Dare Bioscience, Inc.

Welcome to the conference call hosted by DARE Bioscience to review the company's third quarter financial results and to provide a general business update. This call is being recorded. My name is Chris, and I'll be your operator for today. With us today from DARE are Sabrina Martucci-Johnson, President and Chief Executive Officer, John Fair, Chief Commercial Officer, and Lisa Walters-Hofford, Chief Financial Officer. Ms. Johnson, please proceed.

Thank you. Good afternoon and welcome to the DARE Bioscience Financial Results and Business Update Call for the quarter-ended September 30, 2023. Today, we will review our third quarter results and discuss developments and expectations for our pipeline and portfolio. 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 any reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by cautionary statements in the company's SEC filings, including our Form 10-Q for the quarter ended September 30, 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, November 9th, 2023. DARI undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. For those of you joining us via webcast, you should be able to access presentation slides from within the webcast module. We've included these slides to provide some additional context to 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. As you know, our sole focus at DARE is women's health. Women's health products make up 27% of total Blockbuster products while contributing to 35% of total Blockbuster sales, and there continue to be many unmet needs in the market. We believe we have an exceptionally strong pipeline of product candidates that positions us well for the short, medium, and long term. I'm excited to share today the recent strides we've made to advance innovative therapies for women with our most promising near-term opportunities. Since the beginning of the third quarter, we have had several important achievements. First, We achieved our first commercial milestone for Zasciato, which was the initial shipment of the product associated with the launch. Second, we shared additional positive data from our Phase TB response study of Sidenafil cream, which has the potential to be the first FDA-approved treatment for any form of sexual arousal disorder in women. And third, we made further progress toward patient enrollment for the anticipated start of our pivotal phase three study of Obaprene, our potentially first-in-class hormone-free monthly intravaginal contraceptive candidate. Overall, we continue to advance our key pipeline programs, each of which, if approved, represents a potential first-line or first-in-category opportunity. Additionally, we are actively engaging our commercialization collaborators, including leading players in women's health, Organon and Bayer, as we steadily execute on our mission to accelerate innovative treatments that women want and need. I'll now provide an update on our potentially disruptive late-stage candidates, Sidenafil Cream and Oviprene. Then John will provide an update on Zasciato's launch, And Lisa will review our financial results for the quarter ended September 30th. So let's start with Sidenafil Cream, which is our investigational therapeutic candidate to treat female sexual arousal disorder, or FSAD, and female sexual interest arousal disorder, or FSIAD. Last week we announced additional updates from our Phase 2b response study results in preparation for our confirmed upcoming end-of-phase II FDA meeting this year. Sidenafil, which is a PDE5 inhibitor, is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra for the treatment of ED, erectile dysfunction, in men, which was undoubtedly one of the most successful prescription products ever launched. Our Sidenafil cream is an investigational, proprietary, topical treatment, cream formulation, specifically designed to be used on demand at the time of sexual activity to increase blood flow to the genital tissue in women. If development is successful, Sudetafil cream has the potential to be the first FDA-approved product to treat any form of arousal disorder in women. Women who experience no or low sexual arousal are bothered by and dissatisfied with their sex lives. They're frustrated with their sexual problems, They experience guilt about their sexual difficulties, and they are likely to feel sexually inadequate, inferior, and embarrassed. Market research suggests that approximately 20 million women in the U.S., age 21 to 60, experience symptoms of low or no sexual arousal, and approximately 10 million women are considered distressed and actively seeking treatment. We believe this is a promising untapped market, given the numerous equivalent products approved for men, not only Viagra, but also Cialis and Levitra, to name a few. Last week, we announced additional positive data from our Phase IIb response study of Sidenovir cream, having completed our study analyses in preparation for our upcoming FDA meeting. Importantly, These additional analyses indicate that we can use our Phase IIb study approach in Phase III. Specifically, this means we can propose a Phase III study with the same co-primary endpoint structure that we used in Phase IIb, which assesses arousal sensation and evaluates concerns related to the difficulties with sexual arousal. and two, that we can propose that in the phase three study, we evaluate sedentafil cream in a broader patient population of women that includes not only women with arousal disorder only, or FSAD, but also those with arousal plus desire disorder, otherwise stated as women with female sexual interest arousal disorder, or FSIAD. This would be the first ever phase three pivotal study of a therapeutic candidate for the treatment of arousal disorder in women, and we remain on track for our end of Phase II meeting with the FDA this year. We look forward to keeping you updated on those developments. Now I'd like to turn to Obaprene. Obaprene is our investigational, potentially first in category, hormone-free, monthly, intravaginal contraceptive. We have been working closely with our Phase III study collaborator, the National Institute of Child Health and Human Development, or NICHD, of the NIH, on the pivotal study planned to start later this year. The pivotal Phase III study of oviprene is being supported by NICHD's Contraceptive Development Program, which oversees the Contraceptive Clinical Trials Network, or CCTN, which was established in 1996 to conduct studies of investigational contraceptives like oviprene. We remain on track to start enrolling patients this fourth quarter of 2023, and we will issue an announcement after the first patient is enrolled. As a reminder, the study is a multicenter, single-arm, non-comparative, pivotal phase three contraceptive study of oviprene to evaluate its effectiveness as a contraceptive along with its safety and usability. Based on our communications to date with the FDA, if successful, We believe that only this single registration study will be required to support a pre-market approval application submission with the FDA. We believe ibuprene has the potential to be a disruptive product in the contraceptive category and potentially life-changing for women who cannot take hormone-based therapies, such as some cancer patients or those who would prefer not to do so. In fact, survey data indicate that nearly 85% of women would prefer a monthly option with a lower hormone dose than the oral birth control pill. In addition to providing innovation as a non-hormonal contraceptive, the clear differentiation and disruptive potential of oviprene is in its convenience and potential efficacy. Its convenience includes easy monthly use and self-administration, without requiring action at the time of intercourse, with target efficacy approaching hormonal birth control methods. There are currently no FDA-approved monthly hormone-free contraceptives. And based on market research, approximately 35 million women in the U.S. are potential candidates for oviprene. We see parallels to NuvaRing when it entered the market as the first monthly intravaginal hormonal contraceptive and to Mirena when it entered the market as the first hormone-releasing intrauterine system. And Bayer, which commercializes Mirena, is a leader in commercializing contraceptive products in the United States, and they hold the U.S. commercial rights to Obaprene under a license agreement with us. In summary, I am very excited about the progress we've made on our late-stage program since our last call in August. As the only company solely focused on developing women's health products, DARI is developing first in category products. Our investigational products are some of the most potentially disruptive candidates for women in decades. And we collaborate with leading companies to commercialize and deliver these treatments to as many women as possible. And as you'll hear from Lisa later on this call, we do all of this with thoughtful and efficient capital deployment and leveraging non-dilutive sources of capital wherever feasible. I'll now turn it over to John to provide a commercial update on the Organon-Zaciato launch, as well as oviprene pre-commercialization activities underway in collaboration with Bayer.

Thank you, Sabrina. As a reminder, Zaciato, clindamycin phosphate vaginal gel, is a lancosamide antibiotic for single-dose vaginal administration indicated for the treatment of bacterial vaginosis, or BV, in female patients 12 years of age and older in the United States. As many of you know, Organon recently launched Zasciato. The product is in the channel as of last month, and the initial focus in Q4 is on high BV prescribers in the U.S. aligned to end-of-year product availability in select retail pharmacies. As we have communicated on previous calls, Organon's go-to-market strategy leverages the knowledge and experience of the established Nexplanon commercial team. Organon believes there's a roughly 95% overlap of healthcare providers who prescribe their contraceptive product Nexplanon that also have the potential to prescribe Xaxiato based on provider treatment patterns. And to drive product pull-through, their skilled market access team is meeting with customers to review Xaxiato. Because of the strong relationships the Organon sales team has with these healthcare providers, we expect them to be well-positioned to detail Xaxiato. Looking ahead to our phase three trial initiation for Oviprene, We are excited to begin phase three study activities with our U.S. commercial collaborator, Bayer. In parallel, our team has been collaborating with Bayer on key downstream commercial initiatives intended to ensure a seamless transition from clinical development to commercial introduction. These activities will help set the foundation to maximize the value of this disruptive technology. With that, I'll turn the call over to Lisa.