Earnings Call Transcript - DARE Q2 2020

Operator, Operator

Welcome to the conference call hosted by Daré Bioscience to review the Company's Financial Results for the Quarter Ended June 30, 2020, and to provide a general business update. This call is being recorded. My name is Chris, and I will be your operator today. With us today are Sabrina Martucci Johnson, Daré's President and Chief Executive Officer; John Fair, Daré's Chief Strategy Officer; and Lisa Walters-Hoffert, Daré's Chief Financial Officer. Ms. Johnson, please proceed.

Sabrina Martucci Johnson, CEO

Thank you, and welcome to our financial results and business update call for Daré Bioscience. We are looking forward to discussing our second quarter results and highlighting recent developments and anticipated milestones for the remainder of 2020 and beyond. Before we begin, I'd like to remind you that today's discussion will include forward-looking statements within the meaning of 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 facts 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, and therefore 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, 2019, which was filed on March 27, 2020, and our quarterly report on Form 10-Q for the quarter ended June 30, 2020, which was filed today. I'd also like to point out that the content of this call includes time-sensitive information that is current only as of today, August 12, 2020. Daré takes 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 a leader in women's health innovation, and we're squarely focused on improving the life and wellbeing of women. Our value creation strategy is to accelerate the availability of new prescription products for women by selecting and advancing product candidates that we believe have the potential to be first in category and first line, and have meaningful commercial opportunity with clinical stage programs in contraception, vaginal health, and sexual health. Our contraception pipeline includes our novel contraceptive candidate Ovaprene, an investigational hormone-free monthly vaginal contraceptive under a license agreement with Bayer, a world leader in the branded contraceptive market. It is DARE-LARC1, a potential first in category long-acting user-controlled contraceptive, the development of which has received substantial funding from the Bill & Melinda Gates Foundation. It also includes DARE-RH1, a novel contraceptive target that has the potential to be the first contraceptive solution that can be used by women and men and ORB 204/214, potential six and twelve-month injectable contraceptive. Contraception, as you may know, is one of the largest categories in women's health, accounting for over $5 billion in prescription sales in the U.S. alone. In addition to our contraceptive pipeline, we are developing a potential new first-line option for the more than 20 million women in the U.S. estimated to be affected by bacterial vaginosis, a persistent and serious infection that is not adequately addressed by currently available therapies. Our product candidate DARE-BV1 currently in a Phase 3 clinical trial with anticipated topline readout this year has the potential to deliver a meaningful improvement in the clinical cure rate over the current FDA approved products. And our potential first in category Sidenafil Cream program is the only program, to our knowledge, being developed to address female sexual arousal disorder or FSAD, the most analogous in the female sexual dysfunction disorders to erectile dysfunction in men. The estimated FSAD market is expected to be as significant, if not more so, as the erectile dysfunction market in both the U.S. and the rest of the world. In terms of near-term anticipated value drivers, we are currently conducting two clinical studies and anticipate having topline data readouts each year for the next three years across four different indications with four unique product candidates. And we've maintained the pace of our product development and regulatory activities necessary to remain on track to achieve key clinical and regulatory objectives that we have previously disclosed. Now with all life science companies, we continue to monitor the impact of the COVID-19 pandemic on our general business operations and anticipated clinical and regulatory milestones. To date, we have been able to recalibrate our activities to better align with the limitations of the current environment, enabling us to continue to advance our clinical stage programs. Mainly, we commenced two clinical trials this year that we felt were the most conducive to run during the restrictions that COVID-19 imposes on in-person business frequency and study content. Specifically, in June we initiated that pivotal Phase 3 clinical trial of DARE-BV1 for the treatment of bacterial vaginosis. As I mentioned previously, bacterial vaginosis is a condition estimated to impact over 20 million women in the U.S. alone, and this Phase 3 trial is assessing DARE-BV1 as a potential new treatment for this acute infection for which women are not receiving appropriate care, according to our study investigators, and thus we initiated this study and remain on track to report this study's topline results by the end of this year. DARE-BV1 is a novel thermosetting bioadhesive hydrogel containing Clindamycin Phosphate 2% and is being developed as a one-time vaginal administration for the treatment of bacterial vaginosis. As we previously reported, data from an investigator initiated proof-of-concept study demonstrated a clinical cure rate of 86% of evaluable subjects in that study, as a test of cure visit that occurred 7 to 14 days after a single administration of DARE-BV1. In comparison, currently marketed FDA approved products for the treatment of bacterial vaginosis have clinical cure rates ranging from the mid 30s to high 60s on a percentage cure basis. If DARE-BV1 delivers a similarly high clinical cure rate in the Phase 3 pivotal study, we believe DARE-BV1 could become a new frontline treatment option for women diagnosed with bacterial vaginosis. DARE-BV1 received both Fast Track and Qualified infectious disease product designations from the FDA for the treatment of bacterial vaginosis. A drug that receives Fast Track designation is eligible for more frequent meetings with the FDA to discuss the development plan and the collection of appropriate data needed to support drug approval, more frequent written communication from the FDA about such things as the design of the clinical trials and eligibility for accelerated approval and priority review if relevant criteria are met. Turning to another candidate we believe will be a value driver, in July we announced that we initiated our Phase 1 clinical study of DARE-HRT1, a novel intravaginal ring designed to deliver non-oral bio-identical hormone therapy for the treatment of menopausal symptoms. DARE-HRT1 is designed to deliver bio-identical estradiol and bio-identical progesterone continuously over a 28-day period, and it is being developed as a potential new option for hormone therapy for the treatment of vasomotor symptoms commonly called hot flashes and degenerative urinary symptoms of menopause to prevent bone loss and fractures associated with menopause. More than 45 million women in the U.S. are approaching or in menopause. The North American Menopause Society or NAMS, which is known for its top leadership and evidence-based menopause treatment guidelines, supports the use of hormone therapy in peri and postmenopausal women and recommends administering both estrogen to treat symptoms and progesterone to prevent the thickening of the uterine wall and observed that non-oral vaginal administration may offer advantages over orally administered therapies. DARE-HRT1 has the potential to be the first FDA approved intravaginal ring or IVR product to meet demand guidelines. We believe the Phase 1 study of DARE-HRT1 will provide important scientific information for both DARE-HRT1, and also for DARE-FRT1, which is another candidate in our portfolio that utilizes the same IVR technology as DARE-HRT1 and that same bio-identical progesterone as an active ingredient. Specifically, while this Phase 1 study will evaluate the ability of DARE-HRT1 to achieve its target dual release objective as well as the ability of the IVR technology to release two different actives at two different rates, we anticipate collecting useful pharmacokinetic characteristics in the bio-identical progesterone alone, which can be expected to directly apply to DARE-FRT1, which is our bio-identical progesterone only IVR that we are developing as part of an in vitro fertilization regimen for luteal phase support, as well as a more convenient treatment option for the prevention of preterm birth. The Phase 1 study of DARE-HRT1 is being conducted by our wholly-owned Australian subsidiary at specialty women's health sites in Australia. Lisa is going to provide an overview of the Australian tax incentive program for which our subsidiary will apply for cash payments for eligible study expenses, which will offset costs of the program. We expect to report the topline data from this study in the first half of 2021. Turning now to our Sildenafil Cream and Ovaprene studies, we believe we will be in a position to commence both of these studies in 2021 and still maintain our prior guidance of expected topline data readouts for those programs. Specifically, for our Sildenafil Cream program, we expect to report topline results of the planned Phase 2b study in 2021. You may recall that we announced in December 2019 the important alignment we reached with the FDA on the Phase 2b study design and the novel patient reported outcomes which I would highlight on instruments to be measured to assess the treatment and the primary efficacy endpoints. Sildenafil Cream 3.6% has the potential to be the first FDA approved product for female sexual arousal disorder. So as I mentioned earlier, FSAD is the female sexual dysfunction disorder most analogous to erectile dysfunction in men. Sildenafil is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra for the treatment of erectile dysfunction in men. Our Sildenafil Cream is a topically administered formulation of that same Sildenafil, which means the active ingredient is delivered in a cream formulation that is applied locally by women to vaginal tissue. It is designed to increase local blood flow and thereby improve the genital arousal response using the same pathway that is active in erectile dysfunction medications for men. While the oral version of Sildenafil is effective for men, the side effects associated with the oral formulation are particularly challenging for women, and therefore oral delivery is not an optimal way to achieve that same arousal response in women. So with the potential to deliver Sildenafil in a fast-acting cream that can be applied locally, the formulation has been designed to offer the same benefits of increased blood flow and improvement in the genital sexual arousal response without the systemic issues observed with the oral formulation. As I also mentioned, we believe the FSAD market is as big or bigger than the erectile dysfunction market. Market research suggests that 33% of women in the U.S. ages 21 to 60 experience symptoms of low or no sexual arousal, and 16%, which is approximately 10 million women in the U.S., are distressed and are seeking a solution to improve their condition. To put some market opportunities for an FDA approved FSAD treatment in context, the prevalence for the male version of erectile dysfunction is estimated to be just 5% of men aged 40, increasing to just about 15% at age 70. The planned Phase 2b study of Sildenafil Cream will review our endpoints related to our readout on patient-reported outcome measures to gauge achievement and the primary efficacy endpoint, namely approval of localized genital sensation with arousal and reduction in the distress that women with FSAD experience. We continue to focus our efforts on preparing to initiate that Phase 2b study, such as preparing the electronic diary, conducting the startup activities, and other nonclinical activities to support that future NDA submission. As I noted, the Phase 2b study is designed to evaluate Sildenafil Cream versus placebo over a 12-week testing period by studying subjects in their own home setting, followed by a non-drug and placebo run-in period. As I mentioned earlier, we expect to report topline results of the study by the end of 2021, and we expect to report topline data for our planned pivotal study for Ovaprene by the end of 2022. Ovaprene, as I mentioned upfront, is our investigational hormone-free monthly vaginal contraceptive currently in clinical development for the prevention of pregnancy. If approved, it could be the first monthly, non-hormonal contraceptive product. Earlier this year, Bayer, the marketers of the billion-dollar global Mirena franchise and Daré announced our license agreement under which Bayer can exclusively commercialize Ovaprene in the United States upon the satisfaction of certain conditions in the agreement, including a $20 million payment to us by Bayer payable at their sole discretion following the completion of our pivotal trial of Ovaprene. Under the license agreement, we are also eligible to receive up to $310 million in commercial milestone payments plus royalties on net sales in the double-digits. Bayer is supporting our development and regulatory process for Ovaprene, providing internal experts in an advisory capacity. These resources have already added value to the planning and implementation of the Ovaprene clinical regulatory manufacturing and pre-commercialization planning work streams. More information about the terms of the agreement can be found in our filings with the SEC. We believe the licensing agreement with Bayer is validation of our broader strategy and certainly confirmation of Ovaprene's market potential as the first monthly non-hormonal contraceptive product. Bayer is committed to bringing to market innovation in women's health, and they are the only company, as I mentioned, to have developed a contraceptive brand family in excess of a billion dollars. With regards to Ovaprene, over the next several months we intend to continue the regulatory, manufacturing and nonclinical activities needed to advance the programs. We have been using the last several months truly to align with the FDA on the development plan and the submission strategy. We're going to continue to leverage this pre-submission process with the FDA. Continuing those discussions as we prepare to file an Investigational Device Exemption Application or IDE for Ovaprene. In light of these discussions and our intent to commence enrollment in a pivotal contraceptive efficacy and safety study of Ovaprene in 2021, our plan is to file the IDE next year. Then pending FDA's review and clearance of the IDE, we would plan to initiate the study before the end of 2021. That timeline supports topline data readouts by the end of 2022, as we have guided. If successful, we expect that study's data to support marketing approvals for Ovaprene in the U.S., Europe, and other countries worldwide. We believe that the variety of our programs and the diversity of our women's health indications and development stages enable us to direct our resources and our investment across the portfolio in ways that allow us to advance our programs as we have continued to do in this challenging environment. Of course, we recognize that the COVID-19 pandemic and the restrictions put in place to slow its spread have the potential to disrupt our business and increase anticipated development costs and timelines for our product candidates, and we'll therefore continue to closely monitor the rapidly evolving circumstances. Currently, however, we remain on track to deliver the topline clinical results as we have guided, as well as the regulatory milestones on the target timelines we've just discussed. We believe our financing strategies, such as our at-the-market program and the equity line established earlier this year, together with the flexibility and capital allocation afforded by our business model, provide optionality on how and when we raise capital that supports and aligns with enhancing shareholder value. Further, we expect the pricing structures and dedicated staff and expertise in clinical development of women's health products provided under our agreement with the Contract Research Organization, Health Decisions, which we announced in May, will continue to support the acceleration of clinical development of our reproductive health assets in a capital efficient manner. And with that, I'll now turn the call over to John to provide a business and corporate partnership update.

John Fair, CSO

Thank you, Sabrina, and good afternoon, everyone. I'm pleased to provide you with a brief update on our ongoing alliance with Bayer to support the continued development of Ovaprene for its first-in-category contraceptive potential. The relationship continues to be highly productive and value-added, and our collective teams have achieved alignment across key areas, including clinical, nonclinical, and regulatory work streams. Bayer, as we've mentioned, is a worldwide leader in branded contraceptive sales and marketing, and their insights and expertise as applied to Ovaprene continue to be invaluable in our opinion. As those of you familiar with our story know, partnerships and out-licensing transactions are core to our model. We remain very encouraged by the level of interest in our portfolio, and we continue to proactively pursue meaningful partnership opportunities with well-established and emerging companies, both in the U.S. and globally, that are focused on delivering new innovations to women. Naturally, we have more to say if and when agreements are executed, but I want to highlight at this time that this is a priority focus for our company, and we are actively exploring partnerships that we believe will allow us to efficiently advance the portfolio and achieve the broadest commercial access opportunity possible, while at the same time maximizing shareholder value. With that, I will turn it over to Lisa to give you a financial update.

Lisa Walters-Hoffert, CFO

Thanks, John. Hey everyone, and thanks for joining us today. I would now like to summarize Daré's financial results for the quarter ended June 30, 2020. Daré's business model is to assemble, advance and monetize a portfolio of novel product candidates in women's health. As a result, our expenses consist of corporate overhead, portfolio acquisition and maintenance costs, and research and development activities to generate the clinical and other data necessary to advance our candidates through regulatory milestones including approval. For the quarter ended June 30, 2020, Daré's general and administrative expenses were approximately $1.6 million, license expenses were approximately $21,000, and research and development or R&D expenses were approximately $5.6 million. In addition to the personnel costs of our R&D team, our primary Research and Development expenses this quarter included preparations for and the start of our DARE-BV1 pivotal Phase 3 study, ongoing regulatory affairs and other work related to Ovaprene, and preclinical development activities for DARE-LARC1 which, as Sabrina noted, were supported by our grant from the Bill & Melinda Gates Foundation. Our comprehensive loss for the quarter was approximately $7.1 million. Net cash provided by financing activities for the six months ended June 30, were approximately $11.3 million. This represented cash from sales of stock under our at-the-market or ATM facility and equity line, exercises of warrants and options, and loan proceeds. We ended the quarter with approximately $5.3 million in cash and cash equivalents. Now there were several developments over the last four and a half months that are worth highlighting given their current and anticipated future impacts on both our cash burn and our operating expenses. First, in April, we received a final notice of award of approximately $731,000 of the total $1.9 million in grant funding from the NIH for certain Ovaprene clinical development activities. When funds are received under this NIH grant, they are recognized in our financial statements as a reduction to the Ovaprene program development costs. In May we announced the partnership with Health Decisions, which is the CRO specializing in women's health clinical research and diagnostic development. This agreement provides for dedicated resources and new pricing structures, both of which, together with Health Decisions' expertise and established relationships, are expected to accelerate the critical development of key programs, and to do so in a cost-efficient and capital-efficient manner. In June, we announced the receipt of $1.6 million in additional grant funding from the Bill & Melinda Gates Foundation to support development activities related to DARE-LARC1. Grant proceeds in this case are recognized in our financial statements as a reduction or offset to the allowable costs associated with the DARE-LARC1 development program. Finally, in July, as Sabrina noted and I would expand upon, we initiated a Phase I study of our DARE-HRT1 program in Australia. The Australian Government has created attractive incentives for conducting research and development in the country. Currently, Australia's research and development tax incentive gives 43.5% of every dollar spent by eligible companies on eligible R&D activities back to those companies in the form of a cash payment. At the conclusion of the Phase 1 study, our Australian subsidiary intends to apply for the maximum refundable cash credits then available under this program. In summary, we believe that the Australian R&D tax incentives, our NIH grant, proceeds from the Bill & Melinda Gates Foundation grant, and our partnership with Health Decisions will collectively serve to reduce our costs of development in the months ahead and help us manage our cash resources efficiently. Subsequent to the quarter's end, from July 1 through August 11, we took steps to further strengthen our cash position by raising approximately $3.5 million, net of costs from sales of stock under our ATM equity line and from warrant exercises. Following these activities, the shares of our common stock outstanding on August 11 were approximately 31.6 million. We will continue to explore ways to access additional capital to advance our product candidates and to satisfy our working capital needs and other liquidity requirements for the next 12 months. Since our inception, we have raised cash through various means, from the sale of equities, M&A transactions, warrant and option exercises, non-dilutive grants, and license fees. We will endeavor to be creative and opportunistic in seeking capital and we need to not only maintain but to build the value as we advance our candidates, but we also seek to be highly efficient with the use of such capital. In terms of COVID-19 as Sabrina discussed, we are continuing to monitor the pandemic, its associated restrictions, and potential impacts on our business, financial condition and results of operations, including the potential to adversely affect our ongoing and planned clinical trials and our ability to raise capital when needed. Due to the rapidly evolving circumstances and the many uncertainties surrounding the pandemic, including governmental responses, we are unable to predict with any reasonable accuracy the full financial and business impacts on our company at this time. We encourage investors to review the more detailed discussion of our financials and financial condition, our liquidity and capital resources, and our risk factors in the 10-Q filed today, and to also review our audited financial statements, related notes, and risk factors included in our 10-K, which was filed on March 31, 2020. I would now like to turn the call back to Sabrina.

Sabrina Martucci Johnson, CEO

Thank you. And I will turn the call back over to the operator who can now open the lines for any questions.

Operator, Operator

Thank you. The first question comes from Nathan Weinstein with Aegis Capital. Your line is now open.

Nathan Weinstein, Analyst

Hi, good afternoon, Sabrina, Lisa, and John. Thanks for taking my question. Congrats on the progress in the quarter. Number of moving pieces here, and I guess just to start with, you've moved your HRT-1 up, so maybe just sort of philosophically kind of what is behind the decision and just in general, how do you decide kind of which products to move into the clinic?

Sabrina Martucci Johnson, CEO

Thank you, Nathan, that's a really great question. There are definitely a number of factors that are involved because everything in our portfolio pretty much has an opportunity to be first in category, right? They're all super exciting from our perspective opportunities, and there are products we also selected for the portfolio because of their potential attractiveness to partners. With the HRT-1 program in particular, we saw a few really compelling reasons to want to get that program moving forward. So, if you'll indulge me, I'll highlight each of them. One is from a marketing commercial perspective; I touched on the fact that this has the potential to be the first product frankly to actually meet demand guidelines in terms of delivering the hormones in a way that is non-oral, non-systemic, delivering them vaginally and in a very convenient once every 28-day route. There are significant data demonstrating that hormone replacement in women who can use it can be very impactful in addressing those symptoms experienced in menopause, but importantly also cardiovascular health and bone health. So, the program's market potential is very interesting, and we obviously want to move it forward. From a practical consideration as well, this Phase 1 study is quite efficient from two perspectives, and these are my other two points that I wanted to make in terms of how we selected to advance this one right now. One is conducting the study in Australia certainly offers us some very meaningful cash incentives in terms of the cash rebates. With that currently, 43% rebate, it basically cuts the cost of conducting a study in half, making it a very capital-efficient place to conduct a study. And also right now in the cities and centers that we're working with, given their COVID situation, it was very practical to get this study up and running. Further, it really gives us an opportunity to validate HRT-1 in our portfolio, but because HRT-1 is delivering together both progesterone and estradiol, and we have another similar vaginal ring in our portfolios that delivers only progesterone, the exact same progesterone and the exact same type of vaginal ring. The third reason was it was an exciting program to advance at this time: we're basically it's like a two for one, not only are we getting Phase 1 data on HRT-1, but we're getting Phase 1 data at the same time on FRT-1, and FRT-1 is that progesterone-only 14-day vaginal ring that we are looking to move forward for not only preterm birth, which is obviously a very important condition to give women an option that is likely to be much more convenient than anything available today in terms of injections or vaginal gels, which must be dosed frequently, but also as part of an in-vitro fertilization protocol where women need progesterone for luteal phase support and similarly, the options available today are very cumbersome. Hopefully, those three reasons gave you a sense of what led us to move that program and that study forward in the portfolio. Additionally, we can keep that without affecting the timelines for other lead assets; it doesn't disrupt the BV1 data readout this year, the Sildenafil readout we're targeting for the end of next year, and Ovaprene for the year thereafter. So, it's a nice way to slide it into the portfolio without disrupting the other programs or timelines.

Nathan Weinstein, Analyst

Great, thank you. Interesting comprehensive answer, and so I guess just another slot, a question here on the pipeline, in terms of the competitive dynamics in women's health, you have a number of products that are coming along. Have you seen anything in the landscape that would make you think differently about your portfolio priorities now or I guess versus six or twelve months ago?

Sabrina Martucci Johnson, CEO

Another great question, Nathan, thank you. I have to say it's something that we look at all the time. We look at it in the context of making sure that we are using our shareholders, and our donors, and our money as wisely and strategically as we can to build value. So we do critically look at the portfolio all the time to prioritize programs in the right way, and we also use that outward focus lens to make sure that we continue to have the most robust portfolio in women's health really across the most persistent unmet needs in interesting indications. It is something that we go through very frequently, and frankly, with the beginning of COVID, we did it quite seriously, looking across our portfolio because at the beginning of the pandemic really began to affect companies. We wanted to take a hard look at what trials can we conduct right now. How can we keep our timelines on track, and how can we use our dollars as efficiently as possible to really build value robustly in a time period where for a lot of companies, it is probably hard to do. So that's a very long answer and a long way of saying, yes Nathan, we do that all the time, and we came out the other end of that still very happy with our portfolio, continuing to feel that really across the portfolio the programs are relevant. They are continuing to have the potential to address some of the most persistent unmet needs, and perhaps most importantly, given our business model, are partnerable and address those commercial needs that the companies that are focused and investing in this healthcare space are interested in.

Nathan Weinstein, Analyst

Great, thanks Sabrina, and just a final question from me. In our ongoing conversations, one of the themes that keeps coming up is the perennial under-investment that's going on in women's health. This question is really about international markets through your future products. When they become commercial, do you see opportunities in key markets like Europe and Asia, and has investment in women's health in those markets lagged behind the U.S.?

Sabrina Martucci Johnson, CEO

Yes, let me answer that, and John will give you some perspective because in his role a lot of what he has been doing is, as he mentions, talking all the time to all of our potential partners in the U.S. and in Europe, and I feel sure the interest has been robust really across continents. You know in our portfolio, but let me let him share some of that.

John Fair, CSO

Yes, I know, thanks Nathan, I think it's a great question. It dovetails nicely with your previous question too, which I will just add to that. That's one of the reasons we look at categories that can really be first in category, or opportunities to be first in category so that we're not immediately competing with something that's already there. By the way, this plays very well across the globe, not just across the country, because all these opportunities become innovations in and of themselves. Our European opportunities are as big and rich as they are in the U.S., and those discussions are really meaningful. As I mentioned, we've only talked about them when there's something to discuss, but we are in really deep discussions across a variety of assets in the portfolio across a variety of territories. So more to come on that, but great question. Thanks for asking that.

Nathan Weinstein, Analyst

Guys, thank you so much for taking my questions, and congrats again on your progress in the quarter.

Sabrina Martucci Johnson, CEO

Thank you, I really appreciate it.

Operator, Operator

Thank you. Our next question comes from Jason McCarthy with the Maxim Group. Your line is now open.

Joanne Lee, Analyst

Hi, guys, this is Joanne Lee on behalf of Jason McCarthy. Thank you for taking my questions, and congrats on the progress this quarter. Just one from me. I know there's a lot going on with the activities regarding the company's pipeline. There's Ovaprene, DARE-BV1 all entering its pivotal stage. I was just wondering if you could perhaps expand a little more on your DARE-LARC1 program. If I recall, this product was acquired through the Microchips acquisition, and I was just wondering if you could provide some details on the timeline for this program? And if perhaps the study's design and endpoints could possibly reflect those of Ovaprene since they're both in the same contraceptive space?

Sabrina Martucci Johnson, CEO

Yes, thank you for asking about that program. There's a lot of interest in that program really across constituents in the women's health space because it is such a novel technology. DARE-LARC1, as I mentioned, is a user-controlled, long-acting, reversible contraceptive technology. It's an implanted device that allows the user the flexibility to have effective contraception over several years, but have the ability to turn it on or off as needed without removal of the device. This is a significant innovation in the contraceptive category. There isn't anything like that available at this time. The Bill & Melinda Gates Foundation, which as we mentioned upfront has contributed significantly to the development of this technology, has been continuing with their grant funding of the product. At this stage in its development, it's still a preclinical program. We are in the midst of animal studies, looking at that drug release. It is designed to release hormonal contraception. The technology itself is an exceptional platform that could be used for any indication where someone wants to deliver drugs over a long period and have the flexibility to increase or decrease dosage or turn it on or off. While we are obviously exploring contraception first, this work that the Bill & Melinda Gates Foundation has been funding really validates the technology and platform in general. So at this point, it's in the preclinical stage, but we're definitely excited about this work, which will continue into next year. We hope to have some exciting news to share regarding what the next stages are with the program after we complete this preclinical assessment.

Joanne Lee, Analyst

Okay, thank you. That was really helpful. Thanks for those details and again, congratulations on the progress.

Sabrina Martucci Johnson, CEO

Thank you.

Operator, Operator

Thank you. And ladies and gentlemen, this does conclude today's question-and-answer session. I would now like to turn the call back to Sabrina Martucci Johnson for any closing remarks.

Sabrina Martucci Johnson, CEO

Well, thank you Chris, and thank you all for taking the time this afternoon. To summarize, as we highlighted, we'll continue to focus our near-term efforts on the conduct of our DARE-BV1 Phase 3 study this year, with the topline data expected by the end of this year. The DARE-HRT1 study is underway, and we will continue those activities. Obviously, we will continue all the startup activities in other nonclinical work necessary to support our overall program objectives for both Sildenafil and Ovaprene and keep them on track for their respective topline data readouts in 2021 and 2022. We'll also continue to focus, as John touched on, our ongoing partnering activities and really opportunities to monetize our pipeline of potential first in category women's health products. We look forward sincerely to keeping you updated on our progress and remain very grateful for our entire team, but frankly, to our shareholders, for their commitment and dedication to our mission, particularly now during these challenging times. So, thank you all for taking the time today.

Operator, Operator

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