Dare Bioscience, Inc.

Welcome to the conference call hosted by DARE Biosciences to review the company's financial results for the year ended December 31st, 2021, and to provide a general business update. This call is being recorded. My name is Catherine, and I'll 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-Harford, DARE's Chief Financial Officer. Ms. Johnson, please proceed.

Thank you. Good afternoon and welcome to our full year 2021 financial results and business update call for DARE Bioscience. Our plan today is to review last year's results, discuss development since our last call in November, and use the time to highlight objectives and milestones anticipated for 2022, as well as other insights for the year. 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 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 any 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 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, March 31, 2022. DARI undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. DARI 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, partners, and, of course, our shareholders. Our strategy involves identifying areas of high unmet need, selecting promising candidates to address such needs, conducting research and development activities in a thoughtful and capital-efficient manner, and if approved, developing an appropriate commercialization strategy for each candidate with the goal of reaching as many potential users as quickly as possible. With our diverse portfolio, we seek to bring to market differentiated prescription therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes primarily in the areas of contraception, fertility, and vaginal and sexual health. Today, we have seven candidates in various stages of development and one product that has received FDA approval last December. We're going to spend much of our time today providing an update on our late-stage development candidates and our FDA-approved product. As it pertains to that FDA-approved product, Zosciato, we look forward to reviewing the announcement we made today regarding the global license agreement we entered into with Organon to commercialize Zosciato, which is clindamycin phosphate vaginal gel 2%, our FDA-approved treatment for females 12 and older with bacterial vaginosis. Before we discuss Zosciato and our late-stage programs, such as Oviprene, I want to first review the many factors we consider when evaluating new potential candidates for our portfolio, since those factors ultimately impact the commercialization strategies for those products and opportunities to enter into collaboration such as those that we have established to date with Organon for Zasciato and Bayer for Oviprene. Key considerations include the following. candidates must have the potential to be a first-line or first-in-category option. Candidates must represent a meaningful commercial revenue opportunity. We ideally seek product candidates that utilize differentiated and different APIs and target different indications or drug delivery modes that are personalized for her. And finally, we are particularly fond of candidates that can be developed via a 505b2 regulatory path or have existing proof of concept, allowing us to move quickly to later stages of clinical development and potentially shortening the overall development time and cost to obtain a marketing approval in the US, as was the case with Zasciato, where we achieved FDA approval of Zasciato just three years after acquiring rights to the program. Now, before we look forward to what is ahead in 2022, I'd like to take a moment to highlight a few important achievements during 2021, since those achievements set us up for where we are today and what is yet to come. We were awarded a grant for up to $48.9 million over approximately five years to support our preclinical DARE-LARC-1 contraceptive program. The FDA accepted our NDA for DRBV1, which is now referred to as Ashiato, and the FDA subsequently approved our application on scheduled PDUFA date of December 7, 2021. We entered into a Collaborative Research and Development Agreement, or CRADA, under which a pivotal Phase III clinical study of oviprene will be supported financially by NICHD's Contraceptive Development Program and conducted within its Contraceptive Clinical Trial Network and we continued our collaboration with Bayer, who has the commercialization rights for oviprene. We initiated the Phase 2B response study, evaluating sidenafil cream, 3.6%, as a treatment for female sexual arousal disorder, her version of erectile dysfunction, for which there are no current FDA-approved treatments. We initiated a Phase 1-2 clinical study of DER-VVA1, our proprietary investigational formulation of tamoxifen, for intravaginal administration to treat vulvar and vaginal atrophy in women with or at risk for hormone-receptive positive breast cancer. And finally, we generated positive Phase I clinical data for HRT1, our investigational hormone therapy vaginal ring for the treatment of both the vasomotor as well as the vaginal symptoms associated with menopause. So first, now, let's talk about bacterial vaginosis. our FDA-approved treatment, Zosciato, and our global license agreement with Organon to commercialize Zosciato. First, the unmet need. Bacterial vaginosis is the most common vaginal condition and the most common cause of vaginitis worldwide and is estimated to affect approximately 21 million women in the United States. The condition results from an overgrowth of bacteria, which upsets the balance of the natural vaginal microbiome and can lead to symptoms of odor and discharge. Zasciata received both Qualified Infectious Disease Product, or QIDP, and fast-track designations from the FDA for the treatment of bacterial vaginosis. Organon shares our commitment to advance critically needed innovation in women's health. We are excited to be collaborating with one of the premier companies in women's health, as we believe that Organon's commercial capabilities will ensure that Zasciata reaches the women most impacted by this condition. Through Organon's strong commercial capabilities and expertise in women's health, Organon is in a unique position to bring Zasciata to market and enable women across the U.S. to access this important option. Under the terms of the agreement, we'll receive a $10 million upfront payment from Organon. We're eligible to receive potential milestone payments of up to $182.5 million and tiered double-digit royalties based on net sales. Zasciato is expected to be available commercially in the U.S. in the fourth quarter of this year. Completion of the transaction is subject to review under the Hart-Skart-Rodino Antitrust Improvements Act and other customary conditions, and the transaction is expected to close in the second quarter of 2022. I will shortly turn the call over to John to share some additional insights regarding our collaboration strategy and objectives in selecting Organon as our commercialization collaborator for Zasciato. But before doing so, I'll briefly provide updates on certain of the development milestones and objectives this year for our other programs. Oviprene is our potential first in category option in the over $7 billion contraceptive category. It is our novel hormone-free monthly contraceptive candidate whose U.S. commercial rights are under a license agreement with Bayer. In the third quarter of 2021, we announced the CRADA that I mentioned with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, which is part of the NIH, the National Institutes of Health, for a pivotal Phase III study of oviprene. The CRADA reflects the NICHD's continued support for the development of oviprene and will allow us to leverage the tremendous development expertise of the NIH in contraceptive clinical studies and to share the cost of the pivotal phase III study with the NIH. So that next stage of clinical development for oviprene is that pivotal phase III contraceptive study that we will be connecting with them. In order to initiate the pivotal phase III study, we must have an FDA-approved IDE in place, and so we initiated that IDE process for oviprene early this year. And pending the FDA's review and approval of the IDE, we seek to initiate the pivotal study this year. Under the license with Bayer, DARI receives access to Bayer's extensive clinical and market expertise, through an up to approximately 80 hours per week in advisory support, while retaining control over overprint development and regulatory approval processes. Bayer has the right to obtain exclusive rights to commercialize the product in the U.S. following completion of the pivotal trial, the one that is being planned to be undertaken by DARI and the NICHD, by making to DARI a $20 million payment. We will also be entitled to receive commercial milestone payments potentially totaling $310 million in addition to double-digit tiered royalties on net sales. Sidenafil cream is our investigational product to address her version of erectile dysfunction, as I mentioned. In March of last year, we commenced our Phase 2B study evaluating Sidenafil cream, 3.6%, our investigational cream formulation of Sidenafil, which, as you know, is 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 general arousal during sexual activity. Sound familiar? Of the various types of female sexual dysfunction disorders, it is the most analogous to erectile dysfunction in men, and yet there is no FDA-approved product that exists today to treat FSAD. If our clinical development is successful, Sidenafil cream has the potential to be the first FDA-approved FSA-D treatment option. We continue to enroll women in the Phase 2b RESPOND clinical study evaluating sedentary cream as a potential treatment for FSA-D at sites located across the United States. Our study protocol does have a planned interim analysis. It's to evaluate the power calculations and trial sizing. So once we conduct that analysis, which is planned this year, We will provide guidance on anticipated timing for the top-line data. Next, DARE-HRT1. The results of the completed Phase I study of our Investigational Hormone Therapy product, or DARE-HRT1, last year demonstrated its potential as an effective hormone therapy for both the vasomotor and the vaginal symptoms associated with menopause. DER-HRT1 is a unique vaginal ring. It's designed to deliver bioidentical estradiol and bioidentical progesterone together continuously over a 28-day period as part of a hormone therapy regimen. As the next step in the development program, we are now commencing a Phase I-II clinical study of DER-HRT1 in Australia in the second quarter of this year. This open label study will evaluate the PK of the lower and high dose versions that we had studied previously of DRHRT1 in approximately 20 healthy postmenopausal women over now approximately three consecutive months of use. The study will also collect safety, usability, acceptability, and symptom relief data. There are currently no FDA approved IVRs that deliver bioidentical progesterone in combination with bioidentical estradiol. As such, DARE HRT1 has the potential to be a first-in-category product that offers monthly convenience for women. And the last portfolio candidate I will discuss today is DARE VVA1. More than 3.8 million women in the U.S. have a history of breast cancer. Hormone receptor positive is the most common type of breast cancer. And the prevalence of vulvar and vaginal atrophy in postmenopausal breast cancer survivors is estimated to be 40% to 70%. We would like to provide an option to those women. DER-VVA-1 is our proprietary investigational formulation of tamoxifen for vaginal administration to treat VVA. As a non-hormonal approach to addressing vaginal atrophy, it could be an important option for women with a history of or at risk for hormone-receptive positive breast cancer. VVA is often also the outcome of effective breast cancer treatments. And as I mentioned, it can lead to vaginal discomfort, including painful intercourse, which, as you can imagine, causes significant distress. For many women, an appropriate treatment for vaginal atrophy is supplemental estrogen. However, estrogen may pose a risk to women at risk for hormone receptor-positive breast cancer. And hence, DARE VVA-1 may offer a solution for these women and others for women whom hormonal treatment is not an option. As I mentioned in my opening remarks, we initiated that Phase 1-2 clinical study in Australia in the third quarter of last year for what we refer to as this Breast Cancer Survivorship Vaginal Ecstasy Treatment Program, DRVBA-1, and we expect to report top-line data from the DRVBA-1 Phase 1-2 study during the second half of this year. Now, you've been waiting to hear more about Zasciato. I'm going to turn the call over to John to provide our perspective on commercialization and collaboration strategies in women's health.

Thank you, Sabrina. As Sabrina noted at the start of the call, we closed 2021 by achieving a number of important milestones for DARE. Chief among them was the FDA approval of Zasciato in December of 2021. As we communicated on our last call, we are a company focused on providing better therapeutic options for women and and collaborations are core to our business model. In the context of Zasciato, our objective was to identify the right commercial collaborator for the product, specifically one with strong commercial capabilities and expertise in women's health that would be in a unique position to bring Zasciato to market and leverage the clinical outcomes achieved in the phase three clinical study. Zasciato uses a novel thermal setting gel formulation containing clindamycin at a concentration of 2% present as clindamycin phosphate with one-time dosing. In the phase three trial, Zasciato demonstrated clinical cure rate of 70% at the test of cure visit, the day 21 to 30 visit, as compared to 36% for placebo. The potential to offer women a new option for treating bacterial vaginosis enabled us to engage with the most capable potential partners in the women's health landscape, and we are excited that Organon will be leveraging its strong commercial capabilities and expertise in women's health to bring Zasciato to market. Organon's goal to deliver innovation, improve access, and expand choice to help address therapeutic gaps in women's health is clearly aligned with our mission and what we wanted to accomplish with Zasciato. Transitioning to Overprene, our Overprene collaboration with Bayer has remained focused on activities to support the IDE process with the FDA, including manufacturing activities, and importantly, pre-commercialization activities that inform the design of the pivotal study targeted to commence later this year, and ultimately, the launch strategy for this potential first in category contraceptive candidate. We are fortunate to work with collaborators that share our vision to deliver innovation in women's health, and have the access and expertise and sales capabilities to enhance our impact. I will now turn the call over to Lisa, who will give you a financial update.