Dare Bioscience, Inc.

Welcome to the conference call hosted by Darre Bioscience to review the company's financial results for the quarter ended September 30th, 2022. And to provide a general business update, this call is being recorded. My name is Paula and I will be your operator today. With us today are Sabrina Martucci-Johnson, Darre's President and Chief Executive Officer, John Fair, Darre's Chief Strategy Officer, and Lisa Walters-Hoffert, DARE's Chief Financial Officer. Ms. Johnson, please proceed.

Thank you. Good afternoon and welcome to our third quarter of 2022 Financial Results and Business Update call for DARE Bioscience. Our plan today is to review our third quarter results, discuss development since our last call in August, and use the time to review our business strategy, including why we believe investment in women's health is efficient and disproportionately impactful, and to highlight some important objectives and milestones anticipated through the end of the year and in 2023. 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 undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company's FCC filings, including our annual report on Form 10-K for the year ended December 31st, 2021, which was filed on March 31st, 2022, and our quarterly report on Form 10-Q for the quarter ended September 30th, 2022, 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 10th, 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. As you know, 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 and partners and, of course, our shareholders. We work to accelerate innovative, differentiated product options in contraception, vaginal health, sexual health, and fertility. that expand treatment options where none exist, that enhance outcomes where current standard of care has meaningful shortcomings, and that improve ease of use for women where a more compelling form factor can drive adoption. Why? Because these are compelling markets impacting millions of women, and we have seen that innovation in these areas has led to commercially successful brands. Specifically, We find these statistics that I'm about to share about innovation in women's health compelling. Approximately only 1% of healthcare research is invested in female-specific conditions beyond oncology. And women's health conditions outside of oncology comprise less than 2% of the current healthcare pipeline. Yet, women's health products outside of oncology make up 27%. of the total number of Blockbuster products, products that each have over 500 million in annual sales. And women's health products contribute 35% of the total sales dollars generated by Blockbuster products. So think about that for a moment. A therapeutic category that receives less than 2% of healthcare research investment is contributing 35% of the revenue generated by Blockbuster brands. This is why we believe investment in women's health will be efficient and disproportionately impactful in terms of translating dollars invested in R&D to ultimate revenue generated and is therefore not only good for the 50% of the population to whom these products are targeted and who, by the way, control 80% of U.S. healthcare purchasing decisions, but it's also a good business model. As a reminder, DARI's portfolio that is focused solely and squarely on women's health is built upon the following core principles. One, each product candidate must target a meaningful market opportunity. Two, each product candidate must have first line or first in category potential because we seek to offer meaningful, not incremental improvement. And three, Our goal is a diversified mix of candidates that can be developed efficiently in terms of time and capital and whose regulatory pathways often leverage well-known and well-characterized active pharmaceutical ingredients or API. Specifically, in addition to our FDA-approved product for bacterial vaginosis, a condition estimated to affect approximately 21 million women in the U.S., what are our big ideas in women's health? Well, it's the four novel contraceptive candidates or potential candidates in our portfolio. First hormone-free monthly contraceptive candidate, oviprene. First six- or 12-month injectable that we call a DARE 204214. First long-acting reversible contraceptive system, DARE LARC1. And a hormone-free contraceptive target for women and men, DARE RH1. It's the three vaginal health product candidates or potential candidates in our portfolio specifically, DER-HRT1, the first hormone therapy estradiol plus progesterone monthly intravaginal ring. DER-VVA1, the first hormone-free vaginal atrophy therapy for women with hormone receptor-positive breast cancer. And glycerol monolaurate, a naturally occurring fatty acid monoester that has shown broad antimicrobial activity and that may be developed to potentially treat and or prevent vaginal infections of various sources. It's our sexual health product candidate in our portfolio, the first topical cream with the same active ingredient as Viagra, being evaluated as a potential first in category treatment for female sexual arousal disorder, FSAD. And it's our pregnancy maintenance and management product candidates in our portfolio, DARE FRT1 and PTB1, the first intravaginal ring designed to release bioidentical progesterone over 14 days. We continue to drive our portfolio forward to deliver value as evidenced by the milestone achieved just in the last few months and the milestones expected by the end of 2022 and into 2023. Zasciato, clindamycin phosphate vaginal gel, 2% for bacterial vaginosis. Zasciato is a lincosamide antibacterial for a single-dose vaginal administration indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older. Bacterial vaginosis is the most common vaginal condition in women of reproductive age. This marks the first FDA-approved product from DARI's portfolio, a potential first line or first in category development candidates. Our commercialization collaborator is Organon. And we are thrilled that commercial launch preparation activities have begun and are ongoing. The Organon market access team is meeting with customers now to review Zasciato and obtain competitive coverage in the bacterial vaginosis marketplace. Organon will leverage its established Nexplanon sales team to accelerate Zasciato uptake at launch. Organon believes there is roughly a 90% overlap of those healthcare providers who prescribe Nexplanon and who diagnose and treat bacterial vaginosis. The strong relationships the sales team has with these providers are expected to enable immediate access as early as day one. And the first commercial sale is anticipated in the first half of 2023 in the U.S. Ovaprene, our hormone-free monthly birth control candidate. Ovaprene is an investigational potential first in category hormone-free monthly intravaginal contraceptive. Our commercialization collaborator is Bayer. and our pivotal study collaborator is the NIH. We announced ID approval by the FDA in October for our planned pivotal study, and we are currently reviewing and implementing additional FDA design recommendations in order for this study to serve as the primary clinical support for a future premarket approval submission to the FDA. In other words, if successful, We expect this study to be the single pivotal study necessary to support a PMA submission to the FDA. The NIH is holding an investigator meeting with the oviprene investigators in December of this year, 2022, and we anticipate initiating recruitment mid-2023. We will target about 200 subjects, completing 12 months or 13 cycles of use. Sidenafil cream. are female sexual arousal disorder product candidates. Sidenafil cream is an investigational potential first in category treatment for female sexual arousal disorder, FSAD, which has no FDA approved therapies. It's a novel cream formulation of Sidenafil, the same active ingredient as in Viagra. Subject screening for the exploratory phase 2b response study was completed in October. Approximately 160 to 170 subjects in total are expected to complete the clinical study, and approximately 100 subjects have completed all study assessments to date. Top-line data announcement is currently targeted for the second quarter of 2023. DARE-HRT1, our hormone therapy for the treatment of menopause symptoms, It has the potential to be a first in category convenient combination hormone delivery product for the treatment of vasomotor and vaginal symptoms of menopause. DER-HRT1 is an investigational intravaginal ring designed to release bioidentical estradiol and bioidentical progesterone over 28 days. It has the potential to be the first monthly format product with both hormones. There are no FDA-approved options with both hormones in one monthly intravaginal reign. Last month, we announced top-line data from a Phase 1-2 study in approximately 20 healthy postmenopausal women. The primary objective of the study was to describe the safety, tolerability, and pharmacokinetics, or PK, of two different dose combinations over 12 weeks of use. Secondary objectives were to assess the usability, participant tolerability, and preliminary effectiveness for both the vasomotor symptoms, or VMS, and the vaginal symptoms of menopause. Despite the small sample size, we were very pleased to announce that the levels of estradiol released from both the lower and higher dose formulation of DER-HRT1 evaluated in the study achieved statistically significant improvements compared to baseline in the vasomotor as well as the general urinary symptoms of menopause. vaginal pH, and maturation index, all at the P less than 0.1 level. And Dandere HRT1 had a high level of acceptability in the study, with 100% of the subjects reporting that the IVR was comfortable to wear, and over 95% of the subjects stating they would be either somewhat or very likely to use the IVR for a women's health condition or even unrelated disease if needed. We look forward to top line PK data from this study later this quarter. So why are the findings from this study important? Well, the data support the potential of DARE-HRT1 to deliver effective hormone therapy in a 28-day intravaginal ring. 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 consistent dosing to women suffering from menopausal symptoms. There are currently no FDA-approved non-daily products that continuously deliver hormone therapy with both estradiol and progesterone together over multiple consecutive weeks. And DARE VVA-1, our vaginal atrophy treatment candidate for women with breast cancer. DER-VVA1 has the potential to be a first in category hormone-free vaginal treatment for vulvar and vaginal atrophy, or VVA, in a hormone receptor-positive breast cancer patient population. DER-VVA1 is an investigational proprietary formulation of tamoxifen for vaginal administration. It has the potential to be the first therapeutic specifically approved for treatment of vaginal atrophy in patients with hormone receptor-positive breast cancer. There are currently no FDA-approved products labeled for vaginal atrophy treatment in a hormone receptor-positive breast cancer population. Globally, breast cancer is the most frequently diagnosed cancer type, accounting for over 2 million cases each year. And approximately 4 million women in the United States have a history of invasive breast cancer. And of all breast cancer diagnoses in U.S. women, it's estimated that more than 68% hormone receptor positive vaginal atrophy prevalence in postmenopausal breast cancer survivors is estimated at 42 to 70 percent there's a clear unmet medical need for an effective non hormonal treatment for vaginal atrophy caused by anti-cancer endocrine therapy in patients diagnosed with hormone receptor positive breast cancer historically Estrogen-based therapies delivered through creams, rings, and vaginal suppositories have been prescribed for the treatment of vaginal atrophy symptoms. However, the use of these estrogen-based products for the treatment of vaginal atrophy and hormone receptor-positive breast cancer patients can be challenging for both healthcare providers and their patients, as the use of estrogen in any form is often contraindicated for this patient population. If we are successful, their VBA1 has the potential to become a new standard of care as the first and only vaginally administered product approved for the treatment of vaginal atrophy in a hormone receptor positive breast cancer population. We are on track to announce the Phase 1-2 study top line data before the end of this year. I will now turn the call over to John to provide an overview of the two commercialization collaboration agreements we have in place. for Zasciato and Ovaprene, respectively.

Thank you, Sabrina. Given the stage of our current portfolio and the market dynamics in the therapeutic categories, specific to Zasciato and Ovaprene, we believe the best way to generate value for DARI and shareholders is via external commercialization collaborations or out-license agreements, rather than attempting to commercialize these assets on our own. Opportunities to enter into such collaborations are ultimately contingent upon developing differentiated products that demonstrate the potential to be first line or first in category. So let me begin first with bacterial vaginosis and our first FDA-approved product, Zasciato. Organon, our global collaborator for Zasciato, shares our commitment to advance critically needed innovations in women's health, and we believe that Organon's unique focus on women's health, coupled with their strong commercial capabilities, will ensure that Zasciato reaches women most impacted by this condition. We believe that Organon is uniquely positioned to bring Zosciato to market and will drive patient and provider awareness, ultimately leading to the use of Zosciato based on Zosciato's unique and differentiated product profile. As Sabrina mentioned, Organon will leverage its established Nexplanon sales team to accelerate Zosciato's uptake at launch. Organon believes this is roughly a 90% overlap of those healthcare providers who currently prescribe Nexplanon and are also diagnosing and treating bacterial vaginosis. These strong relationships that Nexon sales team has developed will help us and the providers and expect that we would be able to get access to these providers as early as day one of the launch. Under our license agreement with Organon that allows them to commercialize Zasciato, we received a $10 million cash payment from Organon after the license became effective in June. And we're also eligible to receive potential milestone payments of up to $182.5 million as well as tiered double-digit royalties based on net sales. Launch activities are ongoing in the current quarter, and Zasciato is expected to be available commercially in the U.S. in the first half of 2023. Let me transition now to the commercial activities underway for Oviprene, our novel hormone-free monthly intravaginal contraceptive candidate, whose U.S. commercial rights are under a license agreement with Bayer. As a reminder, as part of our license agreement with Bayer to commercialize Oviprene, DARI has access to Bayer's extensive clinical, manufacturing, and commercialization resources in an advisory capacity for approximately 80 hours per week while we retain full control over Opaprene's development and regulatory approval process. Bayer has the right to obtain exclusive rights to commercialize Opaprene in the U.S. following completion of the pivotal Phase III study by making a $20 million payment to DARE. Thereafter, DARE will be entitled to receive commercial milestone payments, potentially totaling $310 million, in addition to double-digit tiered royalties on net sales. As we mentioned before, overprint is a distinct and novel contraceptive candidate. There is no predicate device for overprint, meaning there is no existing FDA-approved product that the FDA can use as a reference to compare with overprint. And Bayer has proactively initiated pre-commercialization activities, including discussions with payers, providers, and women. Their commercial team is uniquely focused on identifying key drivers and points of differentiation that will resonate with payers and providers and patients. Bayer has a unique leadership position in the hormonal and hormonal category with their Mirena franchise, and they're looking to establish a similar leadership position in the non-hormonal category with Oviprene. As we've mentioned, they're actively engaging payers and providers to gain meaningful insights into the best way to position Oviprene to maximize market uptake, and are simultaneously collaborating with DARE by providing input into the Phase III study design to reflect these important commercial insights. So, I'll now turn the call over to Lisa to provide a financial update.