Dare Bioscience (NASDAQ:DARE) Q2 2020 Earnings Call

0:00 Welcome to the conference call hosted by Daray 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'll be your operator today. With us today are Sabrina Martucci Johnson, Daray's President and Chief Executive Officer, John Fair, Daray's Chief Strategy Officer, and Lisa Walters-Hofford, Daray's Chief Financial Officer. Ms. Johnson, please proceed.

0:33 Thank you. Welcome to our financial results and business update call for DARE Bioscience. We're 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 fact should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by these statements due to unknowns. and Noun, Risk and Uncertainties, and so 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 31st, 2019, which was filed on March 27th, 2020, and our quarterly report on Form 10-Q for the quarter ended June 30th, 2020, which was filed today.

1:41 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. DARE 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, DARE is a leader in women's health innovation, and we're squarely focused on improving the life 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 clinical stage programs in contraception, vaginal health, and sexual health.

2:31 Our contraception pipeline includes our novel contraceptive candidate, Oviprene, and Investigational Hormone-Free Monthly Vaginal Contraceptives. It's under a license agreement with Bayer, a world leader in the branded contraceptive market. It includes DARE LARC1, a potential first in category long-acting user-controlled contraceptive, the development of which has received substantial funding from the Bill and 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 ORB204214, potential 6- and 12-month injectable contraceptives. 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.

3:23 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 III clinical trial with anticipated top-line 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 FSAG, the most analogous to the female sexual dysfunction disorders to erectile dysfunction in men. And the estimated FSAG market is expected to be as significant if not more so as the erectile dysfunction market in both the US and the rest of the world.

4:30 In terms of near-term anticipated value drivers, we are currently conducting two clinical studies and anticipate having top-line 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 our anticipated clinical and regulatory milestones. To date, though, 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.

5:24 Namely, 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 visit frequency and study contact. Specifically, in June, we initiated that pivotal phase three clinical trial of DRBV1 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 three trial is assessing DERBV1 as a potential new treatment for this acute infection for which women are not postponing care according to our study investigators and thus we initiated the study and remain on track to report the study's top line results by the end of this year.

6:14 DERBV1 is a novel thermosetting bioadhesive hydrogel containing clindamycin phosphate 2% and it's 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 available subjects in that study at the test of cure visit that occurred seven to 14 days after a single administration of DRBV1. In comparison, currently marketed FDA-approved products for the treatment of bacterial vaginosis have clinical cure rates ranging from mid-30s to high-60s on a percentage cure basis. If DARE BV1 delivers a similarly high clinical cure rate in the Phase III pivotal study, we believe DARE BV1 could become a new frontline treatment option for women diagnosed with bacterial vaginosis.

7:14 DER-BV1 received both fast-track and qualified infectious disease product designations from the FDA for the treatment of bacterial agenosis. A drug that receives fast-track designation is eligible for more frequent meetings with the FDA to discuss the drug's development plan and ensure 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 I clinical study of DARE-HRT1, a novel intravaginal ring designed to deliver non-oral bioidentical hormone therapy for the treatment of menopausal symptoms.

8:09 DER-HRT1 is designed to deliver bioidentical estradiol and bioidentical progesterone continuously over a 28-day period, and it's being developed as a potential new option for hormone therapy for the treatment of vasomotor symptoms, commonly called hop flashes, and the genitourinary symptoms of menopause to prevent bone loss and fractures associated with menopause. More than 45 million women in the U.S. are approaching or are in menopause. The North American Menopause Society, or NAMS, which is known for its thought leadership and evidence-based menopause treatment guidelines, supports the use of hormone therapy in peri- and postmenopausal women and recommends administering both estrogen to reduce symptoms and progesterone to prevent thickening of the uterine wall and observes that non-oral routes of administration may offer advantages over orally administered therapies.

9:07 DARE-HRT1 has the potential to be the first FDA approved intravaginal ring or IVR product to meet the NAMS guidelines. We believe the phase one study of DARE-HRT1 will provide important scientific information for both DARE-HRT1 but also for DARE-FRT1, which is another candidate in our portfolio which utilizes that same IVR technology as DARE-HRT1 and that same bioidentical progesterone as an active ingredient. Specifically thus, this phase one study will evaluate the ability of DER-HRT1 to achieve its target dual release objectives, as well as the ability of the IVR technology to release two different actives at two different rates.

9:54 But in addition, we anticipate collecting useful pharmacokinetic characteristics of the bioidentical progesterone alone, which can be expected to directly apply to DER-FRT1. which is our bioidentical progesterone-only IVR that we are developing as part of an in vitro fertilization regimen, soluteophase support, as well as a more convenient treatment option for 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 on 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.

10:43 We expect to report the top-line data from this study in the first half of 2021. Turning now to our sidenafil cream and oviprene studies, We believe we will be in a position to commence both of these studies in 2021 and still maintain our prior guidance with respect to top-line data readouts for those programs. Specifically, for our Sudentifil Cream program, we expect to report top-line results of the planned Phase 2b study in 2021. You may recall that we announced in December of 2019 the important alignment we reached with the FDA on the Phase 2b study design, and the novel patient-reported outcomes, which I'll refer to as PRO, instruments should be measured to assess the achievement of the primary efficacy endpoints.

11:35 Sivetafil 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. and Sidenafil 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 Sidenafil cream is a topically administered formulation of that same Sidenafil, which means that active ingredient is delivered in a cream formulation that is applied locally by women to the genital tissue. It's designed to increase local blood flow, and thereby improve that general arousal response using that same pathway that's active in erectile dysfunction medications for men.

12:29 While the oral version of Sidenafil 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 Sidenafil in a fast-acting cream, that can be applied locally. The formulation has been designed to offer those same benefits, so that increased blood flow and improvement in that general 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, experienced symptoms of low or no sexual arousal, and 16%, which is approximately 10 million women in the US, are distressed and are seeking a solution to improve their condition.

13:32 To put the market opportunity for an FDA-approved FSA-D treatment in context, The prevalence for the male version erectile dysfunction is estimated to be just 5% of men age 40, increasing to just about 15% at age 70. The planned Phase IIb study of sedentifil cream will utilize that agreed-upon PRO instrument to measure achievement at the primary efficacy endpoints, namely improvement of localized general sensations of arousal and reduction in 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 and conducting other startup activities, as well as other non-clinical activities to support that future NDA submission.

14:22 As I noted, the Phase 2B study is designed to evaluate sedentary cream versus placebo over a 12-week dosing period by study subjects in their own home setting, and that'll follow both a non-drug and a placebo run-in period. And as I mentioned earlier, we expect to report top-line results of the study by year-end 2021. And we expect to report top-line data for our planned pivotal study for oviprene by year-end 2022. Oviprene, as I mentioned up front, 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.

15:11 And earlier this year, Bayer, the marketers of the billion dollar global Mirena franchise, and DARE announced our license agreement under which Bayer can exclusively commercialize oviprene in the United States upon the satisfaction of certain conditions in the agreement. which include a $20 million payment to us by Bayer, payable at Bayer's sole discretion, following the completion of our pivotal trial of Oviprene. 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. Bayer is supporting our development and regulatory process for Oviprene, providing internal experts and an advisory capacity.

15:57 These resources have already added value to the planning and implementation of the oviprene clinical regulatory manufacturing and pre-commercialization planning workstreams. 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 oviprene'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're the only company, as I mentioned, to have built a contraceptive brand family in excess of a billion dollars. With regards to oviprene, over the next several months we intend to continue the regulatory manufacturing and non-clinical activities needed to advance the programs.

16:49 We've been using the last several months truly to align with the FDA on the development plan and the submission strategy and we're going to continue to utilize the next several months to on-go and keep on-going those discussions to leverage this pre-submission process with the FDA and continue those discussions as we prepare to file an investigational device exemption application or IDE for oviprene. In light of these discussions and our intent to commence enrollment in the Pivotal Contraceptive Effective and Safety Study of Oviprene in 2021, Our plan is to file the IDE next year, and then pending FDA's review and clearance of the IDE, we would plan to go ahead and initiate the study before year-end 2021.

17:36 That supports, that timeline supports, a top-line data readout by year-end 2022, as we have guided. And if successful, we expect that study's data to support marketing approvals for oviprene 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 will therefore continue to closely monitor the rapid evolving circumstances.

18:33 Currently, however, we remain on track to deliver the top line 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 in 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 that we announced in May will continue to support acceleration of clinical development of our reproductive health assets in a capital-efficient manner.

19:30 And with that, I'll now turn the call over to John to provide a business and a corporate partnership update.

19:37 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 Overbrain for its first in category contraceptive potential. The relationship continues to be highly productive and value-additive, and our collective teams have achieved alignment across key areas, including clinical, non-clinical, 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 Overprint, continue to be invaluable, in our opinion. And those of you familiar with our story know that partnerships and outlicensing 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.

20:25 and global, that are focused on delivering new innovation 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.

20:54 Thanks, John. Hey, everyone, and thanks for joining us today. I would now like to summarize DARI's financial results for the quarter ended June 30, 2020. 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 ended June 30, 2020, DARI'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.

21:44 In addition to the personnel costs of our R&D team, our primary research and development expenses this quarter included Work to Prepare for and to Start, our DARE BV1 Pivotal Phase 3 Study, Ongoing Regulatory Affairs and Other Work Related to Oviprene, and Preclinical Development Activities for DARE LARC1, which as Sabrina had noted are supported by our grant from the Bill and 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 30th 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.

22:36 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 impact on both our cash burn and our operating expenses. So 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 overpring clinical development activities. When monies are received under this NIH grant, they are recognized in our financial statements as a reduction to the oviprene 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.

23:25 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 clinical development of key programs and to do so, in Dari's case, in a cost-efficient and capital-efficient manner. In June, we announced the receipt of the $1.6 million in additional grant funding from the Bill and Melinda Gates Foundation to support development activities related to DARE-LARC-1. Grant proceeds in this case are recognized in our financial statements as a reduction or an offset to the allowable costs associated with the DARE LARC-1 development program. And finally, in July, as Sabrina has noted and said I would expand upon, we initiated a phase one study of our DARE HRT-1 program in Australia.

24:18 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 credit then available under this program. So in summary, we believe that the Australian R&D Tax Incentive, our NIH grant, proceeds from the Bill and Melinda Gates Foundation grant, and our partnership with Health Decisions will collectively serve to reduce our cost of development in the months ahead and help us to manage our cash resources efficiently.

25:10 Subsequent to the quarter's end, so in our case, this would be from July 1st through August 11th, We took steps to further strengthen our cash position by raising approximately $3.5 million net of fees from sales of stock under our ATM equity line and from warrant exercises. Following these activities, shares of our common stock outstanding on August 11th 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 a variety of ways, 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.

26:19 In terms of COVID-19, as Sabrina discussed, we are continuing to monitor the pandemic, its associated restrictions and their potential impact 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 impact 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 file 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.

27:17 I would now like to turn the call back to Sabrina.

27:21 Thank you. And I will turn the call back over to the operator, who can now open the lines for any questions. Thank you. And as a reminder, to ask a question, you need to press star 1 on your telephone. will draw your question. Please press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from the line of Nathan Weinstein with Aegis Capital. Your line is now open.

28:00 Hi, good afternoon. Sabrina, Lisa, and John, thanks for taking my question. And congrats on the progress in the quarter. A number of moving pieces here. I guess just to start with, you moved their HRT1 up. So maybe just philosophically, kind of what was behind the decision? And just in general, how do you decide kind of which products to move into the clinic?

28:23 Thank you, Nathan. That's a really great question. So there are definitely a number of factors that are involved. And because everything in our portfolio pretty much has an opportunity to be first in category, right? So they're all super exciting from our perspective opportunities and they're all products we also selected for the portfolio because their potential attractiveness to partners. With the HRT1 program in particular, we saw a few really compelling reasons to want to get that program moving forward. And 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 the NAMS 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 with both hormones together. And there are significant data demonstrating that hormone replacement in women who can use it can be very impactful in not only addressing those symptoms that she experiences in menopause, but importantly, also cardiovascular and bone health as well.

29:39 So the program from a market potential is very interesting. We obviously want to move it forward. From a practical consideration as well, this phase one 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 rebate. So it essentially, with that currently 43% rebate, it basically cuts the cost of conducting a study to almost in half. And so it makes it a very capital-efficient place to conduct a study. And also right now in the cities and centers that we're working with, With their COVID situation, it was a very practical study to get up and running from that perspective.

30:35 And further, it really gives us an opportunity to not only validate HRT1 in our portfolio, but because HRT1 is delivering together both progesterone and estradiol, and we have another similar vaginal ring in our portfolio that's delivering only progesterone, the exact same progesterone in the exact same type of vaginal ring. The third reason this is an exciting program to advance at this time is that we're basically, it's like a two for one. Not only are we getting phase one data on HRT1, but we're getting basically phase one data at the same time on FRT1, and FRT1 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 has potential to be much more convenient than anything that's available to them today in terms of injections or vaginal gels that have to 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.

31:51 So hopefully those three reasons gave you a sense of, you know, with this particular program, the market opportunity, the practicality of running the trial in a COVID environment in a very cost efficient way, and the fact that really it's valid and can be validation for two of our programs, not just one, are what led us to move that program and that study forward in the portfolio. And being able to do so, frankly, without affecting the timelines for our other lead assets, right? It doesn't in any way disrupt, you know, maybe one data readout this year, so then it's a readout that we're targeting for the end of next year and overprinting for the year thereafter. So, you know, nice way to slide it into the portfolio without disrupting the other programs or timelines.

32:39 Great, thank you. That's a really interesting, comprehensive answer. And so I guess just another thought or question here on the pipeline in terms of the competitive dynamics in women's health and the number of products that are coming along, have you seen anything in the landscape that's shifting in terms of competitive dynamics that would make you think differently about your portfolio priorities now, I guess, versus six or 12 months ago?

33:06 Another great question, Nathan. Thank you. I have to say it is something that we look at all the time. We look at in the context of making sure that we are using our shareholders and our donors and our money as absolutely wisely and strategically as we can to build value. So we really do critically look at the portfolio at all times to make sure that we're prioritizing programs in the right way. you know 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 and interesting indications. So 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 affecting companies and with the shelter in place we also wanted to take a hard look at What trials can we conduct right now? How can we keep our timelines on track?

34:10 And how can we use our dollars as efficiently to really build value robustly in a time period where for a lot of companies it's probably hard to do? And so that's a very long answer, 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 and continuing to feel that really across the portfolio the programs are relevant. They're continuing to have that potential to address some of the most persistent unmet needs. And maybe most important, 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.

34:55 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 underinvestment that's gone on in women's health, and that's a comment on the U.S., but I guess this question is really about the international markets and for your future products, if you know, when they become into the commercial arena, you know, do you see opportunity in key markets like Europe and Asia, and has investment in women's health in those markets lagged behind the U.S.?

35:24 Yeah, and let me, I'm going to turn it over to John to give you some perspective because, you know, in his role, a lot of what he's been doing is, as he mentioned, talking all the time to all of our potential partners, both in the U.S. and in Europe. And as he'll share, the interest has been, you know, robust really across continents, you know, in our portfolio. But let me let him share.

35:47 Yeah, no, thanks, Nathan. I think it's a great question. I think 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. And that, by the way, plays very well across the globe, not just across the country, because all of these opportunities really become innovation in and of themselves. And so when we look at our European opportunities, they're as big or as rich as they are in the U.S. And those discussions have been really meaningful. And as I mentioned, we will only talk about them when there's something to talk about, but we are in really deep discussions across a variety of assets in the portfolio across a variety of territories. More to come on that, but great question. Thanks for asking that.

36:33 Guys, thank you so much for taking my questions, and congrats again on your progress in the quarter.

36:39 Thank you. Really appreciate it. Thank you. And again, ladies and gentlemen, as a reminder to ask a question, you need to press star 1 on your telephone. And to withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. Our next question comes from the line of Jason McCarthy with Maximum Group. Your line is now open.

37:03 Hi, guys. This is Joanne Lee on the call for Jason McCarthy. Thank you for taking my question, and congrats on the progress this quarter. Just one for me. I know there's a lot going on with activities regarding the company's pipeline. There's Overprime, DARA BB-1, all entering its pivotal stage. And I was just wondering if you could perhaps expand a little more on your DARA LARC-1 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, if the studies, design, and endpoints could possibly reflect those of overprint, since they're both in the same contraceptive space.

37:45 Yeah, thank you for asking about that program. It's one where there's just a lot of interest involved. in that program, really across constituents in the women's health space because it is such a novel technology. So just for the benefit of everyone, DARE LARC-1, as I mentioned, is a user-controlled, long-acting, reversible contraceptive technology. It's an implanted device that really allows the user the flexibility to have effective contraceptive over several years but have the ability to turn it on or off as needed without removal of the device. So this is a very, very significant innovation in the contraceptive category.

38:33 There really is not anything like that certainly available at this time. And that is why, for instance, the Bill and Melinda Gates Foundation, which as we mentioned up front, has contributed quite 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 a preclinical program still. We are in the midst of animal studies with the technology, really looking at that drug release. It is designed to release hormonal contraception in this case. Obviously, the technology itself is an exceptional platform that could be used frankly for any indication where someone wants to deliver drug over a long period of time and have the flexibility to increase or decrease dose or turn it on or off. So while we're obviously exploring contraception first, this work that the Bill and Linda Gates Foundation have been funding really is validation for the technology in general and the platform in general.

39:36 So at this point, it's in that preclinical stage, but we're definitely excited with this work, which will continue into next year. and hope to have some exciting news to share from that in terms of what the next stages are with the program after we complete this preclinical assessment.

39:55 Okay, thank you. That was really helpful. Thanks for those details. And again, congratulations on progress. Thank you. Thank you. And ladies and gentlemen, this does conclude today's question and answer session. I will now turn the call back to Sabrina Martucci Johnson for any closing remarks.

40:14 Well, thank you, Chris, and thank you all for taking the time this afternoon. So maybe to summarize, you know, 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 top-line data expected by the end of this year. As we talked about, the DARE HRT1 study is underway, and we'll continue those activities and obviously we'll continue all the startup activities and other non-clinical work necessary to support our overall program objectives for both sidenafil and oviprene and as I mentioned keeping them on track for those respective top line data readouts in 2021 and 2022. And 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. So we look forward sincerely to keeping you updated on our progress, and we remain very grateful to obviously 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.

41:28 Ladies and gentlemen this concludes today's conference call. Thank you for participating. You may now disconnect.