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 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 discussion our first quarter results and highlighting the recent development 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 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 March 31, 2020 which is filed today.I'd also like to point out that the content in this call includes time-sensitive information that is current only as of today, 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 wellbeing 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 discuss the impact of the COVID-19 pandemic on our…

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.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 area 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 women's health clinical research and diagnostic development to help us advance our portfolio programs.The pricing structure in the agreement along with the opportunity 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…

Thanks John, and thanks to all of you for joining us today. I would now like to summarized Daré 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 three categories; corporate overhead, portfolio, acquisition and maintenance costs and research and development expenses related to clinical, non-clinical 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, licensed expenses were $12,500 and research and development expenses were approximately $2.4 million.During the quarter our research and development activities included or to prepare for the initiation of the DARE-BV1 pivotal Phase 3 study this July as Sabrina mentioned, regulatory and other activities related to Ovaprene work on two 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 microchip space contraceptive program that we acquired in November of 2019 and personnel costs of the R&D team.Our comprehensive loss to the quarter was approximately $4.3 three 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 three 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…

Thank you. [Operator Instructions] And our first question will come from line of Yasmeen Rahimi from ROTH Capital. You may begin.

Hi. This is Rachel Yang on for Yasmeen. Thank you for taking our questions. 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 types of discounts do you receive in clinical trial costs by working with your partner? And I've a follow-up. Thank you.

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 two 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 -- this will be a dedicated team that is assigned to Daré and our programs.We will have the opportunity to continue working with that teams. By the way we already worked with on our Ovaprene successful post coital 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 we're really officially formally right at the beginning of study startup mode, we can do those things real time significantly sooner. And as an example, there's conversations we have about Ovaprene for instance that studies 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.

Thank you. 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 involved and the personnel included? And what types of trials are their expertise? Thank you.

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 is contraceptive research division. That includes -- it's 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 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 demonstrate great clinical success and outcome and acumen and relationships. And in terms of the staff that we receive as dedicated staff, it really it runs the gamut of kind of 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. Thank you so much for the details. That's very helpful. And congrats on the progress.

Thank you so much.

Thank you. And our next question will come from line of Jason Kolbert from Dawson James. You may begin.

Hi guys. Congratulations on preserving a timeline in your balance sheet which is not an easy thing to do with what's going on with COVID.

Thank you.

Yes. You're very welcome. I guess I'd like to understand how you've been able to do that clinically. I mean, it just seems like a elective procedures have been in chaos. Why you feel confident that you can maintain these timelines? If you could just kind of tell us a little bit about what it's taken and maybe contracting with this particular CRO as a piece of that puzzle, I don't know?

Yes, Jason. Thank you. That is -- that's really a great question. And there are a couple things that's 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 with most critical for us as a company in terms of a 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 the vaginal exam and it is a very, very bothersome condition for the women that are affected. The 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 healthcare 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 you their ability to continue to conduct the study on the timeline 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 the sites that have been identified to…

Okay. Makes a lot of sense.

But 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. 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 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 it in the way that is…

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.

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. So thank you very much. Really appreciate the update. Talk you soon.

Jason, thank you so much. Thanks for your comments. It’s really appreciated.

Thank you. And our next question comes from the line of Sally Yanchus from Brookline Capital. You may begin.

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

Yes. I'll let Lisa address that. But just to the high level I think it's helpful for people listening and we're 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 program 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 NDA 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 lines either. Over the course if you know what we said this year is going be straight line. So it is going to ebb and flow and there's no great way for us to guide other than that high level might be.

Yes. And I would just -- and Sally, I just would add to that. But 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 environments. So -- but thank you for asking that.

Okay. And 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's for Ovaprene because it's a little bit different than a hormonal product. So typically with hormonal products, yes, you're looking at you know 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 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 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 for ethical work for whatever reasons I'm not sure why they do it this way, but that there is no placebo arm. So everyone get their contraceptive product and you look at pregnancy rates over the course of the trial duration. And there either -- there's six to 12 months typically in duration studies. So you're looking at pregnancy rates. But everyone is exposed to your study drug.

Okay. All right. Well, thank you very much. Very helpful.

Yes. Thank you.

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. You may begin.

Hi, guys. Thanks for taking my question. I have just had a quick question on the studies came out in the New England Journal of Medicine on Lactin-V to prevent recurrence of bacterial vaginosis. That's -- 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. Jim, thanks for asking that question and thanks for being on top of that, because I 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 and 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 2b. So important given its comparison to the standard of care right now FDA approved with 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 non antibiotic 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 three 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 occurrence 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 -- I think, we think it's complimentary to DARE-BV1 in the sense that we're treating the underlying infection to resolve it and then this product is something that can prevent future recurrence.

So rising tide lifts our boat I would think, I'll agree with that.

Absolutely.

Thank you.

Thank you. And our next question will come from the line of Nathan Weinstein from Aegis Capital. You may begin.

Hi, Sabrina, Lisa and John. Thank for taking my question. 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. And 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 the awareness of the condition, the comfort that people can have talking about it. Looking at if you think about what happened in a reptile 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, 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 and 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 environment where women can feel very comfortable speaking out similar to men do now with the erectile dysfunction, which is important, because frankly this is just as distressing to women as a erectile dysfunction to men.

Great. Thank you so much.

Thank you.

Thank you. And I'm not showing any further questions at this time. I 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 its going to help us to accelerate the clinical development of our reproductive health programs, and both the time and as we talked about cost-efficient manner as well.In addition, we'll continue to focus on near term efforts on the conduct of our DARE-BV1 Phase 3 study this year as we discussed with the topline data expected before the end of the year. And we'll continue to study startup activities and the other non clinical work that we alluded to necessary to support our overall program objective 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.