Dare Bioscience (NASDAQ:DARE) Q4 2022 Earnings Call

0:00 Welcome to the conference call hosted by Dore Bioscience to review the company's financial results for the year ended December 31st, 2022 and to provide a general business update. This call is being recorded. My name is Abby and I will be your operator today. With us today are Sabrina Martucci Johnson, Dore's President and Chief Executive Officer, John Fair, , and Lisa Walters-Hofford . Ms. Johnson, please proceed. Thank you.

0:41 Good afternoon and welcome to our year-end December 31, 2022 Financial Results and Business Update call for DARE Bioscience. Our plan today is to review our four-year results, discuss development since our last call in November, 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 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.

1:38 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 annual report on Form 10-K for the year ended December 31, 2022, which was filed today. I'd also like to point out that the content of this call includes time-sensitive information that is current only as of today, March 30th, 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. By the time 2022 came to a close, we had secured our second commercial collaboration, in this case, for our FDA-approved product, Zasciato, with Organon. We received FDA acceptance to commence what we believe will be the single pivotal study required for our monthly hormone-free contraceptive candidate, Oviprene, commercial rights to which are under a license agreement with Bayer.

2:35 We announced that we completed enrollment in our Sidenafil Cream Female Sexual Arousal Disorder Phase 2B study, and we announced two positive Phase 1-2 study top-line readouts, one for our hormone-free vaginal atrophy treatment candidate, DARE VBA1, and one for our 28-day vaginal ring hormone therapy candidate for the vasomotor symptoms of menopause, DARE-HRT1. These accomplishments in 2022 position us well to potentially achieve additional commercialization, clinical and regulatory milestones in 2023 that I look forward to sharing shortly. And our 2023 milestones include not only objectives related to the programs I just identified, but to other portfolio candidates as well.

3:24 Those of you who've been following DARA know that we are focused solely and squarely on women's health. With 12 independent standalone development stage candidates in our portfolio, we have, to our knowledge, the deepest pipeline of women's health product candidates of any other company, including global pharmaceutical companies. It has been reported that a mere 1% of healthcare research is invested in female-specific conditions beyond oncology. And yet, based on IQVIA data for 2013 to 2022, women's health products make up 27% of the blockbuster products, as in those that generate over $500 million in annual sales. And those products contribute 35% as a revenue generated by all blockbuster products.

4:14 Thus, given those statistics, with 12 development stage candidates in our portfolio, we like our odds of generating value for our shareholders and the disproportionately impactful investment a women's health product candidate can potentially represent, particularly given that a number of our candidates are in the contraceptive, menopause, and sexual health categories. all of which have seen over $1 billion and even over $2 billion individual brands, including the potential of our sexual health program, Sedentifil Cream, since there is yet to be an FDA-approved product for arousal disorder in women, the most analogous condition in women to erectile dysfunction in men. We would love to be first and more on our Sedentifil program shortly.

5:04 So as such, it is our belief that prioritizing women's health is not only good for the many women lacking effective or convenient therapeutic options and for the broad set of stakeholders that care about women's health, including family members and partners, but importantly, also for those investing in the category. Our current innovation efforts are focused in contraception, vaginal health, reproductive health, menopause, sexual health, and fertility. We chose these areas because we saw opportunities to bring new innovation to women in indications where we could be first to market, have a first in category product, or develop the first line product in a given therapeutic category.

5:50 So while we have a broad portfolio, importantly, every single product candidate in our portfolio has to stand on its own merits to justify our investment in that individual product candidate. specifically, before we select a new candidate for development, we make a determination that it meets these strict criteria. First, the product candidate has to address a meaningful market opportunity in the form of a persistent unmet need. Second, it has to have the potential to be first line or first in category or both. Third, it should already have demonstrated proof of concept and ideally use well-characterized active pharmaceutical ingredients which commit at gate development time, cost, and Evan Risk. And finally, it should represent an opportunity to deliver a clear improvement over the standard of care as measured by clinical outcomes and patient acceptability and as ultimately evidenced by a clearly differentiated product label, which is critical for market access and pull-through.

6:54 Our focused efforts to deliver differentiated innovation in women's health have resulted in 12 development stage programs across nine distinct indications, with more than five milestone events anticipated in 2023 that we will discuss shortly, three candidates in or nearing phase three development, two potentially transformative transformational collaborations with leaders in women's health product commercialization, Bayer and Organon, and one FDA-approved product, Zasciato. I want to share with you now DARI's key 2022 results and milestones and our anticipated 2023 milestones. In addition to my remarks, I encourage you to read our press release issued this morning since it provides a more comprehensive review of our 2022 accomplishments.

7:46 We have important upcoming milestones for Zasciato, Oviprene, Sildenafil Cream, DARE VVA-1, DARE HRT-1, and Dare PDM1. So I'm going to focus my comments today primarily on those programs. So let me begin by highlighting our global license agreement with Organon that supports the commercialization of Zosciato, clindamycin phosphate vaginal gel 2%. As a reminder, Zosciato is a lancosamide 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 Zasciata story is a great validation of our portfolio candidate selection and development strategy.

8:36 Bacterial vaginosis is the most common vaginal condition in women of reproductive age, estimated to affect approximately 23 million women in the U.S. alone. But yet a number of women with the condition have been underserved by currently available products. We hoped that by focusing on improving outcomes and her overall user experience, we could deliver a novel option. Understanding the differentiation drives value, we strove to design a phase three study that would generate the data necessary to support the target labeling. And by doing so, create the opportunity for a commercialization collaboration that could drive value. We are thrilled that Organon, The women's health focus spin out of Merck is launching Xasiato and that they will leverage their established Nexplanon sales team to accelerate Xasiato uptake.

9:34 Specifically, with the manufacturing validation activities required to support the commercial launch now nearly completed, we are excited about the commercial launch activities underway at Organon. In preparation for what will be Organon's first pharmaceutical product launch into the women's health category since spinning out of Merck, Given that the Nexplanon sales team will be leveraged for the Zosciato launch, we expect to benefit from the track record of commercial success that team has demonstrated. Organon believes that there is roughly a 90% overlap of those healthcare providers who prescribe Nexplanon and are viable Zosciato targets based on treatment patterns. The strong relationships the sales team has with these providers are expected to enable immediate access.

10:23 We anticipate the first commercial sale before the end of the second quarter. More on the Zosciato commercial activity when John provides his update. In terms of our oviprene program, the FDA's acceptance of our oviprene IDE last year was an important milestone for the program, as it allows us to commence what we believe will be the single pivotal clinical study required to support the PMA submission for registration. Obaprene is our investigational potential first in category hormone-free monthly intravaginal contraceptive whose commercial rights are under a license agreement with Bayer. We announced IDA approval for our planned pivotal study by the FDA in October 2022 and confirmed our belief that a single pivotal study of approximately 12 months duration will be sufficient to support a PMA submission to the FDA.

11:20 The study will target having around 200 to 250 subjects complete 13 menstrual cycles of use. The pivotal study is being conducted under a Collaborative Research and Development Agreement, or CRADA, with the NIH's NICHD Division and with NICHD's Contraceptive Clinical Trial Network. And in December, NICHD brought the investigators from those sites together for an investigator meeting. We anticipate initiation of Pivotal Phase 3 study subject recruitment in the middle of 2023. So that's two innovative brands, Zasciato and OverCream, and two potentially transformational collaborations, one with Organon and one with Bayer.

12:07 So what's next for DARI on our unpartnered programs? Well, let's begin with Sidenafil Cream, 3.6%, a product candidate with the potential to create a completely novel category in women's health. We are looking to address the lack of physical general 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 pathophysiology as well as target pharmacology. and the addressable markets are also quite comparable in size. We completed enrollment in our exploratory Phase 2b study in 2022, and as we approach the Phase 2b top-line data readout projected for the second quarter of 2023, we wanted to give you a sense of what you can expect.

13:05 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. Obviously, Vaginal probes and genital temperature sensors are not practical endpoints for a Phase III program. Thus, the exploratory Phase IIb study was designed to evaluate the performance of sedentary cream and to evaluate a number of different potential ways to ask women questions about their genital sensations and improvements, referred to as patient-reported outcomes, in the at-home setting. in order to identify and select the appropriate patient-reported outcomes to take forward into the Phase 3 program.

14:13 Therefore, as we bring our exploratory Phase 2b study to a conclusion, we will, as a first step, report top-line data for a number of the assessment tools we utilized in the study. And 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 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 no FDA approved product option to address their condition today.

14:59 Third, I'd like to highlight the positive top line results from the two Phase 1-2 studies completed last year, one for DARE-HRT1 and another for DARE-VBA1, both of which were conducted through our wholly owned Australian subsidiary. So let's start first with the Phase 1-2 study of DARE-HRT1, menopausal hormone therapy for the treatment of the vasomotor symptoms of menopause or VMS. Fortunately, many of you probably watched the Super Bowl and saw Estella's ad challenging people to answer the question, what is VMS? But it may be worth reminding you that VMS stands for vasomotor symptoms and menopause, which are commonly referred to as hot flashes. With over 45 million women in the U.S. estimated to be in or approaching menopause each year, and with a legacy brand in the category having generated $2 billion in annual revenue, It's not surprising that the condition was the subject of a Super Bowl ad. So what are we developing for the condition?

16:02 Well, DRHRT1 has the potential to be a first-in-category convenient combination hormone delivering monthly vaginal product for the treatment of the vasomotor symptoms of menopause. Specifically, DRHRT1 is an investigational intravaginal ring. designed to release bioidentical estradiol and bioidentical progesterone through this vaginal ring over 28 days. So DARE-HRT1 has the potential to be the first non-daily, non-oral, monthly format product with both bioidentical hormones. There are no FDA-approved options with both hormones in one monthly IVR. Hormone therapy remains the most effective treatment for the vasomotor symptoms of menopause and the genitourinary syndrome of menopause, and has also been shown to prevent bone loss and fracture. The 2022 Hormone Therapy Position Statement of the North American Menopause Society, or NAMS, supports hormone therapy in peri- and postmenopausal women, and NAMS observes the non-oral routes may offer advantages over oral routes administration.

17:13 We previously announced the top line data from that Phase 1-2 study of two different dose combinations of DRHRT1 over 12 weeks of use in approximately 20 healthy postmenopausal women. And as we reported, the levels of estradiol released from both the lower and the higher dose formulation of DRHRT1 achieved or exceeded the levels that were targeted for hormone therapy. In addition, despite the small sample size, The levels of estradiol released from both the lower and higher dose formulation evaluated in the study achieved statistically significant improvement compared to baseline in VMS, as well as the genitourinary symptoms of menopause and vaginal pH and vagination index, all at the P less than 0.1 level. These data support the potential of their HRT1 to deliver effective hormone therapy in a convenient 28-day vaginal ring.

18:07 Following clinical development, we intend to leverage the existing safety and efficacy data on the active ingredients in DER-HRT1, estradiol and progesterone specifically, to utilize the FDA's 505 pathway to obtain marketing approval of DER-HRT1 in the U.S. That pathway, that 505 , that's the same pathway we use for Zosciato. We intend to seek FDA approval of DER-HRT1 for the treatment of moderate to severe vasomotor symptoms due to menopause in women with intact uteri. Based on pre-IND communications with the FDA and the top-line pharmacokinetics or PK data from the DRHRT1 Phase 1-2 study, we believe FDA approval of DRHRT1 for that indication is achievable via that 505 pathway supported by a single placebo-controlled Phase 3 clinical trial.

19:02 of DARE-HRT1, and a scientifically justified PK Bridge, basically via relative bioavailability trial, between DARE-HRT1 and the selected listed estradiol and progesterone drugs. Ongoing activities to support the progressing directly into that single Phase III study to support registration include manufacturing and nonclinical studies to support the IND submission and the planned, therefore, IND opening Phase III study. We look forward to providing further updates on the timelines to Phase 3 as these activities continue to progress this year. The second Phase 1-2 study conducted in Australia was for DRVVA1, our hormone-free vaginal atrophy treatment candidate.

19:48 There are currently no FDA-approved products labeled as safe for use in hormone receptor-positive breast cancer. DARE VVA-1 has the potential to be the first in category hormone-free vaginal treatment for vulvar and vaginal atrophy or VVA. DARE VVA-1 is an investigational proprietary formulation of tamoxifen for intravaginal menstruation. Approximately 4 million women in the U.S. have a history of invasive breast cancer. It's estimated that more than 66% are hormone receptor positive cases. VBA, which can lead to painful intercourse and associated interpersonal distress, is prevalent in postmenopausal breast cancer survivors with rates estimated at 42% to 70%.

20:35 These women are generally not candidates for hormone-containing therapies despite their vaginal atrophy symptoms, as the use of estrogen in any form is often contraindicated for hormone receptor-positive breast cancer patients and survivors. So there is a clear unmet medical need for an effective non-hormonal treatment for VBA. And in November of 2022, we announced the positive top-line results from our Phase 1-2 study of DARE VBA-1. In that study, DARE VBA-1 demonstrated improvement in vaginal cytology parameters and bothersome symptoms of VBA, supporting the ongoing development. Following clinical development, we intend to similarly leverage the existing safety and efficacy data on the active ingredients in DER-VVA1 Tamoxifen, and again, to utilize the FDA's 505 pathway to obtain marketing approval of DER-VVA1 in the US. As we continue to engage with the FDA on the IND process this year, we'll provide additional updates on the timeline to phase two.

21:38 The last development candidate I'd like to highlight is DER-PDM1. are an investigational product to treat primary dysmenorrhea or menstrual cramps by delivering the NSAID diclofenac vaginally, utilizing our proprietary hydrogel formulation, the same formulation technology that is used in Dashiato. We initiated a phase one study of JRPVM1 this year in Australia, and top line data are also expected this year. Primary dysmenorrhea is defined as painful menstruation, and women with normal pelvic anatomy typically described as cramping pain in the lower abdomen before or during menstrual period. Recent market research suggests that the global market for dysmenorrhea treatment is estimated to be valued at $13 billion in 2022 and that the size of this market is expected to increase to $28 billion in 2029.

22:33 Primary dysmenorrhea usually begins during adolescence. and is a leading cause of recurrent short-term school absence in adolescent girls and a common problem in women of reproductive age. According to the American College of Obstetrics and Gynecologists Committee on Adolescent Health Care, it's the most common menstrual symptom among adolescent girls and young women, and most adolescents experiencing it have primary dysmenorrhea. The prevalence rates vary, but they range from 15% to 90%. The most common interventions for temporary relief for the painful symptoms include oral NSAIDs or hormonal contraceptives, which often can produce undesirable side effects. Oral NSAIDs, which are available over the counter, may cause an increased risk of gastrointestinal adverse events, including nausea, vomiting, bloating, or ulcerations.

23:22 And hormonal contraceptives can also produce a number of undesirable side effects. So by leveraging a vaginal route administration, we believe we can provide a localized treatment option that addresses The pain-related symptoms of the condition while minimizing side effects commonly seen with the oral medications. Because there are currently no FDA-approved vaginal diclofenac treatment options for primary dysmenorrhea, DARE PDM-1 has the potential to be a first-in-category product, delivering diclofenac in a convenient vaginal format that may extend the duration of pain relief and reduce side effects commonly associated with the oral delivery of NSAIDs. Now, in my opening comments, I noted that part of our strategy is to identify promising candidates that can be developed efficiently in terms of time and cost. The ability to leverage our hydrogel platform technology that has recently undergone successful preclinical and clinical testing and regulatory review could offer both time and cost savings and advantages in the development of new candidates to address meaningful unmet needs in women's health.

24:34 It is our hope that the development of DARE PDM-1 and DARE LBT-1, which I have not discussed today, but similarly relies on the hydrogel platform, will benefit from the use of a technology that has already been closely evaluated. I will now turn it over to John to provide an overview of the two license agreements we have in place for commercialization of Zasciato and Oviprene, respectively.

25:04 Thank you, Sabrina. As Sabrina outlined, we strive to develop differentiated first-line or first-in-category products. We believe this creates optionality for our commercialization strategy by allowing us to enter into commercialization agreements, as we have with Zasciato and Oviprene, on a product-by-product basis and in no circumstances where we believe a collaborator with an established commercial capability in women's health is the most effective and efficient way to bring a DARI product to market. and the optimum way to provide value to DARE stakeholders. Our model gives us the flexibility to work with top commercial companies in women's health for certain products, but also directly engage in commercial activities for other DARE products when we believe it's most appropriate strategy given the target product profile and the stage of development within our portfolio.

25:53 As Sabrina outlined, we retain this level of optionality with the remaining 11 development stage product candidates in our portfolio. To date, we have entered into commercialization license agreements with what we believe to be are two of the best commercial companies in women's health. The value of having the breadth and experience of a women's health commercial market leader behind the brand is clear when we consider the Zasciato go-to-market strategy. We continue to remain excited about Zasciato's launch as we look forward to seeing Zasciato added to the healthcare providers armamentarium. As Sabrina noted, Organon has been working on launch activities, taking a holistic approach to the product's introduction, which will include direct selling, which is also known as personal promotion, as well as non-personal promotion efforts, and utilizing key digital platforms as well as payer and healthcare provider channels.

26:48 Organon has what we believe to be a truly integrated go-to-market plan targeting all of the key stakeholders, which are the healthcare providers, the payers, and the patients in order to quickly drive interest and awareness in the brand. And importantly, we have reported previously, Organon's market access team has been meeting with health plans and PBMs to review Zosciato and obtain competitive coverage in the bacterial vaginosis category, which is critical to support patient access and product pull-through, as Sabrina mentioned earlier. Organon will leverage its established Nexplanon sales team to maximize Zosciato uptake at launch and they believe there's roughly a 90% overlap of those healthcare providers who are already prescribing Nexplan and have the potential to be Zosciato prescribers. That strong relationship with the sales team and the provider relationships they have in place is expected to enable access to these HCPs and coupled with Organon's payer outreach and planned patient-centered activities, we think that allow us to be well positioned for in-market success, and we look forward to Organon launching the brand by the end of the second quarter.

28:01 Under our license agreement with Organon to commercialize Zasciato, we received a $10 million cash payment from Organon after the license became effective in June, and we are entitled to receive $2.5 million following the first commercial sale. We are also eligible to receive potential additional milestone payments of up to $180 million as well as tiered double-digit royalties based on net sales. Let me transition now to pre-commercialization activities underway for Overprene, 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 Overprene in the U.S., Bayer currently supports the Overprene program by providing up to 80 hours per week of an advisory capacity giving DARE access to Bayer's extensive clinical, regulatory, manufacturing, and commercialization resources while we retain control over Overprin's development and regulatory approval process.

29:00 Bayer has the right to obtain exclusive rights to commercialize Overprin in the U.S. following the completion of a pivotal Phase III study by making a $20 million payment to DARE. Thereafter, we will be entitled to receive commercial milestone payments potentially totaling $310 million in addition to double-digit tiered royalties based on net sales. Bayer has initiated activities to gain meaningful market and key stakeholder insights. Bayer continues to be a great collaborator, including recently sharing important commercial input that we were able to leverage for the phase three study design. And with that, I'll turn it over to Lisa for a financial update.

29:37 Thank you, John, and thanks, everyone, for joining us today. I'd now like to summarize DARI's financial results for the year end of December 31st, 2022, which I will also refer to as the current year or 2022. DARI's business model is comprised of two parts. The first is to assemble in advance a portfolio of differentiated product candidates that address meaningful unmet needs we've identified in women's health. The investment required to do so includes corporate overhead, portfolio acquisition and maintenance costs, and ongoing research and development or R&D expenses. The second part of our model involves monetizing the value of the portfolio's clinical and regulatory advances over the near and long term. There are many ways to generate value from a portfolio and one approach includes securing payments upfront and over time in the form of license fees, commercial milestones and royalties on net sales. This is the arrangement we put in place for Zasciato.

30:36 and as John just outlined, pursuant to the terms of our global license agreement with Organon for Zasciato, we've already received $10 million upfront upon the agreement's effectiveness and we will be entitled to receive a milestone of $2.5 million following the first commercial sale and thereafter, we will be eligible to receive potential additional milestones of up to $180 million and tiered double-digit royalties on net sales. But back to our current year. During 2022, we recognized our first revenue from the $10 million license fee from Organon that I just mentioned. Our general and administrative, or G&A, expenses were approximately $11.2 million. Our R&D expenses across our entire portfolio, which varied from period to period based on our clinical, preclinical, manufacturing, regulatory, and other activities, They were approximately $30 million and primarily reflected the costs of our late-stage programs, such as the ongoing Sildenafil Cream 3.6% Phase IIb RESPON clinical trial and manufacturing and regulatory affairs activities related to oviprene.

31:47 Our comprehensive loss for 2022 was approximately $31.1 million. We ended 2022 with approximately $34.7 million in cash and cash equivalent. During the year, we received approximately $24.1 million in non-dilutive funding. This included the $10 million license fee from Organon, approximately $13.3 million in grant funding, and approximately $800,000 from the Australian government as a research and development cash rebate from clinical studies that we have performed in 2021. Grant funding consisted primarily of funding for the DARE LARC-1 program under a 2021 grant agreement and for the DARE LBT-1 program under a November 2022 grant agreement. But also, in addition to those sources, our grant funding included an NICHD funding for the DARE 204-214 and DARE PTB-1 programs. As we've said before, non-dilutive sources have and will continue to play a very important role in our funding strategy.

32:56 Our CRADA with the NICHD will allow DARI to share costs of the upcoming oviprene pivotal study and to tap into the NICHD's extensive experience in conducting contraceptive studies. Under our existing CRADA, we are responsible for providing clinical surprise of oviprene for the study, coordinating interactions with the FDA, preparing and submitting supporting regulatory documentation, and providing a total of $5.5 million to the NICHD to be applied towards the cost of conducting the pivotal study, $5 million of which has already been paid. NICHD is responsible for other costs related to the conduct of the study. As of December 31, 2022, we had outstanding warrants issued in February of 2018 that were exercisable for up to approximately 1.4 million shares of our common stock. Subsequent to the end of the year, all of those warrants were either exercised or have expired, and today none of those warrants are extending.

34:01 We received approximately $1.3 million in cash and issued approximately 1.4 million shares as a result of such warrant exercises. As of March 28, 2023, DARI had approximately 86.2 million shares of common stock outstanding. In closing, We will endeavor to be creative, collaborative, and opportunistic in seeking the capital necessary to advance our candidates and to build shareholder value. We also encourage investors to review the more detailed discussion of our financials, our financial condition, liquidity, capital, resources, and risk factors on our Form 10-K for the year ended December 31st, 2022, which we filed this afternoon. I would now like to turn the call over to the operator.

34:51 Thank you for attending the conference call. We will now begin our question and answer session. If you would like to ask a question during this time, please press star then the number one on your telephone keypad. We'll pause for just a moment to compile the question and answer roster. Your first question comes from the line of Catherine Novak from Jones Research. Your line is open.

35:19 Hi, good afternoon. Congrats on all the progress. Thanks for taking my question. Just thinking about the upcoming RESPOND data, can you talk about the different components that are going into the arousal sensation domains in both of the primary composite endpoints, both the SFQ28 and the SDSDAO? What would be considered a clinically meaningful improvement on some of these endpoints? And then, again, thinking about this patient population, what proportion of women with FSIID would fall under the category that you are enrolling into the Phase IIb?

35:58 Great, great question. So, thank you. And thank you for the kind words about our accomplishments. Let's start first with the, you know, questionnaires and the nature of the questions specifically in those primary endpoints. And that's a great, and what's clinically meaningful, right? That's a great place to kind of take a step back and, again, explain what the use of this study is, right, and what we're trying to do here. And you just highlighted one of them. So in any clinical trial, you can only use as your primary endpoint something that has already been validated. And in the place of sexual health, there are not a lot of validated questionnaires for women, not surprisingly, given that there haven't been a lot of sponsored programs, right, to take products through the FDA.

36:49 But the endpoints you highlighted, those questionnaires have been. And those questionnaires on the sexual functioning questionnaire, it does have a subset of questions It has questions about pretty much everything you can imagine that happens in a sexual experience, you know, all across the journey. And some of those questions are very specific to what you would experience as part of a genital arousal response, right? They're questions specifically about what happens in the general region, specifically actually when you get blood flow to the region, because that's what elicits those sensations that she could experience.

37:35 So it does have some questions that are very relevant, right, to what sidenafil does. And the distress questionnaire that we use, the definition, right, the arousal condition definition includes the fact that this lack of an ability to attain or maintain a sufficient general arousal response can lead to distress. And so there is, therefore, as part of the co-primary, a specific question about distress. Because these questionnaires have not been used before in the context of arousal disorder, there is an opportunity for us on the primaries as well as actually on all of our exploratory endpoints. So we included a number of exploratory endpoints in this study that specifically came out of what's called content validity work we did with women with the condition to understand the words they use specifically to talk about it and the symptoms they care about and what they might feel is a clinically meaningful improvement. So all of that was included in the Phase 2b as well as a whole component that has to do with exit interviews as well as psychometric work that happens after we have all the study data.

38:47 that is important to do exactly what you just asked about, to demonstrate what amount of improvement is considered clinically meaningful and to validate any of the endpoints that we have included here so that any of the endpoints we have included here are candidates for the phase three. And that is why I say, so this is a super exciting study. It's a very rich study in terms of the data that we are going to be generating which is why I say we will make a top line data announcement obviously as soon as we have those data in the second quarter but there will definitely be a deeper dive assessment so that as we do exactly what you've outlined is then we take all that information, we take the exit interviews that were done, we take what we have demonstrated to be a clinically meaningful improvement and we pick what do we want to take forward in phase three and why and that's a great tie-in to the second part of your question which is How does our population, patient population, how does the endpoints we're looking at, right, how does that all relate to different definitions and different populations within the arousal disorder community? Because the nomenclature and how the condition is defined, like in the DSM, which is where this condition is defined, continues to evolve. And that's because there is and Interplay. This should not be surprising for anyone.

40:14 Again, no different than erectile dysfunction. There's a physical component to an arousal response. And then there's an emotional component, an interest-level component. If you are not able to have a physical arousal response, a portion of the population will not be interested over time, right? Because they're no longer, you know, it's all related in some ways. And so there is a population, some studies have estimated around 50% who have both arousal disorder and lack of interest. So similarly, we have attempted to conduct our Phase IIb study and our selection of the patient populations, and this is part of why we took time in enrolling subjects and characterizing them and screening them So that we will actually be able to, with our data set, look at data a lot of different ways. Women who only have arousal disorder, women who have a combination of arousal and lack of interest, as well as others, right? There's women who have arousal disorder and anorgasmia.

41:18 So there's lots of different permutations that we're going to be able to look at, and we're super excited to be getting, you know, it's a big step for the field. to be getting these data. And I think there's going to be a lot that we're going to be able to dig into and then hopefully, you know, get ready for those interactions with the FDA on the next step. That was a long answer to your question, but hopefully that covered it.

41:45 That's helpful. Looking forward to the data readout next quarter. Thanks again for taking my questions. Have a great afternoon. Thank you. Thank you so much. Your next question comes from the line of Douglas Sao from H.C. Wainwright. Your line is open.

42:02 Hi, good afternoon. Thanks for taking the question. So maybe first on this adenofil cream program, how are you thinking about the commercialization strategy? And what I mean specifically is obviously with Zasciato and Overprime, you have pursued partners. I know in the past you've contemplated or said that, you know, you're thinking about the right time to potentially become a commercial organization. When do you think you need to make that decision? Is that something that would be done like with Ashiado after, you know, we have phase three data and maybe not necessarily after approval, but or would this be something that potentially could happen before a phase three program?

42:47 and then also as a final follow-up just in terms of enrollment or thinking about the phase three, I understand your point about sort of looking at the data in terms of and cuts in terms of patients with arousal as well as lack of interest, but is one study enough to potentially sort of validate or give you confidence that you could enroll patients with sort of multiple Manifestations of Sexual Dysfunction. Thank you.

43:20 Great. Both of those great questions. I'm actually going to take them in the opposite. I'm going to start with the second one and then I'll talk about our go-forward strategy because they're kind of tied together. So first of all, as you highlighted, And that's why we really refer to this as a Phase IIB exploratory study. There's a lot we're going to learn from this study. It's fantastic to be groundbreaking as we are in this way. It really affords you a lot of opportunities to pave a path that others will have to follow who come behind you. And so that's definitely something that we're going to be looking at closely here as we look at these data, is how do we want to define the patient population? We wanted to find it the best we can for our cream, our sidenafil cream, and where this product is going to do well and do well in a way that whoever follows is going to have a hard time meeting. And so as we're thinking about the patient population to study, and this is why purposefully in the Phase 2b, we worked hard to make sure that we had some different patient profiles to be able to analyze. It's really going to allow us to figure out and to determine, you know, what direction we want to go for the Phase 3.

44:38 You know, we do think that actually we are going to need two Phase 3 trials for registration because this is such a novel indication and novel formulation of Sidenafil. So even though it is the 505 pathway that I talked a lot about today, You know, this would be a circumstance unlike Zasciato, unlike HRT1, where one phase three, you know, is adequate. This is one where two phase threes would be required. And that does also give us some opportunity to potentially have some differences in those studies, all of which would need to be discussed with the FDA. And that kind of goes to the first part of your question, which I'm taking in the second part. So first of all, as we said before, and John highlighted just today, right, we look at each of our products on an individual basis and further with, you know, 12 development stage candidates in our portfolio, we certainly have a lot of flexibility in terms of how we think about go-to-market strategy because we have such a broad portfolio on women's health, all the same call point that, you know, there comes a time where It's not a single product going to market.

45:45 It's multiple products on market at the same time potentially, right, as you think about the portfolio as it advances. So we take into consideration a couple different factors as we think about how and when to partner. First of all, you know, it comes down to how and who is going to be running the development program. and how that can be done in a way that is most advantageous for the brand. I'm going to take Overprint as a great example. You know, we and Bayer aligned together for that program and the nature of that, you know, kind of very novel product, novel education, needing to be nimble, needing to be flexible and creative, that it made a lot of sense for DARE to take the lead on that development program. through the people who study with BEAR behind us, supporting us, lifting us up, giving us advice, giving us insights, but that we would lead that program. And whereas with Zosciato in bacterial vaginosis, that's a very straightforward regulatory approval pathway.

46:53 And we knew what we needed to do to get a very differentiated label there. And we knew also that we didn't need a commercial partner's insight along the journey and that we, you know, we could get it there.

47:07 So as we think about this at NFL program, there are always pros and cons.

47:12 And this is a long way of me saying, you know, in the end, we always evaluate the opportunities and we evaluate what the program needs and we evaluate what DARI needs and ultimately we evaluate what is going to be best in building the value The biggest value we can create and the fastest way to get to that value. And that's exactly the, you know, the analysis that's going to come, you know, on the student NFL program. Clearly, there aren't a lot of opportunities to have such a groundbreaking product. It's truly creating a new category and that obviously generates interest. And, you know, so we will just have to, as we do, we evaluate everything and we evaluate the possibilities and we'll make the determination on what makes sense.

48:02 And the beauty for DARI is that we have that optionality. We have a portfolio that supports us being able to contemplate all different go-to-market strategies because we're not, you know, we're not relying on a single product.

48:19 Great, thank you so much. Yes, thank you. Your next question comes from the line of Kumar Raja from Roth Capital. Your line is open.

48:31 Thanks for taking my questions. I had a question on PDM-1. So in terms of the doses that are being tested, how do they compare with systemically dosed versions? And is the expectation that a single dose would be sufficient for most of the patients where the pain is typically seen in the first 24 hours?

48:59 Both great questions. Thanks for asking about that program. Since we've initiated the study, we've just been so excited about the level of interest in that program that we're running in Australia. So we're very much looking forward to the results. And the trial is very much, and the dosage forms that we're studying, is very much designed to answer exactly what you're asking. So first of all, we of course did take into consideration what's delivered with the oral doses of diclofenac. and what you see systemically, and diclofenac in particular has demonstrated benefits in dysmenorrhea, actually not just for the pain, but also even sometimes in the heavy bleeding that women can have. So we did look at that, but as you can appreciate, when you're going from systemic oral delivery to delivering localized, it's not one-to-one. Again, Zosciata is a wonderful example here.

49:54 We have very... have low levels of clindamycin systemically. That's why we were able to get some of the safety labeling we were able to get in Zosciato is because of that. But we have very good concentrations of clindamycin locally, right where you need it. So we're trying to do the same thing with PDM1. So we selected doses, again, taking into consideration the amount of diclofenac you have systemically, but not trying to match those dose levels, but trying to think about, therefore, the amounts that we would want to be achieved localized in that localized tissue environment. So that's how we selected the doses. And to your question on how fast we can see effect and duration of effect, similarly, that's what we're looking to understand better in this study. And so the way the study is designed, first of all, the women in this study will have the condition. So it's healthy normals, but they're healthy normals with dysmenorrhea. So they will have the conditions, so that's why we're also able to look at, and not powered for efficacy, but also be able to look at what effects they may experience with the product. And it's designed to look at both single administration and multiple administration.

51:08 So it's going to give us a lot of insights. Again, we know from our Zasciato experience that this formulation stays resident. in the vaginal environment. So it's not just at the time of dosing, but beyond that when you look at both vaginal and systemic PK levels. So we're expecting to see the same thing. So I wish I had answers for you today, but what we're hoping, we know from Dashiato how the product and how that formulation technology performs. So we took that into consideration as we designed DARE PDM-1. And then the Phase 1 is really designed to answer those exact questions, like how long Does the product stay resident? How long of an effect does she have after one time of dosing? How long does it stay resident? And then what happens if we allow her actually to dose multiple times?

51:58 Great. I just had a question on that. John alluded to this a little bit. So in terms of payer negotiation, what can you guys share with us? And is the expectation that there is going to be some step edits there? Maybe just a little bit of clarity on where you guys stand there right now.

52:25 Yeah, absolutely. So let me say a couple words, and then I'll turn it over to John in the event he has anything to add. So first of all, I want to clarify one thing, because I think it sometimes does get confusing sometimes, because we talk about launch, and then we talk about first commercial sale. So as John alluded to, activities that you do, right, that are part of that launch strategy, such as payer interactions, those started. Those actually started last year. Those activities have been underway, and as you noted, very, very important activities. It's the actual first commercial sale that is being targeted for the second quarter, but those kind of launch activities and launch preparation activities have obviously already been underway.

53:14 And while we are not in a position, given that we and Organon are both publicly traded companies, we're not in a position to share the specifics around all the activities we're doing and all the details on what the objectives are. What we can do is give you a little more perspective on just your question specifically around step edits because that's something really important to understand that is very unique about this category compared to other categories where step editing, even if it was required, is not as big of an issue is not as big of an impediment as it might be in another category because of how recurrent bacterial vaginosis is and the fact that many of these women will have already been through that. So, John, if you can maybe just talk a little bit about the recurrence rate of bacterial vaginosis and how common it is for women to have already been on a treatment in a prior period and what that means for having already stepped through.

54:18 Yes.

54:21 Will do. Thank you, Sabrina. Yeah, and I think just taking a step back, so bacterial vaginosis, you know, it's not a very heavily managed category. It's not a big budget hit for a lot of health plans. So there's not a lot of utilization management happening in there already. But in terms of your direct question, you know, in about 50% of all cases, women are going to recur. And recurrent bacterial vaginosis is essentially three or more episodes in a given year. When a step edit is applied, it's generally when she needs to graduate through something to get to something. And in our situation, and again, we believe this to be the case. We're not speaking for anybody else. There are going to be a number of women who will automatically sort of step through a previous therapy. So that step, if there's a step edit, which we're not clear that there will be because, again, the category is not managed that tightly.

55:09 But if there is, it's very likely that a big portion of the population will have already, quote, unquote, stepped through. and should have access to the brand.

55:17 Thank you, John.

55:19 Yeah, that's very helpful. Thanks so much. Sure. Absolutely. Your next question comes from the line of Jason McCarthy from Maxim Group. Your line is open.

55:32 Hi, good afternoon. This is Joanne Lee on the call for Jason McCarthy. Congratulations on all the progress and thanks for taking my question. So lots of questions were asked around this identical program, but I wanted to ask about the HRT1 program as well, for which we saw the positive efficacy data on Q4, and this was followed by the safety and PK outcomes earlier this year. And now the company, you know, you guys are positioned to file the Phase 3 IND. Can you briefly, just as a reminder, walk us through some of the key data that has emerged from the Phase 1-2, as well as other factors, including the maybe the unmet need in this space that may have attributed to the decision to progress that drug straight into the Phase 3 program.

56:17 And as a follow-up, what are the expectations in terms of the timelines around the IND submission and the study initiation? Thank you. Great.

56:26 Thank you for asking. First of all, thank you again for the kind words. And thank you for asking about that product. It is definitely one that we're quite passionate about at the company for some of the reasons that you cited. So first of all, you know, taking a step back, and I mentioned this briefly in some of my comments, but the North American Menopause Society, so by the way, a little commercial, you know, for anyone looking for information about menopause, they are a great, reputable source of information. These are the clinicians that have very much taken on menopause Care, right, as something that's important to them. And they've really studied menopause and studied, you know, what happens during menopause and what are the needs that women have during menopause and what are the appropriate approaches to address that. And as a medical group, I think as a group, it's frustrating that there are not as many options as one would hope to address these conditions and these symptoms that are very debilitating in terms of a woman's quality of life and her ability to function.

57:36 We joke about hot flashes, but the disruption to the sleep and the downstream consequences of that are a big deal. But there's other factors that happen in women when the hormones deplete. So there are factors related to bone health. There are factors related to cardiovascular health. So hormone therapy, as the North American Menopause Society say, can play a very important role But the objective is you really want to deliver hormones, particularly the estradiol, at the lowest possible dose that you can to still see beneficial effects, and you want to counterbalance it for safety with progesterone. So you really want the two hormones together, and clinicians have been a little bit limited because they haven't had – and ideally because these hormones are not efficiently metabolized through the oral route, you – and therefore you have to give really higher doses when you're dosing orally.

58:34 A non-oral route can have benefits, but you really want both hormones together. So we're excited about HRT1 because there's not been a product yet that does that in this convenient once a month, both hormones together, vaginal form, you're delivering them in that red administration. So very much an unmet need and Very excited about a product that, you know, can address that unmet need. And excited to have the opportunity, hopefully, to deliver something that is aligned with what the North American Menopause Society, you know, position paper on menopause indicates may have a lot of value. Now, having said that, to your question on what do we see, why are we excited?

59:19 Well, we're excited, obviously, about the form factor for all the reasons I said. But with hormone therapy, we know, right? With hormone therapy, we know the levels that you want to see. We know them for two reasons. We know them because of the products that are already FDA approved and have demonstrated benefits. So you can go through one exercise and just look at our levels and compare them to already FDA approved products to say, okay, check.

59:42 Yep, we're delivering enough like that product.

59:46 But also importantly, what you're doing with hormone therapy is you're replacing the hormones that she no longer has. and we know what targets we want to replace. We want to get her to a certain part of her cycle in the premenopausal phase, right? When she had certain levels of hormones. Not the high levels that she has when she's ovulating, but the low levels that she has at certain phases of her cycle. So the PK data basically allow us to see that. They allow us to make that comparison to see, yep, we're at low doses, but look, we're at effective levels because we know what has been achieved with some other products, with other form factors, what they've seen systemically, and then we also know what our target is through what you want to achieve in the premenopausal women.

1:00:33 So for all those reasons, that's why we are so thrilled, and obviously thrilled with the significance we saw, even though it was a small study, the fact that we were able to exhibit that level of improvement. In terms of what we need to do, though, and so therefore we were thrilled in the pre-IND discussions with the FDA that that this path of going to a single phase three is an option for us. What that means now is we have to execute against that. So from a manufacturing perspective, obviously we've got to manufacture the GMP product for the phase three trial. And so there are obviously activities underway to support that, to be able to support those supplies being ready for the phase three.

1:01:19 And then similarly, you know, having the reason you have pre-IND discussions is to clarify what is expected in the IND. And there's some non-clinical work that we will need to do as well to support that for the IND. So all of that work is underway. What I wish I could do for you today, but I can't yet, but we look forward to giving that update when we can, is tell you the exact timeline. Like, so what does that mean in terms of when exactly we expect to to be in, you know, in that phase three study. What I can say is that is one of our very important milestones for this year, right, are the IND-related activities for DARE HRT1 and the phase three, you know, clinical study initiation plans and work that needs to happen. So please stay tuned for more on that one.

1:02:09 We definitely look forward to giving more updates because we are, you know, we're very, very excited about this program.

1:02:17 Got it. I appreciate all the additional color. And for the company's earlier stage program, which, you know, there are several assets you guys are planning to advance, specifically regarding DARI PDM-1, which, as you've mentioned, is being developed using the same validated platform technology used to develop sildenafil cream. I wanted to ask if you could talk a bit about the importance of bringing a safer drug to this population of women with primary dysmenorrhea. And, you know, given the 505B2 drug pathway, as Diclofenac is, you know, what's a well-established NSAID. What could we interpret, you know, a positive phase one study to mean? And although it's not powered for efficacy, would PK be almost sufficient to imply efficacy? Because, you know, we already know the drug sort of works, which heavily risks the program already. Thank you.

1:03:07 Yeah, thank you for the question. And for clarity, it's the same gel that's in Zosciato. Yeah, so the... We are definitely to one, like the 505 pathway. Obviously, we've talked about so much today. We love that pathway, right? Because you're getting to rely on drugs that have already demonstrated safety and have already demonstrated efficacy. So, in the case of PDM-1, we absolutely can look at, we know the levels of diclofenac systemically for effectiveness. We don't know the local levels of diclofenac for effectiveness, but we know the systemic levels, and we know the systemic levels for sure for safety. What we have, and so first I'm going to talk about the regulatory part, and then I'm going to talk about the other part of your question, which is like the unmet need and the why. But from a regulatory perspective, What I will say, what we have, you know, the beauty of working in one therapeutic category and being so broad in it as we are is we have a lot of interactions at the FDA all the time with, you know, a lot of the same people at the FDA.

1:04:12 And you start to see trends. That's part of also the value of the way we work and the efficiency, right, of the way we work. So the trend we have seen is that, and so then it feels a great example where we've had very mature discussions at the FDA, that because in the case of Sidenafil, it's a brand new indication and it's a brand new route of delivery. They want two trials, right? Two phase three trials. And we saw with HRT1 that because we know about hormone therapy and even though it's novel for us to have both hormones together vaginally, there's support for a single phase three trial. PDM-1, hard to know today where it's going to land.

1:04:58 Because to your point, Diclofenac's already well-known, very well-established, labeled for this indication already. We're just delivering it in a different form. So we are hopeful, obviously, that we will be able to get to leverage the Phase I data robustly to the benefit of a more efficient, you know, streamlined registration program. Little early to project on that one. What I will say about the unmet need, though, is that I alluded to a lot of the women that are very bothered by this are reproductive age women, that's younger women. It doesn't get better. It's not like they just grow out of it in a year.

1:05:43 This is a problem that can be very persistent for them, very disruptive for them. There is There are a lot of data around the potential risk of long-term use of oral NSAIDs in terms of other risk factors and complications apart from just the disturbance in the side effect profile that they can have from a GI perspective. So there's therefore interest in thinking about how great it would be for these women to have an option that can deliver effectiveness in a non-oral route in a vaginal route administration that, again, has that potential benefit. So that's why we're looking forward to and excited about it and excited to have a possibility of giving women an option that's very different from anything that is available to them today and, again, is more in mind and delivering something more resident to where she's having the problem.

1:06:45 Thank you. That was really helpful. And yes, I did mean to shout out, so thank you for that as well. Yes, I know you did. Congratulations again on all the accomplishments, and we're looking forward to all the additional updates this year. Great. Thank you so much. Your final question comes from the line of Kemp Dolliver from Brookline Capital Markets. Your line is open.

1:07:12 All right, thank you. I'm going to ask two hopefully brief questions. First, how are you thinking about 2023 spending levels relative to 2022?

1:07:26 Yeah, great question. As you know, we typically don't give a lot of like forward-looking guidance around our spend. and we have been fairly, you know, consistent historically with how we spend. But the important thing to keep in mind is that the spending, you heard GMAs around, you know, last year was around 11 million, right? What we spend is primarily associated with the development programs, right? That's the bulk of where we use our capital. And The majority of the expenses, again, not surprising, is with our later stage programs, right? And so, as we think about the first half of this year, right, our research and development expenses are going to be primarily associated with the completion of the sidenafil study and manufacturing activities around the oviprene study, right, to prepare for oviprene.

1:08:25 So, we're always closely monitoring our cash and our resources. and, you know, thinking about the timing of incurring expenses versus our opportunities to bring in capital, right? We also always, we're a development stage company. We're always bringing in capital in different, you know, ways and means. So, you know, so as we think about this year, we obviously, we have some important activities around Sovenifil and Oviprene primarily that we're very focused on in the first half of this year. But we obviously have that, yes, we can control, but that we're going to incur as we think about progressing the other programs in the later part of the year that we talked about. But that's where the variability is.

1:09:12 The GNA has been very fixed over time, pretty consistent. It's really around where we spend on development.

1:09:21 Super. And my second question relates to the sildenafil study and So the questionnaire and the amount of data you need to analyze. And so how many questions or answers are in this questionnaire, depending on what's the better way to think about it? And then how long do you think you'll need to analyze the data to put together the Phase 3 design?

1:09:51 Yeah, that's a fantastic question. So first of all, in terms of just the primary and secondary questions, You know, it's a very reasonable number, right? It's less than 10, you know, kind of individual questions and domains. The bigger piece is related to the exploratory. This study was designed to ask even sometimes the same question in different ways. So we have electronic diary data that is, you know, post a sexual event over the course of the week. over the course of months. We have other data that's collected only on a monthly basis. So there is absolutely a lot of information. Having said that, we are very motivated to go as quickly as we possibly can to pull all these data together and get it to the FDA this year.

1:10:44 That is a clear priority for us. you know we'll have top line data in the second quarter as you talked about and then you know we're looking to very shortly thereafter have the full data set and we've already you know lined up our advisors to be working with us you know as we kind of mine through that and prepare and you know request that and to phase two meetings with the FDA. And as we always do, I alluded to already, we have a lot of interactions with the FDA and we try to be super communicative. So we have already given, let the FDA know where we are on the program and that we look forward to speaking with them about the phase three results.

1:11:31 So our hope is that we will be able to move very quickly this year towards those conversations.

1:11:39 That's very helpful. Thank you. That concludes our question and answer session. Ms. Johnson, I turn the call back over to you. Thank you.

1:11:51 And I'm looking at the time, and thank everyone for your time this afternoon to hear about our recent updates and our ongoing commitment to driving value for all of DARI's stakeholders, the women, the healthcare providers, our shareholders. With our diverse portfolio, we really seek to bring to market differentiated prescription therapies that prioritize women's health and well-being, expand those treatment options where none exist, enhance the outcomes where current standard of care has meaningful shortcomings, and improve ease of use for women where a more compelling form factor can drive adoption. And as we talked about today, primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health, and fertility. and our focused efforts to deliver differentiated innovation in women's health, as we talked about, have resulted in our 12 development stage programs across nine distinct indications.

1:12:45 The more than five milestones anticipated for this year, 2023, the three candidates and are nearing phase three development are two potentially transformational collaborations with the leaders in women's health product commercialization, Bayer and Organon, and our first FDA-approved product, Zasciato. So as I mentioned at the onset of the call, it's our belief that prioritizing women's health is good for the many women lacking effective or convenient therapeutic choices and good for a broad set of stakeholders, including their families and partners and, of course, our shareholders. So we very much look forward to keeping you updated on our progress, on the milestones that I outlined earlier that we have anticipated for this year. So we're talking a lot about this NFL CREAM Phase 2 response study top-line results. the U.S. Launch of Zosciata by Organon, the initiation of our Pivotal Study of Oviprene, the IND-related activities that we were talking about for DARE-HRT1 and DARE-VBA1, and importantly, the Phase III and Phase II, respectively, clinical study initiation plans, and those DARE-PDM1 Phase I study top-line data that we're looking forward to this year as well.

1:13:55 So thank you for your time today. Thank you for following, and thank you for those who asked all the great questions. This concludes today's conference call. You may now disconnect.