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spk04: Welcome to the conference call hosted by Darre Bioscience to review the company's financial results for the quarter ended September 30th, 2020, and to provide a general business update. This call is being recorded. My name is Chris, and I'll be your conference operator today. With us today are Sabrina Martucci-Johnson, Darre's President and Chief Executive Officer, John Fair, Darre's Chief Strategy Officer, and Lisa Walters-Hofford, Darre's Chief Financial Officer. Ms. Johnson, please proceed.
spk01: Thank you. Welcome to our financial results and business update call for DARE Bioscience. We are looking forward to discussing our third quarter results, reflecting on some important achievements to date in 2020, highlighting anticipated developments and milestones for the remainder of 2020, and providing some perspective regarding our plans for 2021. But before I 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 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, 2019, which was filed on March 27, 2020, and our quarterly report on Form 10-Q for the quarter ended September 30, 2020, 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, November 12, 2020. DARI undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. Now, as you know, DARI is a leader in women's health innovation, and we are squarely focused on improving the lives and well-being of women. Our value creation strategy is to accelerate 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 four clinical stage programs in vaginal health, sexual health, contraception, and menopause. As we approach the end of 2020, we are particularly looking forward to our phase three top line data readout for our DARE BV1 program this year. DARE-BV1 is our potential new first-line option for bacterial vaginosis, a serious condition that is estimated to affect approximately 21 million women in the U.S. alone. Many of the existing therapies are considered to be less than adequate, and DARE-BV1 has the potential to deliver a meaningful improvement in the clinical cure rate over the current FDA-approved products. We are excited to report that enrollment in the Phase III study was completed last month. and all subjects have also completed their last visit. We therefore expect to announce top-line data before the end of this year. During today's call, we will provide additional context on the upcoming DRBv1 Phase III readout, as well as next steps toward regulatory submission and the partnering strategy to support eventual market introduction and commercialization. We will also provide updates on activities to support ongoing development of our novel contraceptive candidate, oviprene, and investigational hormone-free monthly vaginal contraceptive under a license agreement with Bayer, a world leader in the branded contraceptive market. And we'll discuss activities we plan to commence in 2021, including the Phase 2B for our potential first-in-category Sidenafil cream program, which is the only program to our knowledge being developed to address female sexual arousal disorder, or FSAD, the most analogous of the female sexual dysfunction disorders to erectile dysfunction in men. Before we provide updates on our anticipated near-term value drivers, including those regulatory and corporate partnering milestones, as well as planned top-line data readouts occurring each year for the next three years across several product candidates, we do want to spend a moment reflecting on the accomplishments to date in 2020. 2020 has been quite a year of firsts for all of us, but for DARE, we achieved a number of important firsts that we believe serve as validation of our strategy, and our forward-looking opportunities. We started the year in January by announcing our first commercial partnership agreement. Specifically, Bayer, the marketers of the billion-dollar global Mirena contraceptive franchise, and DARE announced a license agreement under which Bayer can exclusively commercialize oviprene, our potential first-in-category contraceptive investigational product, in the United States upon the satisfaction of certain conditions in the agreement. which include a $20 million payment to us by Bayer, payable in Bayer's sole discretion, following the completion of a pivotal trial of Obaprene. Under the license agreement, we're also eligible to receive up to $310 million in commercial milestone payments plus tiered royalties on net sales in the double digits. To our knowledge, the transaction we entered into with Bayer represents the largest such transaction for any development stage contraceptive in terms of the aggregate disclosed milestone value. We believe the transaction validates not only the Obaprene commercial opportunity, but also DARE's business model of strategic partnerships to provide capital and achieve commercial objectives. Shortly after the start of the year, as with all life science companies, we had to contend with the impact of the COVID-19 pandemic on our general business operations and our anticipated clinical and regulatory milestones. However, we were fortunate in that we were 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 towards the target top line data readouts previously projected. As a result, in June, we commenced our first phase three trial at DARE, which is a major milestone on its own. And we're excited to confirm that we expect to have that top line data readout from the DARE BV-free trial, our pivotal study of DARE BV-1 for the treatment of bacterial vaginosis this year, per our previous guidance. Assuming a positive outcome, we believe the DARE BV-free phase three study positions us for a new drug application or NDA submission in the first half of 2021, and potentially also regulatory action in late 2021. We were also able to advance another novel program into the clinic during 2020, our DARE HRT1 program, which utilizes our innovative vaginal ring technology originally developed at MIT and offers a potentially new and more convenient way to address the vasomotor symptoms associated with menopause. In the U.S. alone, more than 45 million women are estimated to be approaching or are in menopause. We're excited to share with you that we have been successfully enrolling patients into our DARE HRT1 Phase 1 study, utilizing a cost and time efficient strategy that leverages our subsidiary in Australia, and thus our eligibility to receive R&D tax incentives in the form of cash payments for conducting the clinical research in Australia. We started this study, our first phase one in Australia through our subsidiary, in July, and we expect to have top-line results in the first half of 2021. If successful, this study could provide important clinical data, not only for the DARE HRT1 product candidate as a potential treatment for the vasomotor symptoms of menopause, as I mentioned, but also for DARE FRT1, which utilizes the same vaginal ring technology and also delivers bioidentical progesterone. As you may recall, we're developing DARE-FRT1 as a more convenient treatment option for the prevention of preterm birth and broader luteal phase support as part of an in vitro fertilization regimen. Another exciting development for DARI was announced in August when we announced we received a notice of award for a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, a division of the NIH, to support that phase one clinical study of DARE-FRT1. NIH funding is awarded in phases, so the NICHD award granted to date is approximately $300,000, and then we may be eligible to receive an additional award for the next segment of the project outlined in our grant application for up to a total of approximately $2.3 million in grant funding to support that DARE-FRT1 Phase I Human Clinical Study. And in line with our non-dilutive funding strategy in 2020, we also announced in 2020 the receipt of a total of $2.4 million in funding under the current grant for our user-controlled, long-acting, reversible contraceptive program, DARE-LARC1, from the Bill and Melinda Gates Foundation. DARE-LARC1 is potential breakthrough technology as the first long-acting, user-controlled, reversible contraceptive solution And it's been supported by approximately 20.5 million in grant funding from the Bill and Melinda Gates Foundation to date. Thus, if I were to sum up the year 2020, 2020 has been a year of firsts and a year of important milestones for DARE, as highlighted in the partnerships, the study initiations, the non-dilutive capital accomplishments that we have been talking about. And we look forward to continuing that momentum in 2021. With that said, I'd like to provide some perspective on what we expect in 2021. First, as I mentioned, there are a number of important milestones associated with the DARE BV1 program. So DARE BV1, which is designed as a one-and-done vaginal administration of 2% clindamycin phosphate in a novel thermosetting hydrogel formulation, has the potential to deliver a meaningful improvement in the clinical cure rate over the current FDA-approved products for bacterial vaginosis. As we previously reported, data from an investigator-initiated proof-of-concept study demonstrated a clinical cure rate of 86% of valuable subjects in the study at the test of cure visit that occurred at day 7 to 14, days after that single administration of DRBB1. In comparison, the currently marketed FDA-approved products for the treatment of bacterial vaginosis have clinical cure rates ranging from the mid-30s to the high 60s on a percentage cured basis. If DARE-BV1 delivers a clinical cure rate in the Phase III pivotal study that demonstrates superior efficacy compared to that current standard of care range of mid-30s to high-60s, we believe DARE-BV1 could become a new frontline treatment option for women diagnosed with bacterial vaginosis. Importantly, DARE-BV1 received both fast-track and qualified infectious disease product designations from the FDA for the treatment of bacterial vaginosis. We plan to request a pre-NDA meeting with the FDA for early 2021, such that we can submit that NDA in the first half of 2021, assuming the DARE-BV-free study is successful. Given that we have that fast track and qualified infectious disease product status, the NDA should be eligible for priority review, which, if granted, would allow for a 2021 PDUFA date and, assuming approval, an early 2022 commercial launch in the U.S. Given the prevalence of bacterial vaginosis and the potential benefits of the DARE BV1 treatment compared to the current standard of care, we are pleased with the partnering prospects and structures being contemplated for eventual commercialization. We've always planned to partner this program post the phase three study to have the ultimate optionality on deal structure. John is going to provide additional insights on how we're approaching the process to capture maximum strategic value for our shareholders. But I want to take this moment to thank our investors for supporting us and putting us in this position to complete the Phase III study and exercise this optionality that partnering on the heels of those data provide. We also anticipate important milestones for our sidenafil cream and oviprene programs in 2021. In the first quarter of 2021, we anticipate commencing the Phase IIb study for sidenafil cream. positioning us for a potential top-line data readout of that Phase IIb study by the end of 2021. Our potential first-in-category sedentafil cream program is the only drug product to our knowledge being developed to address female sexual arousal disorder, or FSAD. And the potential FSAD market is estimated to be as significant, if not more so, as the erectile dysfunction market in the U.S. Sidenafil cream, as I mentioned, has that potential to be the first FDA-approved product for female sexual arousal disorder. And being the most analogous condition to erectile dysfunction in men, we've selected Sidenafil, which is the active ingredient in tablets for oral administration currently marketed under the brand name Viagra for the treatment of erectile dysfunction in men. 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% are distressed and are seeking a solution to improve their condition. Let's put that in perspective. In the context of erectile dysfunction, the prevalence of complete erectile dysfunction is estimated to be only 5% of men at age 40, increasing to only about 15% at age 70. The other phase three candidate in our portfolio is oviprene. We expect to commence our oviprene pivotal study by year end 2021, which should position us to report top line data for that pivotal study by year end 2022. As I mentioned, oviprene is an investigational hormone-free monthly vaginal contraceptive currently in development for the prevention of pregnancy. If approved, it could be the first monthly non-hormonal contraceptive product. with the potential to offer a new and compelling option for the ever-increasing number of women seeking more reliable, convenient, and hormone-free and monthly contraceptive solutions. Worldwide sales of the first monthly hormonal contraceptive product, NuvaRing, were $879 million for 2019. Over the next several months, we intend to continue regulatory manufacturing and non-clinical activities to advance that oviprene program. We've been using the last several months to align with the FDA on the development plan and submission strategy, and we'll continue to utilize the next several months to leverage that pre-submission process with the FDA to continue those discussions and prepare to file an Investigational Device Exemption Application, or IDE, for Obaprene in the second half of 2021. Pending the FDA's review and clearance of the IDE, we plan to initiate that pivotal study by year-end 2021, as I mentioned, to support that top-line data readout by year-end 2022. If successful, we expect this one study's data to support the marketing approval for oviprene in the U.S., as well as countries outside the U.S. as well. In addition to the late-stage programs already mentioned, DERBV1, sidenafil cream, and oviprene, In 2021, we also anticipate that top-line readout for our Phase 1 study of DARE HRT1, the candidate for the treatment of the vasomotor symptoms of menopause, and to initiate Phase 1-related activities for both our DARE FRT1 program, which, as I mentioned, has funding from the NIH, and our DARE VVA1 program. You may recall that DARE VVA1 is our hormone-free treatment for vulvular and vaginal atrophy in a hormone-receptor-positive breast cancer population. Our 2020 results and our 2021 plans demonstrate a feature of our business model that is core to its value-driving potential. Namely, the variety of our programs and the diversity of our women's health indications and development stages of our programs enable us to direct our resources and investment across the portfolio in ways that can advance the program against numerous milestones simultaneously. in both a time and a capital efficient manner, as we have demonstrated even in this challenging environment. Of course, we recognize that the pandemic and restrictions put in place to slow the spread of COVID-19 do have the potential to disrupt our business and increase anticipated development costs and timelines for our product candidates, and we will definitely continue to closely monitor the rapidly evolving circumstances. Currently, however, we remain on track. to deliver top line clinical study results and regulatory milestones on the target timelines we've just discussed. I'll now turn the call over to John to provide a business and corporate partnership update.
spk02: Thank you, Sabrina. Strategic partnerships are core to our model, particularly when it comes to how we plan to unlock value for shareholders and achieve commercialization objectives for our portfolio. The level of interest in our portfolio has been and continues to be strong, both from well-established large pharmaceutical companies as well as mid-sized and emerging companies, both U.S. and global. We are actively advancing partnership discussions that we believe will allow us to maximize downstream commercial execution and provide access to the broadest patient population in the respective therapeutic categories. By being good stewards of these products and partnerships, We believe we can have a positive impact on the lives of women while at the same time delivering shareholder value. For those of you familiar with the women's health category, you will appreciate that healthcare provider dynamics create commercial efficiencies and allow for a targeted call point across multiple indications. There are a number of established and emerging entities, meaning commercial companies, in the category looking for opportunities to enhance their portfolios and amortize their field sales force costs, which we expect will give us a lot of flexibility in terms of partnership structures, timing of partnerships, and also finding the best fit opportunity to create value for our shareholders, and especially as we transition from a development portfolio to a commercial portfolio. As an example, we believe our agreement with Bayer for our investigational monthly hormone-free vaginal ring overprime provides us with a robust commercial economic structure in the form of milestones and royalties, while at the same time gives Overprene the maximum commercial opportunity by putting the launch and commercialization in the hands of our partner, Bayer, as they look to expand their billion-dollar contraceptive franchise beyond Marina and beyond the long-acting market segment. But we also have the flexibility to look for partnership opportunities for our other product candidates, which may include elements such as co-promotion, strategic cost sharing, risk sharing, and commercial structures where DARE takes more of an active role without bearing the burden of the commercialization infrastructure and associated expenses. Given our portfolio of potential first in line and first in category product candidates and the underlying commercial potential of these candidates, we have the flexibility to consider structures that range from directly managing commercial capability to partnering or co-promoting our products or to fully licensing the commercial rights And this essentially means we can do what we believe is best for DARE and our shareholders in every case. We are fortunate to have such a unique and diversified portfolio because it allows us to be in a position to consider all of these structures, which we are currently doing with DARE BV1. And for DARE BV1, we are specifically interested in opportunities that we believe will prioritize the product in a way that will allow us to unlock the most value for healthcare providers, for patients, and for payers, as well as shareholders. So we look forward to providing you with additional insights on the DARA BV1 partnership and commercialization strategy following the top line data announcement later this year. And with that, I'm going to turn the call over to Lisa for a financial update.
spk06: Thank you, John, and thanks to all of you for joining us today. I would now like to summarize DARA's financial results for the quarter ended September 30th, 2020. As you know, DARI'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 just ended, September 30th, 2020, DARI's general and administrative expenses were approximately $1.4 million, license expenses were approximately $25,000, and research and development, or R&D, expenses were approximately $6.2 million. In addition to the personnel costs of our R&D team, this quarter's R&D expenses primarily reflect costs of the ongoing DARE BV1 Phase III study, activities related to overprint, and preclinical development activities for DARE-LARC1 with the DARE-LARC1 program supported by our grant from the Bill and Melinda Gates Foundation. Our comprehensive loss for the quarter was approximately $7.6 million. Net cash provided by financing activities for the nine months ended September 30th, 2020, was approximately $16.7 million. Such proceeds were generated primarily from sales of stock under our ATM or at the market facility and equity line, the exercise of warrants and loan proceeds. We ended the quarter with approximately $5.4 million in cash and cash equivalents. Now, there were several developments over the past few months worth highlighting given their current and anticipated impact on our cash burn and operating expenses. As Sabrina discussed earlier, in August, we announced the receipt of a notice of award of a $300,000 grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development in support of a Phase I clinical study of DARE-FRT1. As she also noted, DARE may be eligible to receive an additional $2 million award in further support of the Phase I study of DARE-FRT1 for a total of up to $2.3 million in funding based on the grant application submitted. In September, we announced the receipt of $900,000 of funding that remained under the pre-existing grant from the Bill and Melinda Gates Foundation to support DARE LARC 1 development activities. And this brings total funding from the foundation for that program to approximately $20.5 million. Recall that grant proceeds are recognized in our financial statements as a reduction or an offset to allowable costs associated with the DARE LARC 1 development program. Also in September, we announced an agreement with Avameen, under which Avameen will provide contract product development laboratory services with a team specifically assembled to support the advancement of DARI's innovative pipeline in a manner that is both time and cost efficient. In July, we commenced our phase one study of DARE HRT1 in Australia. and we intend to apply for the maximum refundable cash credit then available under Australia's R&D Tax Incentive Program. Currently, the program allows for eligible companies to receive up to 43.5 percent of their eligible R&D expenses in the form of a cash payment the following year. So, in summary, based on these activities, we believe the Australian R&D Tax Incentive Program, our NIH grant for DARE FRT1, the Bill and Melinda Gates Foundation grant for DARE LARC-1, and our partnerships with Abamine, as well as health decisions, which we discussed during our previous earnings calls, will collectively serve to reduce our cost of development in the months ahead and help us to manage our resources efficiently. Now, subsequent to the quarter's end, or for us it's the period October 1st through November 11th, We took steps to further strengthen our cash position by raising approximately $4.5 million net of fees from sales of our common stock under our ATM and equity line. Following these activities, and as of yesterday, November 11th, shares of our common stock outstanding were approximately $38 million. We will continue to explore ways to access additional capital to advance our product candidates and to satisfy our working capital needs. Since our inception, we have raised cash through the sale of our equity securities, M&A transactions, warrant and option exercises, non-dilutive grants, and license fees. We will endeavor to be creative and opportunistic in seeking capital that we need to not only maintain, but to build value as we advance our candidates and to be highly efficient in the use of such capital. In terms of COVID-19, and as Sabrina touched on, We are continuing to monitor the pandemic, its associated restrictions and their potential impact on our business, our financial condition, results of operation, including their potential to adversely affect our ongoing and planned clinical trials and our ability to raise additional capital when needed. Due to the many uncertainties surrounding the pandemic, including governmental responses, We are unable to predict with any reasonable accuracy the full financial and business impact on our company at this time. We encourage investors to review the more detailed discussion of our financials and financial condition, liquidity and capital resources, and the risk factors in the 10-Q that we filed today, and to also review our audited financial statements and related notes and risk factors included in our 10-K that was filed on March 27, 2020. I would now like to turn the call over to Chris, our operator, for Q&A.
spk04: Thank you. And as a reminder, to ask a question, we need to press Start 1 on your telephone. To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. And our first question comes from the line of Dara Jalaa with Roth Capital Partners. Your line is now open.
spk05: Hi, guys. This is from Ross. Just had a couple of questions here, and thanks again for the update. I think the first one just has to do with, you know, what everyone's probably focused on here, the data for DARA BV1 is expected before the end of the year. If that is, you know, really encouraging and, you know, supportive of, you know, a filing, just kind of want to know, how you're thinking about partnership, what you're looking for. I think you said John was going to provide some details on that. So what are you looking for in a partner? Could you take this forward alone, or you definitely plan to have this partnered?
spk01: Yeah, and maybe I'll take this opportunity to – and this is Sabrina speaking, of course – to reinforce some of the comments that John made to really kind of point out how we're addressing that question for you. So one of the things about DARI in our portfolio, as we both touched on, is that it's a very diversified portfolio. We have a number of candidates at various stages and phases of development. And so that really does allow us to consider a number of types of different transaction structures, right? So on the one hand, you have the type of transaction that we did with Bayer for Obaprene, which we felt was definitely the right transaction for that product with a partner like Bayer that has demonstrated they can build over a billion dollar contraceptive brand, and with that opportunity, that's the right thing for shareholders to take it. With other aspects of our portfolio and products like DARE BV1, we have a lot of flexibility to consider a variety of structures for a few reasons. One, there are a variety of structures that can continue to be accretive for shareholders, and there's a lot of ways you can take a product to commercialization, and they can include different structures that range from co-promotion to out partnering to fully licensing to managing commercial infrastructures, there's a variety of approaches that we can take. And with a product like DRBB-1 specifically, we can really actually contemplate all of those approaches. So it is intended to be and we think has the potential to be a first-line product, which is obviously a really great opportunity for anyone in the women's health category, whether they have a commercial infrastructure in the category in bacterial vaginosis or not. You know, it's a great addition to any women's health portfolio. But also, unlike oviprene, we're not looking for someone who can actually build a brand-new therapeutic category. Oviprene is so unique that a partnership like Bayer is so important to build that category. So hopefully what you heard from John's comments, and I'm reinforcing, is that we are talking to a number of potential partners around BV1, and we are looking at a full range of structures and possibilities as it pertains to that. And in the end, we are going to select the structure that we think best fits with DARE's strategic objectives and shareholder value. And the beauty is that we have a lot of flexibility in what we select because of how we're structured today.
spk02: Yeah, and I would just echo that. That's exactly what I wrote down, actually, when you asked the question. So it's really about maintaining our optionality, really creating value for shareholders and making sure we're maximizing the opportunity, and then really finding that best-fit opportunity, that best-fit partnership structure. So, you know, that's to be determined. Obviously, we never announce anything until we have something, you know, to announce, but know that we're working hard on the back end to make that happen.
spk05: Thank you. And then another thing I was just wondering in terms of structuring of the deal, is it possible that you could throw into Denafil – into that bill because that's progressing very well, and I think there's some synergies there.
spk01: Yeah, so thank you first of all for recognizing that we have a portfolio of products, and it does give me an opportunity to say, I mean, one of the beauties of having a portfolio, and I touched on this in my comments, and I want to take this opportunity to reinforce that, that fact that we have a variety of programs, that they're diversified across indications and development stages, Not only does it give us the opportunity, as I mentioned, to deploy our resources in very creative ways and deploy investment in creative ways and create opportunities to advance things simultaneously that have very different risk profiles and timeline profiles, even in a challenging environment. But the other thing it allows us to do, frankly, is always be in front of all of the players in the women's health space. and also continue to look at a variety of creative structures that DARE is uniquely suited to do in the women's health category. To our knowledge, we're the only company that has a portfolio of this nature, of these kind of first in category opportunities across therapeutic indications. And as you noted, that uniqueness of our portfolio can provide unique partnership opportunities. So we are always always exploring what is going to make the most sense. And as John noted, partnerships, it's about who's the other party, what structure makes sense, but sometimes also timing. So we're weighing all of those variables as we look at. And for DRBV1, for instance, we specifically purposely made a decision, as I mentioned up front, to partner after phase three top line readout because that puts us in the strongest potential for that program. But as you noted, other programs provide different types of partnership opportunities, and we will explore those fully.
spk05: Thanks, guys. Looking forward to the data.
spk01: Yes. Thank you. There we go.
spk04: Thank you. Thank you. And as a reminder, ladies and gentlemen, if you would like to ask a question, that is the star and the one key on your touchtone telephone. And to withdraw your question, that is the pound key. Our next question comes from the line of Jason Colbert with the Dawson James. Your line is now open.
spk03: Hi, guys. Congratulations on a lot of fronts. Preservation of capital on the balance sheet, I see that as positive and, you know, keeping your options open when it comes to partnering. In terms of BV1, I think it would be helpful for me and maybe for others if you could just remind us of the trial powering and the therapy assumptions so that we can just refamiliarize ourselves with the probabilities of, you know, of hitting the primary endpoint and what would be perceived as, you know, great data? Thanks.
spk01: Thank you for that question and that opportunity to highlight that. So let's start with the current standard of care today. So the current standard of care have cure rates in the mid-30s to the mid-60s. So that's all your FDA-approved products for bacterial vaginosis, and that includes oral as well as vaginal methods. The challenge with bacterial vaginosis treatments is that many of the treatments on the market require administration over several days, which is often challenging both in terms of compliance and then outcomes. So on top of the cure rates, you have the challenges and just how many of those products are administered. But, however, they tend to rely upon two of the same antibiotics predominantly. metronidazole or clindamycin. So in the case of BV1, we are using 2% clindamycin. It's a dosage form and an antibiotic that has been previously studied in bacterial vaginosis, has a cure rate in that range that I talked about. The challenge, and physicians typically and patients prefer a vaginal administration in this indication because of the types of symptoms she's experiencing. There's benefits to delivering something vaginally. given also that it's a highly recurrent condition, so you want to avoid as much as possible recurrent administration of oral antibiotics. The challenge with vaginal administration is, frankly, just keeping the product where it needs to be. So products tend to leak out vaginally, and that is likely what has negatively impacted the cure rates of antibiotics like clindamycin that really are time-cored. They need to be present. You need to have them resident to fight the infection. So the innovation in DRBB1 is that drug delivery platform. It's the hydrogel, thermosetting hydrogel formulation that's quite viscous and bioadhesive and thermosetting, so it becomes more so once it's heated to our body temperature, and that one-and-done delivery. So it's just one administration of the product. So she only has to do it once. In terms of, now I'm going to turn to the cure rate and the trial design. So the nice thing about bacterial vaginosis in terms of clinical studies is that pretty much, you know, we've, across time, essentially, as products have been developed in bacterial vaginosis, they're looking at some permutation, whether looking at two or three or four, but it's always been kind of the same sort of clinical signs and symptoms that distinguish the condition and become part of the cure calculation. And in the recent years, the FDA actually in 2019 finalized their guidance. So typically you're looking, and now you're specifically looking at whether there's resolution in a very distinctive vaginal odor that is present, a very distinctive vaginal discharge that is present with bacterial vaginosis. And then you're looking for a reduction, a specific percent reduction down to below 20% in a type of cell called clue cells that are associated with this sort of... inflammatory sort of response. So that is how you determine cure. And like I said, that same array of symptoms, and sometimes pH is looked at as well, has been looked at kind of across time of the products that have been approved for bacterial vaginosis. So with our program, given that the range right now of the approved treatments is mid-30s to mid-60s, most of them, with few exceptions, are multiple-dose administrations. There are one-time vaginal and one-time oral, but most of the products are multiple-dose administrations. Frankly, a cure rate in that high end of that range is great because this is a one-time administration. It's a very clean formulation. It's aesthetically, because of how bioadhesive it is, there are some features and benefits that are attractive to a potential user. And this is all data, by the way, that were also, you know, had captured in the phase three is around that acceptability and her perception of the product. The investigator-initiated pilot study using that same criteria, but at day seven to 14, I'm going to talk about the time points in a second, showed that 86% cure rate. And it maintained in that 80 range even out to day 21 to 30. And so, you know, we'd love to see cure rate in that range, but your question of, like, what do we need? We don't need that range. We'd love to see it. You know, anything that shows an improvement over the standard today of the mid-30s to mid-60s, and given that this is a one-time vaginal clear gel formulation, is definitely very attractive. In terms of the trial design and what you should expect, so we announced in the queue that there were a total of just over 300 patients that we ended up enrolling in the study. A little bit higher than we expected. So one thing I'll say is that, you know, you're hearing a lot about COVID and impact of COVID on studies. We did not see any impact on enrollment in this study. And in fact, we ended up over our enrollment target because of how fast enrollment was going and, you know, what we needed to do to support that. And so we ended up a little higher than what we had expected, which is fine. It's 2 to 1 active to placebo. The primary endpoint is that test of cure assessment that I talked about, that vaginal odor discharge and clue cells returning to non-BV state at day 21 to 30. So I'll also highlight that of our clinical programs, this was a If you're going to pick two clinical programs to run during COVID, I would say our BV1 and our HRT1 programs, at least out of our portfolio, were the obvious choices for us. They were both 30-day studies, so they're fairly quick for the patient in terms of duration of commitment. And they allowed us, frankly, to get a lot of really valuable information that we are now using as we're planning for our sedentifil cream and oviprene studies, which are longer than a month. So in terms of what you should expect, when we announce top line, it's really around that primary endpoint, which is test of cure in the active arm versus placebo. And we're looking for statistical separation between the two.
spk03: Of course. Thank you. That was really, really helpful, and that was a great reminder for me. Good luck. Thanks.
spk01: Thank you so much. Yeah, we're obviously... You know, really exciting, excited about it. It's always, you know, the first phase three is super exciting when you're at a company.
spk04: Thank you. And this concludes today's question and answer session. I would now like to turn the call back to Sabrina Martucci-Johnson for any closing remarks.
spk01: Yes, thank you. We went a little longer than anticipated. So thank you with your patience. I'm sorry to have to stop the Q&A a little earlier than we hoped. But thank you all for attending the conference call. We really appreciate you taking the time this afternoon. So I do want to take a couple minutes. Sorry, we want to leave a couple minutes just to summarize what we talked about. So as I mentioned, we're really looking forward to wrapping up 2020 with that phase three top line data readout for DARE BV1. And we're looking for the milestone events that we planned in 2021 and to get to move forward on those. So specifically, I just want to close the call with a reminder of what we're expecting in terms of those key milestones for our mid- and late-stage programs for the remainder of this year, and then, like I said, going into 2021. So, as we've been discussing, for DRBv1, we've got that Phase III top-line data readout before the end of this year. Assuming a positive outcome, the data from this study would lead to a series of regulatory activities to support that NDA submission in the first half of 2021, which is our target. And as we've been talking about as well, that strategic partnership to support the commercialization in the United States. Sidenafil for our arousal disorder program, as I mentioned, we intend to and plan to start that Phase 2B study in the first quarter of 2021. We expect that should support a top-line data readout by the end of 2021 for that Phase 2B. And then, as I mentioned also, oviprene activities to support the pivotal study start by year-end 2021 are certainly something we're working on and that we believe would continue to allow for a top-line data readout by the end of 2022. As I touched on briefly, but want to remind, be on the lookout for the DARE HRT-1 phase one top line data readout in the first half of 21. And then as I mentioned, we also expect to be making announcements in 2021 about the phase one related activities for both the DARE FRT-1 program under that NIH grant, as well as DARE VBA-1 in that breast cancer population. And as John noted, in addition to the clinical and regulatory milestones, and as we've been discussing in the Q&A, we will, of course, continue to focus on our ongoing partnering activities and opportunities to monetize our pipeline of potential first in categories women's health products across the entire portfolio, as we've been discussing, and across geographies, as John mentioned. So we look forward to keeping you updated on our progress, and we're grateful, certainly obviously to our team, but importantly to our shareholders for their commitment and dedication to our mission. So thank you for taking the time today.
spk04: Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
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