Dare Bioscience, Inc.

Welcome to the conference call hosted by DARE Bioscience to review the company's financial results for the year ended December 31st, 2020, and to provide a general business update. This call is being recorded. My name is Sarah, 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-Hofford, DARE's Chief Financial Officer. Ms. Johnson, please proceed.

Thank you. Good afternoon and welcome to our 2020 financial results and business update call for DARI Bioscience. Our plan today is to review last year's financial results, discuss notable achievements since our last call in November, and use the time to highlight developments and milestones anticipated for 2021. Before I 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 annual report on Form 10-K and our quarterly reports on Form 10-Q. I would also like to point out that the content of this call includes time-sensitive information that is current only as of today, March 30, 2021. DARI 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, DARI 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 commercial opportunity. with four clinical stage programs in vaginal health, sexual health, contraception, and menopause. Despite the unique challenges posed for all of us during 2021, we achieved two important corporate firsts in 2021. We started the year in January by announcing our first commercial partnership agreement with Bayer for oviprene commercialization rights. We believe that this partnership not only validates the oviprene commercial opportunity, and allows DARE to benefit from Bayer's expertise in development, regulatory affairs, and commercialization of first-in-category contraceptive products for women. But with opportunity for a 20 million clinical milestone, up to 310 million in commercial milestone payments, plus double-digit tiered royalties on net sales, that it also can provide capital to support broader portfolio objectives. Then we ended the year in December with the completion of our First Portfolio Phase III Study. Specifically, we announced positive top-line data from the DARE BV-Free Phase III Study of DARE BV-1 for the treatment of bacterial vaginosis, positioning DARI for our first NDA submission. The advances in 2020 across the portfolio set the stage for meaningful portfolio objectives in 2021. So for those of you who are new to DARE, 2021 is an interesting time to get to know us. Our prior three positive clinical readouts across three different portfolio programs, the phase one thermography study for sedentafil cream and the pre-pivotal study of oviprene, both announced in 2019, and the DARE BV1 phase three that I just mentioned announced in 2020, and able us to target two more clinical readouts and an NDA filing and potential approval action in 2021. The 2021 key portfolio objectives include the following, which encompass not just the three programs I already mentioned, but two additional clinical stage development programs as well. We'll cover each of these in more detail during today's call, but here are the highlights as we look forward in 2021. For DARE BV1, The New Drug Application, the NDA Submission, the Potential PDUFA Action, and Strategic Commercialization Agreement Sudenafil Cream, the Phase TB Clinical Study Commencement and Potential Topline Data Oviprene, the Investigational Drug Exemption Submission DARE-HRT1, Phase 1 Clinical Study Topline Data and DARE-VVA1, Initiation of Phase 1 Clinical Study So I'm going to start first with DARE-BV1. DARE-BV1 is our novel investigational thermosetting bioadhesive hydrogel formulated with clindamycin phosphate 2% as a first-line, single-administration vaginal treatment for bacterial vaginosis. We announced the successful completion of the DARE-BV-free Phase III clinical study in 4Q2020. DARE BV1 demonstrated best-in-class curative potential for the most common vaginal infection in women of reproductive age, affecting an estimated 21 million women in the U.S. Bacterial vaginosis causes very disruptive symptoms for HER, a vaginal odor and discharge, and is importantly linked to health risks, including preterm birth, sexually transmitted infections, post-surgical infection, and pelvic inflammatory disease. It is estimated that 16% of these women have symptomatic disease, and studies have shown recurrence rates of up to 60% within 12 months of treatment. The DARE-BV-free study demonstrated DARE-BV1's potential to provide improved clinical cure rates and improve patient outcomes compared to those of current branded prescription products for the treatment of bacterial vaginosis, which those current products have cure rates in the 37% to 68% range, including in both the modified intent to treat population which is the primary efficacy assessment and FDA guidance documents as well as the per protocol population. Those current branded vaginal prescription products are at the lower end of that range with the vaginal product cure rates of 37 to 54% on a modified intent to treat basis and 64% on a per protocol basis. As I mentioned in our Phase 3 study, DERPV1 delivered better clinical cure rate values than those that have been demonstrated by the currently marketed FDA-approved vaginal and oral products for the treatment of bacterial vaginosis on both a modified intent to treat and a per-protocol population basis. Specifically, in the modified intent to treat population, the clinical cure rates for DARE BV1 and the DARE BV3 study were 70% at the test to cure visit, which occurred 21 to 30 days after the study administration, the primary endpoint, and 76% at the assessment visit that occurred just seven to 14 days after study drug administration, compared to 36 and 24% for placebo cream, respectively. In the per-protocol population, The clinical cure rates for DRBV1 were 77% at the day 21 to 30 endpoint analysis and 81% at the day 7 to 14, compared to 42 and 30 for placebo cream, respectively. Further, these results were achieved in what we believe was a representative patient population, including a large proportion of patients who reported one or more episodes of bacterial vaginosis in the 12 months before they were randomized into the study. 75% of the intent to treat population. And in addition, this was the first study conducted under the new 2019 FDA guidance for bacterial vaginosis treatment that requires that all subjects in the modified intent to treat population, the primary endpoint population, not only meet the clinical diagnostic criteria for bacterial vaginosis, but at baseline they also need to meet the bacterial morphology classification. or a Nugent score of at least seven reflective of bacterial vaginosis. Given these data, we believe DRBV1 is positioned to be an important first-line option for the treatment of bacterial vaginosis, and we're working to advance DRBV1 toward regulatory approval in the U.S. The NDA submission to the U.S. Food and Drug Administration, the FDA, is planned for the second quarter. The product candidate's fast-track and qualified infectious disease product designation allows for a priority review request at the time of NDA submission, which, if granted by the FDA, could lead to a 2021 PDUFA goal date. Specifically, that means that as long as the NDA is submitted by June 30th of 2021, we would be notified of acceptability of the filing by July 31st of 2021, and whether priority review is granted. And if priority review is granted, the PDUFA action date would be prior to December 31st, 2021. A 2021 FDA approval would allow for commercialization of DRBV1 in 2022. Ongoing strategic discussions and other activities to support a robust market introduction in 2021, in 2022, if approved, are thus underway. So in 2021, we intend to finalize and announce the collaboration strategy for DRBB-1 commercialization in the U.S. John will discuss this in greater detail shortly and will provide additional insights on how we seek to capture maximum strategic value for our shareholders in our approach to the process. I'm now going to talk about sidenafil cream 3.6%. So sidenafil cream is an investigational cream formulation of sidenafil, the active ingredient in Viagra, for topical administration to treat female sexual arousal disorder, or FSAD. FSAD is a physiological condition characterized by the inability to attain or maintain sufficient genital arousal during sexual activity. and of the various types of female sexual dysfunction disorders, it is the most analogous to erectile dysfunction in men. FSAD represents a large unmet need with an estimated 10 million women in the U.S. experiencing distress from symptoms of low or no sexual arousal and actively seeking treatment. Nonetheless, no FDA approved products exist today to treat FSAD. Even though the FSA-D market is estimated to be as significant, if not more so, as the erectile dysfunction market in both the U.S. and the rest of the world. On March 24th, we announced that we commenced our Phase 2b RESPOND clinical study, evaluating sidenafil cream as a potential treatment for FSA-D, with a top-line data readout targeted for year-end 2021. If clinical development is successful, The Phase 2B Response Study will evaluate Sidenafil cream compared to placebo cream in pre- and perimenopausal women over 12 weeks of at-home use following both a non-drug and a placebo run-in period. Patient-reported outcome or PRO instruments will be used to screen eligible women with FSAD and to measure achievement of the primary efficacy endpoint, namely improvement in localized general sensations of arousal and reduction in the distress that women with FSAD experience. Commencing the study now positions us for a potential top line data readout by the end of 2021. And over the next several months, we will provide updates on our progress towards that target. Women have suffered far too long without a viable intervention to address FSAD, so it is exciting to be working at the cutting edge of research focused on women's sexual health and to advance a potential first-in-category treatment option for women suffering with FSAD. We are very much looking forward to keeping you updated on our progress this year with that program. Next, I'm going to talk about opiprine. Obaprene is our novel, investigational, hormone-free, monthly intravaginal contraceptive. As already mentioned, we entered into a commercial partnership agreement with Bayer in January of 2020 on the heels of that positive pre-pivotal data announcement in 2019. People often ask how involved Bayer is currently in the program. Given under the terms of our agreement with DARE and with them, DARE is responsible for the ongoing regulatory interactions and the upcoming pivotal trial to support the FDA submission. Well, as you may recall, under the terms of the agreement, Bayer provides up to two full-time equivalents at this point for advisory support. So put another way, up to 80 hours per week of advisory support to DARE. Thus, our teams meet multiple times per week and these meetings include interactions across functional areas such as manufacturing, clinical, regulatory, medical affairs and commercialization planning. Unlike bacterial vaginosis where clinicians have familiarity with the concept of a one-time vaginal treatment and are very familiar with bacterial vaginosis, which in turn reduces the amount of preparation that's required pre-launch, The pre-commercialization activities are critical with a disruptive product like oviprene that is so unlike any contraceptive available today. Thus, similar to the launch preparation work that Bayer had to undertake before they successfully launched the Mirena franchise, the first hormone-releasing intrauterine device franchise to the billion-dollar-plus revenue it represents today, there is oviprene work underway already. to ensure that pending successful completion of the pivotal study and FDA approval, we are ready as partners. In terms of next steps on that path to commencing that pivotal study for FDA registration, the IDE submission to the FDA is planned for the fourth quarter of 2021. This is a requirement for initiating a pivotal contraceptive clinical study in the U.S. We are designing the study to evaluate oviprene when used over a period of at least six months and up to 12 months and will seem to confirm alignment with the FDA on the study's design prior to commencement. Pending clearance of the IDE, the pivotal phase three clinical study commencement is planned for the first quarter of 2022, enabling a six-month data readout by the end of 2022. I'm now going to touch on DER-HRT1. Dear HRT1 is our unique investigational 28-day intravaginal ring, or IVR, containing bioidentical estradiol and bioidentical progesterone for the treatment of the vasomotor symptoms and genitourinary syndrome associated with menopause. On March 22nd, we announced completion of the enrollment in the Phase I clinical study in Australia and that we expect top-line data readout in the second quarter of 2021. The IVR drug delivery technology used in DHRT1 was developed by Dr. Bob Langer from MIT and Dr. Bill Crawley from the Massachusetts General Hospital and Harvard Medical School. And it's an important platform for DARE, as we believe it offers a versatile drug delivery system in women's health with the potential to improve convenience and outcomes. In fact, our DARE-FRT1 program utilizes the same vaginal ring technology and is being developed to deliver bioidentical progesterone over a 14-day period for the prevention of preterm birth and broader luteal phase support as part of an in vitro fertilization or IVF regimen. You may recall that a grant awarded in 2020 by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, a division of the NIH, is supporting our preclinical development activities for DARE-FRT1 and that we may be eligible to receive up to 2.3 million in total grant funding in support of continued development of DARE-FRT1, including that phase one clinical trial that we're targeting for 2022. The objective of the DARE-HRT1 phase one, where we just completed enrollment, is to evaluate the ability of DARE-HRT1 to achieve its dual release objectives, as well as the ability of the IVR technology to release two different active drugs at two different rates, As Lisa will discuss shortly, conducting the phase one study activities through our subsidiary in Australia is an example of an approach similar to securing the non-dilutive grant funding that I just talked about to be capital efficient as it makes us eligible to receive future R&D tax incentives in the form of cash payments back to DARE through Australia's R&D tax incentive program. Finally, before I turn it over to my colleagues, I wanted to just mention the DARE VVA-1 Phase 1 study that we plan to commence this year that I mentioned up front. So DARE VVA-1 is our proprietary investigational formulation of tamoxifen for vaginal administration to treat vulvar and vaginal atrophy, or VVA, in women with or at risk of hormone receptor-positive breast cancer. We plan to commence the Phase 1 clinical study in the second half of 2021 in Australia, where we plan to leverage that development tax incentive of currently 43.5% of every eligible dollar spent as a cash payment back to the company. With that, I'm now going to turn it over to John to provide a business and corporate partnership update.

Thank you, Sabrina. We're entering an exciting time for DARE BV1 as the NDA submission will move us one step closer to the introduction of this important new product for the treatment of bacterial vaginosis. We continue to be impressed with the level of interest in the product candidate as we are seeing broad activity from large strategic pharmaceutical manufacturers as well as emerging specialty healthcare companies interested in adding a new and differentiated product to their portfolio. As we've communicated in the past, we look forward to announcing our commercialization strategy for DARE BV1 following the execution of a definitive agreement. However, because we are often asked about timing, I wanted to start by providing some context on our process. I can reiterate that we believe it's in our best interest to continue to advance our partnering discussions in parallel with our regulatory discussions, which we believe de-risks and adds value to the DARE BV1 program. We have the flexibility to work in parallel because of the clinician awareness of bacterial vaginosis and the straightforward product profile of DARE BV1 which mitigates some of the traditional market softening efforts required with an NCE or a new therapeutic indication. We believe that we are positioned to execute a definitive commercialization agreement before the end of the year. And as we think broadly about our commercialization strategies, we also have considerable optionality on what type of commercialization partnership structure we can contemplate. The fact that we have a portfolio of multiple women's health products in development means that all forms of structures are viable, from direct involvement in commercialization, to a collaboration with a contract sales organization, to a complete commercial out-license, similar to the deal we executed with Bayer for Overpreem, where Bayer has complete responsibility for commercialization. Being able to play a role in the commercialization of DARE BB-1 is much more tenable for us today than it was 18 months ago. and the reasons for that are driven by the appreciable reduction in the size and scale of a field force that we believe would be required to reach the targeted number of healthcare providers to make the brand successful. With the implementation of remote and virtual provider detailing, driven almost entirely by the COVID-19 pandemic, organizations like ours can achieve a much greater efficiency and scale more quickly with fewer full-time resources and thus reduced expense. Doctors have adjusted their workflow to accommodate virtual visits with sales representatives, and we believe this will continue even after the pandemic is over. All of this taken together provides us greater optionality to pick the commercialization partnership structure that we believe is best suited for DARE BV1 for patients and for our shareholders. In summary, given the data from the DARE BV3 Phase 3 study and the compelling value proposition of DARE BV1, All options are on the table. Turning briefly to Overprene, I want to reiterate some of the comments Sabrina made about the Bayer partnership. We believe our relationship with Bayer continues to be value additive for both companies. Our two organizations are operating synergistically across a number of key work streams, ranging from manufacturing, regulatory affairs, medical affairs, and brand planning, which includes pre-commercialization planning. We anticipate that this collaboration will only grow stronger in the coming months as we plan to coordinate our efforts both internally and externally in preparation for the filing of the IDE later this year and enrollment of the pivotal clinical trial in 2022. Finally, I wanted to say a few words about the strength of the DARE brand in the broader women's health ecosystem. We have been and will continue to be active on a number of fronts, to seek to continue to drive value into and through our pipeline. What's new about that for this year is that the DARE brand has been elevated and our success both on the development side and the partnering side has translated into real interest from a variety of stakeholders to help us continue to develop and deliver new and differentiated products into the category. So we are really excited to embark on what we think is the next growth phase for DARE and look forward to keeping you updated as collaboration, exploration, and discussions advance. With that, I will turn the call over to Lisa.