Dare Bioscience, Inc.

Welcome to the conference call hosted by DARA Bioscience to review the company's financial results for the quarter ended March 31st, 2021 and to provide a general business update. This call is being recorded. My name is Ryan and I will be your operator today. With us today are Sabrina Martucci-Johnson, DARA's President and Chief Executive Officer, John Fair, DARA'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 first quarter 2021 financial results and business update call for DARI Bioscience. Our plan today is to review the last quarter's results, discuss development since our last call in March, and use the time to highlight objectives and milestones anticipated for 2021. Before we begin, I'd like to remind you that today's discussion will include forward-looking statements within the meaning of the 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 March 31st, 2021, which was filed today, as well as our annual report on Form 10-K for the year ended December 31st, 2020, that was filed on March 30th, 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, May 13th, 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 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 lines, and have meaningful commercial opportunity. We currently have four clinical stage programs in the areas of vaginal health, sexual health, contraception, and menopause, and most of my remarks today will address these candidates. 2021 could prove to be a meaningful year for us. The advances and momentum in 2020 across the portfolio really set the stage for us to reach some important portfolio objectives in 2021. I'm going to start the call, and heads up, I'm also going to end the call with a summary of the potential meaningful development for DARI this year. This year alone, since there are many of them, and those of you new to the DARI story will likely appreciate hearing this list of 2020 milestones, 2021 milestones repeated. So first, in the area of bacterial vaginosis and vaginal health for our DARE BV1 program, during 2021, we intend to submit the NDA, enter into and announce a strategic commercialization agreement, and have a PDUFA goal date, which could result in FDA approval by year end. In the area of sexual health, specifically our Sidenafil CREAM program for female sexual arousal disorder, our Phase 2B clinical study is ongoing, and we seek to have top line data by the year end 2021. In the area of contraception, our oviprene program, we intend to file our investigational device exemption for oviprene application this year, or IDE, in the fourth quarter to enable a pivotal study start in 2022. And in the area of vaginal sexual health, specifically menopause, our DARE HRT1 program is in phase one, and we do anticipate having that study top line data this quarter, in quarter two. And then, additionally, I'm going to talk a little bit about our vaginal atrophy program in vaginal and sexual health, specifically for hormone receptor-positive breast cancer, where we seek to initiate a Phase I clinical trial later this year. So I'll start first with that vaginal health program, specifically bacterial vaginosis, our DRB1 program. So, as you know, we ended 2020 with an announcement of the positive top line data from the DRBV-free phase three study of DRBV-1 for the treatment of bacterial vaginosis. And as I mentioned, we're preparing to submit a new drug application or NDA with the FDA this quarter. Completing this clinical study on time and on budget, despite the operational constraints of the pandemic, was an accomplishment about which we are certainly proud. And it also allowed for some lessons learned that we're applying now to our sidenafil phase 2B study, and I'll address that shortly. For those of you who are new to DARI, I'd like to just take a minute to highlight the unique attributes of DARE-BB1, the positive results of our completed phase 3 study, and our next steps with the NDA submission and commercialization strategies. So, BB1 is a novel investigational thermosetting bioadhesive hydrogel. It's formulated with clindamycin clindamycin phosphate 2% as a first-line single administration vaginal treatment for bacterial vaginosis. Bacterial vaginosis is the most common vaginal condition in women of reproductive age, affecting 21 million women estimated in the United States. It causes very disruptive symptoms for her of vaginal odor and discharge, and it's importantly linked to health risks, including preterm birth, sexually transmitted infections, post-surgical infection, and pelvic inflammatory disease. Current FDA-approved treatments have clinical cure rates in the range of only 37% to 68%, leading to unresolved symptoms and linked to high rates of recurrence. For this reason, in 2018, we identified bacterial vaginosis as a persistent unmet need, impacting a large number of women, and we set about finding a potential solution. We selected DARE BV1 in light of the ability the bioadhesive hydrogel demonstrated in early clinical studies to keep the antibiotic clindamycin, which is a proven broad-spectrum antibiotic that is bacteriostatic and inhibits protein synthesis, resonant over multiple days. Simply put, in order for an antibiotic to be effective in the vaginal environment, it must remain present. We believe the single-dose convenience of this unique, clear bioadhesive hydrogel provided such an opportunity. And in our DARE BV3 phase 3 study, DARE BV1 demonstrated the potential for improved clinical cure rates versus current branded FDA-approved marketed vaginal and oral products for the treatment of bacterial vaginosis. Specifically, in the modified intent to treat population, The clinical cure rates for DRBV1 were 70% at the test of cure visit, which occurred 21 to 30 days after study drug administration. That was the primary endpoint. And 76% at the assessment visit that occurred 7 to 14 days after study drug administration. Importantly, in the per protocol population, which includes only those patients in the modified intent to treat population who didn't have a major protocol violation or who didn't receive or received any other bacterial vaginosis therapy for any reason, the clinical cure rates in that group were 77% at day 21 to 30 and 81% at day 7 to 14. And further, these results were achieved in what we believe was a representative patient population including a large proportion of patients who reported having one or more episodes of bacterial vaginosis in the 12 months before they were randomized into the study. Specifically, 75% of the intent-to-treat population reported at least one prior episode of bacterial vaginosis in the 12 months before the study. And nonetheless, the DRBV1 demonstrated the 70% clinical cure rate at day 21 to 30 in this population. And in addition, this was the first study conducted under the new 2019 FDA guidance for bacterial vaginosis treatment. The new guidelines required that all subjects in the MITT population not only meet the clinical diagnostic criteria for bacterial vaginosis, but at baseline, they also had to meet the bacterial morphology classification or Nugent score of at least seven reflective of bacterial vaginosis. So given these data, we believe DRBV1 is positioned to be an important first-line option for the treatment of bacterial vaginosis. And as mentioned, we're planning to submit that NDA to the FDA this quarter, Q2. Members of our team have, before joining DARE, been involved in numerous successful NDA submissions, but we're excited now at DARE to be submitting our first NDA as a company. DARE BV1 has both fast track and qualified infectious disease product designations. This allows for a priority review request at the time of the NDA submission. If our request is granted by the FDA, the NDA could have a PDUFA action date by the end of 2021. A 2021 FDA approval would allow for commercialization of DARE BV1 in 2022. Thus, ongoing strategic discussions and other activities to support a robust market introduction DRBV1 in 2022 if approved or underway. This year we plan to finalize and announce the commercialization strategy for DRBV1 in the U.S. I should note that we expect the launch strategy to be relatively straightforward given that antibiotics are frequently used to treat bacterial infections and vaginal administration of a drug for vaginal bacterial infection like bacterial vaginosis is common and often preferred by both clinicians and patients. since it provides a targeted localized treatment versus a systemic exposure to antibiotics. So we believe this ability to leverage existing knowledge may expand our options for commercializing Dear BV1, and John's going to discuss this in greater detail shortly. And he'll 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 transition to sexual health and specifically speak about our sidenafil cream program and the Phase IIb study that's ongoing. So sidenafil cream is an investigational cream formulation of sidenafil, which is the active ingredient in Viagra. Our formulation has been developed for topical administration to treat female sexual arousal disorder. Female sexual arousal disorder, or FSAD, is a physiological condition characterized by the inability to attain or maintain sufficient genital arousal response during sexual activity and of the various types of female sexual dysfunction disorders, it's the most analogous to erectile dysfunction in men. FSAD similarly 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. There are no FDA-approved products today to treat FSAD, despite the fact that FSAD market is estimated to be as significant, if not more so, than the erectile dysfunction market in both the U.S. and the rest of the world. In March of this year, we commenced the Phase 2B RESPOND clinical study evaluating Sidenafil cream as a potential treatment for FSAD. We're targeting completion of the study and having top-line data by year-end 2021. If clinical development is successful, sedentafil cream has the potential to be the first FDA-approved FSAD treatment option. The Phase 2b response study will evaluate sedentafil cream compared to placebo in pre- and perimenopausal women over a period of 12 weeks at home. They use the product at home, and this will follow 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 at the primary efficacy endpoint, namely improvement in that localized general sensation of arousal response and reduction in the distress that women with FSAD experience. In the months ahead, we will provide updates on our progress towards having top-line data by year-end. Women have suffered far too long without viable interventions to address FSAD, so we're excited 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. I'm now going to transition to talk about oviprene in the contraceptive category. So oviprene is our novel investigational hormone-free monthly intravaginal contraceptive. As you'll likely recall, we entered into a commercial partnership agreement with Bayer in January of last year, and since that time, we've been working in collaboration with Bayer to prepare for the next stage of clinical development, which is a pivotal contraceptive study. People often ask about Bayer's level of involvement with the program right now, and as you may recall, under the terms of the agreement, Bayer provides up to two full-time equivalents for advisory support, or put another way, that's up to 80 hours per week of advisory support on the program. So our teams meet multiple times each week, and the meetings include interactions across functional areas, including manufacturing, clinical, regulatory, medical affairs, and importantly, commercialization planning. The ongoing work is designed to ensure that, pending successful completion of the pivotal study and FDA approval, we are ready as partners. Unlike DRBV1, where the pre-commercial activities in the bacterial vaginosis space we expect to be straightforward, The list for oviprene will likely be a little heavier given that it's a disruptive product for which there are no comparable products on the market today. Prior to the launch of Mirena, Bayer needed to prepare the market for the introduction of what was then a revolutionary hormone intrauterine device. Today, Mirena is a popular contraceptive brand with annual revenue of the Mirena family of products exceeding a billion dollars. So likewise, we expect oviprene will require education and pre-commercialization activities. which is why we selected Bayer as the commercial partner for our unique investigational monthly non-hormonal intravaginal contraceptive Overprene and why we entered into that partnership when we did in advance of the pivotal study. Our next significant regulatory step for Overprene involves filing an IDE with the FDA, as we must have an approved IDE in place in order to initiate our pivotal contraceptive study. and one pivotal contraceptive study is necessary for approved registration. So our current plan is to file the IDE for oviprene in the fourth quarter of this year. We are designing the pivotal study to evaluate the use of oviprene over a period of at least six months and up to 12 months, and pending the clearance of the IDE, the pivotal phase three clinical study commencement is planned for the first quarter of next year, 2022, enabling a six-month data readout by the end of 2022. I want to talk a little bit now about the HRT1 program in menopause and then briefly on FRT1 for preterm birth and then VVA1. So our 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, which can improve convenience and outcomes across multiple indications. as exemplified by the programs we're advancing today. The IVR technology was developed by Drs. Bob Langer from MIT and Bill Crawley from the Massachusetts General Hospital and Harvard Medical School. And the first application of this technology that we are clinically testing is what we call their HRT1 which is an investigational 28-day intravaginal ring containing bioidentical estradiol and bioidentical progesterone delivered together for the treatment of the vasomotor and the genitourinary syndromes associated with menopause. Earlier this year, we announced that enrollment in that Phase I study that we're conducting in Australia is complete. The objective of the Phase I is to evaluate the ability of DRHRT1 to achieve its dual release objectives as well as the ability of the IVR technology in general to release two different active drugs at two different rates as targeted. And we expect to report those top-line data this quarter. Our second application of the same technology platform is DARE-FRT1, which is an investigational intravaginal ring being developed to deliver bioidentical progesterone alone over a 14-day period. And that's for the prevention of preterm birth as well as blood or luteal phase support as part of an IVF or in vitro fertilization regimen. You may recall that we were granted an award in 2020 by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, which is a division of the NIH. to support our preclinical development activities for DER-FRT1, and that we may be eligible to receive up to approximately $2.3 million in total in grant funding to support the continued development, including the Phase 1 clinical trial that we're targeting for 2022. And before I turn it over to my colleagues, finally, I just want to mention a little bit about the DER-VVA1 Phase 1 study, since we are planning to commence that this year. So DARE VVA-1 is our proprietary investigational formulation of tamoxifen for vaginal administration to treat vulvar and vaginal atrophy or VVA in a non-hormonal approach to addressing VVA. It could be an important option for women with or at risk for hormone receptor-positive breast cancer. VVA is often the outcome of an effective breast cancer treatment regimen, and so one of the unpleasant side effects of VVA is painful intercourse. For many women, an appropriate treatment for VBA is supplemental estrogen. However, estrogen may pose a risk to women at risk for hormone receptor-positive breast cancer. Thus, our DARE VBA-1 may offer a solution for these women and others for whom hormonal treatment is not an option for their VBA. We plan to commence that Phase I clinical trial in the second half of this year in Australia, thus also leveraging our Australian subsidiary in this specific I'm now going to turn the call over to John to provide a business and corporate partnership update.

Thank you, Sabrina. With our first NDA submission plan for later this quarter, we are entering an exciting time for DARE BV1. As noted during our March call, we are advancing our partnership discussions in parallel with GARABV1's regulatory developments and believe that we are well positioned to execute a definitive commercialization agreement and to announce our commercialization strategy before the end of this year. We believe that there is broad clinician awareness of bacterial vaginosis, and based on stakeholders we've spoken to, we believe that this category is ready for a new, potentially more effective, and more convenient prescription option than what is currently available. It's our belief that a one-time vaginally delivered product with the potential to deliver the best clinical curates in the category will be a welcomed addition to the bacterial vaginosis diagnosis and treatment plan for the healthcare providers who routinely diagnose and treat the serious and often persistent condition. As we discussed on our last call, DARE BV1's differentiated product profile gives us a lot of optionality as it relates to how we go to market, And in the interest of doing the right thing by patients and other key stakeholders, we are exploring all options to make sure we identify the most effective way to get the product into the hands of patients if we have regulatory success. These options range from a full-out license, where DARE would likely be eligible to receive milestones and royalty payments, but where DARE has no role in commercialization, through to a scenario where DARE plays a more active role in commercialization. And in addition to planning for the go-to-market strategy in the U.S., we are actively exploring commercialization options with potential partners outside the U.S. So we look forward to continuing to keep you apprised of our partnership progress for both the U.S. and ex-U.S. opportunities. And with that, I will turn it over to Lisa for a financial update.