Dare Bioscience Inc (DARE) 2020 Q1 法說會逐字稿

Welcome to the conference call hosted by Daré Bioscience to review the company's financial results for the quarter ended March 31, 2020, and to provide a general business update. This call is being recorded. My name is Victor, and I will be your operator for 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.

Thank you, and welcome to our financial results and business update call for Daré Bioscience. We are looking forward to discussing our first quarter results and highlighting the recent developments and anticipated milestones for 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. 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 March 31, 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, March -- May 14, 2020. Daré undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law.

So as you know, Daré is a biopharmaceutical company squarely focused on improving the life and well-being of women, primarily in the areas of contraception, vaginal health, sexual health and fertility. Our value creation strategy is to accelerate availability of new prescription products in women's health by selecting and advancing product candidates that we believe have the potential to be first in category and first line.

On our last call, we discussed the impact of the COVID-19 pandemic on our general business operations as well as our anticipated clinical and regulatory milestones. As we discussed, we believe the uniqueness of our business model allows us to react quickly to changes in circumstances. And since then, we have maintained the pace of our product development and regulatory activities necessary to remain on track to achieve the clinical and regulatory objectives we discussed.

Namely, we remain on track to conduct and report top line results this year for a Phase III clinical trial of DARE-BV1 for the treatment of bacterial vaginosis, a condition estimated to impact over 20 million women in the U.S. alone. We're also confirming our prior guidance with respect to our Sildenafil Cream program. We expect to report top line results of the planned Phase IIb study of Sildenafil Cream in 2021. We believe our Sildenafil Cream candidate has the potential to be the first FDA-approved treatment option for female sexual arousal disorder, the female sexual dysfunction disorder most analogous to erectile dysfunction in men.

And finally, we continue to anticipate reporting top line results in 2022 for our planned pivotal clinical trial of Ovaprene, our investigational hormone-free monthly contraceptive, with the potential to be a first-in-category product and whose U.S. commercial rights are under our license agreement with Bayer.

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 investment across the portfolio in ways that enable us to advance our programs 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 as well as the potential to increase anticipated development costs and time lines for our product candidates, and therefore, we continue to closely monitor the rapidly evolving circumstances.

However, currently, we remain on track to deliver top line clinical study results and regulatory milestones on the time lines we've discussed. We believe our financing strategies, such as our at-the-market program and the equity line we recently established, 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 the dedicated staff, with expertise in clinical development of women's health products provided under the agreement with health decisions that we announced this week, can support acceleration of clinical development of our reproductive health assets in a capital-efficient manner.

We'd like to spend a little more time now to review our plans for the DARE-BV1 Phase III study and the data readout this year and next steps with our Sildenafil Cream and Ovaprene programs. We'll also provide additional insights into our partnership with Health Decisions as well as an update on partnering activities in general, and our first quarter financial results.

I'll start with DARE-BV1 for bacterial vaginosis. DARE-BV1 is a novel thermosetting bioadhesive hydrogel, containing clindamycin phosphate 2% and is being developed as a onetime vaginal administration for the treatment of BV. As I mentioned, a highly prevalent condition estimated to affect more than 20 million women in the U.S. alone.

As we've previously reported, data from an investigator-initiated proof-of-concept study demonstrated a clinical cure rate of 86% on the valuable subjects in the study at the test-of-cure visits that occurred 7 to 14 days after that single administration of DARE-BV1. In comparison, currently marketed FDA-approved products for the treatment of BV have clinical cure rates ranging from the mid-30s to the high-60s, on a percentage cured 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 front line treatment option for women diagnosed with BV.

DARE-BV1 has received both Fast Track and Qualified Infectious Disease Product designations from the FDA for the treatment of BV. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. 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 FDA about such things as the design of the proposed clinical trial and eligibility for Accelerated Approval and Priority Review, if relevant criteria are met. Our Fast Track designation for DARE-BV1 underscores that BV is a serious infection, for which current treatment options are inadequate and it validates DARE-BV1's potential to address this unmet medical need.

As we've indicated in our recent posting on ClinicalTrials.gov, we expect to commence enrollment in our Phase III clinical study of DARE-BV1 in July, with an anticipated top line data readout by the end of 2020. Based on the FDA's guidance document on developing drugs for treatment of BV and recent discussions we've had with the FDA, the Phase III study will include a placebo control and assess the primary end point of clinical cured BV, defined as the resolution of specified clinical signs and symptoms from the baseline visit at the test-of-cure visit to occur 21 to 30 days after enrollment in the study. If this single Phase III study in approximately 220 women and the nonclinical studies to be conducted in parallel with the Phase III are successful, we intend to file a New Drug Application for DARE-BV1 in 2021.

I'll now talk about Sildenafil Cream. We announced in December 2019 the important alignment we reached with the FDA on the Phase IIb study design and the novel patient-reported outcomes, or PRO, instruments to be used to measure achievement of the primary efficacy end points. Sildenafil Cream, 3.6% has the potential to be the first FDA-approved product for female sexual arousal disorder, or FSAD. FSAD is the female sexual dysfunction disorder most analogous to erectile dysfunction in men, and 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.

Sildenafil Cream, our formulation, is a topical administration formulation of sildenafil, which means the active ingredient is delivered in a cream formulation that's applied locally to the vaginal tissue. It's designed to increase local blood flow and thereby improve the genital arousal response, utilizing the same pathway that's active in erectile dysfunction medications for men.

While oral 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 the same arousal response in women. With the potential to deliver sildenafil in a fast-acting cream that can be applied locally, the formulation has been designed to offer the benefits of increased blood flow and improvement in the genital sexual arousal response without the systemic issues observed with the oral formulation.

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% of them or approximately 10 million women in the U.S., are distressed and are seeking a solution to improve their condition.

To put the market opportunity for an FDA-approved FSAD treatment in context, the prevalence of complete erectile dysfunction is estimated to be about 5% of men at age 40, increasing to 15% at age 70. The planned Phase IIb study of Sildenafil Cream will utilize the agreed-upon PRO instruments to measure achievement of the primary efficacy end points, namely improvement in that localized genital sensation of arousal response and reduction in the distress that women with FSAD experience.

Over the next months, we'll focus our efforts on preparing to initiate that Phase IIb study, such as preparing the electronic diary and conducting other start-up activities as well as other nonclinical activities to support a future NDA submission. The Phase IIb study is designed to evaluate Sildenafil Cream versus placebo over 12 weeks of dosing by study subjects in their home setting, following both the nondrug and placebo run-in period. As I mentioned, we expect to report top line results of the study before the end of 2021.

And now I'll talk briefly about Ovaprene. Ovaprene is an investigational hormone-free monthly vaginal contraceptive currently in clinical development for the prevention of pregnancy. If approved, it could be the first monthly nonhormonal contraceptive product. Earlier this year, Bayer, the marketers of the $1 billion Mirena contraceptive franchise, and Daré announced a license agreement, under which Bayer can exclusively commercialize Ovaprene in the United States, upon the satisfaction of certain conditions in the agreement, which included a $20 million payment to us by Bayer, payable on Bayer's sole discretion following the completion of a pivotal trial of Ovaprene. 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 Ovaprene by providing internal experts in an advisory capacity. These resources have already added value to the planning and implementation of the Ovaprene clinical, regulatory, manufacturing as well as the precommercialization planning workstreams. More information about the terms of the agreement can be found in our filings with the Securities and Exchange Commission. We believe the licensing agreement with Bayer is validation of our broader strategy and confirmation of Ovaprene's market potential as the first monthly nonhormonal contraceptive product. Bayer is committed to bringing to market innovation in women's health, and they are the only company to have built a contraceptive brand family in excess of $1 billion.

Over the next several months, we intend to continue the regulatory, manufacturing and other nonclinical activities to advance the program. We plan to file an investigational device exemption application, or IDE, for Ovaprene this year. And pending the FDA's review and clearance of the IDE, we plan to initiate a pivotal contraceptive effectiveness and safety clinical study of Ovaprene. If successful, we expect this study to support marketing approvals of Ovaprene in the U.S., Europe and other countries worldwide. We believe we can commence this study even in 2021 and still report top line data in 2022 as projected.

I'll now turn the call over to John to provide a business and corporate partnership update.

Thanks, Sabrina. To follow up on some of the remarks made by Sabrina concerning our relationship with Bayer, we're pleased to announce we've implemented a really robust alliance management framework with Bayer, facilitating effective connectivity and communication with their global team. The framework enables us to leverage their internal expertise and align on clinical, manufacturing development, regulatory planning and the potential launch strategy for Ovaprene in the United States.

As Sabrina mentioned, Bayer is the current real-time world leader in contraceptive sales and marketing. Their insights and expertise across a wide range of functional areas, including commercial planning, have been invaluable. We believe our agreement with Bayer for the commercialization of Ovaprene is a validating event for the Ovaprene contraceptive technology and for Daré. Our relationship with Bayer has raised our profile in women's health, which has been a great tailwind for us as we actively engage on a number of fronts across our portfolio, and continue to execute against our broader strategy and engage with potential partners on subsequent collaborations and follow-on transactions.

For those of you familiar with the Daré story, you know that partnerships and out-licensing transactions are core to our model. And one of the imperatives for our company is to ensure we have a pipeline of differentiated assets and to keep those assets moving along an aggressive development continuum in a cost and time-efficient manner. To that end, we announced an alliance with Health Decisions, a full-service contract research organization, or CRO, specializing in women's health clinical research and diagnostic development to help us advance our portfolio of programs. The pricing structure in the agreement, along with the opportunity to have dedicated staff with expertise in clinical development and women's health products, is expected to accelerate the clinical development of our key programs in a resource-efficient manner.

Health Decisions is the statistical and clinical coordinating center for the NICHD, which is a unit of the National Institutes of Health or NIH. They've conducted over 40 clinical trials in contraception, and they are active across a number of therapeutic areas that are aligned with our portfolio. And we have successfully worked with Health Decisions on prior clinical studies, including the successful postcoital test, or PCT, clinical study of Ovaprene, and we're currently working with them on the planned DARE-BV1 Phase III study on bacterial vaginosis. As I mentioned, the agreement with Health Decision includes dedicated resources and new pricing structures. When combined with Health Decision's clinical expertise, robust network, the relationships with key investigators in the women's health community, we expect this alliance to enable us to accelerate our clinical programs and our pipeline.

In order to maintain the high level of interest in our portfolio that we've seen over the past several months and to execute on our partnering strategy, it's incumbent upon us to continue to deliver against meaningful clinical and regulatory milestones, and we believe our new relationship with Health Decisions will strengthen our ability to do that and enable us to provide new solutions to address persistent unmet need in women's health.

And with that, I'll turn it over to Lisa for a financial update.

Thanks, John, and thanks to all of you for joining us today. I would now like to summarize Daré's financial results for the quarter ended March 31, 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 tend to fall into 3 categories: Corporate overhead; portfolio acquisition and maintenance costs; and research and development expenses related to clinical, nonclinical and preclinical work to generate safety and efficacy data and advance our candidates through clinical and regulatory milestones.

For the quarter ended March 31, 2020, Daré's general and administrative expenses were approximately $1.9 million, license expenses were $12,500, and research and development expenses were approximately $2.4 million.

During the quarter, our research and development activities included: Work to prepare for the initiation of the DARE-BV1 pivotal Phase III study this July that Sabrina mentioned; regulatory and other activities related to Ovaprene; work on 2 of our vaginal rings, one for hormone replacement therapy, and that's DARE-HRT1, and the other for pregnancy maintenance, DARE-FRT1; work on our vaginal tamoxifen candidate, DARE-VVA1; activities related to the microchips-based contraceptive program that we acquired in November of 2019; and personnel costs of the R&D team.

Our comprehensive loss for the quarter was approximately $4.3 million. Net cash provided by financing activities for the quarter ended March 31, 2020, was approximately $6.9 million and consisted of net proceeds from the sale of stock under our ATM and proceeds from warrant and option exercises. We ended the first quarter with approximately $5 million in cash and cash equivalents.

We will need to access additional capital to advance our programs, particularly our 3 later stage programs, to satisfy our working capital needs, our other liquidity requirements over the next 12 months. Since our inception, we have raised cash through private placements and public offerings of our equity securities, M&A transactions, the exercise of warrants and options for cash, nondilutive grants and license fees. We will endeavor to be creative and opportunistic in seeking capital and to be efficient in the use of this capital.

Subsequent to the end of the quarter, we took steps to further strengthen our cash position. On April 1, we announced the receipt of a third Notice of Award of approximately $731,000 in grant funding from the NIH towards certain development costs of Ovaprene, of which $428,000 has since been applied for and received. We raised additional cash of approximately $2 million, net of fees, through May 12 of this month from sales of stock under our ATM.

On April 23, we announced a purchase agreement with Lincoln Park Capital Fund for the potential sale of up to $15 million in shares of our common stock over a 36-month period, with the timing and the amount of any such sales to be controlled by us and subject to the satisfaction of conditions and in limitations under the purchase agreement. As you may have seen, we recently filed an S-1 registration statement and a prospectus related to this purchase agreement. Following all of these activities, as of May 12, we have approximately 26.6 million shares of common stock outstanding.

In terms of COVID-19, as Sabrina mentioned, we are continuing to monitor the pandemic, its associated restrictions and the potential impact on our business, our financial condition, results of operation, including potentially to adversely affect our planned clinical trials and our ability to raise additional capital when needed. Due to rapidly evolving circumstances and many uncertainties around the pandemic, including its severity and duration and the implementation and easing of various governmental restrictions, we are unable to predict with any reasonable accuracy the full financial and business impact on our company at this time.

We also encourage investors to review the more detailed discussion of our financials and financial condition, our liquidity, capital resources and our risk factors in the 10-Q that was filed today, and to also review our audited financial statements and related notes and the risk factors included in our 10-K that was filed on March 27, 2020.

I would like to now turn the call back over to the operator.

(Operator Instructions) And our first question will come from the line of Yasmeen Rahimi from Roth Capital.

This is Rachel Yang on for Yasmeen. So two questions. First, can you provide some color on how much faster the partnership with Health Decisions allows you to move your clinical program? And what type of discounts do you receive in clinical trial costs by working with your partner? And I have a follow up.

Yes. Thank you, and this is Sabrina. Thank you for that question. As both I and John noted, we're really excited about that partnership. And you kind of hit on really the 2 key benefits: One being the efficiencies it provides us in time, which I'll address; and also the fact that it's really going to allow us to advance our program in a cost-efficient manner, because of the type of pricing structures that are part of that arrangement.

So some examples, in terms of time efficiencies. As John noted, part of the agreement includes basically a dedicated team that is assigned to Daré and our programs. We will have the opportunity to continue working with that team who, by the way, we already worked with on our Ovaprene successful postcoital test study. We'll be able to continue to work with them on our DARE-BV1 program and as well as other programs as we advance them under this partnership.

And so what that means is that team continues to work with us in a very seamless way. So certain activities that in a normal clinical research organization relationship that you might not be able to engage in until you literally like signed your contract and were really officially formally right at beginning of study start-up mode, we can do those things real time, significantly sooner. And as an example, there's conversations we have about Ovaprene, for instance, that, that study is not starting tomorrow, but we can be having those conversations now with them so that when we're ready to pull the trigger, it really gives us that efficiency. So it's the team that's dedicated and it's the ability to engage with them really like an extension of the Daré team and family.

And in terms of the pricing structures, there's some nice optionality under how we structure the partnership to allow us to really receive efficiencies in terms of pricing structures that can come in a variety of forms. We haven't disclosed the details, for confidential reasons, with Health Decisions, of course. But suffice it to say, it really represents a benefit to us and our shareholders in terms of how the pricing structures are designed for clinical trial programs that we pursue, both in terms of a more favorable pricing structure, obviously, because we're a very preferred partner. But also just in terms of how those are structured in terms of the timing of payments and things like that, that can often benefit us and our shareholders in terms of when we have to deploy the capital against the programs.

Okay. That's very helpful. And sort of following up on the partnership. Our second question is, can you share with us how many sites does the partnership involve and the personnel included? And what types of trials are their expertise?

Yes. Sure. So Health Decisions is very focused in women's health. That's the reason the partnership was such a great one for us to contemplate in terms of their clinical research expertise and capabilities. As John alluded to, they're part of the clinical trials network that's part of the NIH's contraceptive research division. That includes -- it's a large number of sites that are part of that clinical trials network, and being involved in that, they've supported the conduct of 40 studies through that kind of relationship and partnership. But they're broadly associated in women's health, not just in contraception, but broadly in women's health.

And so we've specifically structured our relationship with them in the therapeutic areas where they clearly have expertise, and that includes, for sure, contraception, vaginal health, that's the BV1 program as well as areas such as fertility and general gynecologic health. And so we're really leveraging the areas where they've already demonstrated great clinical success and outcome and acumen and relationships.

And in terms of the staff that we received as dedicated staff, it really -- it runs the gamut as kind of the -- all the different functional areas that you need for an effective and efficient conduct of a clinical trial. So that includes your monitors and project manager as well as leads in the area of statistics and design, and all those parameters. So it's really a group that represents all the functional capacity that we need to effectively run a clinical trial.

Okay. That's very helpful. And congrats on the progress.

Thank you so much.

And our next question will come from the line of Jason Kolbert from Dawson James.

Congratulations on preserving a time line in your balance sheet, which is not an easy thing to do with what's going on with COVID. I guess I'd like to understand how you've been able to do that clinically? I mean it just seems like elective procedures have been in chaos. Why do you feel confident that you can maintain these time lines? If you could just kind of tell us a little bit about what it's taken? And maybe contracting with this particular CRO is a piece of that puzzle? I don't know.

Yes, Jason. Thank you. That's really a great question. And there are a couple of things at play. One that I wish we could take credit for, and we can't, is luck. As luck would have it, the clinical trial that was most critical for us as a company in terms of the data readout this year is our bacterial vaginosis program.

And as you very appropriately mentioned, clinicians are not seeing patients for elective procedures or things that are not urgent, and they're doing as much telemedicine as they can, right, whenever possible, but bacterial vaginosis is -- really can only be diagnosed and treated with a vaginal exam. And it is a very, very bothersome condition for the women that are affected. The kind of side effects of the condition in terms of vaginal odor and discharge are bothersome enough that this is a condition where women today, in the COVID world, are still actively seeing a health care provider and a health care provider needs to actively see them.

So to your point, based on our relationship with Health Decisions, which started, obviously, as I mentioned, with the Ovaprene study. So it's a relationship that we've had for some time. As we started talking about our bacterial vaginosis program and in light of this COVID environment, we obviously had some very real conversations with them and the sites that we had identified for the study, as to their ability to continue to conduct the study on the time line that we have communicated.

And whether we would see delays and really across the board, both in terms of -- are obviously working closely with Health Decisions and the efficiencies that, that provides, but also with all of the conversations we've had with all of the sites that have been identified to begin enrollment in July into this study. Everyone, they're still seeing patients. They're still seeing bacterial vaginosis patients, and they -- everyone believes we can be on track with the study really because of the condition.

So it is a little bit of circumstance, right, that this is a condition where women are still going in to see their clinicians, which helps, and it's one where, obviously, the relationship with Health Decisions is important.

And as it pertains to sildenafil and Ovaprene, similarly, we've been able to really look at our programs critically in the light of COVID and look at our planned activities and recalibrate a little bit, if necessary, in terms of maybe the sequencing of certain activities or how we can do certain things to keep the programs on their time lines. And with both Ovaprene and sildenafil, we had 2 factors working in our favor. One is there are start-up activities with both of them that we need to engage in and other nonclinical activities that we can be doing right now that are going to be needed for the ultimate regulatory filings that we can -- those things aren't impacted or delayed, and we can go ahead and take advantage of the time to get those out of the way. And then like I mentioned, things like electronic diary for the sildenafil program that can happen right now even before we enroll subjects.

So a combination of those factors. And then just the lead times for our time lines that we had built really allowed us for that flexibility as well to stay on track. Thank you for asking the question.

Sure. And just a follow-up is, when I look at the market volatility, as a result of COVID, there have been just some wild swings in both directions. And one of the things that I see that that's translated in is a very significant increase in high-volume days. And so my assumption is that on those high-volume days, you're taking advantage of those with the ATM, and that's how you're able to preserve the balance sheet for now. Is that fair?

Yes. As Lisa reported, in the quarter, we've had some ATM activities. And to your point, it's a great way for us to bring in capital and place shares, right, in the market, in a very efficient manner that can preserve shareholder value, preserve the pricing on those days. But to your point, give us that optionality to do in a way that is not...

Well, to take advantage of the volatility that exists in the market without hurting the fundamental stock price. So it's kind of a no-brainer as a tool.

Exactly. Yes, you nailed it.

Yes. I mean when I look at kind of what's going on, short of placing stock with truly fundamental institutional investors to take advantage of the volatility we're seeing just makes good, good business sense. Really appreciate the update.

Jason, thank you so much. Thanks for your comments. Really appreciate it.

And our next question will come from the line of Sally Yanchus from Brookline Capital.

Sabrina, Lisa, a couple of questions. One, I just wonder, do you expect your R&D expenses to remain around $2.5 million a quarter for the rest of this year?

Yes. I'll let Lisa address that. But just at a high level, I think it's helpful for people listening and who are learning about Daré to understand our R&D expenses will very much vary. Lisa uses the term lumpy, which is probably a really great way to describe them as programs kind of ebb and flow and as activities ebb and flow.

So for instance, for the DARE-BV1 program, we've guided, it's a $10 million spend all-in through the MDA (sic) [FDA] filing. That, obviously, is not all happening this year. Some of it happened last year. Some of it's happening next year. As I mentioned, we look to make that filing in 2021. And it's not going to be straight-lined either over the course of what we said this year is going to be straight lined. So it is going to ebb and flow, and there's no great way for us to guide other than that high level like.

Yes. And Sally, I just would add to that, that clearly, our goal is to start the DARE-BV1 study in July. So once we start actively enrolling, there will be some expenses. But as Sabrina said, it's not a straight line, because we kind of can turn certain other activities, preclinical and clinical, on and off, based on the cash we have available and also the market environment. So -- but thank you for asking that.

Okay. I have another question. On the Ovaprene trial, I'm just curious. How many patients will be enrolled?

Yes. So with Ovaprene, again, just high-level quick background for those who may not be as familiar, but Ovaprene is a combination product. It's regulated with the device division of the FDA leading the review. And that was relevant because it's a little bit different than a hormonal product. So typically, with hormonal products, yes, you're looking at typically 2,000 or so subjects and exposed to the product to support a registration. On the device division, it's typically around 250 subjects.

And so yes, so big difference, which makes, obviously, a difference in terms of time and spend. So that's helpful with the program. And so as I mentioned, we are in the process of working on the IDE submission that is planned for this year. Once that process is completed and we have FDA clearance on that, we're going to be able to give very, very specific guidance on exactly how many subjects. But that is the norm for that division of the FDA, and we don't expect to treat it differently.

So I'm curious. With this type of a product, what will be the placebo control?

Yes. So contraceptive studies, you -- for ethical, for whatever reasons, I'm not sure why they do it this way, but there is no placebo arm. So everyone gets the contraceptive product, and you look at pregnancy rates over the course of the trial duration, and they're either -- they're 6 to 12 months typically in duration studies. So you're looking at pregnancy rates, but everyone is exposed to your study drug.

Very helpful. And congratulations on good progress.

Thank you very much.

Thank you.

And our next question will come from the line of Jim Molloy from Alliance Global.

I had just a quick question on the studies that came out in the New England Journal of Medicine on the Lactin-V to prevent recurrence of bacterial vaginosis. That study, I guess, I know it just came out today. Is this sort of old news? Can you walk through how that impacts or speaks to the market for BVI?

Yes. No, Jim, thanks for asking that question, and thanks for being on top of that because that just came out today. Yes. So if you think about, again, indulge me for a second. Just take a step back on bacterial vaginosis. When you think about the condition, there's really two things we think about with bacterial vaginosis in managing the women who are dealing with the condition. One is treating the acute infection. So when she has that acute infection, you really want to get it under control as quickly as and efficiently as possible because of the nuisance side effects I mentioned, obviously the odor and the discharge, but it's also associated with preterm birth and infertility. So it's an important infection to get under control.

So one, you want to get that infection under control quickly. And that's what DARE-BV1 is targeted at doing, right? That's where the 86% cure rate that was seen in the investigator-initiated Phase IIb is so important, given its comparison to the standard of care right now. FDA-approved where the cure rates are 30% to mid-60s.

The publication that came out today, which we're also super excited about seeing and following, is really looking at nonantibiotic approaches to prevent or slow the recurrence of infection. So women who get this condition, and often these are the women who have the most bothersome symptoms, also unfortunately get several bouts of the condition per year, so 3 or more. So those are women who have recurrent infection.

And so not only are you trying to get rid of the infection as quickly as possible, acutely, when she has a bad bout, you're also trying to delay, kind of increase the time or reduce the rate of recurrence, and that's what the probiotic product, the lactobacilli product that was reported, is looking to do. And we think that's also a very exciting approach and an important approach in the category.

Yes. And I would just say -- this is John. I would just say that we think it's complementary to DARE-BV1, in the sense that we're treating the underlying infections to resolve it, and then this product is something that can prevent future recurrence.

Yes.

And our next question will come from the line of Nathan Weinstein from Aegis Capital.

Sabrina, Lisa and John, I just have a big picture question on Sildenafil Cream and the FSAD indication. Maybe you could give us your thoughts on how awareness of the condition has evolved historically? And sort of opine on how that could evolve over time?

Great question. That -- I mean it's a condition that, obviously, we're very passionate about. And great timing for the question, too, because you actually had a call yesterday with one of our key opinion leaders we work with, Dr. Sheryl Kingsberg, just around that program. And talking about just this, the awareness of the condition, the comfort that people can have talking about it, looking at -- if you think about what happened in the erectile dysfunction category, go back in time before Viagra and after Viagra and the openness that people talk about it.

And in this COVID environment, there's also some really interesting trends of telemedicine and how people are using telemedicine, and it brought out some interesting factors in terms of people being more open with telemedicine, about talking about conditions like this that maybe they weren't coming forward with about before in a more intimate clinical in-the-office setting. And so there's definitely a lot more awareness in general about the condition. That is going to continue, in our belief, to grow and enhance as we advance this program through clinical development, and that creates more awareness and conversations about the condition.

So we really do expect it to follow a very similar market awareness kind of trajectory that erectile dysfunction did with the advent of new pharmaceutical treatments, both during their development and once they came on the market. So we really expect a similar trajectory today. And frankly, with this program, as it advances. And frankly, this COVID environment has also given us some insights into potentially even new tools and new ways to think about it and talk about it, to create environments where women can feel very comfortable speaking out similar to men's do now with erectile dysfunction, which is important because, frankly, this is just as distressing to women as erectile dysfunction is to men.

And I'm not showing any further questions at this time. I'd like to turn it back over to Sabrina for any closing remarks.

Great. Well, thank you, everyone, for taking the time this afternoon. We appreciate it. And maybe just to summarize. Our partnership with Bayer, that we talked about, is off to a great start, and we're really looking forward to a long and productive relationship with Bayer as we work to advance the Ovaprene program through clinical development and bringing that new innovation into the contraceptive category.

And as we mentioned, our partnership with Health Decisions is a nice adjunct to that, with the expectation that it's going to help us to accelerate the clinical development of our reproductive health programs in both the time, and as we talked about, cost-efficient manner as well. In addition, we'll continue to focus our near-term efforts on the conduct of our DARE-BV1 Phase III study this year, as we've discussed, with the top line data expected before the end of the year. And we'll continue to study start-up activities and the other nonclinical work that we alluded to, if necessary, to support our overall program objectives for both Sildenafil Cream and Ovaprene.

And we look forward to keeping you updated on our progress, and we remain grateful to the entire Daré team and importantly, to our shareholders, for their commitment and dedication to our mission, particularly now.

So with that, we thank you and look forward to keeping you informed.

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