Dare Bioscience, Inc.

Welcome to the conference call hosted by Daray Bioscience to review the company's financial results for the quarter ended September 30, 2021 and to provide a general business update. This call is being recorded. My name is Abigail and I will be your operator today. With us today are Sabrina Martucci-Johnson, Daray's President and Chief Executive Officer, John Fair, Daray's Chief Strategy Officer, and Lisa Walters-Hoffert, the RAISE Chief Financial Officer. Ms. Johnson, please proceed.

Thank you. Good afternoon and welcome to our third quarter 2021 financial results and business update call for Dari Bioscience. Our plan today is to review last quarter's results, discuss development since our last call in August, and use the time to highlight objectives and milestones anticipated for the balance of 2021, as well as insights into 2022. 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 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 Form 10-Q for the quarter ended September 30, 2021, which was filed today, as well as our annual report on Form 10-K for the year ended December 31, 2020, filed on March 30, 2021. 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, 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. DARI is solely and squarely focused in women's health. Our strategy is to identify, develop, and bring to market a diverse portfolio of 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. Prioritizing women's health is, of course, good for women, and through this focused approach of addressing unmet needs with candidates that have the potential to be first-line or first-in-category options, have a meaningful commercial opportunity, and, in many instances, can be developed via a 505b2 regulatory path allowing us to move directly into later stage clinical development and potentially shortening the overall development cycle for the U.S., our strategy seeks to create value and yield benefits for all of our stakeholders. Significant progress on several key clinical and corporate initiatives with the portfolio was achieved during the third quarter, and we are actively advancing clinical development and strategic partnerships to maximize the value of our pipeline candidates. Specifically, this summer we announced a grant for up to $48.9 million over approximately five years to support one of our preclinical stage contraceptive programs. Positive phase one data for our hormone therapy product candidate, DARE-HRT1. The FDA accepted our NDA for DARE-BV1 for priority review with a PDUFA target date of December 7th, 2021. And we entered into a collaborative research and development agreement, also known as a CRADA, under which a pivotal Phase III clinical study of oviprene will be supported by the NICHD's contraceptive development program and conducted within its contraceptive clinical trials network. Additionally, in September, we initiated a Phase I-II 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 receptor-positive breast cancer. And we're also continuing to enroll patients in our Phase IIb response study, evaluating Sidenafil cream, 3.6%, as a treatment for female sexual arousal disorder. And for this fourth quarter, we have three important objectives. The FDA's PDUFA action on our NDA for DERBV1, plans to announce a commercial strategy for this bacterial vaginosis product candidate, And we expect to submit an investigational device exemption or IDE for oviprene to be able to commence the pivotal phase three contraceptive trial in 2022. So while our portfolio includes several programs, my comments today will focus on our NDA stage DRBV1 program, our four clinical development stage candidates, all of which are utilizing different APIs and targeting different indications, bacterial vaginosis, sexual health, contraception, hormone therapy, and breast cancer survivorship vaginal atrophy treatment. So I'll start with DARE BV1, which is in the vaginal health category of bacterial vaginosis specifically, which impacts an estimated 21 million women in the United States alone. In the third quarter, as I mentioned, we announced that the FDA accepted for filing the NDA for DARE BV1 for the treatment of bacterial vaginosis, and they granted this application priority review and set a Prescription Drug User Fee Act or PDUFA date of December 7, 2021. As a reminder, the FDA grants priority review to applicants and applications for potential drugs that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment of a serious condition. And bacterial vaginosis is a condition that can cause serious health risks and very disruptive symptoms. It has always been our goal to bring to market a product with the potential to improve outcomes and convenience for millions of sufferers, and we believe DARE BV1 has demonstrated the potential to do that. Current FDA-approved branded products indicated for the treatment of bacterial vaginosis have clinical cure rates in the range of only 37% to 68%. In the DARE BV-free Phase III study, a single vaginal dose of Darabeev-1 achieved clinical cure rates of 70% to 81%. Specifically, the Darabeev-free study met its primary endpoint, demonstrating that as a primary therapeutic intervention, a single vaginal dose of Darabeev-1 was statistically superior to placebo at the day 21 to 30 test of cure visit in the modified intent to treat population. That was 70% compared to 36% of subjects clinically cured in the placebo group. And additionally, DARE BV1 demonstrated clinical cure rates of 77% at the day 21 to 30 test of cure visit and 81% at the day 7 to 14 assessment visit in the per-protocol population, compared to 43 and 30% for placebo cream, respectively. DARE BV1 has received both Qualified Infectious Disease Product, QIDP, and fast-track designations from the FDA for the treatment of bacterial vaginosis. And under the QIDP designation, if approved, we expect DRBV1 will receive five years of market exclusivity in addition to the three years available for having generated new clinical data. We are in active strategic discussions and engaged in other activities to support a robust market launch of DRBV1 in 2022 if approved. And we plan to announce our commercialization strategy for DRBV1 in the U.S. by year end. John will provide some additional color in a moment. But before we do that, I want to talk a little bit about the other programs. So next, in the sexual health category, I'll now provide an update on sidenafil cream, 3.6%, which is our investigational product to address her version of erectile dysfunction. In March of this year, we commenced our Phase 2B clinical study evaluating sidenafil cream as an investigational cream formulation of sidenafil with the active ingredient that's 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 is 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. No FDA approved products exist today to treat FSAD despite the fact that the FSAD 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. If our clinical development is successful, sidenafil cream has the potential to be the first FCA-approved FSAD treatment option. We are actively enrolling subjects in the Phase 2B RESPOND clinical study evaluating sidenafil cream as a potential treatment for FSAD at sites located across the United States. Our study protocol has planned an interim analysis to evaluate power calculations and trial sizings. And once we conduct that analysis, we'll be providing some guidance on the anticipated timing for the top line data readout from the trial. I'd now like to provide an update on our investigational product, Oviprene, a potential first in category option in the over $7 billion contraceptive category. So in the third quarter, as I mentioned, we announced a CRADA with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, which is part of the National Institute of Health, or NIH. This is 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 costs of the pivotal Phase III study. Specifically, Oviprene is our novel hormone-free monthly contraceptive candidate whose commercial U.S. rights are under a license agreement with Bayer. The next stage of clinical development for Oviprene is this pivotal Phase III contraceptive study that we will conduct under the CRADA with NICHD. Grant funding previously provided by NICHD supported the conduct of our pre-pivotal clinical study of oviprene. In order to initiate the pivotal phase III study, we must have an FDA-cleared IDE in place. We currently plan to file the IDE for oviprene by the end of 2021 and, pending the FDA's review and clearance of the IDE, to initiate the study in 2022. In terms of the pivotal study, DARE will be responsible for providing clinical supplies of oviprene and coordinating the interactions with and preparing and submitting supportive regulatory documents to the FDA. DARE and NACHD together will each provide medical oversight for the trial and will work together to prepare the final report of the trial results. U.S. commercial rights for oviprene are under that license agreement with Bayer. Under the agreement, DARE receives access to Bayer's extensive clinical and market expertise through and up to approximately 80 hours per week in advisory support, while we retain control over Obaprene's development and regulatory approval process. Bayer has that right to obtain that exclusive license to commercialize the product in the U.S. following completion of the pivotal clinical trial being undertaken by DARE and the NICHD by making a $20 million payment to DARE. We will also be entitled to receive commercial milestone payments, potentially totaling $310 million, in addition to double-digit tiered royalties on net sales. Next, for the estimated 45 million women in the U.S. and are approaching menopause, let's talk about our investigational hormone therapy product, ARHRT1. We believe our unique intravaginal ring or IVR platform technology offers a versatile drug delivery system in women's health with the potential to deliver different active drugs at different rates and thereby improve convenience and outcomes across multiple indications. This IVR drug delivery technology was developed by Dr. Bob Langer from the Massachusetts Institute of Technology and Dr. William Crawley from Massachusetts General Hospital and Harvard Medical School. And the first application of this versatile technology that we've clinically tested is DARE HRT1, which specifically is an investigational 28-day intravaginal ring for hormone therapy containing bioidentical estradiol and bioidentical progesterone for the treatment of the vasomotor symptoms of menopause and the genitourinary syndrome associated with menopause. In June, we announced the positive top-line results from our Phase 1 clinical trial of DHRT1 that we conducted in Australia. For some women, hormone therapy is a highly effective treatment for the symptoms associated with menopause, such as the hot flashes and the vaginal dryness, and it may also prevent bone loss and fracture. So the delivery of hormone therapy over 28 consecutive days with no daily intervention supports DARE HRT1's potential to be a first-in-category offering and option, providing ease of use and continuous dosing to women suffering from menopausal syndrome. There are currently no FDA-approved products that continuously deliver hormone therapy with both estradiol and progesterone together over multiple consecutive weeks, as is the design of DARE HRT1. Our clinical development strategy is to leverage the existing safety and efficacy data on the active ingredients in DARE-HRT1, the estradiol and progesterone, and to seek approval using the 505 regulatory pathway in order to obtain marketing approval of DARE-HRT1 in the U.S. We are in the process of updating our regulatory and clinical development strategy given these positive Phase I data, and we will be providing guidance on next steps with this program as soon as possible. We've not yet commenced clinical testing of our second application of this novel IVR technology, specifically DER-FRT1, for the prevention of preterm birth and luteal phase support during IVF procedures. However, we have received a grant from the NIH for certain non-clinical activities with the potential for additional end-age funding to support a phase one study of DER-FRT1, and we will continue to provide updates as those activities advance. And finally, for the more than 3.8, as you know, more than 3.8 million women in the U.S. have a history of breast cancer. And 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 42 to 70%. We would like to provide an option for those women. And that is in our program, Dear VVA1. As I mentioned in my opening remarks, we initiated a Phase 1-2 clinical trial in Australia in the third quarter for this breast cancer survivorship vaginal atrophy treatment program, DARE VVA-1. DARE VVA-1 is our proprietary investigational formulation of tamoxifen for vaginal administration to treat VVA. As a non-hormonal approach to addressing VVA, it could be an important option for women with a history of or at risk for hormone receptor-positive breast cancer. VVA is often the outcome of effective breast cancer treatments, and it can lead to vaginal discomfort, including painful intercourse, which, as you can imagine, causes significant distress. For many women, an appropriate treatment for VVA is supplemental estrogen. However, estrogen may pose a risk to women at risk for hormone receptor-positive breast cancer. So VVA-1, DARE VVA-1, may offer a solution for these women and for others for whom hormonal treatment is not an option. We currently expect to report top line data from the DARE VBA1 Phase 1-2 study during 2022. I will now turn the call over to John to provide a strategic update on DARE VBA1.

Thank you, Sabrina. The DARE VBA1 partnering process has been purposely aligned with the DARE VBA1 regulatory process. With the NDA for DARE BV1 under priority review by the FDA, we have accelerated the three main commercialization strategies under discussion, which include a straight-out license to a strategic partner where the partner is solely responsible for commercialization in exchange for milestone and royalty payments to DARA, a second scenario where we strategically partner DARE BV1 but retain the option to have a role in the commercialization of the product, And a third scenario where we can play a direct and active role in commercialization, that includes being able to fully market the product through an introduction via partnership with a full service contract sales organization or CSO. All three options remain under active discussion as we approach the December 7th PDUFA target action date. And as a company, we reflected across our entire portfolio of product candidates, we are really focused on providing better therapeutic options for women. In the context of DARE BV1, we are motivated to find the right commercial structure for the brand because we believe it should be the new standard of care for the treatment of bacterial vaginosis. And as Sabrina previously mentioned, currently available FDA-approved treatment options for bacterial vaginosis work about half the time on average. What has been particularly insightful for us and our team based on real-time market insights that we mentioned during our previous update call is there's a fundamental underestimation of the effectiveness of the currently approved products both on the part of the healthcare providers and the payers. We believe this is likely due to the lack of innovation in the category and the lack of promotion for bacterial vaginosis products. And based on our market research and our current understanding of the market, it's our belief that Dara BV1 will be the top promoted brand in the category at the time of its launch if it's approved. That will give Dara BV1 commercial team, whether that's Dara or a partner, a dominant share of voice in the category. And that's an important point. As those of you who are familiar with pharmaceutical marketing can appreciate, being able to dominate share of voice is generally viewed as a key performance indicator for success. And in addition to being able to dominate share of voice, we expect the in-market messaging to feature the differences in clinical cure rates for DERA BV1 versus other FDA-approved products, as well as positive data on the patient experience. In our DARE BV-free study, we saw positive patient-reported data that suggests DARE BV-1 was able to rapidly resolve some of the most bothersome symptoms of bacterial vaginosis for patients, including the vaginal odor and vaginal discharge. When you add the potentially best-in-class clinical curates in the category with the opportunity for the patient to experience rapid relief of some of the most bothersome symptoms, all by the way achieved with a single administration, a one-time vaginal dose, We believe that the product is well positioned for success, pending ongoing discussions with the FDA and approval of our NDA. I'd also like to highlight another insight from the recent round of market research specific to payers. Payers, as many of you know, are absolutely critical to the success of any new product, and that's particularly true for women's health. And our research has shown that payers are very interested in a product that positively impacts patients who have been previously treated for bacterial vaginosis, or what you might call recurrent patients. The good news for us and for DARE BV1 is that the DARE BV3 study data suggests DARE BV1's potential to produce the same high clinical cure rate in recurrent patients as in patients who have never been treated for bacterial vaginosis. Therefore, any positive impact on recurrent patients is viewed as a key factor that could influence payer coverage considerations for DARE BV1. So in summary, we are encouraged with the progress of our discussion specific to DARE PV1 commercialization. We are excited about the prospect of bringing an important new therapeutic option to women and healthcare providers. And with that, I'm going to turn the call over to Lisa to give you a financial update.