Dare Bioscience, Inc.

Q1 2024 Earnings Conference Call


spk03: Welcome to the conference call hosted by DAR-A Bayou Science to review the company's first quarter financial results and to provide the general business update. This call is being recorded. My name is Alex, and I will be your operator for today. With us today from DAR-A are Sabrina Martucci-Johnson, President and Chief Executive Officer, and Marty Haring-Layton, Chief Accounting Officer. Ms. Johnson, please proceed.
spk05: Thank you. Good afternoon and welcome to the DARE Bioscience Financial Results and Business Update Call for the quarter ended March 31, 2024. Today, we'll review our first quarter results and discuss developments and expectations from our pipeline and portfolio. I would 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 these statements due to known and unknown risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our Form 10-Q for the quarter ended March 31, 2024, 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, May 14, 2024. DARE undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. Before we begin today's update, I'd like to take a minute to remind those of you who may be newer to the DARE story of our purpose and mission. We believe DARI is the only publicly traded company focused solely on women's health, pharmaceutical product development broadly, and we remain dedicated to advancing disruptive products for the health and well-being of women through clinical development, regulatory review, and ultimately to market. Our commitment and focus is to improve health outcomes and the lives of women by leveraging the basic science and pharmacology that is understood about certain active pharmaceutical ingredients and marketed products to accelerate innovative treatments that women want and need by boldly addressing existing therapeutic gaps. We seek to optimize these treatments for our target indications to enhance outcomes, convenience, and side effect profile, or to address a novel indication where the pharmacology is well-suited but has not been previously applied to the indication in question for women. We believe we have assembled the broadest portfolio of potential high impact first in category product candidates, many of which have already demonstrated proof of concept and that our robust pipeline positions as well for the short, medium, and long term. On our recent full year 2023 financial results and update call, we discussed the strides we made last year to advance innovative therapies for women and the key milestones anticipated for 2024. So today, in addition to the continued commercialization by our collaborator organon of Zasciato Clindamycin Phosphate Vaginal Gel 2%, the first FDA-approved product to emerge from our portfolio, and a treatment for bacterial vaginosis in female age 12 and older that's now available by prescription nationwide. On that last call, we discussed anticipated 2024 milestones. focused on our first-in-category product candidates relating to continued progress toward a Phase III clinical trial of sidenafil cream 3.6% in female sexual arousal disorder, for which there are no FDA-approved treatments, and enrollment in our Phase III study of oviprene, our potentially first-in-category hormone-free monthly intravaginal contraceptive candidates. Today, we're going to cover our first quarter 2024 accomplishments, as well as some important recent highlights, including the 22 million non-dilutive strategic royalty financing we announced a couple weeks ago. We'll also review our progress against the anticipated 2024 milestones, providing context and metrics that are important to our current and future shareholders, with a focus on those phase three candidates, oviprene and sildenafil cream. Before I do, I'm going to first turn it over to our Chief Accounting Officer, Marty, to review our first quarter financial results.
spk00: Thanks, Sabrina, and thanks, everyone, for joining us today. I would now like to summarize DARE's financial results for the quarter ended March 31, 2024, which I will refer to as the first quarter. As Sabrina mentioned, DARE's business strategy is to assemble in advance a portfolio of differentiated product candidates that address meaningful unmet needs we've identified in women's health, and then to monetize the value of our portfolio's clinical and regulatory advances over the near and long term. The investment required to build and advance a portfolio includes corporate overhead, portfolio acquisition and maintenance costs, and ongoing research and development, or R&D, expenses. During the first quarter of 2024, our general and administrative expenses were approximately $2.7 million. Our R&D expenses, which vary from period to period based on clinical, preclinical, manufacturing, regulatory, and other R&D activities across our entire portfolio, were approximately $3.3 million for the first quarter, which is a 34% decrease compared to Q1 2023. Closeout costs related to the Phase IIb respond clinical study of sildenafil cream and other clinical studies conducted in 2023 contributed significantly to our first quarter R&D expenses, which will not be the case in future quarters. Until we commence a sildenafil cream Phase III clinical study, we expect R&D expenses for future quarters to be lower than the first quarter R&D expenses. Our comprehensive loss for the quarter was approximately $6.8 million. We ended the first quarter with approximately $3.6 million in cash and cash equivalents and had approximately 101 million shares of common stock outstanding as of May 13th. We recently announced a royalty monetization transaction with ZOMA in which DARE received $22 million in gross proceeds, and following a pre-specified total return to ZOMA, ZOMA will make upside-sharing milestone payments to DARE equal to 50% of all remaining cash flows sold to ZOMA under the transaction. This monetization of future net royalty and net milestone payments accelerates potential cash flows from the future commercial success of Zasciato and ensures that DARE and our shareholders have the opportunity to participate meaningfully in Zasciato economics as commercialization progresses. This non-dilutive financing provides significant capital to help achieve our objectives and importantly allows us to focus on advancing our phase three investigational products, Ovaprene and Sildenafil Cream, both of which represent large market first in category opportunities. The structure of this transaction also underscores the significant potential of oviprene and sildenafil cream with DARE retaining the significant majority of future economics and the ability to achieve attractive margins through retained net sales and all commercial milestones. In addition to this financing, we received total grant funding of approximately $1.8 million in January and April under our grant agreements with the foundation in support of our investigational contraceptive DARE LARP-1 and to fund activities related to bacteria-based live biotherapeutic product development. DARA may receive up to a total of approximately $49 million under our grant agreement relating to DERLARC1 to advance development of DERLARC1 through non-clinical proof-of-principle studies and other work to prepare for the submission of an investigational new drug application with the FDA, approval of which is required to begin testing in humans. To date, DARE has received approximately $29.4 million under the DARE-LARC-1 grant agreement. Together, the royalty financing and latest installment in grant funding represent our commitment to being creative, collaborative, and opportunistic in seeking the capital needed to meet our objectives and to build shareholder value. We encourage investors to review the more detailed discussion of our financials, our financial condition, liquidity, capital resources, and risk factors in our quarterly report on Form 10-Q for the quarter ended March 31st, 2024, which we filed this afternoon, as well as in our annual report on Form 10-K for the year ended December 31st, 2023, which was filed on March 28th, 2024. I would now like to turn the call back over to Sabrina.
spk05: Thank you, Marty. I'm now going to talk through our first quarter 2024 accomplishments and some anticipated 2024 milestones with a focus on our Phase III assets, Sidenafil Cream and Oviprene. But first, I'll provide an update on our on-market asset, Zosciato, clindamycin phosphate vaginal gel 2% or Zosciato. As a reminder, Zosciato is indicated for the treatment of bacterial vaginosis in females 12 years of age and older. It's a colorless, single-dose vaginal gel that can be applied at any time of day, and it's formulated with the goal of limiting leakage and increasing vaginal retention time, known as time spent in place. In the first quarter of 2024, through our commercialization agreement with Organon, Zasciato became available by prescription across the United States. The Organon women's health sales team continues to see strong acceptance from clinicians who have tried with their patients multiple uses of Zasciato in their practice. This progressive ramp up of trial from key healthcare provider targets continues to build momentum as we move through the first full year of launch. I'll now talk about sidenafil cream, 3.6%. During the first quarter, we also announced the successful completion of an end-of-phase two meeting with the FDA on the development of sidenafil cream as a treatment for female sexual arousal disorder. In terms of market and revenue potential, There are currently no FDA-approved treatments for any form of sexual arousal disorder in women, meaning sidenafil cream has the potential to be the first. Sidenafil is the active ingredient in tablet form for oral administration, currently marketed under the brand name Viagra for the treatment of erectile dysfunction in men, which was undoubtedly one of the most successful prescription products ever launched. Market research suggests that approximately 20 million women in the United States experience symptoms of low or no sexual arousal. In terms of probability of success, we've already demonstrated that sidenafil cream increased genital tissue blood flow in quantitative studies. And as we most recently shared during our full-year 2023 results call, we also completed all study analyses of data from the exploratory Phase IIb RESPOND clinical study of sildenafil cream. The patient population and the endpoints identified in the Phase IIb study and proposed to the FDA for Phase III clinical development were those where post-hoc analyses of the Phase IIb study data showed that sildenafil cream demonstrated both statistically significant and meaningful within patient improvement. We are continuing to interact with the FDA as the agency reviews specifically the data generated on the proposed endpoint to take forward into phase three development. The FDA has indicated that it anticipates providing additional feedback during this second quarter on the phase three design, which would be the first ever phase three pivotal study of a therapeutic candidate for the treatment of arousal disorder in women. We look forward to providing updates on the FDA's feedback, Phase III study design and plans, as well as any relevant updates on our collaboration strategy as available this year. And now to Oviprene. We also want to provide an update on the Phase III study of Oviprene, which is our novel, investigational, hormone-free, monthly, intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer. Non-hormonal contraception represents a significant commercial market opportunity, and there are currently no monthly hormone-free contraceptives approved by the FDA. Oviprene has the potential to be a disruptive product in the contraceptive category and an important option for women who cannot use hormone-based birth control products or prefer not to do so. Based on market research, approximately 35 million women in the U.S. are potential candidates for oviprene. Working with study collaborators at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, of the National Institute of Health, or NIH, we commenced patient enrollment in the Oviprene Pivotal Phase III clinical study in December 2023. Recruitment is currently underway at 18 sites across the United States and is supported by a central advertising campaign for the study that launched in March of this year. You can find a link to the campaign materials by visiting our website homepage. We were thrilled to see how many women responded immediately to our call to join the Hormone Free Revolution when we launched the campaign in March by checking if they qualified to participate in the study. We plan to provide updates on anticipated timing for study completion, which involves 12 months of product use, as enrollment progresses and will also provide recruitment and any relevant data updates in the coming quarters. Based on communications to date with the FDA, if successful, we believe that just the single registration study will be required to support a premarket approval application submission with the FDA. And lastly, we announced in the first quarter that we achieved technological proof of concept for our preclinical candidate that Marty was talking about earlier, DARE-LARC1, and importantly for its underlying innovative drug delivery platform, which is designed to store and precisely deliver therapeutic doses of drug over months or years through a single implanted device. This milestone reflects the drug delivery platform's transformative potential in not only women's health, but as well as various conditions outside of women's health, where treatment requires frequent dosing or regular injections. We are developing the DER-LARC1 implant, which utilizes this proprietary drug delivery platform as a user-controlled, long-acting, reversible contraceptive solution designed to combine the benefits of long-acting, reversible contraceptives with the flexibility of shorter-acting methods. But we see the potential of this drug delivery platform technology to transform treatment for certain other chronic conditions as well. So with this milestone, we are excited to begin strategic discussions with pharmaceutical companies working to address chronic conditions such as diabetes, obesity, and other conditions requiring precise and prolonged treatment, leveraging the platform's potential to precisely deliver a wide array of active pharmaceutical ingredients over longer durations with a lower burden for patients. And as Marty mentioned earlier, current development of DER-LARC1 implant technology is supported by an up to $49 million foundation grant. DER-LARC1 and our other grant-funded product candidates, they enhance our portfolio, and we look forward to providing relevant updates on DER-LARC1 and the other ongoing grant-funded programs as relevant this year. So in summary, we're excited about the progress we've made this year and are looking forward to providing more updates as we work to advance some of the most potentially disruptive candidates for the health and well-being of women in decades, collaborating with leading companies, including Organon for Zasciato and Bayer for Oviprene, to commercialize and deliver these treatments to as many women as possible. So I'd now like to turn the call over to the operator for Q&A.
spk03: Thank you, Sabrina. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star 1 again. If you are called upon to ask your question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. Again, press star 1 to join the queue. And your first question comes from the line of Douglas Chow. with H.E. Wainwright, please go ahead.
spk02: Hi, good afternoon, and thanks for taking the questions. I guess, Irina, you're looking now for some additional feedback from FDA on Sedanafil cream. I mean, can you just maybe help us walk through some of the steps that would be needed to initiate that phase three? Thank you.
spk05: Yeah, Doug, thanks. Great question. So, yes, so as I mentioned, we're waiting for some feedback so that we can, you know, make sure we're aligned on the final phase three design and the endpoints for that and, you know, important things like endpoint hierarchy and all of that. But to your question, what we're trying to do is make sure that all of the other activities that are required to start up a clinical trial, that we're doing everything we can to make sure that we are ready. So those activities include things such as, you know, selecting your CRO, right, and having your study budget and materials in place. You know, making sure we have a clear line of sight into these sites that we want to use. Now, obviously, we had, you know, the experience of the Phase 2b study, so that's helpful in terms of selecting sites because we know the sites we used in that study and who we want to continue. But just making sure we're ready from that regard, making sure that we're ready with clinical supplies, materials, the investigational product and placebo to test in the trial. So those are the activities that are underway and that we really started earlier this year, quite frankly, and that are well underway to make sure that as soon as we get the feedback from the FDA that we are ready to move as quickly as reasonable to proceed, and there isn't some other, right, some other gating activity that we had not yet completed.
spk02: Okay, great. That's helpful. And then just maybe on overprint, you know, maybe just help us understand when we should sort of start to think about sort of getting initial data or just the final readout from a timing standpoint? Thank you.
spk05: Yeah, great. Yeah, great question. So the trial, for those who may not be as familiar, so the trial is a 12-month study, meaning the subjects in the study, our goal is to follow them, to have them use oviprene over the course of 12 months. And we'd like to have around 200, 250 women complete 12 months of use with the product. And so we started, as I mentioned, we started enrolling the subjects the end of last year. And the advertising campaign, which is important in studies like this, it went live in March. And as I mentioned in my comments, we were definitely very happy with how much responsiveness we saw to the advertisement campaign, which really leverages like as you can imagine, social media platforms to make sure people are aware of the study and can reach out to express their interest and then matches them to sites. So with the ad campaign just going live in March, it's a little bit early for us to give very specific guidance, which we do want to do, and give some perspective on timelines and when we expect all that. But having said that, we are very happy with how the advertising campaign has been going and the responsiveness that we're seeing to the advertising campaign. And the reason all of that is important, and Doug's question about the timelines are important, is because this is An open label study, meaning everyone is single arm. Everyone is on oviprene. And so obviously having a line of sight into how enrollment is going, you know, gives us an opportunity to understand if there's an opportunity to look at interim data and when that will happen and when the final data will come. So at this point, you know, what I can say definitively, given that we didn't start recruiting until the end of last year, is that we certainly You know, we don't anticipate to have final data this year. You know, that wouldn't really be feasible given the timeline of the study. But we definitely hope to have some meaningful updates that we can share this year. And then as we get a little bit further with the live enrollment with the ad campaign, we'll be able to give better guidance as to exactly when we expect, when we would anticipate last patient out.
spk02: Okay, great. Thank you so much. That's really helpful.
spk05: Yeah. Thank you.
spk03: Your next question comes from the line of Kemp Bolivar with Brooklyn Capital Markets. Please go ahead.
spk01: Okay, thank you. I want to ask a couple of questions regarding your balancing act now between your current funding and your plans because there's some language in the 10-Q that's pretty sober regarding the cash runway, but at the same time, your current spending levels in theory could get you past 12 months and possibly to the over pre readout. You know, based on the step down, we'll likely see an R and D expense and the fact that you really don't have much, you have a small remaining obligation for the over pre trial. So how should we think about the spending and, what we're able to get and where you're able to get with the readouts with the, particularly with the ZOMA financing in place.
spk05: Yeah, thank you. Great, great question. And so, you know, as Marty mentioned in, in, you know, her comments and you noted, R&D spending, until we start the Sedanifil trial, because of the nature of our arrangement on oviprene and the funds we had already remitted to the NIH under a collaborative research agreement, as you noted, there's not a lot left that we've already committed to spend on that. There's another $500,000 payment on that. But otherwise, right, the R&D spend, as Marty noted, is significantly reduced compared to last year. until we start a sidenafil phase three study. As I was mentioning in the response to Doug's question, we want to be prepared to move on that as quickly as we can. A single phase three study, our expectations at this point, at least based on what we know today, is around 15 million. So, you know, so when you look at, you know, just our baseline burn, which we, you know, in our last call had provided some guidance that our expected, you know, GNA this year was about 10 million for the year, right? When you start just taking all of that into consideration, SmartD, 22 million is absolutely impactful and, to your point, really gets us, you know, to some very important milestones in terms of, over preem, you know, progressing, opportunities potentially to look at some of that interim data, timing, and even to your point, depending on how enrollment goes, you know, even further than that. But we want to be very clear, right, in our communication that a single sedentary field trial It's $15 million. In the scheme of things, is that a lot when you think about the potential of like what Viagra did? You know, in the marketplace, no. But we do want to make sure we're being clear in our communication given that dollar amount in relation to the $22 million.
spk01: That's very helpful. And to be clear, does that $15 million include the activities you're engaged in now prior to initiation?
spk05: It does, because the $15 million does include things like manufacturing, right, the cost of manufacturing the product for the clinical trials, you know, certain startup, right, site startup activities. It's what we expect the all-in number to be.
spk01: Okay. And assuming the feedback from FDA is not surprising and they're only minor hiccups along the way with preparation. When do you, when's a reasonable expectation for initiating the trial? Cause it looks like that early 2025 is reasonable, but maybe you can start early in 2024.
spk05: Yeah, that's definitely our hope. That's a great way to look at it, right? Like, we're trying to just make sure that we've checked all the boxes that we can check until we have that final protocol and then, you know, being able to move as quickly as we can once we have the protocol. But, you know, there's startup activities, right? You've got to contract with all the sites. There's things we can't do until we have a final protocol. So our intent is to move as fast as we possibly can. That's our objective. That's our goal. And so, you know, we'd love to be in a position to do that this year. But it definitely, to your point, is predicated on timing of getting the comments back from the FDA. And, you know, and hopefully they're clear, as you noted, so that we can move very quickly. But like I said up front, we're trying to make sure that we have ticked off every other activity so that we're ready to sprint.
spk01: Okay. And you have the flexibility to delay initiating the trial until you have, say, more certainty around your runway.
spk05: Oh, absolutely. It's all within our control, right? So the things that we're doing now are not significant in terms of expenses, but they're important activities, you know, so that we are ready to go at our choice, right, at timing completely 100% in our discretion.
spk01: Great. Thank you.
spk05: Yeah, thank you for the great questions.
spk03: Your next question comes from the line of Katherine Novak with Jones Research. Please go ahead.
spk04: Hey, good afternoon. Just another one on the sildenafil trial, the potential phase three trial. Can you remind us what you are still waiting on with regard to feedback? We know that you were aligned previously on indication and study populations. So what endpoints are you proposing? And then the timing, is this a 12-week study or would it potentially be longer or shorter? What's the duration?
spk05: Yeah, great questions and great reminder to sort of refresh everyone on where we feel we already have great clarity from the FTA-based on our December meeting and where, you know, really given that this is the first phase three study of its kind where, you know, reasonably the FDA needs a little more time to go through all of the information we provided. So to your question, so first of all, importantly, the patient population and the indication statement and the duration of the efficacy period have all been agreed with the FDA. So the indication statement is treatment of female sexual arousal disorder, so very straightforward. The patient population are women with female sexual arousal disorder, including women who may, as a result, right, of their arousal disorder, have a decrease in desire. That's very common. It's not only common in female sexual arousal disorder. It's the same thing that happens in erectile dysfunction. So very common for an arousal dysfunction to lead to a decrease in desire. So that's the patient population. And then in terms of the duration of the efficacy assessment, the FDA guidance document for conditions of this nature, it actually includes a few different sexual dysfunctions, but arousal disorder is in there, suggests that 24-week studies may be necessary for Phase III, but based on our end of Phase II meeting with the FDA and frankly, just the number of sexual events that women had in our study and our ability to show how much data you can capture in a 12-week period in terms of experiences with the product. FDA was comfortable that, you know, an adequately powered 12-week efficacy study would be sufficient. So those are places where, you know, we've got good clarity. And that does, by the way, give us a lot in terms of that's part of why we're able to get so much prepped right now because that tells you a lot in terms of funding, things like that for the duration that are needed. Where we still have some outstanding questions are in a couple areas. One is just really understanding what ultimately may be necessary also to support safety and exposure data on the product. So we included partners, for instance, in our Phase 2b study to see exposure to partners, right? We have, you know, the 12-week safety data from that, so we want to make sure we're clearly aligned on any expectations in that regard. And then second, we want to make sure that, you know, we're clearly aligned on the endpoints. And so your question was around, so what have we suggested? So just as a reminder, the Phase 2b study, the The primary endpoint in the Phase IIb was actually a co-primary endpoint. We had sections of a questionnaire called the Sexual Function Questionnaire. We asked specifically the arousal sensation questions from that questionnaire as part of our co-primary. It's four questions about genital sensations of arousal, so physical things that a woman is going to be feeling. in her genital tissue. They're questions that are really highly linked to what happens when you get increased blood flow to the area, which is what sildenafil does. But we also asked a particular question about distress. So the diagnostic criteria for erectile dysfunction and female sexual arousal disorder include that inability to attain or maintain the physical genital arousal response in men or women, respectively, of those indications. but also in both cases also indicates that that dysfunction causes personal distress. So in our Phase IIb, we had a question about distress. So part of what we've submitted, and then we had a number of exploratory endpoints, questions about desire, questions about orgasm, and lots of other different particular questions about distress. We chose in the Phase IIb a particular question about concern, But that same questionnaire has questions about guilt and feeling inadequate and being stressed, you know, about the condition. It has 15 total questions. So part of what we presented to the phase, for the phase three to the FDA is a very robust analysis of the phase TB data that includes what's called the psychometric analysis. It's part of validating all these different patient-reported outcomes. And we've made our recommendation of the hierarchy, right, of, you know, this is arousal disorder, so obviously the arousal sensations should continue to be a part of the primary. But other than that, what really belongs in the secondary? And we saw improvements in orgasm. We saw improvements in desire. We saw improvements in multiple questions from the interpersonal difficulty and distress scale. So you know, we'd like to have an opportunity to collect and include in our trial and include as, you know, potential to include in the label as many of these other aspects of the condition as possible. So that is what, you know, the FDA is reviewing right now is. And for each of those, we've established through exit interviews from our phase two, what is a clinically meaningful improvement? It's not just enough to have a statistical improvement, but what matters? You know to the woman and so that's what the FDA is looking at right now our proposal for you know arousal sensations clearly should be Primary, but then what goes into secondary and if there's a hierarchy, what's that hierarchy? And and and our focus has been on all these different aspects of the sexual experience Where we saw a clinically meaningful improvement. We're interested in including those in our phase 3 study if possible and So sorry for the long response, but hopefully that helps, you know, very clearly outline, you know, why we're excited about the data we generated in phase two, but also why it takes a little time for the FDA to go through, right, go through all of this. This is all brand new. We're the first sponsor that ever did anything like this.
spk04: Yeah. No, thanks. That's helpful. Looking forward to FDA feedback hopefully later this quarter. And then just one more question on the DARE LART. You know, that's a really interesting technology. And I'm just curious, you know, what does the clinical program like that look for like that? You know, is it comparable to, let's say, what Implanon or Nexplanon looked at? Or are you also trying to test the, you know, the pause and, you know, Resuming dosing aspect of it.
spk05: Yeah, that's a great question. So we've started to obviously do work on what the ultimate clinical program looks like and started to, you know, map out kind of that engagement with the FDA around that. But to the first part of your question, the contraceptive effectiveness part is, yes, it's going to look very much like what an explenon, right, any sort of implant Hormone-releasing implant product looks like where you're able to establish through phase one what your relevant doses of those hormones are and then typically move straight into a contraceptive effectiveness study because you have demonstrated that you have the hormones at the right level. And then you continue to, you know, you do have to study. So similar to like what those products do is you tend to like get your approval in phase increments, right, so you might first go after a one-year, two-year, three-year, right, duration, and then you keep following the women to keep extending your years of effectiveness, so very analogous to what, you know, the hormone-releasing products have done, and like the next one on as well, going for their five-year. So that's, you know, so from that piece, The piece that, and then non-clinically, we've already demonstrated like the pause open on demand component of the pause resume, but that will be a piece that will definitely be part of the conversation with the FDA in terms of what demonstration of that in vivo, right? It will be sufficient to show that in phase one, right? Or would that need to be part of any phase three regimen as well?
spk04: Got it. Okay. Thanks for taking my questions. Great. Thank you.
spk03: That concludes the question and answer session. I would like to turn the call back over to Sabrina Martucci-Johnson for any additional or closing remarks.
spk05: Thank you. Well, I really appreciated the great questions, and I do have some closing comments. First of all, I want to thank everyone for taking the time. To hear about the recent updates and our ongoing commitment to drive value for all of our DARI stakeholders by identifying and advancing potential new therapies to provide additional choices, enhance outcomes, and ease of use for women. And, you know, building on the momentum of 2023, there's no doubt that it's an incredible time to be working in women's health, quite frankly. We continue to be excited about the increased attention on the space through the various White House initiatives and our active participation in them, including the ARPA-H ideation event that we attended in February of this year, the executive order signing at the White House in March. And additionally, we're thrilled to see the recent unveiling of a bipartisan Senate bill that would authorize $275 million to boost research, training and public awareness around menopause specifically and midlife women's health issues, an area that is often stigmatized and overlooked and underfunded and that is particularly relevant to us given that our work on DARE HRT1, which while it was not the focus of today's call, is a program that we are also preparing for phase three. It's a potential first vaginal monthly therapy for the vasomotor symptoms of menopause. as well as our Phase II Ready DARE VVA1, our hormone-free vaginal candidate for sexual pain related to menopause. So we're looking forward to seeing continued progress in the menopause space and the potential progress of this new bill. Earlier this month, we were also selected as a member spoke of the Investor Catalyst Hub, which is the regional hub of ARPA-NetAge, the nationwide health innovation network launched by ARPA-Age. Through our participation, we get access to potential funding and flexible contracting for faster award execution compared to traditional government contracts. We can provide input on ARPA-H challenge areas and priorities and really help to ensure that women's health remains at the forefront of innovation. So these moments truly show just how much can be accomplished by bringing focus and investment to the entire ecosystem so that we can boldly innovate for women. And as you heard today, we're making great progress, and we're excited for what the rest of this year holds for DARE. As we look ahead to the rest of the year, we expect several milestones this year, including, as we've been talking about, oviprene and the pivotal study updates. As we're working to complete what we expect to be the single registration study, and are definitely looking forward to giving updates on our discussions with the FDA and the activities to commence our phase three for our potential first in category treatment option for female sexual arousal disorders, Sidenafil cream. So our unique model and the support of our commercial collaborators through all of that we believe are well positioned to accelerate innovation for women while also driving value for all of our DARI stakeholders. And we look forward to keeping you updated on our progress toward the milestones we discussed today. So thank you.
spk03: Gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

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