IDE process for Ovaprene in early 2022. You may remember that the device division of the FDA is leading the review of Ovaprene.
There's no predicate device for Ovaprene in that there is no existing FDA-approved product that the FDA can use to compare with Ovaprene. As such, Ovaprene will be reviewed via a PMA and not a 510(k) submission. While the regulatory process for such a novel product via a PMA can require more interactions and research to support the approval, the benefit is a clearly differentiated product. We've seen firsthand how challenging the contraceptive payer process can be, and thus are pleased to be working on such a clearly differentiated product, even if it means more FDA discussions and time to prepare for the pivotal study than would be required if Ovaprene were not so clearly differentiated.
Those of you following the company the last couple of years may recall that we've been utilizing the pre-submission process with the FDA to align with the FDA on certain biocompatibility, chemical characterization, and animal studies to support the safety profile of Ovaprene, such as a nine-month sheep study, which was completed and demonstrated the safety of Ovaprene over several months of use. We've also been discussing the phase III study protocol with the FDA, and Bayer, our commercialization collaborator for Ovaprene, has contributed to these and other discussions with the FDA.
Based on these ongoing interactions with the FDA and the IDE process for Ovaprene that we initiated in early 2022, we anticipate continuing the IDE process into the third quarter, and subject to the FDA's approval of the IDE, we are targeting the investigator meeting for the fourth quarter of 2022, that preparatory step to commence the pivotal study. Based on communications with the FDA in terms of study sample size and duration, we expect that at least 200 subjects completing 12 months of Ovaprene use will be adequate. The phase III study will be conducted under our Cooperative Research and Development Agreement or CRADA with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, which is part of the National Institutes of Health, or NIH.
We look forward to collaborating with the NIH and Bayer on the ongoing development of this potential first in category contraceptive. With that, I will now turn it over to John for additional portfolio updates.
Thanks, Sabrina. Given the stage of our current portfolio and market dynamics in the therapeutic categories specific to XACIATO and Ovaprene, we believe the best avenue to generate value for Daré and its shareholders is via external commercialization collaboration or outlicense agreements rather than attempting to commercialize these assets on our own. Opportunity to enter into such collaborations are ultimately contingent upon developing differentiated products that demonstrate the potential to be first line or first in category. Let me begin with bacterial vaginosis and our first FDA-approved product, XACIATO. As we've mentioned on previous calls, bacterial vaginosis is the most common vaginal infection worldwide and is estimated to impact approximately 21 million women in the U.S.
The condition is a result of an overgrowth of bacteria, including Gardnerella vaginalis, an anaerobic bacterium, which disrupts the balance of natural vaginal microbiome and can result in symptoms such as vaginal odor and discharge. Organon, our global collaborator for XACIATO, shares our commitment to advance critically needed innovations in women's health, and we believe that Organon's unique focus on women's health, coupled with their strong commercial capabilities, will ensure that XACIATO reaches the women most impacted by this condition. We believe that Organon is uniquely positioned to bring XACIATO to market and drive patient and provider awareness and utilization of XACIATO based on its unique and differentiated product characteristics. Under our license agreement with Organon to commercialize XACIATO, we received a $10 million cash payment from Organon after the license became effective in June.
We are also eligible to receive potential milestone payments of up to $182.5 million, as well as tiered double-digit royalties based on net sales. XACIATO is expected to be available commercially in the U.S. in the fourth quarter of this year. While we're still very early in our collaboration with Organon, our experience with the various Organon functional teams, including sales and marketing, market access, and really the broader commercial leadership team, has been overwhelmingly positive. We have been collaborating with Organon to accelerate the integration of the XACIATO brand into their larger women's health franchise, and Organon is very focused and highly driven commercial organization in our estimation.
We will be in a better position to provide you with more substantive commercial updates after the product launches, but I can assure you that our team is very pleased with the level of effort Organon is putting into building the XACIATO brand. Let me transition now to commercial activities underway for Ovaprene, our novel hormone-free monthly contraceptive candidate whose U.S. commercial rights are under a license agreement with Bayer. As a reminder, as part of our license agreement with Bayer to commercialize Ovaprene, Daré has access to Bayer's extensive clinical, manufacturing, and commercialization resources in an advisory capacity for approximately 80 hours per week, while Daré retains full control over Ovaprene's development and regulatory approval process. Bayer has the right to obtain exclusive rights to commercialize Ovaprene in the U.S. following the completion of the pivotal phase III study by making a $20 million payment to Daré.
Thereafter, Daré is entitled to receive commercial milestone payments potentially totaling $310 million, in addition to double-digit tiered royalties on net sales. As Sabrina noted earlier, Ovaprene is a distinct and novel form of contraception without an FDA-approved predicate and without a generic equivalent. Bayer has proactively initiated pre-commercialization activities, including discussions with payers, providers, and women, and their commercial team is uniquely focused on identifying the key drivers and points of differentiation that will resonate with payers, providers, and patients. Many of you know that Bayer has a unique leadership position in the hormonal contraceptive category with the Mirena franchise, and they're looking to establish a similar leadership position in the hormone-free category with Ovaprene. They are actively engaging payers and providers to gain meaningful insights into the best way to position Ovaprene to maximize market uptake.
Turning now to Sildenafil Cream, our investigational product to address female sexual arousal disorder, which as Sabrina mentioned, is really akin to her version of erectile dysfunction. FSAD is a physiological condition characterized by the inability to attain or maintain sufficient genital arousal during sexual activity. Currently, there are no FDA-approved therapeutics for this condition, which means our Sildenafil Cream has the potential to be the first and only FDA-approved product in the category. As we previously mentioned, we started the phase II-B RESPOND clinical study in 2021, evaluating Sildenafil Cream as a potential new treatment for FSAD at sites across the country. The immediate interest in the study was so overwhelming that there were over 10,000 online inquiries about the study in the first few months post-initiation.
As this is a first of its kind phase II-B study, we want to be best positioned to learn as much as we can about the endpoints being evaluated and the characteristics of women most responsive to Sildenafil Cream. As such, we've been cautious and thoughtful relative to our enrollment criteria, characterizing each subject and her partner via a series of medical exams, interviews, and screening periods. We are continuing to enroll women in the study at a deliberate pace. We believe that there are thousands of women that will be exceptional candidates for this product if it's approved, but are not optimal candidates for the phase II-B program since, as many of you know or are aware, investigational studies place more demands on subjects than would otherwise be expected with an approved product.
Our study protocol has a planned interim analysis to evaluate the confidence intervals and trial sizing, and we expect to conduct that analysis this year, after which we'll provide guidance on the anticipated timing for top-line data from this trial. Turning our attention to DARE-HRT1, our investigational intravaginal ring or IVR, designed to deliver bioidentical estradiol and bioidentical progesterone continuously over a 28-day period as part of a hormone therapy regimen. As you may recall, we announced positive top-line results from the phase I study of DARE-HRT1 in 2021, and in April 2022, we announced the start of a new phase I/II clinical study.
This open label study will evaluate PK of the lower and higher dose versions of DARE-HRT1, the same two versions evaluated in the first phase I study in approximately 20 healthy postmenopausal women over approximately three consecutive months of use. Incidentally, many of the women that are participating in this study also participated in the first phase I study. In addition to PK data, this study will also collect safety, usability, acceptability, and symptom relief data, giving us a more robust data package and providing us with some preliminary evidence of efficacy. As with the previous study, this study is being conducted in Australia through our Australian subsidiary to take advantage of the clinical and financial benefits of doing so. We expect to report top line data from this phase I/II study during the fourth quarter of 2022.
Finally, we can turn our attention to DARE-VVA1. As previously noted, more than 3.8 million women in the U.S. have a history of breast cancer or are considered survivors. Hormone receptor-positive breast cancer is the most common type of breast cancer diagnosis, and the prevalence of vulvar and vaginal atrophy, or VVA, in post-menopausal breast cancer survivors is estimated to be between 42% and 70%. Currently, there are no FDA approved products to address this very challenging condition in this very important patient population, and we would like to provide a new first in class option for these women. DARE-VVA1 is our proprietary investigational formulation of tamoxifen for the vaginal administration, treatment of VVA.
As a non-hormonal approach to addressing VVA, it could be an important new prescription option for women with a history of or at risk for hormone receptor-positive breast cancer, as many of these women are not ideal candidates for standard estrogen-based interventions. We initiated the phase I/II study in Australia earlier this year and in the third quarter of 2021 for breast cancer survivorship in the program. We'll have an update for you by the end of this year. We expect to report top line data for this, as I mentioned, in the phase I/II study during the second half of 2022, later this year.
In terms of near-term catalysts, we look forward to keeping you updated on the launch of XACIATO, our FDA-approved product for the treatment of bacterial vaginosis, our collaboration with Organon, who is a global leader in women's health, our pivotal study start for our potential first-in-category contraceptive program, Ovaprene, which is subject to a license agreement for commercialization in the U.S. with Bayer, who maintains a global leadership position in contraception, as well as two data readouts from our phase I/II DARE-HRT1 program and our DARE-VVA1 program. I will now turn the call over to Lisa to provide a financial update.
Thank you, John, and thanks everyone for joining us today. I would now like to summarize Daré's financial results for the quarter ended June 30th, 2022, which I will refer to as the current quarter or the second quarter of 2022. Daré's business model is comprised of two parts. The first is to assemble in advance a portfolio of differentiated product candidates that address meaningful unmet needs that we've identified in women's health. The investment required to do this includes corporate overhead, portfolio acquisition and maintenance costs, and ongoing research and development or R&D expenses. The second part of our model involves monetizing the value of our portfolio's clinical and regulatory advantages over the near and long term.
There are many ways to do this and generate value from products with differentiated outcomes, and one approach includes securing payments upfront and over time in the form of license fees, commercial milestones, and royalties on net product sales. For Daré, this occurred during the second quarter of 2022, when we recognized revenue of $10 million from the upfront license fee due in connection with the closing of our global license agreement for XACIATO with Organon. As my colleagues have mentioned, Daré will be entitled to receive additional milestones and royalties once XACIATO is commercially launched. Back to the current quarter. Our general and administrative or G&A expenses were approximately $2.8 million. Our R&D expenses, which vary from quarter -to -quarter based on our clinical, preclinical, manufacturing, regulatory, and other portfolio activities, were approximately $6.8 million.
The current quarter's R&D expenses were actually about $500,000 less than the comparable period for 2021, and primarily reflected the cost of the ongoing Sildenafil Cream phase II-B RESPOND clinical trial and manufacturing and regulatory affairs activities related to Ovaprene. We ended the current quarter with approximately $32 million in cash and cash equivalents. In July, we received additional cash payments of $18 million, representing the $10 million license fee from Organon and a cash disbursement of approximately $7.9 million under our existing grant to fund the DARE-LARC1 program. As touched upon earlier, under our license agreement with Organon, we will be entitled to receive a cash payment of $2.5 million upon the first commercial sale of XACIATO and tiered double-digit royalties based on net sales.
Again, the launch is expected to occur in the fourth quarter of 2022. Thereafter, in addition to the ongoing net sales royalties, Daré will also be eligible to receive future milestones of up to $180 million in the aggregate based on commercial sales and other developments. Now during our quarterly calls, we've highlighted the importance of non-dilutive sources of funding to our strategy. These include grants, collaborations, and tax credits. The $7.9 million payment received in July is part of a larger grant established to finance the development of our novel DARE-LARC1 program over multiple years.
In addition, we have received other grants in varying amounts from the NIH and the NICHD to fund a variety of development and market research activities related to Ovaprene, DARE-LARC1, DARE-RH1, and DARE-PTB1. In terms of collaborations, our CRADA with the NIH allows Daré to share the cost of the Ovaprene pivotal study with the NIH and also to tap into the NIH's extensive experience in conducting contraceptive studies. Finally, in connection with our studies conducted currently in Australia, we will continue to apply and receive partial reimbursement for our eligible R&D expenses, which is currently up to 43% of eligible expenses incurred in Australia for those studies. As of August 8th, 2022, Daré had approximately 84.8 million shares of common stock outstanding. You, our shareholders, recently approved an increase in our authorized shares to 240 million.
We want to thank you for your approval of this proposal at our 2022 annual meeting, as it will allow us to explore and potentially pursue financing and other transactions using shares of our common stock over multiple years in the future as opportunities arise. In closing, to reiterate before, we will endeavor to be creative, collaborative, and opportunistic in seeking the capital necessary to advance our candidates and build shareholder value. We also encourage investors to review the more detailed discussion of our financials, our financial condition, liquidity, capital resources, and risk factors in our Form 10-Q for the quarter ended June 30th, 2022, which was filed today, as well as our annual report on Form 10-K for the year ended December 31st, 2021, which was filed on March 31st, 2022.
I would now like to turn the call back over to the operator for questions.
At this time, I would like to remind everyone. Press star, then the number one on your telephone keypad. We'll pause for just a moment to compile the Q&A roster. Your first question comes from the line of Douglas Tsao with H.C. Wainwright. Your line is open.
Hello.
Operator.
Hello, Douglas. Your line is open. Your next question comes from the line of Kumaraguru Raja with Brookline Capital Markets. Your line is open.
Hi. Thank you. I'm Chapin Jewell for Kumar. Appreciate the business update. Can you share any insights, updates, you know, regarding the DARE-VVA1 trial? Like, how are the patients responding, the safety profile? Whatever you can share. Thank you.
Yeah, thank you for the question. The VVA1 trial is our phase I/II study that's going on right now in Australia for our vaginal atrophy program. Just to give you a little more perspective on maybe what that trial is, right? And what we're looking at in that trial. First of all, the active that we're studying in that case is actually tamoxifen, which is a, you know, as I mentioned earlier, a known chemical entity that is often used as part of a breast cancer treatment regimen. In this case, it's being delivered vaginally. The reason why is tamoxifen has a really interesting profile. It acts as an estrogen antagonist in the breast, but an estrogen agonist vaginally. It makes it a really interesting chemical entity to consider for this condition.
Prior to this phase I/II study, there was actually a proof of concept study that was run, just using a not necessarily optimally formulated vaginal tamoxifen, but looking at tamoxifen delivered vaginally and specifically in that proof of concept study that's been published, and it got us really excited about the opportunity. What they showed was some important improvements. They showed improvements in vaginal pH, so that's often one of the challenges with vaginal atrophy. The vaginal pH rises, and that can lead to other complications in terms of the vaginal microbiome. Also improvement in vaginal dryness. Since that really exciting proof of concept study, what we had done is obviously worked to optimize the formulation.
In this phase I/II study, we're actually looking at a cohort of women, including women with a history of breast cancer. We're actually looking at a number of different treatment groups. We're looking at four different dose levels and placebo. These women will be able to self-administer the product. It comes in sort of a vaginal gel cap, is the best way to describe it. They'll self-administer it intravaginally once a day for the first two weeks and then twice a week for the following six weeks, for a total treatment period of 56 days. We'll get some nice data over that period of time.
Part of the analysis, to your question of what will we be sharing, so part of it is we'll be looking at the pharmacokinetics, so very traditional kind of approach that you would take with any kind of phase I study. We'll obviously be looking at safety.
Tolerability. We're looking, you know, because this is administered vaginally, you look for any sort of vaginal effects as well, as well as just the safety, systemically as well. Again, we're using a much lower dose than what's typically administered orally. The secondary endpoints will really look at that preliminary efficacy of the formulation in terms of a couple things. We are asking these women in the phase I/II study to tell us what their most bothersome symptom is. For some women it is the dryness, for some women it's painful intercourse. We have asked them, when they enroll in the study what their most bothersome symptom is 'cause these are symptomatic women. We will be looking to see if any changes in their most bothersome symptoms.
Importantly, kinda similar to that proof of concept study that was run, we will be looking at things like vaginal cytology and pH, which are really important determinants of success in managing vaginal atrophy. That's why it's really a phase I/II study. It's not powered for efficacy per se, but because these are all symptomatic women, we should be able to get a really nice sense of how they're doing on the product. Those are the kind of data that we'll be able to report when we do the top line data readout in the fourth quarter. Hopefully that was a helpful answer to your question.
Yeah, that was very useful. Thank you so much.
Great.
One more question regarding the like, could you provide some color to the rate of enrollment in the ongoing HRT1 trial? Like how many sites do you have activated, and do you plan to add more sites to it? Thank you.
Yeah. Great. Another great question. The HRT1 study is similarly a phase I/II trial evaluating our vaginal ring for hormone therapy. We have already completed a phase I study, which I point out simply because the study that we've already completed is relevant to your question a couple of ways. First of all, the study that's already been completed with HRT1 really already demonstrated the PK profile, and importantly demonstrated its potential to be effective in both the vaginal atrophy as well as the vasomotor symptoms of menopause. We know the therapeutic dose levels of those hormones, and that has already been demonstrated.
What we wanted to do in this study is give women an opportunity to actually use the product for three months in a row. It's a 28-day vaginal ring, so she'll get to use it three different times, three different rings, over the course of three months. We are looking at the same two doses again. It's about 20 women. They are all postmenopausal, so again, these are women that are in menopause. Similarly to what I talked about with the VVA1 study, we'll be looking at safety, usability, acceptability, as well as symptom relief data. Very similarly, we're asking them about their most bothersome symptoms of menopause before they come in, and then we're gonna ask them how they're doing after three months of using the product.
Again, not powered for efficacy, but will give us some nice signs. In terms of the sites, we do a number of our phase I studies in Australia, very cost effective, right? Because of the Australian R&D cash rebate. We actually have a few sites. You know, Australia's not huge. So we have a few sites that we work with across our studies in Australia, so it's the same sites. As John mentioned in his comments, what we found quite interesting, and I think it says a lot about the product, is women who had been in the prior phase I asked, they you know, at the end of that study said, "My gosh, can't we just keep using this?" No, you can't.
They asked to be notified of any future studies. Many of the participants in this study already had experience with the product because they were in the prior phase I study. We don't need to really add any additional sites. You know, at this point we're following the subjects in the trial, and then we expect, as I mentioned, that top line data readout in the fourth quarter.
Thank you. Sounds great. Thanks for taking my questions.
Great. Thank you.
Again, if you would like to ask a question, press star number one on your telephone keypad. There are no further questions. I will now turn the call back over to Ms. Johnson for closing remarks.
Great. Well, thank you all, so much for taking the time this afternoon to hear about the recent updates and our ongoing commitment to drive value for all of our stakeholders, the women, the healthcare providers, and our shareholders. With our diverse portfolio, we seek to bring to market differentiated prescription therapies that really prioritize women's health and well-being and expand those treatment options where none exist, enhance the outcomes where current standard of care has meaningful shortcomings, and improve ease of use for women where a more compelling form factor can drive adoption, primarily in the areas, as we've been discussing, of contraception, vaginal health, sexual health, and fertility, and where we think there are really compelling market opportunities. Today we have seven candidates in various stages of development and one FDA-approved product expected to be launched commercially in the fourth quarter of this year.
We look forward to keeping you updated on our progress against the important 2022 objectives and milestones we've set for all of our candidates under development, as well as the activities with Organon regarding the XACIATO launch. Thank you for tuning into the call today and for all of your support.
This is today's conference call. You may now disconnect.