Welcome to the conference call hosted by Dare Bioscience to review the company's financial results for the quarter ended September 30, 2022 and to provide a general business update. This call is being recorded. My name is Paula and I will be your operator today. With us today are Sabrina Martucci Johnson, Dare's President and Chief Executive Officer; John Fair, Dare's Chief Strategy Officer; and Lisa Walters-Hoffert, Dare's Chief Financial Officer. Ms. Johnson, please proceed.

Thank you. Good afternoon, and welcome to our Third Quarter 2022 Financial Results and Business Update Call for Dare Bioscience. Our plan today is to review our third quarter results, discuss development since our last call in August and use the time to review our business strategy including why we believe investment in women's health is efficient and disproportionately impactful and to highlight some important objectives and milestones anticipated through the end of the year and in 2023. Before we begin, I'd like to remind you that today's discussion will include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical facts should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our annual report on Form 10-K for the year ended December 31, 2021, which was filed on March 31, 2022, and our quarterly report on Form 10-Q for the quarter ended June 30, 2022, 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, November 10, 2022. Dare undertakes 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, Dare is solely and squarely focused in women's health. It is our belief that prioritizing women's health is not only good for the many women lacking effective or convenient therapeutic choices, but also for a broad set of stakeholders, including their families and partners and, of course, our shareholders. We work to accelerate innovative, differentiated product options in contraception, vaginal health, sexual health, and fertility, that expand treatment options where none exist, that enhance outcomes where current standard of care has meaningful shortcomings, and that improves ease of use for women, where a more compelling form factor can drive adoption. Why? Because these are compelling markets impacting millions of women, and we have seen that innovation in these areas has led to commercially successful brands. Specifically, we find these statistics that I'm about to share about innovation in women's health compelling. Approximately only 1% of healthcare research is invested in female specific conditions beyond oncology, and women's health conditions outside of oncology comprise less than 2% of the current healthcare pipeline. Yet, women's health products outside of oncology make up 27% of the total number of blockbuster products, products that each have over $500 million in annual sales, and women's health products contribute 35% of the total sales dollars generated by blockbuster products. So, think about that for a moment. A therapeutic category that receives less than 2% of healthcare research investment is contributing 35% of the revenue generated by blockbuster brands. This is why we believe investment in women's health will be efficient and disproportionately impactful in terms of translating dollars invested in R&D to ultimate revenue generated, and is therefore not only good for the 50% of the population to whom these products are targeted, and who by the way control 80% of U.S. healthcare purchasing decisions, but it's also a good business model. As a reminder, Dare's portfolio that is focused solely and squarely on women's health is built upon the following core principles. One, each product candidate must target a meaningful market opportunity. Two, each product candidate must have first line or first-in-category potential because we seek to offer meaningful, not incremental improvement. And three, our goal is a diversified mix of candidates that can be developed efficiently in terms of time and capital and whose regulatory pathways often leverage well-known and well-characterized active pharmaceutical ingredients or API. It's the three vaginal health product candidates or potential candidates in our portfolio, specifically DARE-HRT1, the first hormone therapy, estradiol plus progesterone monthly intravaginal ring; DARE-VVA1, the first hormone-free vaginal atrophy therapy for women with hormone receptor positive breast cancer; and Glycerol Monolaurate, a naturally occurring fatty acid monoester that has shown broad antimicrobial activity, and that may be developed to potentially treat and/or prevent vaginal infections of various sources. Our commercialization collaborator is Organon, and we are thrilled that commercial launch preparation activities have begun and are ongoing. The Organon market access team is meeting with customers now to review XACIATO and obtain competitive coverage in the bacterial vaginosis marketplace. Organon will leverage its established Nexplanon sales team to accelerate XACIATO uptake at launch. Organon believes there is roughly a 90% overlap of those healthcare providers who prescribe Nexplanon and who diagnose and treat bacterial vaginosis. The strong relationships the sales team has with these providers are expected to enable immediate access as early as day one. And the first commercial sale is anticipated in the first half of 2023 in the U.S. Ovaprene, our hormone-free monthly birth control candidate, Ovaprene is an investigational potential first-in-category hormone-free monthly intravaginal contraceptive. Our commercialization collaborator is Bayer and our pivotal study collaborator is the NIH. We announced IDE approval by the FDA in October for our planned pivotal study, and we are currently reviewing and implementing additional FDA design recommendations in order for this study to serve as the primary clinical support for a future pre-market approval submission to the FDA. In other words, if successful, we expect this study to be the single pivotal study necessary to support a PMA submission to the FDA. The NIH is holding an investigator meeting with the Ovaprene investigators in December of this year, 2022, and we anticipate initiating recruitment mid-2023. We will target about 200 subjects completing 12 months or 13 cycles of use. Sildenafil Cream, our female sexual arousal disorder product candidate, Sildenafil Cream is an investigational, potential first-in-category treatment for female sexual arousal disorder, FSAD, which has no FDA approved therapies. It's a novel cream formulation of Sildenafil, the same active ingredient as in Viagra. Subject screening for the exploratory Phase 2B response study was completed in October. Approximately 160 to 170 subjects in total are expected to complete the clinical study and approximately 100 subjects that have completed all study assessments to date. Top line data announcement is currently targeted for the second quarter of 2023. DARE-HRT1, our hormone therapy for the treatment of menopause symptoms, has the potential to be a first-in-category, convenient combination hormone delivery product for the treatment of vasomotor and vaginal symptoms of menopause. DARE-HRT1 is an investigational intravaginal ring designed to release bioidentical estradiol and bioidentical progesterone over 28 days. It has the potential to be the first monthly format product with both hormones. There are no FDA approved options with both hormones in one monthly intravaginal ring. Last month we announced top line data from our Phase 1/2 study in approximately 20 healthy postmenopausal women. The primary objective of the study was to describe the safety, tolerability, and pharmacokinetics or PK of two different dose combinations over 12 weeks of use. Secondary objectives were to assess the usability, participant tolerability and preliminary effectiveness for both the vasomotor symptoms or VMS and the vaginal symptoms of menopause. Despite the small sample size, we were very pleased to announce that the levels of estradiol release from both the lower and higher dose formulation of DARE-HRT1 evaluated in the study achieved statistically significant improvements compared to baseline in the vasomotor as well as the general urinary symptoms of menopause, vaginal pH, and maturation index, all at the P less than 0.1 level. And DARE-HRT1 had a high level of acceptability in this study, with 100% of the subjects reporting that the IVR was comfortable to wear and over 95% of the subjects stating they would be either somewhat or very likely to use the IVR for a women's health condition or even unrelated disease if needed. We look forward to top line PK data from this study later this quarter. So, why are the findings from this study important? Well, the data support the potential of DARE-HRT1 to deliver effective hormone therapy in a 28-day intravaginal ring. The delivery of hormone therapy over 28 consecutive days with no daily intervention supports DARE-HRT1s potential to be a first-in-category option offering ease of use and consistent dosing to women suffering from menopausal symptoms. There are currently no FDA approved non-daily products that continuously deliver hormone therapy with both estradiol and progesterone together over multiple consecutive weeks. And DARE-VVA1, our vaginal atrophy treatment candidate for women with breast cancer, has the potential to be a first-in-category hormone-free vaginal treatment for vulvar and vaginal atrophy or VVA in a hormone receptor positive breast cancer patient population. DARE-VVA1 is an investigational proprietary formulation of tamoxifen for vaginal administration. It has the potential to be the first therapeutic specifically approved for treatment of vaginal atrophy in patients with hormone receptor positive breast cancer. There are currently no FDA approved products labeled for vaginal atrophy treatment in a hormone receptor positive breast cancer population. Globally, breast cancer is the most frequently diagnosed cancer type, accounting for over 2 million cases each year. Approximately 4 million women in the United States have a history of invasive breast cancer and of all breast cancer diagnoses in U.S. women, it's estimated that more than 68% are hormone receptor positive. Vaginal atrophy prevalence in postmenopausal breast cancer survivors is estimated at 42% to 70%. There's a clear unmet medical need for an effective non-hormonal treatment for vaginal atrophy caused by anti-cancer endocrine therapy in patients diagnosed with hormone receptor positive breast cancer. Historically, estrogen-based therapies delivered through creams, rings, and vaginal suppositories have been prescribed for the treatment of vaginal atrophy symptoms. However, the use of these estrogen-based products for the treatment of vaginal atrophy and hormone receptor positive breast cancer patients can be challenging for both healthcare providers and their patients as the use of estrogen in any form is often contraindicated for this patient population. If we are successful, DARE-VVA1 has the potential to become a new standard of care as the first and only vaginally administered product approved for the treatment of vaginal atrophy in a hormone receptor positive breast cancer population. We are on track to announce the Phase 1/2 study top line data before the end of this year. I will now turn the call over to John to provide an overview of the two commercialization collaboration agreements we have in place for XACIATO and Ovaprene respectively.

Thank you, Sabrina. Given the stage of our current portfolio and the market dynamics in the therapeutic categories, specific to XACIATO and Ovaprene, we believe the best way to generate value for Dare and shareholders is via external commercialization collaborations or out-license agreements, rather than attempting to commercialize these assets on our own. Opportunities to enter into such collaborations are ultimately contingent upon developing differentiated products that demonstrate the potential to be first line or first-in-category. So, let me begin first with the bacterial vaginosis and our first FDA approved product, XACIATO. Organon, our global collaborator for XACIATO, shares our commitment to advance critically needed innovations in women's health. And we believe that Organon unique focus on women's health, coupled with their strong commercial capabilities, will ensure that XACIATO reaches women most impacted by this condition. We believe that Organon is uniquely positioned to bring XACIATO to market and will drive patient and provider awareness ultimately leading to the use of XACIATO based on XACIATO's unique and differentiated profile. As Sabrina mentioned, Organon will leverage the established Nexplanon sales team to accelerate XACIATO's uptake at launch. Organon believes this is roughly a 90% overlap of those healthcare providers who currently prescribe Nexplanon and are also diagnosing and treating bacterial vaginosis. These strong relationships that Nexplanon sales team has developed will help us and the providers and expect that we will be able to get access to these providers as early as day one of the launch. Under our license agreement with Organon that allows them to commercialize XACIATO, we received a $10 million cash payment from Organon after the license became effective in June, and we're also eligible to receive potential milestone payments of up to $182.5 million, as well as tiered double-digit royalties based on net sales. The launch activities are ongoing in the current quarter and XACIATO is expected to be available commercially in the U.S. in the first half of 2023. Let me transition now to the commercial activities underway for Ovaprene, our novel hormone-free monthly intravaginal contraceptive candidate, whose U.S. commercial rights are under a license agreement with Bayer. As a reminder, as part of our license agreement with Bayer to commercialize Ovaprene, Dare has access to Bayer's extensive clinical manufacturing and commercialization resources in an advisory capacity for approximately 80 hours per week. While we retain full control over Ovaprene's development and regulatory approval process, Bayer has the right to obtain exclusive rights to commercialize Ovaprene in the U.S. following completion of the pivotal Phase 3 study by making a $20 million payment to Dare. Thereafter, Dare will be entitled to receive commercial milestone payments potentially totaling $310 million in addition to double-digit tiered royalties on net sales. As we've mentioned before, Ovaprene is a distinct and novel contraceptive candidate. There is no predicate device for Ovaprene, meaning there's no existing FDA approved product that the FDA can use as reference to compare with Ovaprene, and Bayer has proactively initiated pre-commercialization activities, including discussions with payers, providers, and women. Their commercial team is uniquely focused on identifying key drivers and points of differentiation that will resonate with payers and providers and patients. Bayer has a unique leadership position in the hormonal category with their Mirena franchise, and they are looking to establish a similar leadership position in the non-hormonal category with Ovaprene. As we've mentioned, they are actively engaging payers and providers to gain meaningful insights into the best way to position Ovaprene to maximize market uptake, and are simultaneously collaborating with Dare by providing input into the Phase 3 study design to reflect these important commercial insights.

Thank you, John, and thanks everyone for joining us today. I would now like to summarize Dare's financial results for the quarter ended September 30, 2022, which I will refer to as the current quarter or the third quarter of 2022. Dare's business model is comprised of two parts. The first is to assemble in advance a portfolio of differentiated product candidates that address meaningful unmet needs that we've identified in women's health. The investment required to do this includes corporate overhead, portfolio acquisition and maintenance costs, and ongoing research and development or R&D expenses. The second part of our model involves monetizing the value of our portfolio's clinical and regulatory advances over the near and the longer term. There are many ways to generate value from products with differentiated outcomes, and one approach includes securing payments upfront and over time in the form of license fees, commercial milestones, and royalties on net sales. For our first FDA approved product XACIATO, we recognized $10 million of revenue during the second quarter from an upfront license fee under our global license agreement for XACIATO with Organon, and the $10 million cash payment was received in the current or third quarter. As my colleagues both mentioned, Dare will be entitled to receive additional potential milestones in royalties once XACIATO is commercially launched. But back to our current quarter, during the third quarter of 2022, our general and administrative or G&A expenses were approximately $2.7 million. Our R&D expenses, which vary from quarter to quarter based on clinical, preclinical manufacturing, regulatory, and other activities were approximately $4.5 million and primarily reflected the cost of the ongoing Sildenafil Cream 3.6%, Phase 2b RESPOND clinical trial and the manufacturing and regulatory activities related to Ovaprene. Our comprehensive loss for the quarter was approximately $7.3 million. We entered the current quarter with approximately $40.4 million in cash and cash equivalents. During the quarter, we received $18 million in cash, which includes the $10 million license fee from Organon that I just mentioned, which was recognized as revenue in the second quarter, and a cash disbursement of approximately $8 million under existing grants to fund the DARE-LARC1 program. Now, during our quarterly calls, we've highlighted the importance of non-dilutive sources of funding to our strategy. In addition to grant funding, we've noted that under Australia's current R&D tax rebate program, certain clinical study expenses incurred in Australia are eligible for partial reimbursement, which is currently up to 43% of such expenses. In October of this year, 2022, we received an R&D cash rebate of approximately $786,000 for clinical work performed in Australia during 2021. The rebate will be accounted for as an offset to our research and development expenses. Our collaboration with the NIH allows Dare to share the cost of the Ovaprene pivotal study with the NIH and to also tap the NIH's extensive experience in conducting contraceptive studies. Our share of the expenses under the collaboration involves providing clinical supplies of Ovaprene, coordinating interactions with the FDA, preparing and submitting supportive regulatory documentation, and providing $5.5 million to the NICHD toward the cost of conducting the pivotal study. $5 million of such commitment has already been advanced to the NICHD. As of November 9, 2022, Dare had approximately 84.8 million shares of common stock outstanding. So in closing, we will endeavor to be creative, collaborative, and opportunistic in seeking the capital necessary to advance our candidates and build shareholder value. As Sabrina noted, we encourage all investors to review the more detailed discussion of our financials, financial condition, liquidity, capital, resources, and risk factors in our Form 10 Q for the quarter ended September 30, 2022, which was filed today, as well as our Annual Report on Form 10-K for the year ended December 31, 2021, which was filed on March 31, 2022.

And so when we think about contraceptive methods out there today in both the hormone and the hormone-free category, the Pearl Indices are very broad in terms of range. So you'll have products that are implanted where the Pearl Index can be as low as one. And the way to think about it is essentially the inverse of the Pearl Index is the likelihood of becoming pregnant. So a product with a Pearl Index of 1, like an implant where there's no human error that can be involved, that's essentially a 99% effective product. And then the Pearl Indices range and your typical use effectiveness numbers range hormonal products are also pretty broad range in terms of pills and patches. And there's new data also looking at women with higher BMI and reduced effectiveness in higher BMI. So as you start to look at hormonal products, you can have Pearl Indices as low as 1 or 2 and as high as 8 or 9. And then you have products in the non-hormonal category where you start thinking about things such as condoms. A lot of the devices aren't regulated exactly the same way, so you only see the effectiveness numbers. A condom, a typical use effectiveness would be expected to be about 82%. If you're looking at spermicides, that's about 72% or that would be a Pearl Index of about 27 or 28. And then you've got vaginal gel prescription products Pearl Index of 27. So as you can see, there's a very, very broad range of Pearl Indices for FDA approved products.

And so again, think of that sort of range and there's perfect use and typical use, so a little bit complicated in the data, but that's your range to think about. And then, like I said, you've got condoms, which right now are the most commonly used hormone-free, short-acting contraceptive option. So that's a typical use effectiveness of 82%. So the inverse of that would be a Pearl Index of 18 or so. And then you've got again, in the moment, other in-the-moment vaginal products like a spermicide or like a vaginal gel, and those Pearl Indices are 27. So as you can appreciate, I mean you want a product like Ovaprene and given the form factor, we obviously want it to be as effective as possible. Based on the post-coital test study, which is the pre-pivotal study that was completed which looked at a proxy of typical use effectiveness using a surrogate marker where you look at the ability of sperm to get into the cervix, which had been shown through other studies to be a nice proxy for contraceptive effectiveness, at least translating into that typical use effectiveness numbers, that would anticipate a typical use effectiveness of 86% to 91%, which would translate into that Pearl Index range if you think of the inverse of that of nine to 14. So you're starting to see it. It's what one would anticipate from a product like Ovaprene is to be in that similar range, to similar types of products and similar form factors like Ovaprene have a double action. It's got a physical barrier and a chemical barrier. But the range is pretty broad of where it could play. And so that's really how, that's right now, the best way we can look at it is to think about it in this context. One of the things that obviously as we're going into the pivotal study, you know, obviously how the data are going to be ultimately calculated and how the Pearl Index is calculated, particularly when you're dealing with a non-hormonal product and cycle length can be very variable. This is certainly one of the things that we want to make sure we're very clearly aligned with on the FDA on that study because it can really impact your numbers in terms of how it's calculated when you don't have standard cycle lengths. So it's a very important consideration. I appreciate the question and hopefully you get a sense too that contraceptive methods, it's not all about the efficacy, right? That's why there are contraceptive methods approved and available to women that have a very, very broad range of efficacy. It's about form factor as well. And what we're hoping for with Ovaprene and based on the post-coital study, is that it delivers on all fronts, right? That it has that convenient form factor and based on the postcoital test study should put us in a nice range of effectiveness based on those data that would be in more that condom to short-acting hormonal method range. So hopefully that helps answer the question. Hopefully that gives everyone a little more perspective on how contraceptive methods are evaluated and how we think about them, both from a personal perspective and also a regulatory perspective.

Yes, that's very helpful. And with regard to these 200 subjects that you plan to enroll in the study, what is the expectation in terms of the timeline for that? And also what are your expectations in terms of the dropout rate so that what is the ultimate number of patients who will be included in that? Thank you.

Yes, more great question. So we know from other contraceptive studies that the dropout ranges can range based on all the published literature and also from just the learnings we have of working with the NIH and their contraceptive clinical trials network, is that the range is pretty broad in terms of dropout rates amongst studies, but it's in that sort of 35% to 55% range. Particularly because these studies, like the Ovaprene study, have a duration of 12 months that you expect to follow a woman in the study, and that's definitely the expectation here for Ovaprene for the pivotal, it's a 12-month study of following women. We are planning for and we think that's the most prudent thing to do. We're planning for the higher dropout range in that range so that we can make sure that we adequately enrolled the study to ensure that we have the target 200 women completing the full 12 months of Ovaprene use that we're targeting. So you should expect that we would start with a number of double or more than double that in terms of who we're going to seek to screen and enroll in the study, which then segues nicely into your question of what, well, how long does that take? To get those women in the study? That's one of the places where working with the NIH and their clinical trial contraceptive network is very helpful because they have a lot of experience with these kind of studies, both with hormonal products and non-hormonal products. And maybe not surprising, is enrollment rates can be a little different, hormonal, non-hormonal product studies actually tend to enroll a little faster than hormone-releasing products. So that's exciting. But having said all that right now, the only guidance we're ready to give at this point until we really get enrollment underway and have a better sense of the metrics ourselves for our specific product and our specific study is that we're looking to start those recruitment activities mid-next year. Once that gets underway and we have a good sense of what trajectory we have in terms of those enrollment numbers per site, then we'll be able to give some guidance on how many months it's going to take us to enroll the subjects that we need. But in terms of when one should expect data from the study, being realistic, it's going to be at least 12 months out. It's a 12-month study. So it's really just a matter of how much in advance of that 12 months do we need in order to fully enroll the subject, so more to follow on that, but hopefully that gives at least a little perspective of how we've been thinking about it and what's been seen with other products.

Great, thank you.

Absolutely. Great, well thank you so much and thank you all for taking the time this afternoon to hear about the recent updates and our ongoing commitment to drive value for all of Dare's stakeholders, not just the shareholders and definitely the shareholders, but also the women and the healthcare providers as well. With our diverse portfolio, we seek to bring to market differentiated prescription therapies that prioritize women's health and wellbeing, expand the 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, sexual health, and infertility. Today, as you heard, we have seven candidates in various stages of development and one FDA approved product and two commercialization collaborations under our belt. As I mentioned at the onset of the call, it is our belief that prioritizing women's health is good for the many women lacking effective or convenient therapeutic choices, and also good for a broad set of stakeholders, including their families and partners and of course our shareholders. Our belief is that the programs in our portfolio represent a compelling opportunity given that potential commercial partners are looking for new differentiated products and candidates with meaningful revenue potential to add to their portfolios. Providers are looking for innovative first line or first-in-category products to address the unmet needs impacting the quality of life of so many of their patients. Women are seeking innovative options to help them navigate their needs and preferences over the course of a lifetime. Investors are looking for a diverse pipeline with high revenue potential and with independent outcomes to mitigate risk and enhance the overall commercial opportunity and where the investment has the opportunity to be disproportionately impactful. We look forward to keeping you updated on our progress through the balance of this year and into 2023 on the milestones forthcoming for our candidates under development and as well as activity with Organon regarding the XACIATO launch in the U.S. that are underway. Thank you so much.

Ladies and gentlemen, thank you for your participation in today's event. You may now disconnect.