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

Thank you, and welcome to our financial results and business update call for Daré Bioscience. We are looking forward to discussion our second quarter results and highlighting recent developments and anticipated milestones for the remainder of 2020 and beyond. Before we begin, I'd like to remind you that today's discussion will include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical facts should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by these statements due to unknown and known risks 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 31, 2019, which was filed on March 27, 2020 and our quarterly report on Form 10-Q for the quarter ended June 30, 2020 which was filed today. I'd also like to point out that the content of this call includes time-sensitive information that is current only as of today, August 12, 2020. Daré takes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. As you know, Daré is a leader in women's health innovation and we're squarely focused on improving the life and wellbeing of women. Our value creation strategy is to accelerate 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…

Thank you, Sabrina, and good afternoon, everyone. I'm pleased to provide you with a brief update on our ongoing alliance with Bayer to support the continued development of Ovaprene for its first-in-category contraceptive potential. The relationship continues to be highly productive and value additive and our collective teams have achieved alignment across key areas, including clinical, nonclinical and regulatory work streams. They are, as we've mentioned, is a worldwide leader in branded contraceptive sales and marketing, and their insights and expertise as applied to Ovaprene, continue to be invaluable in our opinion. And those of you familiar with our story know that partnerships and out-licensing transactions are core to our model. We remain very encouraged by the level of interest in our portfolio and we continue to proactively pursue meaningful partnership opportunities with well established and emerging companies, both in the U.S. and 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.

Thanks, John. Hey everyone, and thanks for joining us today. I would now like to summarize Daré's financial results for the quarter ended June 30, 2020. Daré's business model is to assemble, advance and monetize a portfolio of novel product candidates in women's health. As a result, our expenses consist of corporate overhead, portfolio acquisition and maintenance costs, and research and development activities to generate the clinical and other data necessary to advance our candidates through regulatory milestones including approval. For the quarter ended June 30, 2020, Daré's general and administrative expenses were approximately $1.6 million, license expenses were approximately $21,000, and research and development or R&D expenses were approximately $5.6 million. In addition to the personnel costs of our R&D team, our primary Research and Development expenses this quarter included or to prepare for and to start our DARE-BV1 pivotal Phase 3 study, ongoing regulatory affairs and other work related to Ovaprene, and preclinical development activities for DARE-LARC1 which as Sabrina had noted were supported by our grant from the Bill & Melinda Gates Foundation. Our comprehensive loss for the quarter was approximately $7.1 million. Net cash provided by financing activities for the six months ended June 30 were approximately $11.3 million. This represented cash from sales of stock under our at-the-market or ATM facility and equity line, exercises of warrants and options, and loan proceeds. We ended the quarter with approximately $5.3 million in cash and cash equivalents. Now there were several developments over the last four and a half months that are worth highlighting given their current and anticipated future impacts on both our cash burn and our operating expenses. 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…

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

Thank you. [Operator Instructions] The first question comes from the line of Nathan Weinstein with Aegis Capital. Your line is now open.

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

Thank you Nathan, that's a really great question. So there are definitely a number of factors that are involved because everything in our portfolio pretty much has an opportunity be first in category, right? So they're all super exciting from our perspective opportunities and there are products we also selected for the portfolio because their potential attractiveness to partners. With the HRT-1 program in particular, we saw a few really compelling reasons to want to get that program moving forward. 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 demand guidelines in terms of delivering the hormones in a way that is non-oral, non-systemic, delivering them vaginally and in a very convenient once every 28-day route with both hormones together. And there are significant data demonstrating that hormone replacement in women who can use it can be very impactful and not only addressing those symptoms that she experiences in menopause, but importantly also cardiovascular and bone health as well. So, the program's market potential is very interesting and we obviously want to move it forward. So on a practical consideration as well, this Phase 1 study is quite efficient from two perspectives, and these are my other two points that I wanted to make in terms of how we selected to advance this one right now. One is conducting the study in Australia certainly offers us some very meaningful cash incentives in terms of the cash rebates. So it is essentially with that currently 43% rebate, it basically cuts the cost of conducting a study to develop in half. And so it makes it a very capital efficient place to conduct a…

Great, thank you. Interesting comprehensive answer, and so I guess just another slot, a question here on the pipeline, in terms of the competitive dynamics in women's health and you have a 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 or I guess versus 6 or 12 months ago?

Another great question Nathan, Thank you. I have to say, it's 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 values. So we really do critically look at the portfolio in all times to make sure that we're prioritizing programs in the right way and we also use that outward focus lens to make sure that we continue to have the most robust portfolio in women's health really across the most persistent unmet needs and interesting indication. 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 short term place we also wanted to take a hard look at what trials can we conduct right now? How can we keep our time lines on track 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 is probably hard to do. And so that's a very long answer and a long way of saying, yes Nathan, we do that all the time, and we came out the other end of that still very happy with our portfolio and continuing to feel that really across the portfolio the programs are relevant. They are continuing to have that potential to address some of the most persistent unmet needs, and maybe most important given our business model, are partner able and address those commercial needs that the companies that are focused and investing in this healthcare space they are interested in.

Great, thanks Sabrina, and just a final question from me. In our ongoing conversations one of the themes that keeps coming up is the perennial under investment that's going on in women's health and also to comment on the U.S., but I guess this question is really about the international markets through your future products, I think when they become into the commercial arena 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.?

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

Yes, I know, 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 these opportunities really become innovation in and of themselves, and so we look at our European opportunities, they're as big or as rich as they are in the U.S., and those discussions are really have been really meaningful and as I mentioned, we've 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, so more to come on that but great question. Thanks for asking that.

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

Thank you, I really appreciate it.

Thank you. [Operator Instructions] And our next question comes from the line of Jason McCarthy with the Maxim Group. Your line is now open.

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

Yes, thank you for asking about that program. It's one where, there's just a lot of interest 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-LARC1, 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. There really is not anything like that, certainly, available at this time. And that is why for instance, the Bill & Melinda Gates Foundation, which as we mentioned upfront has contributed quite significantly to the development of this technology, have 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 & Melinda Gates Foundation have been funding really is validation for the technology in general and the platform in general. 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.

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

Thank you.

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

Well, thank you Chris, and thank you all for taking the time this afternoon. So maybe to summarize, as we highlighted, we'll continue to focus our near term efforts on the conduct of our DARE-BV1 Phase 3 study this year, with the topline data expected by the end of this year. As we talked about the DARE-HRT1 study is underway and we will continue those activities and obviously we will continue all the startup activities in other nonclinical work necessary to support our overall program objectives for both Sildenafil and Ovaprene and as I mentioned, keeping them on track for those respective topline 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 the - 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.

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