Daré Bioscience, Inc. (DARE) Earnings Call Transcript & Summary

All right. Good morning, everyone, and thanks so much for joining us today. We are so excited to have you with us and to have 2 such fantastic speakers speaking about DARE to PLAY Sildenafil Cream today. My name is Jen Kiang, and I'm with Dare Bioscience. I'll be moderating the session, and it's my pleasure to introduce our Founder and CEO, Sabrina Martucci Johnson, who will share a brief welcome and set the stage for today's discussion.

Thank you all so much for joining. As Jen said, I'm Sabrina Martucci Johnson. I'm one of the founders and the CEO at Dare Bioscience, and we are really appreciative of your time today and so thrilled that we're joined by Dr. Kingsberg and Dr. Simon, who are going to give an overview on DARE to PLAY, this first-of-its kind formulation of Sildenafil Cream designed specifically for women, which as a company is what we're all about. So without further ado, I'm going to turn it over to Dr. Kingsberg to get us started.

Well, thank you, Sabrina. It is such a pleasure to be here, and I am thrilled to talk about DARE to PLAY. Now we're really all here today because we know that female sexual concerns are really very prevalent. And I think we can all agree that women deserve to have healthy sexual function. Yet we don't have enough evidence-based pharmacologic treatment options. And that's particularly true with regard to female genital arousal problems. We certainly know that men have arousal problems. And guess what, there are plenty of treatment options for them, but we have none for women that are evidence-based until today. Now Dare saw that women want treatment options, and they saw it firsthand when over 10,000 women expressed interest in participating in their Phase IIb trial that evaluated their sildenafil cream simply in the first 16 weeks of the posting the trial online, 10,000-plus women. And we also know the importance of having evidence-based options. So I think we should all demand that we have demonstrated and consistent manufacturing quality products to assure women that they're being prescribed a solution that really has been effectively tested. Now we're going to focus the discussion today on genital arousal, but I want to take a step back for just a minute to talk about how the sexual response varies in women and that sexual arousal has an important component in all aspects of the sexual response, including its impact on desire, on orgasm and on overall satisfaction. Now this diagram, many of you can recognize as reflecting Rosemary Basson's Non-Linear Model of the sexual response. And this demonstrates that desire or that there's a -- linear response is not always true for women and that desire, arousal, orgasm is not always the way the sexual response works in women. In fact, for many women, they don't start with spontaneous desire. They don't start with drive. But what can happen is they can start with genital arousal. And so if we can enhance genital arousal that can be a nice starting point for women. And what happens is that the arousal can then prime desire, right? If you feel the genital sensation that can encourage the desire or what we would call responsive desire. And we also know that genital arousal is pretty important as a precursor to orgasm and that without genital arousal, it certainly can have an impact on sexual discomfort. So many women who don't have enough genital arousal may find that their sexual encounter not only isn't very satisfying because they don't have good sensation, but that it can lead to discomfort. Now we also know that blood flow is really an important factor in genital arousal response. And this can impact in a couple of ways. First of all, one, in the clitoral tissue increased blood flow will cause engorgement, which can result in enhanced sensitivity, and we can consider sensitivity really important for feeling genital sensations and pleasure. Second, the vasocongestion in the vaginal tissue, it increases capillary pressure to improve vaginal lubrication. Now why is this important? Because the more lubrication, the more sensation, the increased pressure in the vagina can create the perception of arousal, which is really important. Women will describe feelings of arousal as genital pulsing, of tingling, of warmth. And those are the feelings and the sensations that women will experience as genital arousal, which then can again trigger a responsive desire, can help with orgasm and overall satisfaction. Now there are biologic and psychological factors that can have problematic effects on this pathway. For example, conditions with vascular and neuropathic impacts such as diabetes as a prime example or multiple sclerosis can certainly negatively impact the blood flow to the genitals And many of you, I'm sure, have patients who will complain of having these symptoms. We also know that hormonal fluctuations, for example, after menopause or even after child birth or even due to some hormonal medications, for example, oral contraceptives can inhibit blood flow, which can be a problem for women complaining of genital arousal symptoms. And psychologically, we know that many psychological factors can inhibit the blood flow to the genitals because let's basic, if you're stressed, you're going to be distracted and you're not -- you're going to have potentially muscle contractions, all of which can inhibit blood flow. Depression, we know there's a bidirectional effect on depression and sexual response. And so if you're clinically depressed and depressed mood can negatively impact genital sensations and arousal. And certainly, anxiety would be a prime contributor to the lack of ability to focus on genital sensations and inhibit blood flow.

So it's my turn to talk a little bit about how Sildenafil might assist in individuals who have a need for increased genital blood flow. And I love this picture that says, go with the flow, because we are actually talking about genital blood flow. And Sildenafil, a compound, which is the generic or chemical name for the big blue pill, Viagra, has a very consistent mechanism of action in both men and women. It is a gender-neutral effect, if you will. Sildenafil, and in this case, its citrate form as well as the other PDE-5 inhibitors, phosphodiesterase 5 inhibitors, enhance nitric oxide and nitric oxide is the pathway by which the blood vessels dilate and increase blood flow. Sildenafil and the PDE-5 inhibitors do this by reducing or preventing the breakdown of cyclic GMP. Cyclic GMP is the mediator of that nitric oxide-induced vasodilation that increases blood flow to the genitals in this case. And obviously, you're well aware that sildenafil is FDA approved in its oral form for erectile dysfunction in men. But oral sildenafil may have suboptimal side effects in women at typical reported effective doses, like headaches, flushing and other systemic side effects, which are common to vasodilators and to the entire group of PDE-5 inhibitors. And so a topical formulation for women may better target the genital arousable tissues while minimizing those systemic side effects by reducing systemic exposure. What's unique about this delivery system in Dare's proprietary absorption system and present in DARE to PLAY is what's called the DermaFlux absorption technology. And many drugs, including sildenafil, have charged surfaces and charged molecules that make them difficult to absorb through the skin. Let's remember that the skin has 2 major fundamental purposes. One, to keep literally everything in our environment out; and two, to keep us and everything in our bodies in. And so it is very impermeable to external agents. So a combination of its impermeable nature, part of its being, if you will, and the fact that many drugs have these charged molecules, which make it even more difficult to get through the cutaneous layers of the skin, which are demonstrated for you here in the cartoon, actually exclude many drugs as well as many environmental pathogens. And without targeted delivery of the sildenafil, it would be limited to just applying it to the surface layer or the stratum corneum and it would never get through to the deeper layers where it can act on the blood vessels, improving blood flow and arousal or erection in men, for example. Dare's proprietary DermaFlux absorption technology is designed to obviate exactly that problem by creating large-scale hydrophobic and hydrophilic regions that disrupt hydrogen bonding and thereby facilitate penetration of the applied therapy into the deeper tissues, thereby reaching the blood vessels. So does it work? You should ask, well, that's theoretically great, but does it actually work? And here's some clinical data to show that it does. Recognize that when blood vessels dilate, there's more heat. Our blood is hot, it's kept inside, it's warm, it's the 98.6. And if the blood vessels dilate, there's more temperature to the tissues in which this dilation occur. You all know that when you get flushed in your face because you're embarrassed or drinking some alcohol, the answer is your face gets warm and red. And this study done by Goldstein et al looked at the application of this proprietary sildenafil cream versus a matching placebo on its ability to increase clitoral temperature. It was a small study, but very nicely organized to have baseline effects and then randomly assigned either sildenafil cream or placebo cream. And you can see in the graph that the application of sildenafil cream significantly increased the temperature in the clitoris as done by thermography. And that occurred in a relatively short period of time, 11 to 15 minutes. And more importantly, perhaps, is that the subjects had a cognitive arousal response. They knew it was happening and so significantly greater increases in genital temperature after application of DARE to PLAY Sildenafil Cream were found compared to placebo and those responses were noted in the study subjects. So cognitive understanding of those genital changes of increased warmth, which is exactly what arousal is and what Dr. Kingsberg noted as patients appreciate. Next, please.

Right. So women have perceived the change and that was proof of concept. But now the issue is once proof of concept is demonstrated, we need to evaluate DARE to PLAY in a randomized placebo-controlled trial where women could use the product in a variety of sexual events in what we would consider a real-world setting, not in Dr. Goldstein's lab. But even before a Phase IIb trial could be conducted, the next step was actually to understand what words women use to describe their arousal issues. We need to know how women describe their distress. So to that, Dare performed what we call a Non-interventional Concept Elicitation Study Where women with female sexual arousal disorder, both pre- and postmenopausal were interviewed to understand which symptoms are most relevant to them. And then we could then identify questions that we could ask in a clinical study as an endpoint known as a patient-reported outcome measure to capture the effect of their drug on these symptoms. And I was involved in that Concept Elicitation Study. So it was very interesting to hear women describe themselves what those symptoms were. Now once the Concept Elicitation Study was completed, these findings were then incorporated into the design of that Phase IIb study. And as many of you are aware, when studies use subjective endpoints from patient-reported outcome measures like in depression studies, looking at antidepressants or in desire studies, looking at treatments for hypoactive sexual desire, we do expect a placebo response, which is otherwise known as a nontreatment effect that comes from simply being in a trial, knowing you're in the trial, going to the clinical trial sites, talking about it, talking with their partner, taking a treatment. All of that can lead to a nontreatment or placebo response. And so in order to manage that placebo response, women in the study first underwent a no drug run-in and then everybody got a single-blind placebo run-in for 4 weeks where everybody got the placebo. Why is this important? Because that becomes the baseline for which you then measure efficacy. And if you can already show a treatment effect above and beyond that placebo response, you know that you have a treatment effect, and that's really important. So women were then after that placebo run-in, randomized in a one-to-one fashion to either get the placebo or get the treatment, and they were followed for 12 weeks, after which exit interviews were conducted in order to not just see the effect of the patient-reported outcome endpoints but to see what level of improvement would be a clinically meaningful change for a woman and not just what those endpoints demonstrated, clinically meaningful endpoints. Next.

So let's talk about the results of the study that Dr. Kingsberg just described. First, we have 2 different populations: one, the ITT, the intent-to-treat population, where we're looking specifically at their arousal response. And in this study, there was an improvement in that arousal response. Then let's also look at a post-hoc analysis, specifically at arousal sensation, the warmth or tingling that women report as being part of their arousal response. Not only let's look at how is it different in the DARE to PLAY Sildenafil Cream compared to a matching placebo cream, but then let's also look further about whether it's clinically meaningful, as Dr. Kingsberg mentioned from her exit interviews. And in this case, on a standardized survey, the SFQ, Sexual Function Questionnaire 28, arousal sensation domain, you can see that there was a statistically significant improvement in arousal compared to placebo cream at a P value of 0.04. Very importantly, demonstrating, yes, this DARE to PLAY Sildenafil Cream increased arousal compared to a matching placebo in a randomized trial. Further, that statistically significant increase is at a clinically meaningful level. Next. And in an effort to determine whether it was at a clinically meaningful level, there is a statistical methodology, which I won't go into, that looks at the anchoring of an endpoint, in this case, those desire orgasm or arousal endpoints to see whether the group of women that got active treatment compared to placebo would qualify the degree of their improvement as clinically meaningful. And in this case, we looked at arousal, orgasm and desire and those changes were either at or near clinically meaningful, including orgasm, which approached clinically meaningful change. And you can see the clinically meaningful change required, arousal clearly above clinically meaningful change, orgasm above clinically meaningful change and desired domain approaching but not at clinically meaningful change. So in essence, this arousal medication or this arousal topical DARE to PLAY Sildenafil Cream increased all the domains one would want by improving the arousal response, known mechanism of the therapy itself. So what do we take away from this? First, to Dare's knowledge, this was the first placebo-controlled clinical study specifically evaluating a potential topical sildenafil therapy for treatment of female sexual arousal disorder. The patient population with female sexual arousal disorder either with or without concomitant decreased desire. Remember, the primary focus here was on arousal with secondary investigations into desire. The treatment demonstrated improvement in arousal sensation, orgasm and desire and not described in the previous slide, reduced sexual distress and reduced interpersonal difficulties. These were endpoints that were part of this study, utilizing the DARE to PLAY Sildenafil Cream. That cream was well tolerated by exposed users as well as their partners. Remember, these were, by and large, but not exclusively heterosexual partners who may have gotten the cream on their genitals during the active sex. And so this treatment was well tolerated by both the users and the partners. So in this double-blind randomized placebo-controlled trial, the treatment-emergent adverse effects, which is anything that a study subject reports in the trial could be a headache, could be a nosebleed, could be a hang nail, anything that's reported were low and minimally different between the active users and the placebo users. In fact, they were mild to moderate in severity and typically were reported as to the application of the active or placebo material to the topical site.

Okay. Well, these data got people's attention. In fact, shortly after the positive results of the Phase IIb trial were first announced in June of 2023 and then presented at the first scientific conference, which was the Sexual Medicine Society of North America in that following November, everybody started to pay attention. The media grabbed hold of it because we know that the importance of female sexual function has finally reached the media and people are paying attention. But not only did the media grab on to this, the telehealth sites started jumping on the bandwagon. And all of a sudden, they started coming out with their own untested sildenafil cream formulations. And remember, what Dr. Simon talked about the technology involved in developing a DARE to PLAY, which is amazing. I mean it really is incredible technology to show how it can penetrate the tissue. All these other telehealth companies were coming out with their own topical sildenafil creams that as far as I know, have not gone through the Phase II testing or any kind of accurate effective testing. And in fact, one of the telehealth companies using a 503A pharmacy, which Dr. Simon will talk about, even used Dare data to promote their own sildenafil cream. So it's very interesting how all of a sudden, we have some data and everybody wants to now take their own topical sildenafil and use that data to support theirs. Next...

So let's look at what others don't guarantee but the Dare does. So first, you should understand that Dare is pursuing the approval of and use of this product in 2 distinct ways. First, through an FDA approval of the formulation to be available as a prescription medication through a 503B-registered facility and partnership. In addition, as it relates to DARE to, PLAY, this product is being made available through a custom 503A compounding pharmacy and -- so we, the prescribing public, may have something to provide to our patients outside of clinical trial until the 503B registered FDA inspection and approval are accomplished. But to our benefit, the actual material is being produced in the same registered facility, one that is inspected by the FDA and adheres to good manufacturing practices and the quality control and testing required for FDA-approved therapies. 503A products are typically made in small batches for individual patients, what you and I would call the typical approach to compounding when we order a compounded medication from a pharmacy that doesn't have, let's say, a color or a preservative or some other ingredient, either active or inactive because our patient is allergic or sensitive to it. In this case, DARE to PLAY is manufactured to those same high reproducible quality standards that FDA-approved therapies are. So what you might think. So what? I prescribe compounded stuff all the time. It seems to work. Let's break it down a little bit and be very clear about why this is important. In addition to my prior comments about the methodology allowing penetration of the active ingredient here, Sildenafil through the skin. So here, you have a table that has the following columns. The first column is list branded medications like FDA-approved branded medications. The second column, how are branded medications different from generic medications then how DARE to PLAY Sildenafil Cream is similar or different from branded and generic FDA-approved formulations and then other sildenafil creams in the last column. In the rows, you have formulation, as I've mentioned; demonstrated clinical effect as in clinical research with documentation of benefit as well as prevention or absence of risk. You have blood levels in tissue and good manufacturing processes and standards, that's GMP, that's good manufacturing practices and then on the last row, FDA approved. So for branded medications, you have a check box in each of those areas. For generic medications, you have a check box in each one, except that their approval as a generic medication doesn't have to have demonstrated clinical effect. They partner or add on to the back of the branded medication. And in DARE to PLAY Sildenafil Cream, the only missing checkmark is the FDA approval, whereas other sildenafil creams have done none of these things and do not adhere to any of these important processes, including good manufacturing practices. So very different scenarios comparing DARE to PLAY Sildenafil Cream with other sildenafil creams.

Okay. So how do you DARE to PLAY? Well, there's no dare in this, and I have a feeling that I'm preaching to the choir for those of you who are actually on this webinar. The first thing is talk to your patients. You got to talk about sex in order to be able to treat a condition, right? You can't treat something if you don't know it exists. And many women really still, despite the media attention, are still uncomfortable talking to their health care professionals about sexual health concerns. They really want you to open that door and to know that it's okay. They don't really even know where to turn. And so you need to open that door to ask. And I do understand why for many, it has been a challenge to ask about sexual health concerns because many of you felt, really, I don't have enough options. Certainly, you can refer for psychotherapy or sex therapy, and there have been a couple of options for treating hypoactive sexual desire disorder, but there have been no evidence-based treatments for arousal concerns for women who want to improve their genital arousal. So now there's really no excuse. So I dare you talk to your patients about sexual health because we now have many more approaches for treating sexual concerns. The second thing, you can sign up to receive updates about DARE to PLAY's launch. So you can use that QR code. We all now rely on QR codes for everything, even our menus. So use the QR code or if you don't like that, you can use their website, the daretoplaybio.com. And to get the updates because they expect their launch to be by the end of 2025, which is any minute now. I mean we've got Dr. Simon's birthday coming up in just a couple of weeks. And so we know that December is fast approaching. So please sign up to receive those updates. And the last thing I'd say is if you're going to prescribe a sildenafil cream because there are many options, why don't you consider using the one that has evidence-based data behind it that has used a clinical trial that has incredible technology standing behind it, so elegantly described by graph. So you now have some options for those women who come in talking about sexual health concerns. On the very first slide that I was talking about, the Rosy app, which collects women who have sexual concerns, 64% of them reported having sexual arousal concerns. So this is not a nonevent issue. Women really want approaches that are evidence-based for their sexual health concerns, particularly with genital arousal because we don't have anything for that, that is evidence-based. And so with that, I think we're going to take some questions from you, if you have any.

So I'd like to just jump in. And for those of us who may have additional social or sexual barriers to patients that may make them uncomfortable or even more uncomfortable asking questions. One technique that you might use if you're uncomfortable or if you're an old white guy asking a younger woman about her sex life, I ask everyone in a very matter of fact way, are there any sexual concerns you'd like to raise or like to talk about? Just a matter of fact, are you having any issues with your breast, your bowels, your bladder or your sex life and just let the patient know that I'm comfortable asking those questions and let them respond accordingly. I think it's not threatening and makes it really kind of matter of fact, which allows the conversation to begin.

I might even add to that, Dr. Simon, which is to validate and normalize how common sexual concerns are. So yes, to normalize your comfort in as a review of systems to say, I ask everybody, but I also might validate it by saying most of my patients have questions about their sexual concerns or many women after menopause will have some changes in their arousal or their desire or many women after childbirth so that they don't feel like there's something odd about them in particular. So yes, so normalize it and then validate it.

Fantastic. Well, Sheryl and Jim, that was so incredibly insightful. So thank you so much. I want to open things up now for Q&A. So for our audience members, please go ahead and enter any questions in the chat, and we'll go through as many of those here in our remaining time as we're able to. While people are submitting their questions, I wanted to ask the two of you a couple of things because you're just such experts in your own spaces. Maybe to start with Sheryl because I know you were so integrally involved in the clinical interview process for the Phase IIb. I was wondering if you could share any insights or observations either into that process or any takeaways that stood out to you?

Sure. Well, I think it's important for the audience to know that clinical trials are now being conducted a little bit differently so that when we're trying to recruit women that are appropriate candidates and in this case, women with sexual arousal -- female genital arousal disorder, we had several experts that were centralized so that regardless of where the women were coming in, in the various sites across the country, there were about 9 or 10 of us that conducted the clinical interviews so that we could appropriately make sure that women were coming in with female genital arousal disorder. And so what was interesting, number one, back to the fact that there were 10,000 women that were coming in. And I was -- I actually would ask them, well, what do you hear about the trial? And so many women said Facebook or from a friend, and it was amazing how they were so interested in this. So when we were making the diagnosis, it was very clear who met the criteria for female genital arousal disorder and women could describe their symptoms. And they knew what had happened that they had lost their ability to feel genital sensation. Now many of them did have concomitant desire problems, but you think about it in the downstream effect, as I described from the Basson linear -- Nonlinear Model that many women would say, look, I used to have good genital sensation and now I don't. And that has affected my interest, my desire. And so for many women, they've lost their desire because they couldn't feel good genital sensation and so it was just frustrating for them. On the other hand, there were many women who used arousal as the prime to their responsive desire. And so they -- that also became a problem for women who relied on that priming for arousal so -- for desire. So there are many reasons why that population, women with just general arousal disorder and women who had also arousal and desire problems were the best candidates in this Phase IIb trial. And the women who had orgasm problems that were just not going to be solved by increasing arousal, that's a whole different population. And actually, Dr. Simon and I are now working on consensus guidelines with the International Society for the Study of Women's Sexual Health on orgasmic dysfunction and orgasm to understand that, that is very different so that women who are coming in or tried to come in, and we would exclude them if we could that really had an orgasm problem were not the appropriate candidate because sildenafil is to treat genital arousal disorder and not orgasm dysfunction.

And Sheryl, maybe I can follow on because we did get a question about, could we please identify the ideal candidate for this cream? Should it be used primarily for people experiencing arousal difficulties without coexisting orgasmic dysfunction according to the efficacy data? I think you've more or less answered that, but I just want to make sure we put a point on that.

Yes. So for some women, all they need is appropriate arousal to be able to trigger orgasm, but there were many women that came in that were not an appropriate candidate because really their primary problem was lack of orgasm, and it didn't matter how much arousal they could have. And I'm sure many of you who treat these women will know that women who come in with orgasmic dysfunction say, look, I can get aroused, I just can't trigger that orgasm. And so no matter how much you can increase that genital sensation, that's not going to help. For some women, if what they just needed was the sensation and they did not have an orgasmic problem, that would be -- that's the ideal candidate. So women with and without desire would be perfectly fine because they know that the goal is to increase genital sensation. And for those who like it because it primes their responsive desire, that's great. And for those who just wanted the genital sensation, they're the ideal candidate. And not women whose primary problem is pain unless the pain is just a secondary effect of dryness and they need additional lubrication. But really, we excluded women whose primary symptom was pain as well.

I'd also like to add that there are a large number of women who don't have a disorder or don't reproducibly and have -- don't have arousal problems all the time who may find that DARE to PLAY is a good kind of a rescue medication that is to say, when they need it, they could use it, but they don't fit in the exact study subjects that were described in these clinical trials, but may want to have it in the bedside table for a time when they need it.

Which is fair because in the clinical trial, we required women met the criteria for female genital arousal disorder. And right, what we know is that DARE to PLAY can improve genital arousal with or without having a disorder. So please know that you can ask women about their desire to have improved genital arousal without necessarily needing them to meet the criteria for a genital arousal disorder.

Fantastic. Thank you both. We have another question on any concerns about contraindications? I don't know, Dr. Simon, if you want to take the lead on that?

I don't think there are many concerns in this regard. Remember, this application is almost entirely local in the genital tissues with minimal systemic absorption, possibly the only individual with a contraindication that I would think of would be someone who's recently had a heart attack or where they are unstable cardiovascularly, where that's largely a theoretical restriction or a patient who shouldn't use it. The other would be someone with active herpes who shouldn't use anything topical except perhaps some antiviral treatment. But most importantly, if a person has active herpes, she probably shouldn't be having sex anyway.

Wonderful. And a few others, I think, that can be quick. There are some questions on time to effect as well as, is it edible?

So is it edible? Yes, it's edible. I don't think you should go out and buy it to eat it, but it has a very strong -- it's a very strong question because high percentages of couples have oral sex and their oral genital contact may occur after the DARE to PLAY cream is applied. It's safe to have oral genital contact in that setting for those who are wondering what does DARE to PLAY taste like. It actually is quite salty. Remember, one of the ingredients, the active ingredients is the exact ingredient that we have in salt substitutes, potassium chloride. So it tastes a little salty, but it shouldn't hurt anyone that is engaged in oral genital play.

Fantastic. And Dr. Simon, maybe to add on, I know you obviously see a lot of patients. I wanted to ask kind of generally, when you think about patients who come to you with arousal concerns, what considerations are you thinking about when you offer them options?

So I'm very much focused on the biologic aspects of arousal concerns or arousal disorder. I'm sure Dr. Kingsberg will have some comments in the psychosocial domain or from our knowledge gained in this trial. But someone who has newly -- a new onset or relatively new onset of muted arousal, absent arousal, I'm worried about changes in their vascular system. Those could be vascular changes due to reduced estrogen. Estrogen increases nitric oxide and if they have reduced nitric oxide, they may have reduced arousal. But also delivery of blood to the genital tissues by virtue of vascular disease those with hypertension, those on medications for hypertension, beta blockers, for example, those who have diabetes or prediabetes and those with neurologic problems, as was mentioned, multiple sclerosis up at the top, but other neurologic issues, all of these come into play and just plain aging reduces blood flow to the genitals in both males and females and may be an important consideration for anyone who's menopausal and particularly over the age of 60.

So Dr. Simon, you talked about men having arousal problems. And one of the things when oral sildenafil came out was the fact that asking men about erectile dysfunction might also lead practitioners to be able to determine other problems that might be causing their erectile dysfunction. And so we have the same thing here. We can be asking and it legitimizes asking about arousal issues in women because it can uncover other medical conditions. But in terms of treatment effects or treatment options, regardless of the etiology of an arousal problem, I think not to make sure that I don't go out of business, but psychological interventions always can help because regardless again of the etiology. Once you develop an arousal problem, you start to get anxious about it. And the more you get anxious about it, the more -- or less focused on sensation and desire they're going to be, and that just perpetuates the problem. So being able to use some cognitive behavioral approaches, some mindfulness approaches to addressing the nonjudgmental focus on sensation and reducing anxiety or reducing other stressful distractors certainly can help. And we also, on the psychological -- when we think about the psychological sources of arousal problems, we also want to get to the underlying issues that might be causing those things like stress, anxiety and depression. So again, an arousal problem could be the precursor to us determining that there are other psychological factors going on that we want to address. So that has a bidirectional effect. We can address the depression, we can address the anxiety, we can address the stress, which will then while also improving genital arousal.

The other thing that comes to mind, and I think is very important is that there has to be no pain. So you can't focus on arousal or desire or even orgasmic function if there's pain involved. So whatever is causing the pain has to be treated. And sometimes just dryness or lack of lubrication, a piece of the arousal response is part of the story. And as a result, the question should be in your head, well, what about lubricants or moisturizers? Can they be used along with DARE to PLAY? And the answer is, yes, they can. There's no concerns about those, even though they weren't used in the clinical trials per se. There's no proposed mechanism by which a typical lubricant or moisturizer would interfere or adversely affect one another using the DARE to PLAY product.

To focus on that a little bit in the clinical trial, although women were not allowed to use lubricants, when we were recruiting women and trying to diagnose whether they met the criteria for female genital arousal disorder, number one, you're right. If there is pain that was not resolved by simply adding a lubricant, they were not an appropriate candidate. You need to treat the underlying pain condition. But also women who had arousal problems would say, I know how to use a lubricant, I've used a lubricant. That's not the problem. The problem is the lack of sensation. Remember those descriptors, it's warmth, it's tingling, it's pulsing. Those are the descriptors of the -- what they know of as arousal and not just lubrication. So when you think, well, what if I just tell them to use a lubricant, they may need a lubricant or they may not need a lubricant, but that typically is not going to change the sensation.

Fantastic. Thank you, both. One follow-up question to that. We have a question around, is this a possible treatment for SSRI treatment-emergent sexual dysfunction?

So Dr. Kingsberg can tell you that a significant percentage of the individuals in the trial, I think it was about 1/3 were on stable doses of SSRI or SSRI-like antidepressants. And there's no reason to believe that there's any safety issue in this product. And in fact, they were also responders in the trial. So no big worry here. And obviously, based on the question, which is an important one, there are large numbers of women using these therapies for depression or anxiety. They may have been on them for a particular traumatic episode years prior to when they're asking the question. But being on a stable dose of an SSRI or an SNRI is not a reason that a patient couldn't use the DARE to PLAY product.

Fantastic. Thank you, Jim. And then one more question for the two of you before I want to turn it over to Sabrina. I know we have a lot of questions here about pricing and release date. But before we turn to that, I wanted to ask, there's a question about should this only be prescribed to those with FSAD? Or is it appropriate for those who want to improve genital arousal?

I think we did answer that in that it certainly is available to try, it's a prescription for women who want to improve their genital arousal. So while the clinical trial was in women who have had female genital arousal disorder, there's no reason to think it wouldn't help improve arousal in those who wanted to improve arousal.

Fantastic. All right. I'm going to bring Sabrina up here as well because I think you'll be the best resource. And there are a lot of questions around what will the price be? Will insurance cover it? And when will it be released?

Fantastic. So again, I want to thank everyone for participating, and thank you, Dr. Kingsberg and Dr. Simon for the great talk and the great Q&A. So as I mentioned upfront, I'm CEO of Dare Bioscience. And as we've been talking about, the formulation here is proprietary to Dare And so that women don't have to wait, we're still going through a process. Ultimately, goal is to have an FDA-approved solution for these kinds of conditions. We have partnered with called -- what is called the 503B outsourcing facility. So it's the kind of compounding that Dr. Simon talked about, where it's not made at a pharmacy on a named patient basis. It's actually the kind of compounding where it is manufactured at large-scale facility that's subject to FDA inspection, follows good manufacturing practices for pharmaceuticals. And so they have been working on making this available. So women can have this option. They will be pricing it at around $10 a dose. So what that means is this is an on-demand product. And as Dr. Simon talked about, right, it's a great solution to have in the bedside table for when she wants it, and it's used on demand to have that on-demand effect in the moment. And so the tube will come in initially a size that has 10 doses. So that will be around $100 for that tube that has the 10 doses in it. And then additionally, in the new year, there will also be a smaller tube that will have fewer doses available as well. And so that's the pricing. And in terms of timing for availability, super excited that our 503B partner will be able to make this available in certain states in December. So that is around the corner. So it will be available in certain states in December, and then they're looking to make it broadly available across the country. Again, this is a special kind of compounding under 503B. So there's regulations across the country to make it available state-by-state basis, but looking forward to making it available broadly in the first quarter of 2026. So that's why signing up, if you sign up to get the alerts using the QR code or on the daretoplaybio.com website, you'll be able to get those alerts on when it's available in your state. And how to prescribe?So the prescriptions will be available through one centralized mail order pharmacy called Medvantx. They should be available in any of the provider drop-down menus in your electronic medical record system for that centralized pharmacy that will be mail order dispensing because it's a compounded product and not FDA approved at this time. It is not eligible for insurance, but should be eligible for most health savings accounts, FSA health savings accounts plan. And so that information will be available as the patient goes to pay for the prescription on the cash pay portal through Medvantx.

Fantastic. Thank you, Sabrina. I think we probably have time for 1 or 2 more questions before the end of the hour. And one actually interesting one just came in about probably more of a medical question about what about women during or after cancer treatment? It's someone who takes an antiestrogen pill every day. I wonder if that's something you could speak to.

Yes. So I'm happy to jump in on that. So first of all, the anti-estrogen treatments for estrogen-responsive cancers, largely breast cancers do reduce blood flow and do trigger or aggravate arousal and aggravate arousal or cause the disorder. So this would be a very good treatment for those arousal issues with one proviso recognize that those women may also have dryness and pain related to the anti-estrogenic effect of those treatments. And they will also need to use a good lubricant because of that dryness. So it may be a situation where it's a great use of DARE to PLAY, but where they too will need a lubricant or a moisturizer for the anti-estrogenic effect on the tissues, not only on the blood supply.

Fantastic. Thank you, Jim. Well, I think we're about at time. I want to see Sabrina, if you had any last closing words. Otherwise, we thank you all for joining us today.

Yes. I just want to echo the thanks. Thank you all for taking the time to learn more and to learn about this, and we look forward to keeping you updated as this proprietary first-of-its-kind formula becomes available. Thanks so much.