Welcome to the conference hosted by Daré Bioscience to review the company's financial results for the quarter ended June 30, 2023, and to provide a general business update. This call is being recorded. My name is Mark, 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 Commercial Officer; and Lisa Walters-Hoffert, Daré's Chief Financial Officer. Ms. Johnson, please proceed. Thank you. Good afternoon, welcome to the financial results and business update call for the quarter ended June 30, 2023 for Daré Bioscience. For those of you joining us via webcast, you should be able to access presentation slides from within the webcast module. We've included the slides to provide some additional context on our portfolio that you may find helpful while you listen to the call. The slide deck is also available in the investor relations section of our website under presentations, events, and webcasts, and will remain on the site for two weeks. Today, we will review our second quarter results and discuss developments and expectations for XACIATO commercialization and for two of our late-stage investigational products, our hormone-free monthly intravaginal contraceptive candidate, Ovaprene, and Sildenafil Cream, 3.6%, which is being developed as a treatment for arousal disorder in women. Before we begin, I would 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 Form 10-Q for the quarter ended June 30th, 2023, which was filed today. 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 10, 2023. Daré undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. As a reminder, at Daré, women's health is our sole focus. We believe that innovation in women's health needs to be a priority, and we believe investment in women's health would be efficient and disproportionately impactful. Given that women control 80% of U.S. healthcare purchasing decisions, and that although only 1% of healthcare research dollars are invested in women's health, women's health products nonetheless make up 27% of total products generating over $500 million in revenue annually and contribute to 35% of total blockbuster sales. We are working to identify and advance new therapies that provide additional choices and improve outcomes so that we can make a difference in the lives of women everywhere. Our current innovation efforts are focused in contraception, vaginal health, reproductive health, menopause, sexual health, and fertility. Our portfolio includes 1 FDA-approved product, which is being commercially launched by Organon, and 5 clinical development stage candidates, 3 of which are in or nearing phase III development. Today, I will provide development updates on 2 of the late-stage candidates, Ovaprene and Sildenafil Cream. John will provide an update on XACIATO, and Lisa will review our financial results for the quarter ended June thirtieth. Let's start with Sildenafil Cream. Sildenafil Cream is our investigational candidate to treat sexual arousal disorder in women. Arousal disorder in women is characterized by the inability to achieve a sufficient physical response to sexual stimulation that causes clinically significant distress. Of the various types of female sexual dysfunction disorders, arousal disorder in women is most analogous to erectile dysfunction, or ED, in men. Sildenafil, which is a phosphodiesterase-5 inhibitor, is the active ingredient in a tablet for oral administration, currently marketed under the brand name Viagra for the treatment of ED in men. Sildenafil Cream is an investigational proprietary topical cream formulation of Sildenafil, specifically designed to be used on demand at the time of sexual activity to increase blood flow to the genital tissue of women. If development is successful, Sildenafil Cream has the potential to be the first FDA-approved product to treat any form of arousal disorder in women. Market research suggests that 16% of women in the U.S., ages 21 to 60, or approximately 10 million women, are distressed from experiencing no or low sexual arousal and are actively seeking solutions to improve their condition. In comparison, the prevalence of complete ED in men is estimated to be about 5% of men at age 40, increasing to about 15% at age 70. Women who experience no or low sexual arousal are bothered by and, or are dissatisfied with their sex lives. They're frustrated with their sexual problem, they experience guilt about their sexual difficulties, and they are likely to feel sexually inadequate, inferior, and embarrassed. Sound familiar, like what men with erectile dysfunction experience? As men did before effective ED treatments, women are suffering in silence and are affected by a feeling of shame and embarrassment.... We are working to change this for women by developing a treatment that can address their lack of physical arousal response, which we believe, in turn, will improve their sexual interest and reduce dissatisfaction with their sex lives, as the effective ED treatments did for men. On June fifth, we reported top-line results of the exploratory phase IIb RESPOND clinical study of Sildenafil Cream. On July eleventh, we reported additional positive data from the study and hosted a webinar with KOLs, key opinion leaders, to further discuss the findings from the study. For those of you who missed those updates, I wanted to take a moment today to highlight some of the key results and outcomes of the phase IIb RESPOND study and the implications for future development. Now, the purpose of the exploratory phase IIb RESPOND study was to test the sensitivity of several patient-reported outcomes, also referred to as PRO efficacy endpoints, and their ability to determine a treatment effect of Sildenafil Cream compared to placebo, to inform the ongoing development of Sildenafil Cream. The study also served as a validation study of exploratory endpoints that could be candidate efficacy endpoints in a phase III study of Sildenafil Cream. Because there are no currently FDA-approved treatments for any form of arousal disorder in women, there are no efficacy endpoints that have been previously approved for use in a phase III pivotal study for potential treatment of those disorders. In the phase IIb study, the Sildenafil Cream-treated group showed improvements in multiple aspects of the sexual experience, including arousal, lubrication, achievement, and pleasure of orgasm, and sexual desire. The data indicates that, as compared to placebo, Sildenafil Cream had a therapeutic effect based on several of the exploratory PROs. The data from the phase IIb RESPOND study, we believe, certain of the primary, secondary, and exploratory endpoints based on that study could be candidate endpoints in a phase III study of Sildenafil Cream. Having now completed this pioneering work in the field of arousal disorder in women, we look forward to reviewing the data with the FDA, including discussing the data from assessments as early as the four and eight-week mark after randomization, and continuing the development of Sildenafil Cream, including our objective of initiating the first-ever phase III pivotal study of a therapeutic candidate for the treatment of arousal disorder in women. It is our belief that a candidate that can successfully address the significant unmet need of arousal disorder in women represents one of the largest opportunities in women's health today. We therefore believe that Sildenafil Cream represents a promising clinical candidate and a meaningful valuation driver for our company. Sildenafil Cream has the potential to be the first FDA-approved product to treat any form of arousal disorder in women, and we remain committed to working with our development partner, SST, and the FDA to move this candidate forward. We are continuing to analyze the data from the Phase IIb RESPOND study and are targeting an end of phase II meeting with the FDA before the end of this year, before the end of 2023, which, if successful, would support phase III commencement in early 2024. Following clinical development, which we expect will include two pivotal phase III studies, we intend to leverage the existing safety and efficacy data on the active ingredient in Sildenafil Cream to utilize the FDA's 505(b)(2) pathway to obtain marketing approval in the U.S. We look forward to keeping you updated on this program, particularly as we collaborate with the FDA on the phase III program. I'd like to turn to Ovaprene. Ovaprene is our investigational, potentially first-in-category, hormone-free, monthly intravaginal contraceptive. There truly is nothing like it on the market today. While a monthly hormone-containing vaginal ring product has been available for several years, NuvaRing peak sales reached nearly $1 billion. There is no hormone-free counterpart with a similar monthly intravaginal dosing format. We have been working closely with our phase III collaborator, NICHD of the NIH, on the pivotal study planned to start later this year. Specifically, the pivotal phase III study of Ovaprene is being supported by the NICHD's Contraceptive Development Program, which oversees the Contraceptive Clinical Trials Network, or CCTN, established in 1996 to conduct studies of investigational contraceptives. We expect to commence subject enrollment in the fourth quarter of this year. The study is a multicenter, single-arm, non-comparative, pivotal phase III contraceptive study of Ovaprene to evaluate its effectiveness as a contraceptive device, along with its safety and usability. Based on our communications with the FDA, if successful, this will be the single registration study required to support the premarket approval application submission with the FDA. A few details on the study. This is a non-comparative study, meaning all women will use Ovaprene. There is no placebo in this study. We will target having approximately 250 subjects complete 12 months, that's 13 menstrual cycles, of use. Based on typical dropout rates for contraceptive studies, we will look to enroll more than double of our target number of completers. Once enrollment is well underway and we have a clear sense of dropout rates in this study, we'll be able to provide guidance on when to expect study completion. The primary objective of the study is to assess pregnancy rates over 13 cycles. Primary endpoint, we'll be using a Pearl Index, typical use Pearl Index. This is the common primary endpoint for contraceptive product candidates. Secondary objectives are looking at the contraceptive effectiveness on a typical use pregnancy probability basis over the 13 cycles, as well as safety and acceptability. We recognize that while much work had been done over the last 20 years to improve hormonal contraception, efforts to innovate non-hormonal options have lagged. Therefore, we believe that Ovaprene has the potential to be a disruptive product in the contraceptive category, as NuvaRing was when it entered the market as the first monthly intravaginal contraceptive delivering hormones. As Mirena did when it entered the market as the first hormone-releasing intrauterine system. Speaking of Mirena, Bayer, a leader in commercializing contraceptive products in the United States, holds the U.S. commercial rights to Ovaprene under a license agreement with us. I will now turn it over to John to provide a commercial update on the XACIATO launch activities, as well as on commercial preparedness activities for our development candidates, Ovaprene and Sildenafil Cream. Thank you, Sabrina. As a reminder, XACIATO clindamycin phosphate vaginal gel is a lincosamide antibacterial for single-dose vaginal administration, indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older in the United States. Organon, our global commercial collaborator, believes there is roughly a 90% overlap of healthcare providers who prescribe their contraceptive product, NEXPLANON, and have the potential to be prescribers of XACIATO based on provider treatment patterns. Because of these strong relationships, the Organon sales team has with these healthcare providers, we expect Organon to be well-positioned to detail XACIATO and drive product prescriptions and pull-through on day 1 of launch. We believe that XACIATO should be well-positioned for commercial success, given the knowledge and experience of Organon's NEXPLANON sales team, coupled with their planned marketing and payer outreach initiatives, as we have outlined on previous calls, and we plan to provide further updates once the product is on the market. Organon and Daré are working towards a U.S. launch as soon as feasible. Looking ahead to our later stage programs, in parallel with the Ovaprene phase III study activities, our team has been busy working with our collaborator, Bayer, on key commercial initiatives to ensure a seamless transition from clinical development to commercial introduction. We have organized a cross-functional team to align and activate on key aspects of the brand, including packaging, messaging, and key opinion leader targeting. These activities will help set the foundation for additional downstream post-approval sales and marketing activities. Finally, we are truly excited about the progress on the Sildenafil Cream program. As we continue to analyze the data, we are planning to implement a robust medical communication strategy to make sure we are educating all of the key stakeholders in women's health and sexual health on key aspects of the condition, including pathophysiology and quality of life issues, and plan to work with our colleagues on the medical side to ensure broad dissemination of this information. We will have more information on these initiatives moving forward, but we remain very excited about the opportunity to bring forward a first-in-category solution like Sildenafil Cream, that has the potential to improve the lives of millions of women dealing with sexual disorder and bring a much-needed new option for providers that currently have nothing to prescribe them. With that, I will turn the call over to Lisa. Thank you, John. Thanks for all of you for joining today. I would now like to summarize Daré's financial results for the quarter ended June 30, 2023, which I will refer to as the current quarter or the second quarter. As you know, Daré's business model is to assemble in advance a portfolio of differentiated product candidates that address meaningful unmet needs that we've identified in women's health, and then to monetize the value of the portfolio's clinical and regulatory advances over the near and long term. The investment required to build and advance a portfolio includes corporate overhead, portfolio acquisition and maintenance costs, and ongoing research and development, or R&D expenses. During the second quarter, our general and administrative, or G&A expenses, were approximately $2.9 million. Our R&D expenses, which vary from period to period based on our clinical, preclinical, manufacturing, regulatory, and other activities across our entire portfolio, were approximately $6 million, and primarily reflected the costs associated with the Sildenafil Cream phase IIb RESPOND clinical trial that Sabrina just summarized, and manufacturing and regulatory affairs activities related to Ovaprene's planned phase III study. Our comprehensive loss for the current quarter was approximately $8.7 million. We ended the current quarter with approximately $13.3 million in cash and cash equivalents. As of August 9th, 2023, we had approximately 87.8 million shares of common stock outstanding. Under our license agreement with Organon for XACIATO, we received $1 million in July, and we are entitled to receive $1.8 million following the first commercial sale. Thereafter, we will be eligible to receive potential additional milestone payments of up to $180 million, as well as tiered double-digit royalties based on XACIATO's net sales. We are continuing to explore a variety of options to fund our operations and advance our candidates, monetize the value of our assets, and build share, shareholder value. These alternatives include, but are not limited to, non-dilutive grants like the one we recently received from the NIH for a preclinical candidate, equity sales, license agreements, structured financings, and strategic collaborations or alliances. As we've said previously, we will endeavor to be creative, collaborative, and opportunistic in seeking the capital needed to meet our objectives and to build shareholder value. We encourage all investors to review the more detailed discussion of our financials, our financial condition, liquidity, capital resources, risk factors in the Form 10-Q for the quarter ended June 30, 2023, which we filed today, and in our annual report on Form 10-K for the year ended December 31, 2022, which was filed on March 30th, 2023. I would now like to turn the call over to the operator. Thank you for attending the conference call. At this time, I would like to remind everyone, in order to ask a question, press star, then the one on your telephone keypad. It's star, then the one on your telephone keypad. Your first question comes from the line of Catherine Novak with Jones Research. Kathryn, the line is now open. Hi, good afternoon. Thanks for taking my question. I guess just, you know, a couple of questions on Ovaprene. Can you remind us what's still gating the initiation of the study? You know, what are some key inclusion/exclusion criteria that you are anticipating that might affect the screen rate and enrollment rate of the study? Yeah, great questions, and thanks for your questions, as always. In terms of what's gating the, the start of the study, we're really, you know, gearing up to be ready to go. As I've mentioned in my comments today, we're working with the NIH, the NICHD, on the conduct of the study, and they actually held an investigator meeting with the investigators who are identified for the Ovaprene study actually last December. These investigators have been excited and primed for a while. You may recall there were some comments from the FDA when we got our IDE approval to move forward with the study, with some recommendations on some tweaks around considerations around the protocol that they, you know, encouraged us to make to ensure that it would meet all their expectations. So we have done that, and then we've been getting the sites kind of reoriented to the protocol and ready to go. So we're really preparing to initiate enrollment now in the fourth quarter. Obviously, we've been, you know, manufacturing with our partner to prepare for that. We're super excited to get started, obviously, and, you know, all the pieces are coming together and are on track right now for that. In terms of... and, and all the sites, as I mentioned, they're the clinical trial. They're networks, the Contraceptive Clinical Trials Network sites, that are participating in this study. It's about 20 sites right now that are participating in this study, and so they are, you know, they're all set up. In terms of the key and kind of inclusion, exclusion criteria, it's pretty standard for, for contraceptive studies. Patients, you know, have to be of a certain age. They have to be in a committed partnership. They have to have a commitment to have certain number of sexual events, you know, every month. You know, they, they can't have certain, you know, medical conditions that would be pretty standard in a contraceptive study to be exclusionary. There's nothing really unique in terms of the inclusion and exclusion criteria for this study. What we do see, though, with contraceptive studies, that, as we've looked across a number of these contraceptive studies that have been conducted over the years, and that's one of the nice things about working with the NIH and the Contraceptive Clinical Trials Network, is that we get the benefit of a lot of other studies they've done for, you know, for their sponsors and products. What we've seen is that the we've seen kind of meaningful, frankly, differences in dropout rates and screening rates across different contraceptive studies. Those all can obviously impact kind of your timelines and enrollment. That's one of the reasons that I stated in my comments. You know, we want to get our particular study going in this particular day and age, right, in this environment, and then get a sense of what those metrics look like, and then that'll allow us to, to give kind of strong predictions on, okay, here's when we expect, you know, the study to complete. In terms of initiating enrollment, you know, we're targeting that for the, for the fourth quarter and are very much looking forward to getting started. Hopefully that answered your questions. No, that, that was very helpful. Just curious if you can talk about the, the expected geographic spread of the 20 sites. I'm curious, you know, what you're seeing in terms of enrollment dynamics based on, I guess you would say, the political environment? Yeah, let's go. Yeah. Reproductive rights, you know, what's the, the level of interest across different, areas of the U.S.? Yeah, fantastic question. The sites are spread across the country, so, you know, pretty, pretty good diversity across the country in terms of where the sites are. That also means there's some diversity in terms of kind of what the reproductive right, you know, right landscape is in the particular state, you know, where that site is. What we've seen across the board, these are investigators that have all participated in, you know, lots of contraceptive studies and are very experienced in that regard. You know, their view is that obviously it's, it's a factor, right? It's something that people are considering, and certainly people that are signing up for a contraceptive study. By definition, they have to be open to the fact that they may get pregnant, right? It's an investigational product. So they have to, you know, be aware that that, you know, that that is a factor. Where they reside, you know, that may be more meaningful to them than, you know, maybe in a different state, in terms of, you know, what their propensity and, and comfort with that is. All of the sites, feel that it, you know, it. None of them have really projected that it would change, how they anticipate enrollment progressing, because, you know, their view is that it, it's always a consideration anyhow, and that in general, people who tend to participate in contraceptive studies, you know, generally have a, a good acceptance of the fact that they may get pregnant and are prepared for that outcome. It's definitely something that has been discussed, right? As we think of, you know, the sites, I would say the states where there's been a lot of interest beyond this Contraceptive Clinical Trials Network, because we get lots of inquiries beyond that, of people who want to participate in the Ovaprene study. I will say they do tend to be in, I would say sites that have great access to contraceptives, and so I think they're just state, states and sites that are just excited to get even more products out there. Okay, that makes sense. Just lastly, can you remind us, you know, the estimated cost of the study and how much the split, the cost is split between you and your partner at NIH? Yeah. The way that CRADA is set up with the NIH, we are, like, co-running the study together, right? We have a responsibility for all of the clinical supplies. That we bear 100% of the cost of providing the Ovaprene supplies for the study. Then the way that CRADA works is Daré puts funds into, basically to the NIH, basically into an account for use in this study. We have contributed our $5 million to date to that account. There's another $500,000 that we would anticipate right now providing, you know, later this year to support the study as well. Those funds, you know, should be sufficient. However, you know, clinical trial costs can vary, right? As you've studies progress, things happen, right? Or if we add additional sites. There are a number of factors that could change the cost of the study. If that happens, then we and the NIH would come together and decide, you know, what our contribution would be, what their contribution would be, if that were to happen, and adjust accordingly. Right now, like, we've put our money there, and those are the funds, along with support from the NIH, to conduct the study. Okay. That's, that's very helpful. Thanks for taking my questions. Have a great afternoon. Yeah, thank you. Again, if you would like to ask a question, press star, then the one on your telephone keypad. Your next question comes from the line of Michael Elton. Michael? Oh, I'm sorry, but I think we will lose Michael. Okay, there are no further questions at this time. I would like to turn the call back to our tour centers. All right. Well, thank you for taking the time this afternoon to hear about our recent updates and ongoing commitment to drive value for our Daré stakeholders, women, healthcare providers, and our shareholders. With our diverse portfolio, we seek to bring to market differentiated prescription therapies that prioritize women's health and well-being, expand treatment options where none exist, enhance outcomes where current standard of care has meaningful shortcomings, and improve ease of use for women, where a more compelling form factor can drive adoption, primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health, and fertility. We definitely look forward to keeping you updated on our progress towards the milestones we discussed today, specifically our XACIATO product launch and first commercial sale by Organon. As John mentioned, we are working together to achieve a 2023 launch as soon as feasible. Patient enrollment in the phase III clinical study of Ovaprene, our investigational potential first-in-category, hormone-free, monthly intravaginal contraceptive, whose U.S. commercial rights are under the license agreement with Bayer. As we just discussed, we expect that single pivotal study to support Ovaprene's premarket approval application and enrollment is targeted to commence this fourth quarter of this year. We're also looking forward to our end-of-phase II meeting with the FDA and finalization of a phase III protocol for the Sildenafil Cream study. In addition, we look forward to announcing data later this year from our phase III study, evaluating a vaginal gel formulation of diclofenac being developed as a treatment for menstrual pain and cramps, as well as ongoing activities related to IND and phase III and phase III preparations for our two menopause programs: hormone therapy for the vasomotor symptoms in menopause and a hormone-free vulvovaginal atrophy treatment, respectively. With that, I thank you again for your time today and for your support. Thank you. This concludes today's conference call. You may now disconnect.