Thank you all for standing-by. And welcome to the conference call hosted by Daré Bioscience to review the Company’s Financial Results for the Quarter Ended June 30, 2021, and to provide a General Business Update. Please note that this call is being recorded. This is Jessi, and I’ll 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. Good afternoon and welcome to our second quarter 2021 financial results and business update call for Daré Bioscience. Our plan today is to review last quarter’s results, discuss developments since our last call in May and use the time to highlight objectives and milestones anticipated for the balance of 2021. Before I begin, I’d like to remind you that today’s discussion will include forward-looking statements within the meaning of the Federal Securities Laws, which are made pursuant to the Safe Harbor provision to 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-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 Form 10-Q for the quarter ended June 30, 2021, which was filed today as well as our Annual Report on Form 10-K for the year ended December 31, 2020 was filed on March 30, 2021. I would also like to point out that the content of this call includes time-sensitive information that is current only as of today, August 12, 2021, Daré undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. Daré is a leader in women’s health innovation, and we are squarely focused on improving the lives and well-being of women. Our value creation strategy is to accelerate availability of new prescription products for women by selecting and advancing product candidates that we believe have the potential to be first-in-category and first line and have meaningful…

Thank you, Sabrina. Now that the NDA for DARE-BV1 has been accepted for filing by the FDA, and priority review has been granted. We anticipate acceleration across the three main commercialization strategies we've been progressing in parallel. Given that the DARE-BV1 partnering process has been strategically and purposely aligned with the DARE-BV1 regulatory process.Those scenarios include a straight out license to a strategic partner, where the partner is solely responsible for commercialization in exchange for milestone and royalty payments to Daré based on the revenue generated by the product, a second scenario where we strategically partner DARE-BV1, but we’ve options to have a role in the commercialization of the product. And finally, a scenario we can play a direct and active role in commercialization that includes influencing the go-to-market and planning strategy, including market introduction through a strategic partnership with a full service contract sales organization. All three options are currently under discussion. Principally and in the context of DARE-BV1 and really across all of our product candidates. We are focused on doing what's best for women, which is to ensure that these products have broad commercial access, and that benefits all of our stakeholders, specifically our investors. We will use this lens to help guide us through our process and to solidify the best strategic opportunity for the introduction of DARE-BV1 if approved. As many of you know, women diagnosed with bacterial vaginosis are challenged, often routinely to find interventions that can rapidly address the signs and symptoms of infection and also address and resolve the underlying infection itself. Currently available FDA approved treatment options work about half the time on average. It's our belief that DARE-BV1s product profile will appeal to both patients and providers, as it has the potential to provide a clinically meaningful improvement over currently…

Thanks, John. Hi, everyone. Thanks for joining us today. I would now like to summarize Daré’s financial results for the quarter ended June 30, 2021 Daré’s business model is to assemble, advanced 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 or R&D activities to advance our candidates through clinical and regulatory milestones, including approval. For the quarter ended June 30, 2021, Daré’s general and administrative expenses were approximately $1.8 million and our R&D expenses were approximately $7.3 million. The quarters increase in R&D expenses compared to the same period in 2020 primarily reflects increased costs of clinical regulatory affairs and other development activities related to Sildenafil cream DARE-BV1Ovapreneand DARE-HRT1. Our comprehensive loss for the quarter was approximately $9.2 million. During the six months ended June 30, 2021. net cash proceeds raised from financing activities were approximately $24.6 million and reflected sales of common stock under our ATM program, equity line and warrant exercises. We ended the quarter with approximately $9.1 million in cash and cash equivalents. Subsequent to the quarter’s end between July 1 and August 10, 2021. Daré received additional net cash proceeds of approximately $25.4 million from sales of common stock under our ATM program. In addition, in July, we received an initial cash payment of approximately $11.4 million in non-dilutive grant funding to support the development of DARE-LARC1. The entire grant awarded for up to $48.9 million, the future payments contingent upon the DARE-LARC1program achieving specified development and reporting milestones. As of August 10, 2021, we had approximately 70.5 million shares of common stock outstanding. I'd like to take a few moments to highlight a few other arrangements that we expect will favorably impact our cash…

Thank you speakers. Participants, we will now begin the question and answer session. First question is from the line of Zegbeh Jallah of ROTH Capital Partners. Your line is now open.

Hi, thanks for taking my question. Just have a few here. I think the first is for DARE-BV1. So congrats on the PDUFA date that's happening before the end of the year. We just kind of curious if the approval processes that include an inspection of your manufacturing facility. And then we're also just curious to see who's doing the manufacturing for the product.

Hi, thanks for the question. Yes, so in terms of whether it'll include an inspection, those are done at the discretion of the FDA, often there are pre approval inspections, they're not always held. So at this time given that we just received the NDA accepted to file, I'm not really in a position to answer that question, but definitely would be happy to keep people updated over time. And then we have not disclosed the manufacturer of this product other than to say it's a third-party contract manufacturer that we use. That is really an expert in the manufacturing of vaginal creams and gels. That's what they do for business. And this is not their first time through a process like this. So they were very well versed in commercialization and FDA potential infection. Q – Zegbeh Jallah: Thanks, Sabrina. And then John also mentioned some manufacturing efforts and market assets efforts. Can you elaborate on that if possible for DARE-BV1 and how you are thinking about that also in terms of -- I suppose, helping with the partnership that's coming out giving you more leverage, I suppose.

So as John noted, we're very purposely have been managing our commercialization strategy partnership process in parallel with the regulatory process, which really puts us in a nice strategic position that we are kind of fortunate to be able to do with a product like this, given the understanding of the indication and also the work that we can be doing in parallel to ensure that no matter which approach we then strategically takes, the product is well set up to be successful. And so on the manufacturing front that really means continuing to work with our third-party, which is very easy for us to do, because they are a third-party manufacturer, and therefore, it's very easy to, to get things ready. And then you know, hand that off to someone if that makes sense. And so that includes all of the work that we would need to basically have the commercial supplies ready, right to support any sort of regulatory process inspection process at the manufacturer, and the scaling and, and everything that's needed to ensure that commercial supply is ready when we are ready to watch the product and, and have labeling and all that good stuff. So there's all about work, obviously ongoing with a manufacturer, and then work that happens behind the scenes to support that right, to support the market introduction in terms of sterilization, and things like that, that need to happen. So all of that is going on, on the commercial side in terms of manufacturing. And then on the market access side, which we all know is such an important factor and consideration. There's work that frankly, no matter what path we take to launching this product is going to serve the product well to have in place. And maybe John, if I can turn it over to you to just say a couple words about the landscape analysis market access some of that work that we're doing to prepare for that.

And thanks for the question. So yes, we really view this as fundamental to the strategic launch of the asset, whether that's a scenarios that we've outlined during the call. So, we want to be prepared to understand the patient journey, want to be prepared to understand the market access levers, we're going to need to pull, when the product makes it to market, whether that's in context, or in conjunction with a partner. And we also want to understand the landscape that we're going into. Now, the good news is a lot of this is already well known, well understood. I mean, that's the beauty of bacterial vaginosis is it's a very well known, very well understood therapeutic category. So for us, it's really finding that way to differentiate the product in context of the segment we're talking to. So whether that's a payer, whether that's a provider, whether it's a patient, and that's really what this work is going to support moving forward. Q – Zegbeh Jallah: Thanks, John . And then just another follow-up there. I think that third scenario you mentioned for commercialization was perhaps influence in the market strategy. And so we just wondering, if you were to, kind of have your own sales team? How long do you think that could take to, get the product out there meaning how do you think it will impact the product launch or the timing of the launch? And then how many sales folks do you think you're going to need to have on board for this product?

Yes, so maybe I'll answer this on a on a high level. And then we should probably wrap up your questions which have been great, so that someone else can get in touch. In terms of a high level, let me just say a couple words about this. So in terms of timing of launch, really, we've been managing this process. So whichever one of these potential paths we choose, in the end, the timing really would be the same in terms of the launch timing. So part of what we've been wanting and hoping we're communicating clearly is that because of the nature of this product, and the nature of the therapeutic category, we have the luxury of being able to time the product process for strategic commercialization in parallel with the regulatory process, and not negatively impact or launch timing. So nicely, whichever way we go, the timeline is really the same. In terms of what would be required to launch I also wanted to make sure one thing is clear, which is, as we think about the launch of this product and frankly, this pertains to nearly every program in our portfolio. It's the same call point, meaning we're talking about the same universe of nurse practitioners and clinicians, physicians that manage these indications, and in some cases, some might be a little bit higher than others depending on the indication, but it's really the same call universe. And so it also, that's one of the reasons that we have the flexibility of thinking about strategically what might make sense in terms of inactive participation by Daré in the BV1commercialization because we have a whole portfolio of other women's health products behind the BV1 which have that same call point. And we believe that there are ways that if we were looking to move forward with this strategic partnership scenario with the contract sales organization, that there would be a way to do this responsibly financially and economically and strategically. And so beyond that, that's really at this point, all I'm prepared to say in terms of the strategy until we have more to reveal specifically I like here we get specific. But hopefully that gives you a little bit of context of how we're thinking about it, how we're thinking about the market, how we're thinking about the launch and importantly, that we're moving the process forward in a way that we believe is best for the product best for Daré best for our shareholders. And that includes in a manner that doesn't delay of launch are negatively impacted launch timing. Q – Zegbeh Jallah: Thanks, Sabrina.

Next question is from the line of Doug Tsao of H. C. Wainwright. Your line is now open.

Hello.

Again, Doug Tsao of H.C. Wainwright. Your line is open.

Hi, can everyone hear me?

Yes, Yes.

Yes. Hi, everyone, Chris Bialas here on for Doug Tsao. So congrats on the quarter, particularly on the NDA acceptance. So we just have two questions. The first is, can you give us a little some more detail on how the Ovaprene i.e. processes going? And, aside from the cost savings, what do you see as the main benefit of the collaborative research and development agreement? And how do you think it's the impact the study? And then I have one more after that.

And thanks for asking about that. That is arrangement. So I'll start first with the IDE, we're progressing with those activities to file the IDE it really is a matter of pulling together the non-clinical and manufacturing related information we've shared before that we really do evidential silver lining of the COVID time, basically, last year to take advantage of opportunities to have interactions with the FDA as we're planning the Ovaprene program. And so the IDE filing is really a combination of those discussions and the work that came out of it. So that's underway. And as we mentioned, we're planning to get that filed in the fourth quarter of this year. And along those lines, we have been obviously speaking with the NIH and NICHD, specifically for some time about Ovaprene, as I mentioned, in my opening remarks, they funded through a grant the pre-pivotal studies that that, frankly, led to our partnership was there on this program. And so they've been involved with Ovaprene with the majority perspective from our clinical work from day one on the program in so and had been very helpful throughout that process. And so when the opportunity arose when it was clear that there was an interest on their part, to continue that collaboration into the pivotal study, it was clearly in a really positive outcome for the program. And I'll tell you specifically why. And it really falls into three categories. So one, obviously we talked about is the financial support. We embrace non-dilutive funding strategically for our programs, and clearly did so in this case, as well, it's a great opportunity to offset some of our costs, and particularly in light of the financial arrangement that we have with their downstream. So in our ability to maintain control over…

Awesome, thank you. That was very helpful. So, just a one quick one, you mentioned about your core competency is getting this type of non-dilutive funding. And you made these two major announcements over the last month or so. So can you kind of tell us a little bit more about your strategy for securing such funding? How much effort to devote to this? And should we expect any more such funding in the near-future? Thanks.

Thank you. That’s a wonderful question. And we are very humble at Daré that we are very proud of these accomplishments, because these are not these kinds of relationships and the kind of funding that came forward through both of these relationships that we're talking about the 48.9 million for the DARE-LARC1 program, and then the co-funding from the NIH for the Ovaprene Phase 3, those are not trivial amounts, obviously. And the work that goes into establishing those relationships, the diligence that those parties do on us, and our ability to execute is quite considerable. And so it's not just a matter of time and patience and submitting, but it's also a matter of frankly, Daré executing and our track record of execution that has really enabled those kinds of relationships at those kind of levels with the main. And so it certainly is an ongoing part of our strategy. As Lisa touched on, we really like to look at all sources of funding that can help advance our portfolio we have assembled a portfolio of very interesting potential first and category products across a variety of indications, many of which have this opportunity for non-dilutive funding. So we do continue to fly as you notice, we tend to wait to break the news until we know we got the grant, even though these kinds of efforts are not just days and months, but years in the making. And so we clearly it's something we've focused on across the portfolio, and we are certainly hopeful that we will continue to be successful.

Awesome, thank you very much.

Next question is from the line of Kumar Raja of Brookline Capital Markets. Your line is now open.

Congratulations on all the progress and thanks for taking my questions. First, with regard to BV1, do you expect add-on meeting and also in terms of labeling discussions and label expectations? When is that expected to take place? And how is that going to impact your strategy in terms of partnership?

Yes, great, great question. So I think the first part, bit for me, but I think you have to be expected a panel meeting, BV1 there's a guidance document out, it's a pretty straightforward indication. So it's not something we would anticipate. In terms of the labeling and what we might expect in labeling and how that impacts the partnering strategy. What I was saying on that is that again, there are approved products for the . So, one can definitely look at the approved products in terms of what is typical to go into the label particularly section 14 around the clinical outcomes. And so that's definitely helpful for us. It has sort of ranged evolved over the years of different products have been improved over time. And so that certainly, is something that we’re looking at, and we'd like to take into consideration. But, clearly, we can look at existing product labels to get a sense of how the information is typically communicated. And it is typically communicated in those labels, along the lines of what we shared with cure rates for the primary endpoint, which is typically that modified intent to treat population at a test of cure visit, which in our case is day 21 to 30. But in some cases, it's been day 7 to 14, depending on the product and the time that we choose approve. So and in terms of how our labeling can impact the partnering process. Again, what I would say is, we've been very thoughtfully managing this process and managing it in parallel with certain regulatory kind of milestones and objectives as we've been advancing the programs and advancing the program through this process. And so, we will definitely keep everyone updated, we've guided that we expect to have something that we can share with you more definitively around that commercialization strategy to support that 2022 launch by the end of this year. And that certainly aligns with this regulatory process.

And with regard to Ovaprene, as you think about the pivotal trial, how are you thinking in terms of expectations for the pole index? And also, what are your thoughts on potential exclusion criteria there?

Yes, so, nice, nice question about how we think about the clinical outcomes of Ovaprene. And so the study that we have conducted today, that the post test study, which is the pre pivotal study, it uses a surrogate marker for contraceptive effectiveness. And so at this point in time, those are really the best data we can point to what we would expect Ovaprene to how we would expect it to perform. It uses the likely typically use effectiveness rates is what does that prove pivotal test study is predictive. And so when we look at the outcome of that study, and then we look at other contraceptive studies that have been published that has done the pre pivotal test study, and then it's gone on to one full pregnancy prevention, contraceptive effectiveness studies, the findings would be indicative of a product that should have a typical use effectiveness of 86% to 91%. So that's what just right below the range of hormonal methods, which are 91%, typical use effectiveness method. So that's what the PTT trial, the test trial that we ran would be predictive of. In terms of the actual pregnancy prevention rate, which by the way, effectiveness rate, which tends to be kind of the BBB is effectiveness rate is like the inverse of your . So, we will know that definitively once we conduct the clinical trial that we've been talking about the Phase 3 that based on the pre pivotal, that's the range that we would be predicting, based on this outcome. And for the non-hormonal methods, I should add, that would be quite promising. I mean, this is one of the reasons that there's so much interest by a variety of parties like there at the NIH and Ovaprene, it's because for the non-hormonal methods, apart from the intrauterine device, which is implanted, it's challenging to achieve that level of effectiveness. The only products that have ever historically done that are the diaphragms, they're the only product vaginal gels, the vaginal femicides do not have that level, they've got a 27 index. Condoms do not have that level, they do a little bit better, they're 82% effective. But so only diaphragms have been able to achieve it, but their . So the ability to achieve that kind of effectiveness level with them once a month products would be quite promising for the field. And we're certainly hopeful that that Ovaprene goal will deliver the way that the test study predicted.

And in terms of the exclusion criteria?

Oh, sorry. Yes. So that should be done fairly. What we have been looking at it's fairly standard for contraceptive studies. So they're pretty usable in terms of the expectations both on what requires for inclusion and exclusion, and so we right now are expecting that it will quite closely mere pending, obviously, feedback from the FDA, but what we're looking at would play closely mere other countries that do effectiveness studies.

Thank you participants. I'll now turn the call back over to Sabrina Johnson for final remarks.

Well, thank you, everyone, for taking the time this afternoon for the call for the great questions. And we really appreciate that you took the time to hear about our recent updates, our strategies and to improve options and health outcomes for women. That's what we're doing, and our ongoing commitment to drive value for all of our stakeholders. So in closing 2021, the year with a number of potential meaningful developments for Daré, some of which we already accomplished and talk about and talked about today some of which have yet to come. And so during the remainder of the year, we definitely look forward to keeping you updated on our progress against the important 2021 objectives, and the goals of the milestones that we believe will set us up to achieve important objectives across the portfolio in 2022 and beyond as well. So thank you for your time today.

And that concludes today's conference. Thank you all for joining. You may now disconnect.