Dare Bioscience, Inc.

Darae Bioscience, to review the company's financial results for the quarter ended March 31, 2020, and to provide a general business update. This call is being recorded. My name is Victor, and I will be your operator for today. With us today are Sabrina Martucci Johnson, Darae's President and Chief Executive Officer, John Fair, Darae's Chief Strategy Officer, and Lisa Walters-Hoffert. and Darae's Chief Financial Officer. Ms. Johnson, please proceed.

Thank you and welcome to our financial results and business update call for Darae Bioscience. We are looking forward to discussing our first quarter results and highlighting the recent developments and anticipated milestones for 2020 and beyond. Before we begin, I'd like to remind you that today's discussion will include forward-looking statements. Within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, any statements made during this call that are not statements of historical 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, 2019, which was filed on March 27, 2020, and our quarterly report on Form 10-Q for the quarter ended March 31, 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, May 14, 2020. DARI undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. So as you know, DARI is a biopharmaceutical company squarely focused on improving the life and well-being of women, primarily in the areas of contraception, vaginal health, sexual health, and fertility. Our value creation strategy is to accelerate availability of new prescription products in women's health by selecting and advancing product candidates that we believe have the potential to be first in category and first line. On our last call, we discussed the impact of the COVID-19 pandemic on our general business operations, as well as our anticipated clinical and regulatory milestones. As we discussed, we believe the uniqueness of our business model allows us to react quickly to changes in circumstances. and since then we have maintained the pace of our product development and regulatory activities necessary to remain on track to achieve the clinical and regulatory objectives we discussed. Namely, we remain on track to conduct and report top line results this year for a phase three clinical trial of DARE-BV1 for the treatment of bacterial vaginosis. A condition estimated to impact over 20 million women in the U.S. alone. We're also confirming our prior guidance with respect to our sidenafil cream program. We expect to report top-line results of the planned Phase IIb study of sidenafil cream in 2021. We believe our sidenafil cream candidate has the potential to be the first FDA-approved treatment option for female sexual arousal disorder, the female sexual dysfunction disorder most analogous to erectile dysfunction in men. Finally, we continue to anticipate reporting top-line results in 2022 for our planned pivotal clinical trial of Opiprine, our investigational, hormone-free, monthly contraceptive with the potential to be a first-in-category product and whose U.S. commercial rights are under a license agreement with Bayer. We believe that the variety of our programs and the diversity of our women's health indications and development stages enable us to direct our resources and investment across the portfolio in ways that enable us to advance our programs in this challenging environment. Of course, we recognize that the COVID-19 pandemic and the restrictions put in place to slow its spread have the potential to disrupt our business, as well as the potential to increase anticipated development costs and Timelines for our product candidates. And therefore, we continue to closely monitor the rapidly evolving circumstances. However, currently, we remain on track to deliver top line clinical study results and regulatory milestones on the timelines we've discussed. We believe our financing strategies, such as our at the market program and the equity line we recently established, together with the flexibility and capital allocation afforded by our business model, provide optionality on how and when we raise capital that supports and aligns with enhancing shareholder value. Further, we expect the pricing structures and the dedicated staff with expertise in clinical development of women's health products provided under the agreement with health decisions that we announced this week can support acceleration of clinical development of our reproductive health assets in a capital-efficient manner. We'd like to spend a little more time now to review our plans for the DARE BV1 Phase 3 study and the data readout this year, and next steps with our sidenafil cream and oviprene programs. We'll also provide additional insights into our partnership with Health Decisions, as well as an update on partnering activities in general and our first quarter financial results. I'll start with DARE BV1 for bacterial vaginosis. DARE BV1 is a novel thermosetting bioadhesive hydrogel containing clindamycin phosphate 2%, and it's being developed as a one-time vaginal administration for the treatment of BV. As I mentioned, a highly prevalent condition estimated to affect more than 20 million women in the U.S. alone. As we've previously reported, data from an investigator-initiated proof-of-concept study demonstrated a clinical cure rate of 86% of evaluable subjects in the study at the test of cure visit that occurred seven to 14 days after that single administration of DARE-BV1. In comparison, currently marketed FDA approved products for the treatment of BV have clinical cure rates ranging from the mid 30s to the high 60s on a percentage cured basis. If DARE-BV1 delivers a similarly high clinical cure rate in the phase three pivotal study, We believe DARE BV-1 could become a new frontline treatment option for women diagnosed with BV. DARE BV-1 has received both FAST-TRACK and Qualified Infectious Disease product designations from the FDA for the treatment of BV. FAST-TRACK is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. A drug that receives FAST-TRACK designation is eligible for more frequent meetings with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval, more frequent written communication from FDA about such things as the design of the proposed clinical trial, and eligibility for accelerated approval and priority review if relevant criteria are met. Our FAST-TRACK designation for DRBV1 underscores that BV is a serious infection for which current treatment options are inadequate and it validates DARE BV1's potential to address this unmet medical need. As we've indicated in our recent posting on clinicaltrials.gov, we expect to commence enrollment in our Phase III clinical study of DARE BV1 in July with an anticipated top-line data readout by the end of 2020. Based on the FDA's guidance document on developing drugs for treatment of BV and recent discussions we've had with the FDA, the Phase III study will include a placebo control and assess the primary endpoint of clinical cure of BV defined as the resolution of specified clinical signs and symptoms from the baseline visit at the test of cure visit to occur 21 to 30 days after enrollment in the study. If this single Phase III study in approximately 220 women and the non-clinical studies to be conducted in parallel with the Phase III are successful, we intend to file a new drug application for DRBV1 in 2021. I'll now talk about sidenafil cream. We announced in December 2019 the important alignment we reached with the FDA on the Phase IIb study design and the Novel Patient-Reported Outcomes, or PRO, Instruments to be used to measure achievement of the primary efficacy endpoints. Sodenafil cream, 3.6%, has the potential to be the first FDA-approved product for female sexual arousal disorder, or FSAD. FSAD is the female sexual dysfunction disorder most analogous to erectile dysfunction in men. And Sodenafil is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra. for the treatment of erectile dysfunction in men. Sidenafil Cream, our formulation, is a topical administration formulation of Sidenafil, which means the active ingredient is delivered in a cream formulation that's applied locally to the vaginal tissue. It's designed to increase local blood flow and thereby improve the genital arousal response, utilizing the same pathway that's active in erectile dysfunction medications for men. While oral sidenafil is effective for men, the side effects associated with the oral formulation are particularly challenging for women, and therefore oral delivery is not an optimal way to achieve the same arousal response in women. With the potential to deliver sidenafil in a fast-acting cream that can be applied locally, the formulation has been designed to offer the benefits of increased blood flow and improvement in the general sexual arousal response without the systemic issues observed with the oral formulation. We believe the FSAD market is as big or bigger than the erectile dysfunction market. Market research suggests that 33% of women in the U.S. ages 21 to 60 experience symptoms of low or no sexual arousal, and 16% of them, or approximately 10 million women in the U.S., are distressed and are seeking a solution to improve their condition. To put the market opportunity for an FDA-approved FSAD treatment in context, the prevalence of complete erectile dysfunction is estimated to be about 5% of men at age 40, increasing to 15% at age 70. The planned Phase IIb study of Sidenafil cream will utilize the agreed-upon pro-instruments to measure achievement at the primary efficacy endpoint, namely Improvement in that localized genital sensation of arousal response and reduction in the distress that women with FSAD experience. Over the next months, we'll focus our efforts on preparing to initiate that Phase 2b study, such as preparing the electronic diary and conducting other start-up activities, as well as other non-clinical activities to support a future NDA submission. The Phase IIb study is designed to evaluate sildenicochlorine versus placebo over 12 weeks of dosing by study subjects in their home setting, following both the non-drug and placebo run-in period. As I mentioned, we expect to report top-line results of the study before the end of 2021. And now I'll talk briefly about oviprene. Oviprene is an investigational hormone-free monthly vaginal contraceptive. currently in clinical development for the prevention of pregnancy. If approved, it could be the first monthly non-hormonal contraceptive product. Earlier this year, Bayer, the marketers of the billion-dollar Mirena contraceptive franchise, and DARE announced a license agreement under which Bayer can exclusively commercialize oviprene in the United States. Upon the satisfaction of certain conditions in the agreement, which include a $20 million payment to us by Bayer Payable and VAERS sole discretion following the completion of a pivotal trial of oviprene. Under the license agreement, we're also eligible to receive up to $310 million in commercial milestone payments plus tiered royalties on net sales in the double digits. VAERS is supporting our development and regulatory process for oviprene by providing internal experts in an advisory capacity. These resources have already added value to the planning and implementation of the Obaprene clinical regulatory manufacturing as well as the pre-commercialization planning workstreams. More information about the terms of the agreement can be found in our filings with the Securities and Exchange Commission. We believe the licensing agreement with Bayer is validation of our broader strategy. and confirmation of Oviprene's market potential as the first monthly non-hormonal contraceptive product. Bayer is committed to bringing to market innovation in women's health and they are the only company to have built a contraceptive brand family in excess of a billion dollars. Over the next several months, we intend to continue the regulatory, manufacturing and other non-clinical activities to advance the program. We plan to file an Investigational Device Exemption Application, or IGE, for oviprene this year, and pending the FDA's review and clearance of the IGE, we plan to initiate a pivotal contraceptive effectiveness and safety clinical study of oviprene. If successful, we expect this study to support marketing approvals of oviprene in the U.S., Europe, and other countries worldwide. We believe we can commence this study even in 2021 and still report top-line data in 2022 as projected. I'll now turn the call over to John to provide a business and corporate partnership update.

Thanks, Sabrina. To follow up on some of the remarks made by Sabrina concerning our relationship with Bayer, we're pleased to announce we've implemented a really robust alliance management framework with Bayer, facilitating effective connectivity and communication with their global teams. Framework enables us to leverage their internal expertise and align on clinical, manufacturing development, regulatory planning, and the potential launch strategy for Overprene in the United States. As Sabrina mentioned, Bayer is the current real-time world leader in contraceptive sales and marketing. Their insights and expertise across a wide range of functional areas, including commercial planning, have been invaluable. We believe our agreement with Bayer for the commercialization of Overprene is a validating event for the overprinting contraceptive technology and for DARE. Our relationship with Bayer has raised our profile in women's health, which has been a great tailwind for us as we actively engage on a number of fronts across our portfolio and continue to execute against our broader strategy and engage with potential partners on subsequent collaborations and follow-on transactions. For those of you familiar with the DARE story, you know that partnerships and outlicensing transactions are core to our model, and one of the imperatives for our company is to ensure we have a pipeline of differentiated assets and to keep those assets moving along an aggressive development continuum in a cost and time efficient manner. To that end, we announced an alliance with Health Decisions, a full service contract research organization, or CRO, specializing in women's health clinical research and diagnostic development to help us advance our portfolio programs. The pricing structure in the agreement along with the opportunity to have dedicated staff with expertise in clinical development and women's health products is expected to accelerate the clinical development of our key programs in a resource-efficient manner. Health Decisions is the statistical and clinical coordinating center for the NICHD, which is a unit of the National Institutes of Health, or NIH. They've conducted over 40 clinical trials in contraception, and they're active across a number of therapeutic areas that are aligned with our portfolio. And we have successfully worked with Health Decisions on prior clinical studies, including the successful post-coital test or PCT clinical study of oviprene. And we're currently working with them on the plan DARE-BV1 phase three study in bacterial vaginosis. As I mentioned, the agreement with Health Decisions includes dedicated resources and new pricing structure. When combined with health decisions clinical expertise, robust network, the relationships with key investigators in the women's health community, we expect this alliance to enable us to accelerate our clinical programs and our pipeline. In order to maintain the high level of interest in our portfolio that we've seen over the past several months and to execute on our partnering strategy, it's incumbent upon us to continue to deliver against meaningful clinical and regulatory milestones and we believe our new relationship with health decisions will strengthen our ability to do that and enable us to provide new solutions to address persistent unmet need in women's health. And with that, I'll turn it over to Lisa for a financial update.