Dare Bioscience, Inc.

Welcome to the conference call hosted by DARE Bioscience to review the company's financial results for the quarter ended March 31st, 2023 and to provide a general business update. This call is being recorded. My name is Mallory 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 Commercial Officer, and Lisa Walters-Hoffert, DARA's Chief Financial Officer. Ms. Johnson, please proceed.

Thank you. Good afternoon and welcome to the financial results and business update call for the quarter ended March 31st, 2023 for DARI Bioscience. Our plan today is to review our first quarter results, discuss development since our recent call in March, and highlight some important objectives and milestones anticipated in 2023. 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 facts should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by the 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 31, 2023, 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 11, May 11, 2023. 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 a reminder, DARI's diversified portfolio, which includes one FDA-approved product and 12 development stage candidates, three of which are in or nearing Phase III clinical development, is focused solely and squarely on women's health and is built upon the following core principles. Each product candidate must address a meaningful market opportunity in the form of a persistent unmet need. Each product candidate must have the potential to be first line or first in category or both because we seek to deliver a clear improvement over the standard of care. And ideally, each product candidate has demonstrated proof of concept and or uses well-characterized active pharmaceutical ingredients which can mitigate development time, cost, and even risk. Our current innovation efforts are focused in contraception, vaginal health, reproductive health, menopause, sexual health, and fertility. On our recent 2022 financial results and update call, we discussed the key milestones anticipated for the year 2023. Phase 2B RESPOND studied top-line results for our investigational sidenafil cream for female sexual arousal disorder. the U.S. launch of Xaxiado by Organon, the initiation of the Phase III clinical study of Oviprene, our investigational potential first-in-category hormone-free monthly intravaginal contraceptive, whose U.S. commercial rights are under a license agreement with Bayer, which we expect will be the single pivotal study to support Oviprene's premarket application. IND-related activities for DER-HRT1, which is our investigational 28-day intravaginal ring for hormone therapy for the vasomotor symptoms of menopause, and IND-related activities for DER-VVA1, our investigational hormone-free intravaginally administered treatment for vulva and vaginal atrophy, as well as our Phase III-related clinical study plans for the candidate DER-HRT1 and Phase II clinical study plans for DER-VVA1. And additionally, DARE PDM-1, which is our investigational vaginal hydrogel formulation of diclofenac to treat primary dysmenorrhea or menstrual cramps, the phase one study conduct, and the topline data this year. On today's call, Lisa will review our first quarter 2023 financial results shortly. But we will otherwise focus on our anticipated milestones for this quarter, this second quarter of 2023. So, mainly, we'll spend our time today on the Sidenafil-CREME 3.6% phase-to-be response study top-line results and the commercial launch of Zosciato in the U.S. by Organon. We'll start with the Sidenafil-CREME update, and we will review both the exploratory phase-to-be response study objectives to provide context for the anticipated upcoming top-line data readout, And as importantly, we'll talk about the market dynamics for female sexual arousal disorder, which will highlight why we're so excited to be conducting this Phase 2B study for this yet-unserved indication that's analogous to erectile dysfunction in men. I'll then turn the call over to John, who will provide an update on Organon's Ashiado launch activities. With sildenafil cream, 3.6%, we're looking to address the lack of physical genital arousal response and sensations and the associated distress that are the hallmark of female sexual arousal disorder or FSAD. As I mentioned up front, FSAD is analogous to erectile dysfunction or ED in men. Both in terms of the pathophysiology of the condition as well as the target pharmacology, and the addressable markets are also quite comparable in size. As we approach the Phase IIb top-line data readout expected this quarter, we wanted to give you a sense of what you can expect. First, by way of refresher, previously conducted studies by DARE and our licensor, SST, demonstrated that this cream formulation of sidenafil, which is the same active ingredient as in Viagra, increased blood flow to the female genital tissue, both when assessed via an internal vaginal probe and when assessed via an external temperature sensing camera. These data provide the proof of concept that the formulation is achieving its target activity in the tissue, increasing blood flow. Obviously, vaginal probes and general temperature sensors are not practical endpoints for a Phase III program. Thus, the exploratory Phase 2b study was designed to evaluate the performance of the sidenafil cream and to evaluate a number of different potential ways to ask women questions about their genital sensations and improvements, which are referred to as patient-reported outcomes, in their at-home setting. So this way, we could identify and select the appropriate patient-reported outcomes to take forward into the Phase 3 program. So that's where we're expecting in the Phase 2B readout. So as we wait for the Phase 2B respond data readout, it's a great time to also remind everyone why we're so excited about the FSAD opportunity. We've mentioned on numerous calls that it's our belief that the FSAD market could be as large or larger in terms of potential patients as the ED market. We've also mentioned that our product candidates, the NFL Cream 3.6%, is the only development stage program to our knowledge that is specifically designed to address the lack of genital arousal symptoms associated with FSA-D. As I mentioned, sidenafil is the active ingredient in Viagra, and our innovative topical cream formulation for women is designed to be used on demand prior to sexual activity and to deliver sidenafil directly to the genital tissue to facilitate vasodilation and increase blood flow directly where needed to improve the physical arousal response to address the lack of those genital arousal sensations commonly associated with FSAD. So, sidenafil cream has the potential to be the first FDA-approved product to treat FSAD and create an entirely new market of comparable addressable market size as ED. To put some of the market dynamics into context, We only need to look back to the launch of Viagra in 1998. According to an article published at that time in CNN Money, there were 2.7 million prescriptions filled for Viagra in its first full quarter on the market. And at that time, that was the most prescriptions ever for any pharmaceutical product in its first quarter on the market. According to the same source, more than 160,000 physicians prescribed the product during that period of time. making it one of the most successful product launches in history and helping to double Pfizer's market cap. It can be challenging to be first as a drug developer, blazing a new path as we are with our exploratory phase 2b study, where, as I mentioned, we need to evaluate a number of different potential ways to ask women questions about their genital sensations and improvements in order to identify and select the appropriate patient-reported outcomes to take forward into the Phase III program. But that level of uptake that I described in the Viagra launch from both providers and patients is incredibly impressive. And we see a number of similarities between ED and FSAD markets. So principally in ED, a lack of viable pharmaceutical intervention created a situation where before Viagra, men had a significant condition which often led to depression, isolation, and frustration. As is now the case with women with FSAD, without a viable intervention for ED like Viagra, men were reluctant to have a conversation or ask their provider for help or information. According to a 2004 study conducted by the British Medical Journal, The authors noted that men reported that ED affected their personal relationships, often left them feeling embarrassed, and they generally suffered in silence, as many men felt unable to talk to their partners or friends about their condition. The authors also noted that once Viagra became available and when it provided symptom relief, men reported feeling happy and elated, as well as great improvements in their well-being. These findings mirror the insights that we have uncovered about FSAD. We know that women are similarly reluctant to speak about their condition with their partners and often report feeling dissatisfaction with their sex lives, unhappiness, and general frustration due to their sexual problems. We also believe that without an FDA-approved intervention, women are left alone to suffer in silence and are often affected by a feeling of shame or embarrassment. Given the similarities of ED and FSAD in terms of the pathophysiology of the condition, as well as the psychological and emotional impact that we've been discussing, we believe there is enormous unmet need, and we see the potential for a large amount of pent-up demand for a product like sildenafil cream. Therefore, we're excited to bring our exploratory Phase IIb study to conclusion. This quarter, we plan as the first step to report the top line data for a number of the assessment tools that we utilized in the study. Subsequent to reporting the top line results, when we have the full data set from the study, we will formalize our proposals to the FDA regarding the patient population to study and the endpoints to evaluate in the Phase III program. In addition to the Phase IIb study where the product was used at home, We recently announced the initiation of a supplemental thermography study in a clinical setting. This phase one thermography study of sidenafil cream is expected to enroll around 15 women and to be completed this year. These data are an important part of our comprehensive clinical development and regulatory plan for sidenafil cream, and they'll add to our existing clinical and non-clinical data package to support the ongoing development program. These data are expected to complement the forthcoming clinical findings from our Phase 2B RESPOND trial in preparation for a Phase 3 program. Our goal is to bring a much needed solution to the women, estimated to be 10 million in the United States alone, who are distressed and seek treatment for low or no sexual arousal, and with no FDA approved option to address their condition, Our goal is for sedentafil cream to be the first FDA-approved product for women with FSAD as Viagra was for men with ED. Now, we're not planning on providing detailed updates on the other development programs today, but I do want to note that we've been enjoying working with our collaborator, NICHD of the NIH, on the oviprene pivotal study start plan for later this year. And we continue to expect to commence patient enrollment in mid-2023, and what we expect to be the single pivotal contraceptive clinical study required to support the PMA submission for registration. I also want to mention that we are thrilled with the interest in our DARE PDM-1 study that is underway in Australia. As a reminder, this is our investigational product to treat primary dysmenorrhea or menstrual cramps. by delivering the non-steroidal anti-inflammatory drug diclofenac vaginally, using our proprietary hydrogel formulation, that same formulation technology that is used in Zosciato. The top-line data are expected this year, and recent market research suggests that the global market for dysmenorrhea treatment was estimated to be valued at $13 billion in 2022, and that the size of this market is expected to increase to $28 billion by 2029. So with those updates on the development programs, I will now turn it over to John to provide a commercial update on the Zosciato launch activities.

Thank you, Sabrina. As a reminder, Zosciato clindamycin phosphate vaginal gel is a lincosamide antibacterial for single-dose vaginal administration indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older in the United States. The Zasciato story is great validation of our portfolio candidate selection and development strategy. Bacterial vaginosis is the most common vaginal condition in women of reproductive age, estimated to affect approximately 23 million women in the US alone. However, a large number of women with the condition are underserved by currently available products. We believe that we could deliver a novel option. Understanding that differentiation drives value We designed a phase three study capable of generating the data necessary to support a compelling label. We believe that if we were successful in our clinical development planning, we would be able to create an opportunity for commercialization collaboration that could drive value. And in regard to securing a collaborator capable of maximizing value, we believe we have been very successful. We are thrilled that the women's health company Organon is launching Zasciato, and that they will leverage their established Nexplanon sales team to accelerate Zasciato uptake. With the manufacturing validation activities required to support the commercial launch completed, commercial launch activities are progressing. Given that the sales team for Nexplanon will be launching Zasciato, we expect that Zasciato will benefit from Organon's track record of commercial success in the branded women's health category. Organon believes there's a roughly 90% overlap of healthcare providers or HCPs who prescribe Nexplanon and have the potential to be prescribers of Zosciato based on provider treatment patterns. Because of the strong relationships the sales team has with these HCPs in the women's health space, we expect Organon to be well positioned to inform these HCPs about Zosciato, ultimately providing benefits for their patients. As I mentioned on our last update call, Organon has what we believe to be a truly integrated go-to-market plan targeting all of the key stakeholders, HCPs, payers, and patients in order to quickly drive interest and awareness in Zasciato. With a strong product label and a powerful commercial partner, we are excited about the launch of Zasciato expected this quarter. And Organon has been working on launch activities. They're taking a holistic approach to the product's introduction including ongoing work in the areas of non-Salesforce-related promotional activities and utilization of key symposia and conference events. Organon had a very prominent presence at a recent payer-focused industry conference called AMCP, which stands for the Academy of Managed Care Pharmacy. This annual event is one of the key conferences where payers and manufacturers can interact and share key pharmacoeconomic insights and learnings across a broad range of products therapeutic areas. Organon shared important insights into the pharmacoeconomic and socioeconomic impact of a bacterial vaginosis diagnosis and I attended this conference personally and I really believe this information was very well received by many of the key stakeholders attending the conference as well. In addition to their presence at AMCP and their ongoing work with payers, Organon is planning activities in support of the physician community including their branded exhibit at the Marquee Conference in Women's Health and the American College of Obstetricians and Gynecologists annual clinical and scientific meeting, commonly referred to in our field as the ACOG meeting. The upcoming ACOG meeting, which takes place later this month, provides unique opportunities to interact with key HCPs focused in women's health, which is critical given the role that OBGYN offices play in treating patients with bacterial vaginosis. And finally, I know we touched on this earlier, but I feel it's worth repeating, Organon will leverage its established Nexplanon sales team which currently focuses on contraception to maximize Zasciato uptake at launch. And because the vast majority of sufferers of bacterial vaginosis are also women of reproductive age, the Nexplanon sales force is well-positioned to leverage their existing relationships with HCPs in women's health. So in summary, we believe that Zasciato should be well-positioned for commercial success, given the knowledge and experience of Organon's Nexplanon sales team, coupled with Organon's payer outreach provider and patient-centered initiatives. We are working towards the first commercial sale before the end of the second quarter. And with that, I will now turn the call over to Lisa to provide a financial update.