Dare Bioscience, Inc.

Thank you all for standing by, and welcome to the conference call hosted by Dare Bioscience to review the company's financial results for the quarter ended June 30, 2021, and to provide a general business update. Please note that this call is being recorded. This is Jesse, 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-Hofford, DARI's Chief Financial Officer. Ms. Johnson, please proceed.

Thank you. Good afternoon and welcome to our second quarter 2021 financial results and business update call for DARI Bioscience. Our plan today is to review last quarter's results, discuss developments since our last call in May, and use the time to highlight objectives and milestones anticipated for the balance of 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 to differ materially from those anticipated are implied by these statements due to known and unknown risks and uncertainties. You should not place any reliance on forward-looking statements. Board-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 June 30, 2021, which is 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 today's call includes time-sensitive information that is current only after today, August 12, 2021. DARI undertakes no obligation to update forward-looking statements to reflect new information or developments after this call, except as required by law. 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 opportunities. We currently have four clinical stage programs in the areas of vaginal health, sexual health, contraception, and menopause, and one product in the breast cancer supportive care category soon to enter phase one. And most of my remarks today will address these candidates. The first half of 2021 has been quite eventful for DARE. And the announcements we were able to make over the last two months have been the type of updates that every CEO enjoys making. We announced positive Phase I data for our hormone therapy products, an up to $48.9 million grant over the course of five years for one of our preclinical contraceptive programs, a collaborative research agreement with the NIH to co-financially support and co-conduct our Phase III study for investigational contraceptive otoprene, And just this week, we announced the FDA's acceptance and priority review of our NDA for our bacterial vaginosis product candidate, with a December 7, 2021, producer target action date. It has definitely been a meaningful few months for DARI, and we hope it will continue to prove to be a meaningful year for us, given what we have yet to come. With that backdrop, I'll now provide some additional context on those accomplishments and specifically dive deeper on the relevant updates related to our four clinical stage programs, as well as that supportive care cancer program. In the vaginal health category of bacterial vaginosis, which impacts an estimated 21 million women in the United States, I'll start with DARE BV1. During the second quarter of 2021, and in line with our guidance, we submitted a new drug application, or NDA, to the FDA. We requested a priority review at that time of submission. We announced that the FDA accepted for filing the NDA for DRV-1 for the treatment of actuarial vaginosis, and the FDA granted this application priority review and set a Prescription Drug User Fee Act, or PDSA, date of December 7, 2021 for the target completion of its review of the NDA. The FDA grants priority review to applications for potential drugs that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment of a serious condition. The NDA we filed is supported by positive results from the DARE BV3 Phase III randomized, multi-center, double-blinded, placebo-controlled clinical trial evaluating DARE BV1 in women diagnosed with bacterial vaginosis, a condition that can cause serious health effects and risk and is very disruptive in terms of the symptoms. And as I mentioned, it's estimated to affect approximately 21 million women in the United States. DER-BB-1 is an investigational thermosetting bioadhesive hydrogel containing chondomycin phosphate 2% that's designed as a one-time vaginally administered treatment for bacterial vaginances. The acceptance of this NDA marks a major milestone, not only for Daria as a company, but importantly for the millions of women that are impacted by bacterial vaginosis. It is our goal as a company to bring to market products and products like this that have the potential to improve outcomes and convenience for women. As DARE-BV1 demonstrated, it has the potential to do in the phase three study. where a single vaginal dose of DARE BV1 achieved clinical cure rates in the range of 70 to 81%. Specifically, the results from the DARE BV3 study demonstrated DARE BV1's potential to improve clinical cure rates in a convenient one-time dose compared to those of currently FDA-approved branded products indicated for the treatment of bacterial vaginosis. Patients in the study were evaluated during three clinic visits. Day 1, which is screening and randomization, Day 7 to 14, which is an interim assessment visit, and Day 21 to 30, which was the test of cure visit. This study met its primary endpoint, demonstrating that as a primary therapeutic intervention, a single vaginal dose of DRBB1 was statistically superior to placebo at that Day 21 to 30 assessment in the modified intent-to-treat population, specifically 70% compared to 36% of subjects clinically cured. Additionally, DARE BV1 demonstrated clinical cure rates of 77% at days 21 to 30 and 81% at days 7 to 14 in the per-protocol population, compared to 43% and 30% for placebo clean, respectively. Current FDA-approved products have clinical cure rates in the range of only 37% to 68%. DARE BV1 has received both Qualified Infectious Disease Product, or QIDP, as well as fast-track designations from the FDA for the treatment of bacterial vaginosis. Under the QIDP designation, if approved, we expect DRVV1 will receive five years of market exclusivity in addition to the three years available for having generated new clinical data. Ongoing strategic discussions and other activities to support a robust market launch of DRVV1 in 2022, if approved, are underway and we plan to finalize and announce the commercialization strategy for JRBV1 in the U.S. by year-end. John will be providing additional color in a moment. In the sexual health category, I'll now provide an update on Sedentifocrene 3.6%, our investigational product to address her version of erectile dysfunction. In March of this year, we commenced our Phase IIb clinical study evaluating Sedentifocrene 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 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, Sudentico Cream has the potential to be the first FDA-approved FSAV treatment option. We are actively enrolling subjects into the Phase IIb Respond clinical study, evaluating Sudentico Cream as a potential treatment for FSAV at sites located across the country. During our last call, we said we would continue to provide updates on the progress of the Phase IIb Respond study and the potential impact of COVID-19 are unexpected timelines. We are monitoring this closely and particularly given the evolving COVID-19 guidance and case loads across the country, we feel it's challenging to confirm anticipated timing for the top line data readout until we complete the planned interim analysis to determine the ultimate size of the study. We've recently seen the pace of enrollment at certain sites decline because of those sites being in locations where the caseloads are higher and adhering to government guidelines recommending reductions or changes in their operations intended to reduce the spread of COVID-19. Due to the impact potentially on the pace of enrollment overall for the trial resulting from governmental recommendations or orders intending to reduce the spread of COVID-19 or from other effects related to COVID-19, We cannot predict with reasonable certainty at this time when the interim analysis will be conducted or when we'll report top line data from the trial. As we have done to date, we will continue to provide updates as the trial continues and we can better project timelines. Now, I'd like to provide an update on our investigational product, Ova3, a potential first in category option in the over $7 billion U.S. contraceptive category. Last month, we announced that we entered into a cooperative research and development agreement, which is also known as a CRADA, with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, NICHD for short, which is part of the National Institute of Health, or NIH. This is for the pivotal phase three study of oviprene. The CRADA 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 three study. Oviprene is our novel hormone-free monthly contraceptive candidate whose U.S. commercial rights are under a license agreement with Bayer. The next stage of clinical development for Oviprene is this pivotal phase three contraceptive study that we will be conducting under the creator with the NICHD. Grant funding was previously provided by NICHD, and it supported the conduct of our pre-pivotal clinical study of oviprene. The current agreement reflects the NICHD's continued support for the development of oviprene and will allow us to leverage the contraceptive clinical trial expertise of NICHD while also sharing this cause for the Phase III study with NICHD. Specifically, the study will be supported by NICHD's Contraceptive Development Program, or CDP. The CDP oversees the Contraceptive Clinical Trial Network, or CCTN, which was established in 1996 to conduct studies of investigational contraceptives. And the study will be conducted with the CCTN with this NICHD contractor health decision. DARE will be responsible for providing the clinical supplies of oviprene and coordinating interactions with and preparing and submitting supportive regulatory documentation to the FDA. DARE and NICHD will each provide medical oversight for the trial and final data review and analysis and will work together to prepare the final reports and trial results. Under the CRADA, we, DARE, have agreed to contribute $5.5 million towards the total estimated cost to conduct the Pivotal Phase III study, and the NICHD will be responsible for the remaining costs related to the conduct of the study. And they will manage the payment of expenses to help decisions, the clinical trial sites, and the other parties involved with the study. Lisa will discuss this arrangement in more detail shortly. As I mentioned earlier, the U.S. commercial rights program are under a license agreement with Bayer. Bayer and Dari entered into this exclusive license agreement for the commercial rights to Oviprene in January 2020. Under the agreement, we received access to Bayer's extensive clinical and market expertise through up to approximately 80 hours per week in advisory support, and we maintained control over Oviprene's development and regulatory approval process. Bayer has the right to obtain exclusive rights to commercialize the product in the U.S. following the completion of the pivotal clinical trial being undertaken by us with the NACHD. If Bayer, in its sole discretion, makes the payment to DARI of $20 million, which we intend to apply to reimbursement of our portion of the clinical study and manufacturing cost of the program. And at that point, the exclusive license to commercialize oviprene in the U.S. will become effective. We will also be entitled to receive commercial milestone payments, potentially totaling $310 million, in addition to double-digit tiered royalties on net sales. In order to initiate this pivotal Phase III study, we must have an FDA-cleared investigational device exemption, or IDE, in place. We currently plan to file an IDE for oviprene in the fourth quarter of this year, and then pending the FDA's review and clearance of the IDE, we intend to initiate that pivotal phase study in 2022. Next, for the estimated 45 million women in the U.S. who are approaching or in menopause, let's talk about our investigational hormone therapy product, DARE HRT1. So during the second quarter and in line with our guidance, we reported the positive top line data from our phase one clinical study of DRHRT1, which we conducted in Australia. We believe this unique intravaginal ring 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 improving convenience and outcomes potentially across multiple indications. The IVR drug delivery technology was originally developed by Dr. Robert Meiner from MIT and Dr. Lynn Crowley from the Massachusetts General Hospital and Harvard Medical School. And this first application of this versatile technology that's being clinically tested is the state DARE HRT1 use of it, which is an investigational 28-day intravaginal delivery of hormone therapy via the ring. And the ring contains both, in this case, bioidentical estradiol and bioidentical progesterone for the treatment of the vasomotor symptoms and the genitourinary symptoms and syndrome associated with menopause. On June 28th, we announced the positive top-line results from our Phase I clinical study of DRHRT1 Australia. That randomized, open-label, three-arm parallel group Phase I study was designed to evaluate the pharmacokinetics of DRHRT1 in approximately 30 healthy postmenopausal women with intact uterine. The primary objective of the study was to describe these pharmacokinetic or PK parameters of two different dose combinations over 28 days. Secondary objectives of the study were to assess the safety and tolerability of DHRT1 and to compare the systemic exposure of the estradiol, which importantly is the active form of the therapeutic hormone therapeutic hormone replacement purposes as well as estrone and progesterone from their HRT1 over 28 days and compare those against a combination of FDA approved oral estrogen and oral progesterone products evaluated in that same phase one study. The levels of estradiol released from both the lower and higher dose formulation in their HRT1 evaluated in the study achieved or exceeded the levels that were targeted for hormone therapy. Target levels of estradiol for hormone therapy for either the vasomotor symptoms or the vaginal symptoms of menopause were established by reviewing PK levels that have been published for FDA-approved products for most of the treatment of EMS as well as the genitourinary symptoms of menopause. And based on the estradiol PK data in DARE-HRT1 in the Phase 1 study, the results support the potential of DARE-HRT1 as an effective hormone therapy for both vasomotor symptoms and vaginal symptoms associated with menopause. The levels of progesterone importantly released from both versions of DARE HRT1 evaluation study also met the objectives of releasing progesterone. And specifically, progesterone is used in hormone therapy to reduce the impact of estrogen on non-target sites, such as the endometrium, and to prevent estrogen-induced endometrial hyperplasia. In addition, the treatment was well tolerated with the most common of adverse events consisting of vaginal systems that are consistent with other vaginal products. DER-HRT1 also had a high level of accessibility in the study with over 80% of subjects on either the low or high dose versions of HRT1 product reporting the IVR as comfortable or very comfortable. And additionally, over 80% of the subjects in each dose group stated that they were either somewhat or very likely to use the IVR for a women's health condition or disease if she needed it. For some women, hormone therapy is a highly effective treatment for the symptoms associated with menopause, like the hot flashes and the vaginal dryness, and it may also prevent bone loss and fracture. The delivery of hormone therapy over 28 consecutive days with no daily intervention supports DARE HRT1's potential to be a first-in-category option, offering ease of use and continuing dosing to women suffering from menopausal symptoms. There are currently no FDA-approved products that continuously deliver hormone therapy with both estradiol and progesterone together over multiple consecutive weeks. We plan on submitting that data from that Phase I clinical study for publication in a peer-reviewed journal. And our clinical development strategy is to leverage the existing safety and efficacy data on the active ingredients in DRHRT1, the estradiol and the progesterone, and to utilize the FDA's 505 pathway in order to obtain marketing approval of DRHRT1 in the U.S. We are in the process of updating our regulatory and clinical development strategy given these positive Phase I data. and will provide guidance on the next step with this program as soon as possible. And finally, before I turn it over to John and Lisa, I want to talk about the approximately 3.8 million women in the U.S. who have a history of breast cancer. Hormone receptor positive, of those women, hormone receptor positive is the most common type of breast cancer. And the prevalence of vulvar and vaginal atrophy, or VVA, in postmenopausal breast cancer survivors is estimated to be 42 to 70 percent. We would like to provide a supportive care option for those women, DARE VBA-1. So as I mentioned in my opening remarks, we plan on initiating a phase one clinical study later this year in Australia for this breast cancer supportive care program, DARE VBA-1. Your VBA-1 is our proprietary investigational formulation of tamoxifen for vaginal administration to treat vaginal atrophy. As a non-hormonal approach to addressing vaginal atrophy, it can be an important option for the women with a history of or at risk for hormone receptor-positive breast cancer. VBA is often the outcome of affected breast cancer treatments, and one of the unpleasant side effects of VBA is painful intercourse. For many women, an appropriate treatment for BVA is supplemental estrogen. However, estrogen may pose a risk to the women at risk for hormone receptor-positive breast cancer, and hence, DARE BVA-1 may offer a solution for these women and others for whom hormonal treatment is not an option. We plan to commence that Phase I clinical study in the second half of this year in Australia and look forward to providing updates on the progress of that program. I'll now turn it over to John to provide a business and corporate partnership update on our two latest stage programs, specifically DARE BV1 and Evaprene.

Thank you, Sabrina. Now that the NDA for DARE BV1 has been accepted for filing by the FDA and priority review has been granted, we anticipate acceleration across the three main commercialization strategies we've been progressing in parallel, given that the DARE BV1 partnering process has been strategically and purposefully aligned with the DARA BV1 regulatory process. Those scenarios 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 based on the revenue generated by the product, a second scenario where we strategically partner DARA BV1 but retain the option to have a role in the commercialization of the product, and finally, a scenario where we can play a direct and active role in commercialization that includes influencing the go-to-market and planning strategy, including the market introduction, through a strategic partnership with a full-service contract sales organization. All three options are currently under discussion. Principally, and in the context of DARA VV1, and really across all of our product candidates, we are focused on doing what's best for women, which is to ensure that these products have broad commercial access And that benefits all of our stakeholders, specifically our investors. We will use this lens to help guide us through our process and to solidify the best strategic opportunity for the introduction of DARE BV1, if approved. As many of you know, women diagnosed with bacterial vaginosis are challenged, often routinely, to find interventions that can rapidly address the signs and symptoms of the infection and also address and resolve the underlying infection itself. currently available FDA approved treatment options work about half the time on average. It's our belief that DERA BV1's product profile will appeal to both patients and providers as it has the potential to provide a clinically meaningful improvement over currently approved FDA products, particularly in terms of a better opportunity for a clinical cure, which includes resolutions of the signs and the symptoms of the infection. And in parallel with our strategic partnering discussions for DERA BV1, We are actively executing other commercial introduction work streams, such as manufacturing and market access, with the goal of allowing us and our strategic partner to execute against a robust 2022 launch should we receive FDA approval in December of this year. In summary, we are encouraged with the progress of the DARE BV1 program, and we are excited at the prospect of bringing this important new therapeutic option to women and providers And we believe that we are well positioned to communicate our definitive commercialization strategy before the end of this year. So I'd also like to take a moment to highlight the ongoing partnership with Bayer for our hormone-free monthly contraception product candidate, Overprime. We are delighted to report that the partnership is progressing as well, if not better, than we could have expected. Bayer, as part of their commitment to provide up to two full-time equivalents in an advisory capacity to support the development stage of the program, has been actively supporting DARE across all of the key functional areas, including CMC, regulatory, as well as strategic planning to inform downstream commercialization to optimize the introduction of this exciting new product candidate if it's approved. As I'm sure many of you know, Bayer is a worldwide leader in the conscious effort category, and that was one of the key drivers behind our decision to partner Overprime at this stage of clinical development. We believe that our Overprime partnership with Bayer is a clear example of our commitment to doing what is best for our stakeholders, our shareholders, and for women, which is core to our strategy here at DARE. So we look forward to keeping you updated on the BEAR partnership as well as other key strategic initiatives here at DARE. And with that, I will now turn the call over to Lisa to give you a financial update.