Dare Bioscience, Inc. Stock

Okay. We are ready to get started. Welcome, and thank you for joining the Dare Bioscience's Virtual Bus Tour. My name is Jenene Thomas. I am CEO of JTC IR, and I will be the moderator for today's event. So today, the company completes its virtual bus tour series with the East Coast stop. And for the format today, Sabrina Martucci Johnson, President and Chief Executive Officer of Dare Bioscience, will take you through the Dare story, and then I will open it up for Q&A and take your questions.

So it is now my pleasure to turn it over to Sabrina Martucci Johnson, to take it away. Sabrina?

Thank you so much, and thank you all of you for tuning in today on the bus tour. Before I start, obviously, the presentation does contain forward-looking statements. So I do encourage you to look at our SEC filings for a full overview of the risks and uncertainties associated with the company. So those of you who know us know we really think of ourselves as a purpose-driven biotech, where our sole focus is to close the gap between promising science and real-world solutions for women.

And what does that mean, right? That means that we're focused exclusively on women's health conditions. And as you'll see, as I talk about the portfolio, we work very broadly in the space. And as you're looking at us now and some of the things I want to highlight in today's presentation is really where we are in this kind of exciting time for the company and pivotal time for the company in terms of a snapshot because 2026 is a time where we're now launching commercial products, and we're going to talk about revenue commencing from product sales for a couple of the products in our portfolio.

And then also importantly, we're at a time where we're completing some studies that's going to -- that are going to lead to some clinical milestone events next year as well. So I really want to highlight what's happening in the development portfolio along those lines as well. And what you'll see across the portfolio, what everything has in common, whether it's commercial or development stage is it's based on clinical evidence. And that's the white space we're filling in women's health is bringing women options that are truly backed in science and can close those critical gaps in care.

I'm also going to talk a little bit about the grant funding that we have in the portfolio and how that helps us move products forward with that non-dilutive funding, which is both obviously a validation of the work we're doing, but importantly, also helps us from a funding perspective to move things forward. So as I mentioned upfront, we focus on women's health, and we work broadly. So from contraception to menopause, sexual health to fertility, vaginal health to infectious disease, we're closing critical gaps in care using science that serves her needs and really across life stages.

So we're not a company built around a particular product technology, and we're not a company built around a specific indication. We're looking at where are those gaps in care that we can fill. And so I'm going to focus on a few of the programs in our pipeline. And really, like I said right upfront, I'm going to focus on some programs that have commercial relevance right now. And so we're going to talk about in the DARE to RESTORE family, Flora Sync LF5, which is our vaginal probiotic that started commercializing in July of this year.

I'm going to talk about our prescription product, DARE to PLAY Sildenafil Cream that is expected to start commercialization this quarter as well. I'm going to highlight a couple of our development programs, DARE-HPV in the human papillomavirus treatment therapeutic space in the Phase II trial there and Ovaprene, which is our non-hormonal once-month contraceptive because we got Phase III ongoing right now with the top-line data readout expected next year.

And then I'm going to talk about a couple of our other programs that are really relevant either with the clinical programs starting up, DARE-PTB1 for preterm birth and fertility or DARE to RECLAIM, which is our menopause product for hormone therapy, where we're looking to start commercializing that next year as well. And before I go deep into the portfolio, a couple of highlights that I think are really important to understand upfront to put the opportunity in perspective.

First of all, when we think about women's health conditions and therapeutic options, what's important to understand is many of the things that we're looking to address in women's health, they're not diseases the way you think -- typically think of diseases. And why is that important? It's because there are things that a woman is going to experience simply by having that anatomy and biology and therefore, nearly every woman is going to be affected by thinking about those issues and looking for therapeutic options over the course of her life.

So think menopause, thinking about whether or not to have a pregnancy and maintaining a pregnancy, right? And then there's also conditions that are also very hormone reliant and dependent like sexual health. So again, most women are going to experience changes and disruptions in that as well. So we're going to talk about those markets. And then there are conditions like human papillomavirus infection in women that have been impacted by the fact that it wasn't until 1993 that women were required to be in clinical research.

So there are certain conditions in women that are important. Human papillomavirus is a virus that causes cervical cancer, and we know that. And yet there's no therapeutic option because we're still sort of catching up on those market opportunities. So we like the space because of the size of the market, certainly not niche. It's also been a highly productive category. So even though only 1% to 5% of private health care investment is going into conditions and therapeutic options for conditions affecting women. Those products, though, are disproportionately represented.

So 27% of the brands that generate over $500 million and have an annual revenue are for women's health conditions. So we like that disproportionality there in terms of how efficient the category is in generating blockbuster products, and that's really because women are such motivated health care consumers. And then the third thing that we think is really impactful about working in this space is the amount of grant funding that is available. That's non-dilutive funding that helps to advance the portfolio. So we don't have to rely on equity dollars to do that.

And again, this is in part an artifact of the fact that women's health and women's research wasn't required until 1993 to be included in clinical research. So there's a lot of foundation money as well as government funding that's available to really help bridge that gap. And we've been quite successful over the last several years in accessing that capital. And as you can see across the portfolio, including for our late-stage programs like Ovaprene and DARE-HPV.

All right. So I mentioned right upfront, we're data-driven. And what does that mean? So first of all, I think it's important to understand, we look at all the paths of getting our products to market. So it's not just about prescription options. Sometimes it's a nonprescription product. And it's not always just about FDA approval. Sometimes we think it's really important to get a product on market for women and fill an important gap that exists even as a compounded product.

But regardless of the path we take to market, what all the products have in common is that clinical backing, that clinical development and that clinical evidence behind them. And that really means that we, one, can have proprietary technologies because there's science behind them and they've been studied. Two, it also gives us a lot of optionality in terms of how we think about commercializing our products because they have the evidence behind them to be credible to health care providers.

And so as we talk about our commercial strategy, you'll see that it's important to make sure women have access directly, and we'll talk about the DARE Health Hub and telehealth and what that means and direct patient engagement, but it also is really an opportunity we can leverage where we can also go straight to the health care provider regardless of our path to market. So let's talk first about those commercial opportunities that are happening right now.

So Flora Sync LF5 is our vaginal probiotic. It's a non-hormonal probiotic product that's really designed to restore microbiome balance in the vagina. We talk a lot about gut health. I think we're all familiar with probiotics in the gut health sense, while the vaginal environment also has its own microbiome and similarly, probiotics can be very important in restoring that environment.

Unfortunately, for women, the vast majority of the probiotics that are available for women today, even for vaginal health are gut drive strains that are taken orally. So think about that and think about where you want that probiotic to work, and that's really where we're addressing it. So Flora Sync LF5 is a vaginally delivered probiotic. So the product is going right where you need it. And it's a strain that was developed by isolating it from the vaginal microbiome of women who have never had yeast infection.

So that's where the clinical strain came from. It's backed by science and then importantly, specifically studied in a clinical study to demonstrate that it actually does, right, achieve that vaginal microbiome balance. It's just a 3-capsule administration. So it's available now through the DARE Health Hub. It comes in a box of 6 capsules. It's really something that we are looking to have women incorporate as part of their vaginal wellness routine. So it comes with 6 capsules in the box. That's basically 2 courses.

And I get this question a lot in terms of how do women know that they need to do something to restore their vaginal microbiome balance and what I always say is that women know. So 65% of women are insecure with their vaginal scent. Odor can often be one of the first signals around a disruption in the vaginal microbiome. And so this is something that women are quite aware of and are seeking a clinically evidence-backed solution. So this is available on the DARE Health Hub right now, which we're going to talk about in a second.

But also importantly, there are clinician offices that are looking to make this available to their patients that way directly in the office, which is fantastic for them to have access to a clinically validated solution. And then DARE to PLAY Sildenafil Cream is our next product looking to be commercialized. We are expecting that prescriptions will start dispensing this quarter in Q3. What's interesting about this product is it's a first-of-a-kind arousal cream for women. So it leverages the same active ingredient that is in Viagra for men.

And just like men can benefit from having increased blood flow to the genital tissue, so too can women. That blood flow is really what leads to both pleasurable sensations, but also really important in the natural lubrication response in women. It's mediated by that. And so enhancing that can really help enhance that whole experience. And so this has been formulated specifically and studied and demonstrated that it increases that genital blood flow within just 10 to 15 minutes after application and also demonstrated to improve those arousal sensations using clinically validated FDA-reviewed endpoints. We're making this available as a 503(b) compounded product.

And so what that means is it's not yet FDA approved. We are still working on that NDA pathway. But what it does mean is it's subject to the same quality manufacturing standards as pharmaceutical products are manufactured in a facility that registers with the FDA and is subject to FDA inspection. And we were really thrilled to be able to respond to the clinician demand to have a product that was both clinically studied and is manufactured under those quality standards. There are about 20 million women in the United States alone who are complaining of symptoms of low or no physical sexual arousal.

And so as you can appreciate, at $99 for the tube, that's about a $2 billion addressable, right, total addressable market. The tube comes with 10 doses. So basically 10 uses. It's used on demand. It does require a prescription, which we're going to talk about, which women can get both through the DARE Health Hub or directly through their health care provider. There are prescriptions that have already been written in the system. So clinicians are excited to have this available for their patients and women have been excited to go through telehealth and get a prescription. So we are looking forward to have dispensing starting later this quarter.

And I talked about those clinicians already writing the prescriptions and clinicians looking to stock like DARE to RESTORE Flora Sync LF5 in their offices so they can make it available that quickly to their patients. That all really comes from years of being one of the only companies working solely and broadly in women's health therapeutics and therefore, leveraging those trusted relationships around the clinical development we've done to now turn those into commercial relationships.

So that long-standing relationship that we have with those health care providers means that they can now become supporters of our product and actually peer-to-peer educators around our technology. And so that's really a commercial advantage that we're able to leverage because of the clinical data and behind the products. It's also important, though, that we think about an integrated commercial platform and an ecosystem really designed for growth. So those provider relationships are so critical because that trusted source, that trusted clinical channel that we have to make sure that we are in.

But we also recognize that women are seeking and getting their care a lot of different ways. So we also want to make sure we have telehealth available to women for our products, whether that's directly through our DARE Health Hub or they really want for an asynchronous, right, quick questionnaire to get a prescription to something that they need or through a telehealth relationship with a third party that is really expert telehealth in like menopause care or sexual care.

And so those kinds of relationships are really a critical part of our education and commercialization around our products. As is digital in general, people get their information primarily if it's not directly with their health care provider, it's online. So we're really excited to have really a digital focus with our program. So think about influencers that are clinicians that have podcasts that have followings on Instagram and how we leverage them to make sure that women are getting the information they need.

And for those health care providers, they can talk about our products and be that trusted source of information about products that have been studied. And then the DARE Health Hub is really that central commercial platform that brings it all together. So it is the place where if you're a health care provider, you're submitting a prescription on the back end for fulfillment, all the prescription fulfillment happens through the DARE Health Hub.

All those third-party logistics, payment from the woman for the products that she's seeking, whether it's a prescription or she wants to shop now for Flora Sync LF5 that doesn't require a prescription. If she doesn't have a prescription yet, she can get it through telehealth. And if she's looking for more information, there's ways for her to then learn more about the product and get that educational content.

And as you can see from the photo here, the site, there's this wonderful opportunity also for cross-selling, right? She may go there for one product and then have an opportunity to learn about another because they're all really interrelated. And then I want to spend the last few minutes before we open up for questions, just talking about the development pipeline and specifically some of those important clinical readouts we have coming up.

So Ovaprene is really our first-in-category non-hormonal vaginal contraceptive. There's nothing like that in the contraceptive category today in that it's a once-a-month product that a woman manages and controls all on her own, and it works without hormones. We've now had 2 positive interim data safety monitoring board meetings, really taking an interim look at the safety data. Based on all of that, we expect to complete enrollment later this year, and that really puts us in a position for a top-line data readout next year in 2027.

This is the pivotal Phase III trial for this product, and this has the potential to be the first FDA-approved monthly hormone-free contraceptive. The other active clinical program right now and sorry, to go back to Ovaprene, I meant to highlight the development of Ovaprene has been primarily grant funded, both through the NIH and the Gates Foundation, including that pivotal Phase III.

And DARE-HPV is our product for human papillomavirus infection. So almost 6 million women every year will be infected with a high-risk strain of human papillomavirus. And what does that mean? It means that's a strain that can cause difficult cancer. And there's no treatment today, pharmacologic treatment when she is told she has that high-risk infection. She's told to watch and wait until cervical lesions appear or even cervical cancer appears.

And then the only intervention is surgery that can lead to preterm birth and infertility. So this is a pharmacologic intervention when she has that persistent high-risk strain. It's in a Phase II trial right now, and that Phase II study is completely supported with a grant contract from ARPA-H, which is the division of Health and Human Services, and we expect that data readout next year from this one.

I want to highlight menopause, our hormone therapy product. I touched on it just briefly upfront in terms of a potential commercial product for next year. We're all talking about menopause. We're all talking about hormone therapy, and that is fantastic. And we may even be talking about the shortage in the patches, which is really unfortunate for women.

And despite all that conversation, there is yet no product available to women today that has been clinically studied and that actually meets the Menopause Society guidelines for hormone therapy for women with the uterus, which is both estradiol and progesterone together ideally in a nonoral form, and that's exactly what our once-a-month vaginal ring is designed to do.

So we are looking to make this available next year, similar to what we did with DARE to PLAY Sildenafil Cream, where we start first by making it available as a 503(b) compounded product while the NDA pathway program continues. We are looking forward to that for next year. Injections for IVF, very painful and also to maintain pregnancy. So, really not using equity now in this third quarter, you got DARE to PLAY Sildenafil Cream targeted to go live this quarter and DARE to RESTORE Flora Sync LF5 already live and launched.

And then I mentioned we got the DARE to RECLAIM menopause hormone therapy that's targeted for 2027 on the commercial side. And then couple that with some really important clinical data readouts for next year on Ovaprene, our first-in-category contraceptive and on DARE-HPV, our first-in-category potential pharmacologic intervention for HPV infection.

So hopefully, what you're getting from our time today is that we've really been building the commercial momentum with also multiple catalysts coming. So we got the commercial catalysts this year and coming next year and then there's clinical development catalysts that are coming up for next year as well. And all of that with a very capital-efficient growth strategy, both on how we commercialize our products and how we leverage those provider relationships to do that in digital and then also how we leverage the grant funding on our development programs.

So I will pause there and stop there and open it up for any questions on why DARE and why now?

Excellent. So I will now open up for the Q&A session. So thank you for those who submitted your questions. [Operator Instructions] So our first question is, can you provide an update on the NASDAQ listing?

Absolutely. So the way the process works with NASDAQ for those of you that have been following us, where we were not hitting the metric was on stockholders' equity, and so that was the compliance that we were looking to overcome. And the way that process works, we received the notice from NASDAQ. We were able to request a panel hearing, which we did back in July. And then those panel hearings are held about a month after you make that request, so I think late August.

And then the way the panel hearings work, the company presents its compliance plan. We did complete an offering recently, which does increase that stockholders' equity. And so we present the compliance plan to the panel. It's not just that one event, but also looking over time. And then the panel typically puts out its compliance determination within about 30 days from the hearing. So that's the process that we're in right now. And as I hope is obvious, we do everything in our power to maintain that compliance. It's certainly important to us. We'll keep you updated.

Next question is you have access to significant non-dilutive funding is the reason why you did the financing for the NASDAQ listing?

That's a fantastic question. And I know you're not all accountants. But what's really amazing about our non-dilutive funding, as you highlighted, it's amazing because it's non-dilutive funding and it funds so much in our portfolio. But because of the way it's accounted, it actually does not help us with stockholders' equity. So even though that's like $75 million, right, of capital, right, and money coming into the company over the last several years since 2018, it doesn't actually help us with the stockholders' equity measurement and assessment because it's just how we account for it.

If we were able to account for it on a cash basis, it absolutely would. It would be very meaningful, but we're not able to do that under GAAP. And so that's where things like the equity financing that was recently completed. That's exactly what something like that can do, right, because equity then does go straight to the stockholders' equity calculation.

Okay. Thank you. Our next question is, why is DARE pursuing a Phase III program for DARE to PLAY when a compounded formulation will already begin dispensing soon?

Yes. What's really, I think, strategic for us in thinking about both options is they allow us to do some different things. So obviously, pursuing the 503(b) path means that we can get this product into the hands of women today, right away and have a clinically studied option available for them and for their health care providers to make available to them. And so women shouldn't have to wait, right? Viagra has been on the market for 30 years. For men, we're a little bit overdue on having a clinically studied solution for women. So 503(b) means that we can get a quality manufactured product in the hands of women right away.

But as a 503(b) compounded product, it is cash pay for women, which, by the way, is not a detriment, frankly, because most people do prefer cash pay in when it comes to their sexual health and right, things they might want to be a little more discrete about. But it also means that it's not FDA approved. And our view is that women deserve an FDA-approved option just like men have. And also strategically, that can really also enhance long-term kind of commercial protection. So we really want to look at both options and do that in a thoughtful way.

Okay. There's a follow-up question here. Is there a risk that a negative outcome in the DARE to PLAY Phase III trial could adversely affect sales of the compounded product?

Yes, great question. Obviously, we have a lot of confidence in the product based on the clinical data that's been demonstrated to date, both quantitative in terms of looking at that time to blood flow. That's a quantitative study, not a very fun one for women to participate in, but it's a very quantitative study that tells you it's doing what it's supposed to do in terms of actually getting the product into the tissue and that blood flow creates that warming effect.

And then we have the clinical outcomes from the study that have been completed. So obviously, we wouldn't be moving forward with the Phase III if we anticipated a negative outcome in a Phase III trial. Having said that, obviously, clinical studies, there's always risk, right, with clinical studies, you don't control the clinical output. But that's something that we would be pursuing from a place of confidence in the product and confidence in the clinical outcome that's going to show.

Next question. When do you think we'll see line of sight into the commercialization of Flora Sync LF5?

Yes. So we're definitely early days in the launch. Like I said, we just started commercializing it in July. So we're just about a month in, month in plus into that. And what I will say is that, obviously, as we get -- start having our earnings calls, we'll be giving updates, obviously, on commercial metrics. What we're really looking for in the early days, it's not so much about the dollar amounts. It's really about those fundamental things that sets you up for a very successful launch. So what we want to see is breadth in terms of where the product is going.

We're looking closely at our channel strategy. So right now, it's available on the DARE Health Hub and also clinician offices can make it available through their offices. So as we start talking more about what we're seeing, we're going to really be sharing kind of those insights, right, where are people coming from? Where are they getting the products, which of our podcasts and Instagram collaborations and things like that, what has really led to increased demand coming from the DARE Health Hub, coming from the clinician office channel.

And we are looking at some other retail channels as well. So in these early months of the launch, it's really going to be more around those metrics, right, where are people coming from? Repeat usage, we want to look at as well. We really think this is something that can be incorporated into our vaginal wellness routine. That's not a sense we say all the time, right, as a health care consumer, I'm looking for stuff for my vaginal wellness routine, but we should, right? So just like we worry about our gut health, we should be worried about that vaginal microbiome because it's really, really important. So those are the kind of things we're going to be talking about and that we'll be looking at and watching in the early days.

Right. Well, it looks like those are the questions for today. Sabrina, do you have any closing thoughts? How would you like to end this discussion as well as end this bus tour?

Yes, yes. We got a lot of -- thank you again to people who have tuned in. The bus tour has been just for us a great way of at this really interesting time in the company to get the word out, right, and make sure that people are having an opportunity to see me and engage with us directly and ask their questions directly now this summer because it really is such a pivotal time for the company.

And I really look forward to keeping people updated as we're at this commercial inflection point, but then we've got also these really interesting data readouts coming next year on 2 of our programs. And also, we're going to continue to lean in on that non-dilutive funding. It's just a great way of moving the portfolio forward. Everything that we're advancing right now in development is grant funded. And it really means we can do a lot more because those programs are what then feeds that commercial machine. So just thanking everyone again and really looking forward to keeping people updated.

Excellent. So with that, this does conclude the Dare Bioscience Virtual Bus Tour. The tour may stop here, but the road ahead continues. So thank you for being a part of this journey and for your continued interest in Dare and its mission. So stay tuned for more ways to connect with Dare Bioscience. Thanks, everyone, and wishing everyone a great rest of your day.

Awesome. Thank you.

Thank you.

Hello, and welcome to the Dare Bioscience Second Quarter 2026 Corporate Update Conference Call and Webcast. [Operator Instructions] Note that this webcast is being recorded at the company's request, and a replay will be made available on the company's website following the end of the event.

Joining us today from Dare Bioscience are Sabrina Martucci Johnson, President and Chief Executive Officer; and MarDee Haring-Layton, Chief Accounting Officer.

Ms. Haring-Layton, please proceed.

Good afternoon, and welcome.

Today, we will review our financial results, provide updates on our commercial products and clinical pipeline and discuss the continued execution of our expanded business strategy. That strategy includes a dual path approach, commercializing proprietary formulations through 503B compounding while pursuing FDA approval and advancing select solutions as branded consumer health products that do not require a prescription. In all cases, our goal is to bring innovative women's health solutions to market as efficiently and quickly as possible.

I would 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 actual 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 quarterly report on Form 10-Q for the quarter ended June 30, 2026, which was filed today and our Annual Report on Form 10-K for the year ended December 31, 2025.

Please note that the content of this call includes time-sensitive information that is current only as of today, August 13, 2026. Dare undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law.

I would also like to point out that when we use the term 503B compounding during this discussion, we are referring to compounding drug products by outsourcing facilities registered under Section 503B of the Federal Food, Drug and Cosmetic Act using bulk drug substances on the FDA's interim Category 1 list.

I would now like to turn the call over to Sabrina.

Thank you, MarDee. And good afternoon everyone, and thank you for joining us.

For more than 10 years, Dare has been building towards this moment. We built Dare on a simple conviction, women's health is an investment-grade category, not a niche, not a side project, a category worth building, funding and holding accountable for delivering the healthcare options women deserve. Every asset we developed, every trial we ran, every grant we've secured, every collaboration we've negotiated, all of it has been directed towards this one purpose, closing the gap between promising science and real-world solutions for women.

And over the past few months, that strategy crossed an important threshold. We did not stop being a science-driven development company. We added something new, commercial execution. And that distinction matters. Dare was built not only to develop differentiated solutions for women's health, but to bring those solutions directly to the women who need them. With our first product that we are commercializing directly now on the market and a second approaching prescription dispensing, that vision is becoming a commercial reality.

In June, we launched Flora Sync LF5, the first product in our DARE to RESTORE line. It was Dare's first product to enter the market directly via Dare and a milestone marking a new chapter for our company. At the same time, we continued advancing DARE to PLAY Sildenafil Cream toward prescription dispensing, which we are targeting to begin this quarter.

One product is launched and the second product is approaching dispensing and a commercial platform is now live, and that is what makes this quarter different.

We're still in the early stages of commercialization, and our priority is disciplined execution. The infrastructure, the relationships and the capabilities we're putting in place today are designed to support efficient, repeatable growth as our commercial portfolio expands. The transition is real. Dare now has products moving from pipeline into the market and a strategy designed so that each launch strengthens that platform for the next.

So let me begin with Flora Sync LF5. Flora Sync LF5 is a nonhormonal probiotic vaginal capsule designed to support vaginal microbiome balance, moisture and comfort. Available without a prescription, it's formulated with the form of Lactobacillus fermentum LF5, a proprietary strain backed by more than 30 years of probiotic research.

What differentiates Flora Sync LF5 is the science behind it. Flora Sync LF5 was evaluated in a randomized clinical study involving 100 women with results published in a peer-reviewed journal. That level of product-specific clinical research is unusual in a category where consumers frequently encounter products with limited supporting evidence. And we believe this creates a meaningful commercial opportunity.

One survey found that approximately 65% of women aged 18 to 65 feel insecure about their vaginal scent. Flora Sync LF5 does not need to reach the entire market to become a meaningful product for Dare. Even modest penetration could generate significant commercial value, particularly when considering the potential for repeat use.

Flora Sync LF5 was priced with accessibility and ongoing use in mind. We believe it has potential to become part of a woman's regular vaginal care routine, creating an opportunity to drive initial trial, encourage recurring demand and build lasting consumer relationships.

Let me now turn to DARE to PLAY Sildenafil Cream, our proprietary topical Sildenafil Cream designed for women, which addresses a large and deeply underserved area of women's health. An estimated 20 million women in the United States experience symptoms of low or no sexual arousal. Yet there is no currently FDA-approved treatment specifically indicated for female sexual arousal disorder. Women have waited far too long for solutions developed around their physiology, experiences and needs.

In clinical studies of our formulation, we observed increased genital blood flow and improvements in arousal sensations. The formulation was well tolerated by both users and their partners in our Phase IIb study and no serious safety concerns were reported. By improving physical arousal sensation, DARE to PLAY Sildenafil Cream is designed to support a more positive and responsive sexual experience.

At a price of $99 per tube, which provides for about 10 uses, the estimated addressable population of 20 million women represents a total market opportunity of approximately $2 billion. Even modest market penetration could create meaningful commercial value in an area with limited female-specific treatment options.

Initially, we intended to make DARE to PLAY Sildenafil Cream available by prescription as a 503B compounded product, while continuing to pursue the 505(b)(2) regulatory pathway toward potential FDA approval.

Now you might ask why the dual path regulatory strategy? And the reason is that while the compounded pathway offers a capital-efficient way to enter the market, FDA approval would represent an opportunity for women to have an FDA-approved option as men do.

An FDA-approved product could provide greater confidence among patients and prescribers and support broader commercial adoption, because FDA-approved products can be administered as treatments and considered for coverage by payers. It can also strengthen our competitive position to create a more durable and valuable commercial franchise. And in this way, the compounded product can provide an efficient path to early market entry while pursuing FDA approval is designed to unlock the potential of the product as the potential first FDA-approved product to treat female sexual arousal disorder.

Although DARE to PLAY Sildenafil Cream is not yet dispensing, interested customers can already begin the simple process of obtaining a prescription. While it's still early, I'm encouraged by what we're seeing in terms of geography of prescriptions being written, a healthy split between office providers and telehealth and repeat prescriptions from providers. Dispensing is targeted to begin this quarter.

Let's now turn to our commercial strategy. It begins with providers. OB/GYNs and women's health specialists are trusted voices and their conviction can drive both product awareness and appropriate patient use. Digital marketing expands that reach by educating women directly and helping us identify the messages and audience that converts most efficiently.

Telehealth creates convenient access and national reach. And DARE Health Hub brings education, product access, fulfillment and ongoing engagement into one central destination.

Our recently announced collaboration with MyMenopauseRx further expands that ecosystem through an established women's health telehealth platform. Additionally, this collaboration highlights how we plan to engage with other telehealth platforms where women can receive a prescription for DARE to PLAY Sildenafil Cream. And the DARE Health Hub serves as the foundation of our commercial strategy.

For patients, the DARE Health Hub creates a central destination where women can learn about our products, understand which solutions may be relevant to their needs and navigate the path to access. It brings together education, product discovery, telehealth connectivity, fulfillment and ongoing engagement in a convenient and cohesive experience.

For Dare, the DARE Health Hub creates a direct connection with the women we serve. It gives us greater visibility into the full customer journey from initial awareness and product evaluation through purchase, fulfillment, repeat use and engagement with additional products across our portfolio.

The DARE Health Hub also allows us to maintain that relationship beyond a single transaction. As women return for information, additional support or repeat purchases, we have the opportunity to build trust, deepen engagement and introduce other Dare products that may address their needs at different stages of life.

As our portfolio grows from vaginal health to sexual health and, over time, menopause, each product can benefit from the same digital infrastructure, provider relationships, and expanding customer base. We believe that shared foundation can make each successive launch more efficient while increasing the long-term value of the platform as a whole.

We're also building awareness through trusted voices in women's health. Podcasts, clinician conversations and influencer interviews allow us to engage women in credible relevant settings where they are already seeking information about their health. These channels help translate awareness into action by educating women, introducing them to Dare products and creating clear pathways into the Dare ecosystem.

To add, these conversations have also reinforced the need we set out to address. We're hearing firsthand that women are actively seeking solutions developed specifically for them, and they want better information, greater access and incredible options they can trust. That response has been encouraging, and it validates both the products we're bringing forward and the commercial approach that we're building around them.

And that brings me to how we'll evaluate performance during the early launch period. We're focused on 3 primary groups of commercial indicators, each designed to give us a clear view of how demand is developing and where we're seeing the strongest opportunities to scale.

The first is consumer adoption. Initial interest is important, but the stronger measure is whether that interest converts into a purchase and whether a positive initial experience leads to recurring demand. These indicators will help us understand who our customers are, how they discover our products and what drives them to return.

The second is provider adoption. Providers play an important role in establishing credibility and connecting women with appropriate solutions. Initial provider trial is a positive first step, but consistent prescribing, recommending and stocking will be indicators that our products are becoming part of routine clinical practice.

And the third is commercial efficiency, which will help us determine which channels are producing the strongest results, where additional investment is warranted and how effectively we are translating commercial spending into sustained customer demand. Taken together, these indicators will provide a comprehensive view of adoption, customer behavior and the efficiency of our commercial model.

For 2026, our objective is disciplined execution and commercial validation. We're establishing the performance benchmarks, customer relationships and repeatable processes needed to support stronger and more efficient growth in 2027 and beyond.

I'd now like to highlight several of our other programs where we have made important progress recently. Ovaprene, our investigational hormone-free monthly intravaginal contraceptive continues to advance through its pivotal Phase III study. During the quarter, we reported positive interim results and the independent Data Safety Monitoring Board recommended that the study continue without modification.

We expect to enroll sufficient subjects in 2026 to achieve at least 2,500 menstrual cycles of exposure in 2027, supporting a top line data announcement in 2027. We expect to complete enrollment with between 450 to 500 participants, for less than 250 completers, which was the original FDA requested target.

In August of 2026 this year, the FDA approved our proposed protocol amendment to remove the expectation of 250 completers. While in its approval, FDA continued to strongly recommend a minimum of 250 completers and expressed belief that it may be necessary to adequately characterize the safety of Ovaprene.

Based on the interim safety data reviewed by the DSMB, including the absence of new types of adverse events or increased frequency of adverse events with prolonged use and the study's expected achievement of at least 2,500 menstrual cycles of exposure, we believe the amended protocol will generate sufficient safety data to support a premarket approval submission. We plan to continue to engage with the FDA on this point. With no FDA-approved monthly hormone-free intravaginal contraceptive currently available, Ovaprene has the potential to offer women an important new option in a category where meaningful innovation remains limited.

We also initiated a Phase II study of DARE-HPV, and that's expected to enroll approximately 100 women with persistent, high-risk HPV infection, with top line results expected in 2027. The Phase II study is supported by a contract funded by ARPA-H. During the quarter, in addition to the funding under the contract through ARPA-H, we also received a funding award notice for a second $1 million tranche from the NIAID, bringing the total funding across the project period that began in December 2024 to $2 million.

DARE to RECLAIM estradiol progesterone intravaginal ring represents another important opportunity. Activities to support commercial availability through 503B compounding pathway are underway with dispensing targeted to begin in 2027.

Turning to our earlier-stage pipeline, these programs extend across contraception, pelvic pain, preterm birth, and other areas where women continue to face significant unmet needs, and represent multiple opportunities to expand our commercial portfolio and create value over time.

Importantly, we're advancing many of these programs through collaborations and nondilutive funding. Our NIH and Gates Foundation funding contracts as well as relationships with organizations, including Theramex, the University of Copenhagen and Australia's Research and Development Incentive program, allowed us to access external expertise and capital while maintaining a disciplined approach to investment.

I'd now like to hand the call back over to MarDee for a financial update.

Thank you, Sabrina.

We ended the quarter with approximately $12.6 million in cash and cash equivalents as of June 30, 2026, and a working capital deficit of approximately $0.2 million. Our working capital is calculated as current assets less current liabilities, which included a deferred grant funding liability of approximately $15 million.

Total revenue for the second quarter was approximately $0.2 million compared with approximately negative $21,000 in the same period last year. As you recall from last year, we had an accounting adjustment related to XACIATO royalties. Revenue for the second quarter of 2026 consisted solely of research and development services and royalty revenue. Because Flora Sync LF5 sales began in July, our second quarter results do not include revenue from that product.

Selling, general and administrative expenses were approximately $2.6 million compared with approximately $2.4 million in the second quarter of 2025. The increase primarily reflects a noncash write-down of previously deferred offering costs, along with investments in personnel and commercial readiness activities supporting our expanded business strategy. These increases were partially offset by lower professional services and stock-based compensation expenses.

Research and development expense decreased to approximately $0.2 million from approximately $1.4 million in the prior year period. The decrease reflects significant contra-R&D expense associated with nondilutive funding that offset direct program costs as well as lower spending across several programs. This demonstrates the value of our nondilutive funding strategy and our continued focus on disciplined capital allocation.

Net loss for the quarter improved to approximately $3 million compared with a loss of approximately $4 million in the prior year period.

Looking ahead, we began recording revenue from Flora Sync LF5 sales in July and expect to begin recording revenue from DARE to PLAY Sildenafil Cream in the third quarter. With revenue from DARE to RECLAIM Estradiol Progesterone IVR targeted to begin in 2027. We are building toward a diversified, multiproduct revenue profile across 2026 and 2027.

As always, I encourage investors to review our quarterly report on Form 10-Q filed today with the SEC for a more detailed discussion of our financial results, liquidity and capital resources and risk factors.

Back to you, Sabrina.

Thank you, MarDee.

Dare is entering an important new phase in its evolution with commercial execution underway and multiple opportunities to create value across the portfolio. We now have our first directly commercialized product on the market. And DARE to PLAY Sildenafil Cream is approaching prescription dispensing and a commercial platform designed to support the products that follow. This is the foundation of a scalable multiproduct business focused exclusively on addressing significant unmet needs in women's health.

And at the same time, our development pipeline continues to advance. Together with our earlier-stage programs, these assets provide multiple clinical, regulatory and commercial milestones ahead. By combining focused commercial investment and strategic collaborations and meaningful nondilutive funding, we can continue advancing a broad portfolio while directing resources towards the programs and activities with the greatest potential to create value.

And what makes this moment different is that the pieces are now coming together. We believe this positions Dare to build commercial momentum, reach more women with differentiated solutions and create meaningful, long-term value for patients and shareholders.

I will now turn the call back to the operator for any questions.

[Operator Instructions] And we will take our first question from Douglas Tsao from H.C. Wainwright.

Can you hear me?

Yes.

Congrats on the progress. I guess just maybe as a starting point, I think it'd be helpful to sort of hear your thoughts on sort of the near-term commercial portfolio. So I mean Flora Sync and DARE to PLAY as well as DARE to RECLAIM, because in a lot of ways, when I think about these products, they sort of have very different profiles from an end user and perhaps somewhat have different needs from a sort of promotion standpoint.

And I just -- I'm curious how you sort of think about pulling those together. And do you sort of anticipate building a Dare brand? Or do you think that these products should have their own brand that sort of stands on their own.

Well, on the one hand, they definitely are different, right? Like, Flora Sync LF5 is a nonprescription probiotic. DARE to PLAY Sildenafil Cream is an arousal cream and it's a prescription. And DARE to RECLAIM estradiol and progesterone intravaginal ring is specifically for menopause hormone therapy.

So on the one hand, yes, there may be overlap between the women using the products. And in some cases, they may be distinct users. But what all of the products have in common is that they're all based on clinical evidence. They're all based on credible science. And they're all products that can be very easily understood and talked about and kind of digested by both women directly, but also healthcare providers. And that's really distinct.

And so to your question about the Dare brand, we do think the Dare brand is very important because, to our knowledge, we remain the only biotech company working broadly and solely across women's health therapeutics to bring solutions like this to market. So we have a very, very strong, incredible brand with the healthcare provider community, and we are really leveraging that brand to the consumer community as well.

And so we do think it's really important. And in fact, that's why all the products have DARE, right, which is our ticker symbol, have DARE in the name, and we love that kind of play on words and that opportunity to brand in that way.

So in terms of, therefore, the strategy, and I talked about this a little bit in the remarks, it really allows us to build awareness through a very focused and measurable approach, right, that prioritizes whatever channels are most efficient for these consumer campaigns as well as really focusing on the healthcare provider engagement. And that is, I think, something unique that we can do given the credible science behind our products and then making sure that across the portfolio, we're really targeting digital marketing and patient education and leveraging the DARE Health Hub as that one central commercial platform for that so that we can make sure that we're reaching women that are actively seeking solutions.

And it allows us also to kind of look at the different channels and allocate capital accordingly. And I think the approach is really working. What we've seen with DARE to PLAY Sildenafil cream, even though it's not dispensing yet, is that, as I mentioned, there's a really nice healthy mix between prescriptions coming in from providers, right, that are writing those prescriptions for patients that they're seeing either in their offices or through their dedicated telehealth practices.

But then we're also seeing a really nice mix of women that are going through the telehealth option that we provide on the DARE Health Hub. And so that really means that we're reaching women kind of where they're seeking their information, right? If they're getting their information and they're looking for solutions online and directly, they're likely going to be using our telehealth option on the DARE Health Hub or if they already have maybe a trusted healthcare provider resource, it's great to see that those providers are writing as well.

So I know that was a long answer to your question, but hopefully, that gives you some sense that there really is a through line between the products and that through line is that credible science, and that's the Dare brand, and we really think that that brand is so important and is really one of the big differentiators for us as a company and, importantly, our products for women.

And Sabrina, do you think that that brand is going to resonate more with clinicians? Or do you ultimately see that as a brand that you would like to have resonate with patients?

Yes, really with both. Really with both. And so we have those established relationships across the women's healthcare community. So obviously, that's been a place we've been able to lean into right away. And then we've been using those relationships, obviously, to educate providers and have them educate each other. And they're definitely a trusted source for women, but we can also leverage those same relationships through those influencer providers, right, trusted sources of information online so that we can build our brand directly with women.

And obviously, the providers know us today already, and we're building that brand with women through a lot of these initiatives that are going live right now that we talked about.

Okay. That's very helpful. And if I can, just one more question on DARE to RECLAIM, because I think that that's a product opportunity that's not that far away, but has a lot of tailwinds going forward, in particular, some of the regulatory action in terms of removing sort of warnings around hormone replacement therapy. And obviously, there are a lot of -- millions of scripts written for hormone replacement therapy every year. How do you sort of think about converting them from sort of often compounded products, oral products, et cetera, to DARE to RECLAIM?

I love talking about this product, and I know I didn't talk about it so much in the opening remarks because they're obviously so focused on what's happening today. But as you mentioned, this is something we're targeting to have on market in 2027.

And I think the best way to describe how we're thinking about it and how the healthcare provider community is thinking about it is I just had a call a little bit ago with one of the clinicians that was very instrumental and has been very much seen in all the press and talk about removing the black box warning from the hormone therapy products. And she just -- she can't wait for DARE to RECLAIM to be available, because as she keeps reminding me, they just don't have anything like this available today with the clinical evidence that we're generating the pharmacokinetic levels of both estradiol for basically what is going to resolve the symptoms and the progesterone, which is there for endometrial safety, that have been demonstrated through pharmacokinetics to be at the levels that are needed, and in a non-oral form and that's clinically studied.

And so -- and she keeps highlighting, my gosh, can't you go faster? There's a shortage of patches and we're cobbling together these care solutions for our patients, patches for the estrogen and some other dosing regimen for the progesterone, and it's cumbersome and it's clunky.

So yes, we are super excited. And I think, again, this is one where the product is going to do the work. The product has already done the work to demonstrate the pharmacokinetics, to demonstrate the data. The product has been responsive to what the Menopause Society and the medical community have been asking for.

And so we definitely think this is one where the product is going to do the heavy lift in terms of moving patients, moving women from something that is not as easy to use, that is not as convenient and does not follow the recommendations of the Menopause Society in such a clear way to a product that does. So just fasten up on this one.

We have reached the end of the Q&A Session. I will now turn the call back over to Sabrina Martucci Johnson for closing remarks.

Great. Well, thank you so much. And as we close, I really want to take another moment to share how excited we are here at Dare. We've worked for years to develop solutions that address meaningful gaps in women's health, and it is incredibly rewarding to see that work reaching women while our broader portfolio continues to advance.

We believe this is the beginning of an important new chapter for Dare, and we look forward to sharing our continued progress with you.

The meeting has now concluded. Thank you all for joining this conference, and you may now disconnect.

Okay. We are ready to get started. Welcome, and thank you for joining us for the Daré Bioscience's Virtual Bus Tour. My name is Jenene Thomas. I am CEO of JTC IR, and I will be the moderator for today's event. So we are excited to continue the virtual bus tour series with the Midwest stop. And for the format today, Sabrina Martucci Johnson, she is President and Chief Executive Officer of Daré Bioscience, will take you through the Daré story. I will then open the event up for a Q&A and take your questions.

So now it is my pleasure to turn it over to Sabrina.

Great. Thank you so much, and thank you for all of those of you tuning in today. So before I get started, I definitely wanted to highlight that the presentation will contain forward-looking statements and risk factors about our business. So please do refer to our SEC filing for a full overview of the risks and uncertainties associated with our business.

So for those of you who know us well, you may know that we're focused solely on advancing health for conditions that affect women. And it's a great time to really tune in and get to know us better because 2026 and 2027 are really 2 exciting years for us. So our portfolio is built solely on closing those therapeutic gaps in care using science that serves her needs. And in 2026, as you'll hear, we have 2 products that are commercializing for women. So we're going to talk about those. As well as in 2027, we have 2 products that are going to have really important data readouts. And what you'll see as we go through the portfolio is across the portfolio, whether it's our commercial products, which we strive to make available via all paths that we can leverage to make sure that we're getting these evidence-based solutions in the hands of women. So whether we're talking about our commercial products or we're talking about development stage candidates, what everything has in common is that clinical and evidence basis to the solutions.

The other thing you'll see as I highlight the portfolio and our achievements and what we're doing on the research side is how we leverage grant funding to advance programs in our portfolio. Daré's portfolio is not built around a specific life stage or a specific product. Specifically, we're looking to, again, fill those therapeutic gaps in care wherever they may exist. So from contraception through to menopause, sexual health to fertility and infectious disease, we're closing those critical gaps in care using that science that serves her needs. And as I go through the talk today, I'm really going to focus on 6 of our programs.

And these are programs that I'm going to highlight because they are the programs that are commercializing like Flora Sync LF5 and DARE to PLAY Sildenafil Cream or there are programs that have clinical data readouts like our DARE-HPV program and our Ovaprene contraceptive program or like our estradiol progesterone 28-day vaginal ring, it's something that we're looking to commercialize next year or like our DARE-PTB1 program, it's something that we're looking to get into a Phase I study supported by grant funding.

But before I go into the portfolio in more detail, I really want to take a minute to talk about why women's health and why now. We really love working in this category for a few important reasons apart from the important mission of our work. But from a value perspective, what we like about this category is really 3 important pillars that make it so exceptional. One is despite the disproportionate lack of funding that has gone into women's health, where women's health only receives 1 to 5% of private health care investment, if you look at products that actually generate over $500 million in annual revenue, 27% of those are in women's health. So it's been a disproportionately accretive category from that perspective.

Second, women's health is interesting because so many of the areas where there are therapeutic gaps are not really diseases in a traditional sense, but these are things that women are likely to experience throughout their lifespan, whether it's thinking about contraception, going through a pregnancy or fertility, going through menopause, sexual health that can be impacted by hormonal shifts and life shifts. So that makes it really compelling with those large categories that everyone is affected. And then also because there hasn't been as much investment in the category over the years and women weren't even required to be included in clinical research until 1993, there are a number of conditions that are quite serious that don't have any pharmacological pharmaceutical solution. So think about high-risk HPV infection. It's the virus that causes cervical cancer. 6 million women acquire that infection every single year, and yet there's no FDA-approved product to treat that infection.

And then the third thing that we find so compelling about this category from a development and investment perspective is the amount of grant funding that's available. And we've really leveraged that across our portfolio and from different types of grant makers, whether it's the Gates Foundation or government agencies like ARPA-H or NIH across our portfolio, including our late-stage programs, we've really leveraged that grant funding to advance our portfolio.

And another highlight before I really get into the products is the white space we're filling. There's a lot of conversations happening about women's health, and that is fantastic. But the medicine is not keeping up with the conversation. And many of the options that are available to women today are just not built on science, right? They're marketing language versus actual trials. And so what really distinguishes our products and us as a company is that it's a portfolio built on science. So all of our products go through clinical development. Our proprietary products are protected in terms of novel formulations and development and delivery technologies. And then we're making sure that women have access to them wherever they're getting their care and wherever they're seeking solutions. So whether they're going to a brick-and-mortar health care provider, they're participating in telehealth, they're searching for products online, we want to make sure that our products are directly available to them wherever they are.

So let me dive right into that purpose-built portfolio. So first of all, I want to talk about Flora Sync LF5 because this is live and on the market now. This is a vaginal probiotic. So we might be -- have heard of probiotics in the context of gut health, and the gut microbiome, but the vagina has a microbiome as well, and it can be very easily disrupted from antibiotics, whether activities we participate hormonal shifts. So a lot of things can disrupt that vaginal microbiome. And when a microbiome in the vaginal environment is disrupted, it can lead to things that women experience and will notice in terms of changes and changes in discharge, changes in odor, changes in comfort.

And so a probiotic can really assist with that. The vast majority of the probiotics that are available today for women are gut strains for the stomach that are delivered orally. So those are not really optimized or delivered to the vaginal environment, and that's where Flora Sync LF5 really shines. This is a probiotic that was specifically developed a strain from women, their vaginal microbiome who have never experienced a yeast infection, and it's been clinically studied and backed by over 30 years of research. And in a 100-person clinical study demonstrated that 96% of women achieved that vaginal microbiome balance within just 3 days of onetime use each day of the product at bedtime and 90% maintain that balance 2 weeks out. So it's available now on the DARE Health Hub. It's $49 for the box and the box comes with 2 courses. And that's really purposeful.

This is something that we think women can incorporate into their vaginal wellness routine and really start to think about a vaginal wellness routine. It's available right now exclusively on the DARE Health Hub, but we are actively looking at some other channels, including clinician offices as well as other retail channels for the product. So more on that to follow.

DARE to PLAY Sildenafil Cream is a prescription product that is a first-of-its-kind arousal cream for women. It has been demonstrated to increase genital blood flow within just 10 to 15 minutes of application and to improve arousal sensations and that's been demonstrated using clinically validated and FDA reviewed endpoints. There's really nothing else out there that's available on the market today that has been clinically studied and designed specifically to do this for women. We're making it available as a 503B compounded product. And what that means is it's manufactured at a 503B facility. It's not yet FDA approved, but it's manufactured at a 503B facility that does register with the FDA is, subject to FDA inspection and is required to manufacture the product under the same quality manufacturing standards called good manufacturing practices that pharmaceutical products are required to be manufactured to. And they are looking to make this product available later this quarter and start dispensing.

And I say start dispensing because prescribers are already writing prescriptions and women are already going through telehealth so that their prescriptions are in the queue so that as this product start dispensing, they can be the first to get this product, this first of its kind arousal cream for women. And -- it's available. It comes in a tube. The tube is $99, and it has 10 doses in the tube. And it's just used on-demand per sexual event by women. So we're very excited to make this available this year.

And I want to talk about something that really distinguishes Daré in terms of how we can leverage our commercialization strategy for these products because we're leveraging the clinical relationships that we built through product development. There are not many companies innovating therapeutic prescription products in the women's health space, unfortunately. And so Daré has really stood out in that regard in our clinical development over the last 10 years, and we're really able to translate those clinical relationships into now really a commercial advantage because those providers provide peer-to-peer education about our product, they become prescribers for our product. And as our portfolio continues to expand, it's even more opportunities for us to have that kind of level of provider engagement because these products really speak for themselves.

And in terms, though, as we think about getting our products to market in that really unified women's health ecosystem, it takes those provider relationships that are so critical. But as I mentioned upfront, we want to make sure that wherever she's getting her information or her care, she's going to have access to our products. So in addition to health care providers that have clinical practices in office, it's also really important that we're working with health care providers with a telehealth infrastructure, right, that has national reach and those prescribers can become very important in terms of integrating new products like these into their recommendations and prescribing habits for the women that they serve.

We also want to make sure that we're really leaning into a digital native strategy. So a lot of people are getting their information online. And there's an opportunity for products like this that are clinically and evidence-backed solutions for us to work with really health care provider influencers. So think about influencers, but think about influencers that are clinicians that are health care providers that are institutions that put out information for consumers like the Menopause Foundation. Those kind of organizations are great for us to really leverage as we work to get the word out about our products because they're trusted sources of information and they're looking for trusted products that they can talk about for their -- for the people that follow them as well.

And then in terms of where people can get the products, it's really important that we have a central patient destination that is designed for them and for fulfillment there. So that's our DARE Health Hub, and it's really our central commercial platform. So we work with Medvantx Pharmacy. They really support all the logistics on the back end. And on the DARE Health Hub, women can get access to our prescription products as well as our nonprescription product. So DARE to PLAY Sildenafil Cream and our Flora Sync LF5, they can link to get more information about the products. If they don't have a prescription, they can access telehealth that is serviced through Medvantx and it allows them to also get information across our products. And then on the back end, it's where prescribers can submit their prescriptions. Medvantx is a central mail order pharmacy. They show up in most electronic medical record systems automatically. So it's really seamless. So for both the provider experience and the consumer's experience.

I want to now highlight a few things that I mentioned upfront from the development time line. So the first is Ovaprene. So Ovaprene is a first-in-category non-hormonal vaginal contraceptive. It is a once-a-month nonhormonal contraceptive. There's really nothing like it available today in the contraceptive category. The closest product that has existed to something with a form factor like Ovaprene, that once-a-month form factor vaginal is NuvaRing, which is a hormonal product. But when it was still branded, it peaked at almost $1 billion in annual revenue. So Ovaprene was really designed to similarly be a once-a-month vaginal product, but to work without hormone. So it has a physical barrier and a chemical that it releases, which is a spermiostatic agent. It's in its pivotal Phase III registration study. So this is a study that would be used to submit to the FDA.

So far, it is performing exactly as predicted. We've had 2 now positive independent data safety monitoring Board meetings, one last summer and one this summer. And in both cases, the typical use effectiveness based on the pregnancy rates being seen is continuing to perform in the projected range with 86% to 91%. The adverse event profile has been very consistent throughout the trial as well. And as I mentioned, it has the potential to be the first FDA-approved product of its kind. So right now, based on where we are, we're expecting to complete enrollment to achieve our target of 2,500 cycles of data to evaluate. We expect to complete that enrollment this year and to have those data available and a top line data readout in 2027 for this product.

The other development stage product I want to talk about is DARE-HPV, which is our product that's designed to treat human papillomavirus infection. So human papillomavirus infection is the virus that causes cervical cancer. And despite the fact that we know the virus that causes cervical cancer, there are no FDA-approved products to treat that infection when a woman tests positive. Instead, she's told to just wait until that infection can lead to cervical lesions or precancerous lesions or even cancerous lesions, which then have to be surgically removed from the cervix.

And so DARE-HPV is really designed to be taken right when she has that persistent high-risk infection instead of waiting for her to get those precancerous lesions. So it's in a Phase II trial right now. That trial is funded by ARPA-H through a contract grant funding mechanism we have from ARPA-H. And we expect to have top line data from this trial in 2027 as well.

And then in terms of what's coming down the pipe mix in terms of prescription products on the commercial side is we're working to do the same thing with our DARE to RECLAIM hormone therapy intravaginal ring as we've done with DARE to PLAY Sildenafil Cream, which is make it available as a 503B compounded product while we continue activities that would continue to work to advance it through an NDA pathway. And so we're targeting to have this once-a-month hormone therapy product available for commercialization late next year. Menopause is definitely having a moment. There's more conversation about menopause. But unfortunately, for women, there is still no product available to be prescribed today that is clinically studied and actually follows the Menopause Society guidelines for menopause hormone therapy, which is if it's a woman with the uterus, both progesterone and estradiol together in one product that is nonoral.

And that is exactly what our estradiol progesterone intravaginal ring once-a-month product is designed to do. So looking forward to keeping you updated on that. We're actively looking at activities to also support nonhormonal products for menopause and specifically the genitourinary syndrome of menopause, which can lead to sexual pain and discomfort. This is a really important side effect that women going through a breast cancer -- hormone receptor-positive breast cancer therapeutic regimen may experience and yet hormonal products are often not recommended for them. So this is a non-hormonal solution that the FDA has cleared for us to start preparations for Phase II.

And then the last one I wanted to highlight is our vaginal ring technology with progesterone only. So same kind of technology as we talked about for the hormone therapy product, but progesterone only for IVF support as well as investigational product for preterm birth. So those are places where progesterone injections or other vaginal forms of progesterone are often used. And this is a very convenient vaginal ring that can release progesterone over several days. And we do have support from the NIH to start a Phase I trial with this product. So we're in preparations for that. So more on that to follow.

We have an extensive preclinical pipeline, most of it is supported by grants and outside funding, similar first-in-category opportunities that as they advance, we look forward to keeping you updated on. A couple of highlights from a financial perspective. Our last reported cash balance was $18.5 million. The management team at Daré is highly experienced. They are people that come from both experienced -- we have a team that's experienced both on the clinical development side as well as the commercialization side and women's health specialists as well as general pharmaceutical specialists, which are important in the development -- kind of development programs that we have.

And then I want to end with a couple of slides just really highlighting the near-term catalysts and why Daré, why now. So in terms of things to watch for in the coming months and year, first of all, obviously, there's 2 commercial products that are going live this year, DARE to PLAY Sildenafil Cream for arousal and our DARE to RESTORE Flora Sync LF5, vaginal probiotic, which is available now. Both of those are available on the DARE Health Hub that you can get to by just going to our website, darebioscience.com. And then we've got the Ovaprene non-hormonal contraceptive clinical readout and the DARE-HPV clinical readout next year. And then we're working to get that menopause hormone therapy vaginal ring commercialized as a 503B compounded product next year as well. So stay tuned for that.

And I'll just end on why Daré why now? I started the talk today really highlighting it's a great time to get to know us. This is 10 years in the building, getting to this point now where we are going to be commercializing 2 products directly, one prescription, one not, really looking at all the best ways to get products in the hands of women as quickly as we can. We've got that late-stage pipeline advancing with that nondilutive funding with those clinical readouts next year that are also so important. And then all of it is backed with this really scalable commercial platform in place through our DARE Health Hub and the infrastructure we're building both internally and with our telehealth partnerships to support scalable growth.

So with that, I will open it up for questions, and thank you again for listening in today.

Great. Thank you. So to our audience, if you have a question for Sabrina, the Q&A button at the bottom of your screen and type in your question. So we already have people that are familiar with this process. So we have some questions in queue already, Sabrina.

Okay.

All right. So can you provide an update on the NASDAQ delisting process and whether we should expect any positive development or clarity on retaining the listing?

Sure, absolutely. I mean, obviously, this is important to us, and it's something that we focus on. So the way the process works is basically we were able to request a hearing in late July. The panel, NASDAQ grants those hearings within 30 to 45 days from the request date. At the hearing, we really go in and present our plan for compliance, which is obviously very important to us. And so we present that plan for compliance. And then typically, the panel takes about 30 days to respond to that plan that we put forward. So we are in preparations for that. We work with strategic advisers to help us prepare for that. It's something very important, and we're remaining focused on that. And obviously, all the things we're doing in terms of the products that are launching, all of that, our clinical data, that all becomes a very important part of the narrative that we share with the panels for our compliance strategy and plan as well.

Okay. Our next question, it feels like you have a unique commercialization approach. Can you describe the rationale further and also discuss how your commercial team is comprised?

Yes. So in terms of the rationale for the commercial strategy, so a few of us on the team have backgrounds in pharmaceutical launches historically, myself included. I spent the first part of my professional career on the commercial side. And as we think about kind of where the world has shifted and where we are today, we really saw an opportunity to lean into where people are getting their care, where they're getting their information and how they want to access their products and how they want to pay for their products. And we've seen with telehealth, right, the rise of telehealth, the rise of mail order pharmacies even before telehealth was a thing.

The -- I would say the larger proportion of people that are really interested in cash pay for products so that as long as they're reasonably priced and that they don't have sometimes the complexity and the burden of the prior authorizations and the insurance that they're going through, there are just a lot of things that have shifted. And also, as I mentioned upfront, kind of where are the trusted sources of information. Health care providers are important in terms of those actual office visits. But the other really trusted source of information about products is health care providers that have that digital platform online, right, whether it's a podcast or again, Instagram, Facebook, whatever they're doing, TikTok.

And so we really wanted to lean into that. I mean that's where women are getting the information. That's where women are getting their products. And because we have products that are actually backed in with science and clinical evidence, it opens up all of those channels to us. We don't have to rely on advertising, advertising, advertising and spending that way to get a consumer to try something that doesn't have any data behind it because we can't go to a health care provider, right? We can actually go to those trusted channels. And so that's really what's behind our strategy, and we think it's a more cost-effective strategy that we can leverage. And so we have internal staff. We don't have like the traditional big pharmaceutical sales organization.

Again, we're just believers that, that's not required anymore. Times have changed. We obviously do have professionals who can obviously interact with and really be a partner to the health care provider community to make sure they have the information they need that can partner and enter into relationships and partnerships with telehealth platforms or other organizations that we're going to platform -- that we're going to partner with and then also who support us in our outreach and our implementation of our digital strategy, which is really leaning into, again, podcast, professional influencers. And when I say professional influencers, I mean like health care providers, clinicians, et cetera, who are influencers.

Got it. And we do have a couple of questions that are financial related. I know that you have not reported your second quarter results. So I think maybe we hold on.

Yes. So stay tuned.

I just wanted to make sure that we were aligned there. I know to have another conversation when they haven't been reported.

Yes, yes.

Okay. The next question is, what portion of development spending is expected to be covered by grants or partners rather than Daré's cash?

Yes. So we're really right now prioritizing our development programs that are either 100% grant funded or very significantly grant funded. Those are the programs that we're really prioritizing now from a development perspective because then that requires minimal contribution on our part or not as material of contribution on our part to support those programs. And so strategically, that's what we're doing. So right now, it's really -- it's Ovaprene, which is in Phase III, which is -- we historically had a collaborative research agreement with NIH and then more recently had funding also come through from the Gates Foundation. So we have had some contribution historically to that program. We'll have a little more budgeted to get through the end of the trial as well, but it's very, very heavily grant supported, as you can tell from the financials.

The DARE-HPV program, which is 100% supported by both the grant from ARPA-H as well as NIH. So that's completely grant funded. The DARE-HRT1 program, which is preclinical, which is completely grant funded. We have another nonhormonal contraceptive development program, which is completely grant funded. Our Casea S implantable contraceptive is 100% grant funded and is going through Phase I right now. And then we're looking to get our DARE-PTB1, which is our progesterone vaginal ring into Phase I, and that's funded with a grant from the NIH. So those are really the development programs that we're focusing on because they either have 100% or very, very significant grant funding to support them. So that our contribution is not significant.

Next question. Does MyMenopauseRx direct eligible patients back to Daré? Or does it prescribe, fulfill and ship directly to the patient?

Yes, great question. So it's a great example of the kind of relationships that we're really prioritizing with those kind of digital health platforms, which is they prescribe the product, right? And that -- which is what they do best. They prescribe products for their patients. And when they prescribe it, they can access it right through their electronic medical record system. It goes right to the Medvantx pharmacy that we work with and then that fulfillment can be handled centrally. So it's just a super efficient channel. It leverages the logistics, the pharmacy, fulfillment, which, by the way, includes all the things we're also used to having, right? The pharmacy texting us when our prescription is ready, when it's coming, when is it time for refill, right?

So it gets to leverage all that back end that we've built through Medvantx, but they are educated about our products and know about our product and know how to prescribe it, so they're ready for their patients. But it's so helpful for us to have that relationship with a trusted and truly specialist in women's health so that when patients come to women come to our platform and are looking for not just the asynchronous telehealth visit, which we offer, which is great. Like if you know you want DARE to PLAY and you are ready and you want your prescription, it's fantastic. It's a 10-minute asynchronous questionnaire.

But sometimes, we want more than that, right? We want -- we want to talk about other things. We want to have an interaction with health care provider. It's so hard to find a health care provider that is truly expert in, in this case, menopause care, but also is not like peddling a bunch of products that they made themselves, right, that is going to provide clinically backed solutions. So those are the kind of relationships that we love and want to enter into more. It's a win-win.

Perfect. Our next question, what is revenue guidance for the current year and next year?

Yes. We haven't provided any guidance yet. But what I will say because it's early, right? We're in early days of the Flora Sync LF5 launch and DARE to PLAY Sildenafil Cream hasn't dispensed yet. But what I can talk about are what are some of those key performance indicators that we're going to be looking for? What are we watching in the launches, right? So when I think about either Flora Sync LF5, which is nonprescription or DARE to PLAY Sildenafil Cream, what we're going to be watching for from the consumer perspective is where did she come from, right? How did she get to that product, right? So we'll be watching to understand that, where did she come from? And then what is her use behavior, right? How often does she use the product? How often does she reorder, right, so that we can understand the average kind of woman perspective and based on where she comes from, how are she using the product, how is she incorporating those into her routine.

From the provider perspective, we're going to be looking for are they stocking the products, right? And if they're stocking the products, are they dispensing more frequently than maybe someone that's not stocking the product. So those different behaviors, what are the repeat prescribing behaviors at a prescriber. We want breadth of prescribers, but we want depth, right? We want to see that a product has been integrated into their clinical practice, so they're writing repeat prescriptions. That's super important. So those are the kind of things that we're going to be looking for in the early days of launch. And all of that really feeds into us being able to understand customer acquisition costs and what are our most effective channels so that those could be the ones that we're reinvesting in.

Perfect. I have a question. You had talked about your different approaches using the social channels in really innovative ways and trusted ways of really doing your marketing. So being science-based and having real solutions for women. Do influencers come to you? Do the telehealth providers come to you to...

Yes.

Yes, I would imagine they would because there's not a lot of credible sources for solutions for women out there that are science-backed that have the standards that you apply to your products.

Yes. Thank you for highlighting that. They absolutely do. It goes both ways. There are people that we seek out, right, because we want to make sure they know about what we're doing and what a fit we may be for what they're doing, and we want to make sure they have the information they need. And then also, right, there are people that reach out to us and say, we'd love for you to be on this podcast or we'd love to -- can you provide us just some materials so that we have nice images and right things to share on our platforms because we really want to make sure we get content out about this.

So it goes both ways. And that is one of the things that I think is distinct here, right? We're not having to rely on having to buy our way all -- 100% buy our way into the consumers' mind, right? There's part of that. You need to build awareness, right? But we're able to do that through earned right, earned channels because of the work that we've done.

Great. Our next question, what is the expected time line for completing enrollment in the Ovaprene Phase III study and reporting top line results?

Yes. So we're targeting to complete enrollment this year. We're already in August. So there's not a ton left in this year, but this year. So we are targeting to complete enrollment this year. We haven't given -- we're watching the numbers. So what we're really working towards is getting to a number of women where we feel very confident that we will have ultimately 2,500 safety cycles when the trial -- when we end up completing enrollment. So that is what we are looking for. And so we had shy of 2,000 cycles when we did the interim Data Safety Monitoring Board meeting back in May, so not too long ago this year. So that's the number.

So we expect to complete it this year. We haven't said specifically when. And then remember, we follow women for up to 13 cycles. We don't have to follow them all the way through 13 cycles, and they don't all make it to 13 cycles, but up to 13 cycles. So that's why we said top line data will be 2027 by the time we get there.

Great. A lot of questions from your Midwest attendees here. Another question is, do you expect additional telehealth partnerships?

Yes. So we're talking to a number of organizations. Some are going to be ones that we're really going to highlight on our website because they rise to the level where we want to make sure they're on our website and easily kind of linked to. And that doesn't mean that if they're not on our website, they aren't as good. It's just sometimes that just makes more sense than others depending on the situation.

And sometimes they may not be, but there are organizations that we've done all the right. They're a telehealth platform where we've done all the training with their health care providers, which is a really important step to just make sure they are aware of the products, they incorporate them into their practice guidelines and behaviors and they know they have us in the system for prescribing. So sometimes you'll see them as formal things we announce and sometimes you won't, but they're behind prescriptions that are coming in.

Correct. Okay. Our next question, what are the current priorities and mandates of your commercial organization?

At this point in the launch, it's really around awareness, product like trials writing, right, getting those use experiences and breadth of that, right? So making sure that people are -- that should be aware of the product or aware of the product, making sure they have all the information they need to prescribe the product, if it's to prescribe or share it with their patients, if it's like Flora Sync LF5 and then making sure that, again, the channels that we should be pursuing that we have all of the procedures and materials and processes in place to support them. So whether that's stocking in clinician offices, whether that's retail channels that we're looking at for Flora Sync LF5, those are the priorities right now.

Okay. I have one last question here. What early indicators should we watch to judge whether your consumer commercial strategy is gaining traction?

Yes, it's really going to be all those things I've talked about. So specifically, I'll talk about Flora Sync LF5 and I'll talk about DARE to PLAY because they're a little bit different. With Flora Sync LF5, it's really around we're looking at just orders, magnitude of orders, repeat buying behavior and then also where those are coming from, right, which are our most efficient sort of routes to getting those orders.

On DARE to PLAY, we're going to also be looking at telehealth. So remember, we have telehealth available on the DARE Health Hub, and we have these other telehealth channels. So we are going to be looking at those distinct from what I refer them as brick-and-mortar providers, but like right, providers that you're visiting in an office, somewhere. So we are going to be looking at those metrics very closely because the telehealth metrics are going to be more of an indicator of a little bit more of a direct-to-consumer kind of awareness than the traditional kind of brick-and-mortar health care channel. So those are things we're going to look at specifically the telehealth on the DARE Health Hub because that will be driven solely by consumer awareness.

Excellent. Any closing remarks, Sabrina?

I just -- again, I appreciate the questions today. Fantastic questions and opportunity to share a little bit more about what we're doing and look forward to continuing to provide updates.

Excellent. So with that, this does conclude the Midwest stop on the Daré Bioscience's Virtual Bus Tour. We look forward to seeing at the final stop on the East Coast happening August 26. And with that, this concludes our session, and we wish everyone a great rest of your day.

Awesome. Thanks, everyone.

Thank you.

Hello, and thank you for joining the Daré Bioscience's Virtual Bus Tour. My name is Justin Romanowski, Managing Director of JTC IR, and I'll be the moderator for today's event.

Today, the company will continue its Virtual Bus Tour series with a Southern Stop. And we are joined by Sabrina Martucci Johnson, President and Chief Executive Officer of Daré Bioscience, who will take you through the Daré story. I will then open the event up for Q&A to take your questions.

And with that, Sabrina, I'll turn it over to you to go through the story.

Great. Thank you so much, and thank you, everyone, for tuning in. Obviously, the presentation contains forward-looking statements. So do look at our SEC filings for a full overview of our risk factors, including important risk factors to consider.

We are focused on advancing health for women. And specifically, we're really focused on closing the gap between promising science and real-world solutions for women. I'm going to take you through a few things in our time today that really highlight some of those investment highlights and our business model.

And as you'll see, as I go through the presentation, our portfolio is very much purpose-built. We're focusing on areas where the markets are large and there's clear therapeutic gaps. And as I mentioned upfront, where there's science, that if we pull it forward, can close those therapeutic gaps in care.

I'm going to focus today on highlighting a couple of products that are -- either have just commercialized or about to commercialize this year. So I want to give an overview on those, and also on a few of our highlights in terms of our development portfolio because we do have a couple of data readouts coming next year. So I definitely want to give some perspective on those.

And what you'll see across the portfolio is that we're really focused on bringing forward clinical evidence-based solutions to women using whatever path is the fastest way to get that product in the hands of women.

And so sometimes it's as an FDA-approved product like our already FDA-approved product, XACIATO. Sometimes it's by leveraging 503B compounding and sometimes it's even as a nonprescription product. And you'll see that as we go through the portfolio. And then I'm also going to highlight some of the grant funding that we have received. That nondilutive capital is incredibly helpful as we advance that development portfolio towards commercialization.

As I mentioned upfront, we really focus on closing those therapeutic gaps in care, and we really do that across every stage of life for women. So from contraception through to menopause and everything in between because our focus is, again, where are those therapeutic gaps that science-driven solutions can solve.

I mentioned upfront that I'm going to focus on a few of our programs in our pipeline, and this is to give you a sense, certainly a sense of the breadth of the areas that we cover, but also importantly, the programs that I want to highlight today.

So in the DARE to RESTORE family, we have Flora Sync LF5. It's a vaginal probiotic. It just launched this summer. So I'm going to give some perspective on that. And then we have -- planning to dispense late summer in this third quarter is our DARE to PLAY Sildenafil Cream, a first of its kind arousal cream for women. So I'm definitely going to provide some perspective on both of those products.

I also want to highlight 2 of the products, in particular, that are in development stage. Ovaprene, which is a first-in-category contraceptive product. It's a once-a-month nonhormonal contraceptive. It's in its pivotal Phase III trial right now with the data readout anticipated for next year. So I want to give an overview on that. And DARE-HPV, which is our product to treat the virus that causes cervical cancer, and that's in a Phase II trial right now that's also reading out next year. And both Ovaprene and DARE-HPV are supported with grant funding. So I'm definitely going to highlight those programs as we go through the portfolio.

But before I give any -- go any further, I think it's always helpful to level set on why women's health and why now. And as you'll see, as I talk through some of these points, the market opportunities are significant. There are numerous things that women experience that are diseases in the normal sense of diseases, but they affect a large number of people -- of women, and they are areas where there's big therapeutic gaps that exist today in terms of solving what those women experience as they go through that.

So whether we're talking about contraception or menopause or sexual health, those are great examples of those areas where the markets are very significant in terms of number of people. And there are a lot of gaps in terms of options that are available today that are evidence-backed and clinically studied. And then there are areas like human papillomavirus infection, which causes cervical cancer where 6 million women every single year acquire that high-risk infection and yet there are no therapeutic options whatsoever.

So those are the kind of areas that we really focus on as we think about opportunities in the women's health space.

In addition to the fact that the markets themselves are large, the other thing that we think is really interesting and a value-creating opportunity in this space is the fact that investment in women's health has been highly efficient. So only 1% to 5% of private health care investment dollars go into conditions affecting women, yet 27% of the brands that generate over $500 million in annual revenue are in women's health. Women are very motivated health care consumers. They make 80% of their household health care decisions, and they are definitely focused on their health and well-being.

And then third, the nondilutive funding that is available in the category really creates an opportunity where that funding from leading institutions can help advance the development portfolio in a very capital-efficient manner in terms of minimizing the amount or lessening the amount of equity investment required.

So whether it's from the Gates Foundation or government agencies from ARPA-H to NIH, we really work to leverage the funding that's available. And as you can see, it's across the portfolio. And to date, we've brought in over $75 million in nondilutive funding, and those awards are continuing. We have funding coming in from those awards this year and next as well.

I mentioned right upfront that we really seek to commercialize the products using whatever the most efficient path forward is to market. But regardless of the path we take, what is true across the portfolio is that these are products built on science, clinical evidence, for women, and that's really the white space that we're filling.

There's a lot of conversation right now about women's health, but the medicine has not been keeping up with the conversation in terms of clinically backed evidence-based solution, and that's the void that we're filling by taking products through clinical development, ensuring they're proprietary products, clearly differentiated and then commercializing them in a way that is efficient path to market and efficient path to access for women.

So I'm going to talk first about the commercial products, and then I'm going to talk a little bit about the products that are in development stage and that have some exciting events coming up in the next year.

So first, I'm going to start with Flora Sync LF5. This is a vaginal probiotic. So we talk a lot about our gut health, and I'm sure we've all heard about probiotics that people take for gut health because that's an important microbiome that we're trying to maintain in our gut.

Well, the vaginal environment has its own microbiome. It's distinct from the gut microbiome, obviously. But it's similarly just as important. When that microbiome is disrupted in women, it can put women at a higher risk of infection and also things like preterm birth and infertility. So it's really important to maintain that really healthy vaginal microbiome.

Unfortunately, for women, most of the products that are promoted to women to support the vaginal microbiome are actually oral probiotics that were developed for the gut. The vaginal microbiome is a very different environment and also just, think about it, kind of hard to get there if you're taking something orally.

And so Flora Sync LF5 is really distinct in that it was created from a strain that was isolated from women, their vaginal microbiome, who have never had a yeast infection, and it's delivered to the vaginal microbiome and it's been clinically studied. And in fact, it's been studied for over 30 years. And in a clinical study in women, it was demonstrated that 96% of the women achieved a microbiome balance, that healthy microbiome balance, within just 3 capsules, 3 days in a row -- 1 capsule 3 days in a row and 90% of women maintained that out to 2 weeks.

So we're super excited to have brought this to market commercially. It's available on our DARE Health Hub, which I'm going to talk about in a minute. In terms of the current channel, it's $49 for the box. The box comes with 2 of those 3-day courses. It's really something that we envision women can incorporate into their vaginal wellness routine. So any time they're really noticing that they need to restore that microbiome balance and support that lasting comfort, this is a product for them.

We're targeting also to commercialize this year in the third quarter, our DARE to PLAY Sildenafil Cream. So sildenafil is the same active as in Viagra. And just like men need a product like Viagra sometimes to increase blood flow to the general tissue, women also need blood flow to the genital tissue. That blood flow in women is what leads to pleasurable sensations that women may have. And also, it's part of that lubrication mechanism so that we can support that.

And so DARE to PLAY Sildenafil Cream has that same active ingredient as in Viagra, which is sildenafil, but it's formulated specifically for women. So it's a topical cream that women can use on demand, applied in a similar way as she might apply a lubricant. It's been demonstrated to increase that genital blood flow within just 10 to 15 minutes of application.

And also in a clinical study using clinically validated and FDA-reviewed endpoints, it's demonstrated a clinically meaningful improvement in that physical arousal response and also improvement in desire and orgasm as well. We're really thrilled that we have discovered a way basically to ensure we can get this product into the hands of women and health care providers that have been looking for a clinically studied solution to enhance these arousal sensations in women.

And so specifically, while we are pursuing and working towards ultimately an NDA pathway for this product, we have been able to collaborate with a 503B outsourcing facility, which is a kind of compounding where they can make a product like this available, but where they are required to register with the FDA and follow the FDA manufacturing guidelines for pharmaceutical products and that way, they can make the product available on large scale.

So looking to start dispensing this product, as I mentioned, later in the third quarter. We have, however, started receiving prescriptions. So clinicians are excited to see this being available. So they've started to write prescriptions for their patients and patients are engaging also with the telehealth that we have available. So I'm going to talk about that in a second.

I want to talk about, though, how we can really leverage these clinical relationships into commercial momentum. So to our knowledge, we are one of the only companies, if not the only company, working solely and broadly to develop therapeutic solutions for women's health conditions. And we've been doing that for over 10 years.

And so what that means is we've established relationships with health care providers. And those relationships with health care providers, we can turn that into peer-to-peer communication about products like these that they're seeking and they're interested in and they want to tell their peers about. So those clinical relationships built through the product development, they become a real commercial advantage for us and that we're able to provide that awareness before launch, collaborate with them on those channels and really expand that engagement with them across our portfolio.

But importantly, those provider relationships are one part of what really needs to be that integrated ecosystem that we need to leverage to ensure women have access to a product like this. So we leverage those provider relationships.

Telehealth is also very important. Some women don't have access to what I'll refer to as a brick-and-mortar health care provider. They really need to leverage telehealth and maybe even to get to a specialist in sexual health or vaginal health. And so we do look to collaborate with telehealth providers because that's a fantastic channel for women to have access and for those providers to know about our products.

We really leverage digital marketing. It's a great way for us to focus on getting the products in the hands of the customers and the health care providers where there's a really good connection for these products. So we do that through podcasts and on Instagram and TikTok and collaborating with influencers that are clinical influencers, right? They're very knowledgeable about clinical needs and the products and can communicate about them to their followers.

And then we want to make sure it's seamless for whether it's a health care provider or a woman to get access to these products and make them available. And so we do that all through the DARE Health Hub. It's our central commercial platform. So all of our products that are commercially available will show up there. Right now, it's Flora Sync LF5 and DARE to PLAY is on there now, too, because people can start getting prescriptions.

While we collaborate with third-party telehealth providers, we also have a telehealth access right on our DARE Health Hub. So that is an asynchronous telehealth visit. It's a 10-minute questionnaire. So it's a great way for someone who knows they want access to DARE to PLAY, Sildenafil Cream, which requires a prescription to get access to that very quickly.

And then through that DARE Health Hub, that's where they do their payments. They receive updates on their products, on the shipping status and where they are. They can reorder, refulfill, all of that happens on the DARE Health Hub. And on the back end, that's also where health care providers, through the back-end pharmacy, Medvantx, that supports it, that's where providers can submit prescriptions as well. So it's fully integrated for access.

And now I want to spend a few minutes on the development portfolio and definitely on a couple of those clinical highlights that I mentioned.

So I want to start first with Ovaprene. So this is a first-in-category contraceptive candidate. It's a once-a-month product. It's something a woman inserts vaginally herself and removes herself once a month. It's designed to have both a physical barrier and release a product that is a spermiostatic agent and is completely nonhormonal.

It's in a Phase III trial right now, and this is the pivotal registration study. So this is the study that would ultimately be utilized to support a submission of the FDA. The study has already had 2 Data and Safety Monitoring Board meetings. That's independent experts that review the data specifically from a safety perspective.

One of the things they do look at is pregnancy rates because it is a contraceptive trial. So they want to have an understanding of how many women are experiencing that event. And based on the DSMB meetings to date, like I said, there have been 2 of them so far, the most recent was just in May, the product continues to look like it's performing at around a 91% typical use effectiveness rate, basically, it has a 9% pregnancy rate, which is exactly where the product was expected to be. So that's great in terms of its performance.

And just to give some perspective, the most similar product in the hormonal category is a product called NuvaRing. It's now generic, but when it was not generic, revenues peaked at almost $1 billion in peak annual revenues. And this would be the only once-a-month product in the non-hormonal category. We do expect to complete enrollment this year, and that would put us in a nice position for a top line data readout next year.

The other product that's in active clinical trial right now is our DARE-HPV product. So this is a product to treat high-risk HPV infection. So human papillomavirus is the virus that causes cervical cancer. Despite the fact that we know what virus causes cervical cancer, there's no FDA-approved pharmacologic option for treating that virus today. Instead, there are 6 million women every year who acquire one of these high-risk infections.

And basically, the treatment paradigm is to wait until she has precancerous or cancerous lesion on her cervix and then those have to be surgically removed. And that surgery can lead to preterm birth risk, infertility risk, so certain complications certainly for someone who's still in her childbearing years.

And so we are really striving to advance something that has the potential to be a therapeutic treatment that someone can do when she has that persistent high-risk HPV infection.

We just started our Phase II trial for this in May of this year. The study is funded completely by ARPA-H, which is a government agency, through a $10 million award that we have received. We expect, based on the enrollment rate, that we should complete enrollment next year and have a top line data readout next year as well on this product.

A couple of the other development programs I just want to touch on quickly. One is DARE to RECLAIM, our hormone therapy vaginal ring. So menopause is definitely having a moment because the FDA fairly recently now has removed the black box warning about hormone therapy. And so it's really allowed women to think more broadly about whether hormone therapy can be right for them, which is fantastic.

However, even though we have that important milestone, there is still no clinically studied product available for women that actually delivers both estradiol and progesterone together, which is what women with a uterus need in a nonoral form, which is exactly what The Menopause Society recommends.

And so that's really the gap that DARE to RECLAIM or DARE-HRT1, we call it, is meant to fill. It's a once-a-month vaginal ring that a woman inserts and removes herself once a month, designed to deliver those hormones that women with a uterus need for menopause hormone therapy. And the data to date on the product has been very exciting in terms of not only returning women to the level of hormones that they had premenopause, but importantly, also demonstrating improvement in both the vasomotor symptoms, so hot flashes, night sweats, things like that, but also the vaginal symptoms that they're experiencing.

So similar to what we're doing with DARE to PLAY Sildenafil Cream, the idea with the DARE to RECLAIM product is to strive to make it available as a 503B compounded product. Our target is next year for that, late next year, while in parallel, we continue to work through the NDA pathway.

I want to also highlight a product that's nonhormonal for women where hormones may not be a good option, particularly like breast cancer survivors, where even vaginal hormones are sometimes not something they can contemplate, but vaginal and sexual pain is a really common symptom of their breast cancer therapeutics if they're hormone receptor-positive. So FDA has cleared this product to go into Phase II, and we're working on preparing for that at this time.

And then lastly, I want to highlight our vaginal ring that delivers progesterone. So progesterone is commonly used in injection form, very painful injections to support IVF. It's often also used as part of a potential therapeutic regimen for women who are at risk of preterm birth. This takes those injections and turns them into a ring, so something that she can insert vaginally and is nondaily as an alternative to those. So we have a grant to support this in Phase I from the NIH, and we're preparing for that right now.

And we have a number of earlier-stage programs that I won't talk about today, but similar to everything I've discussed, they're also similarly first-in-category product opportunities and funded primarily with nondilutive funding from the NIH and Gates Foundation.

And then I want to end with a couple of highlights from a corporate perspective. Cash on hand in the last SEC filing was about $18.5 million. Management team, highly experienced, not only in women's health, but therapeutics more broadly in both commercialization and development, which is really important for a company at our stage.

I mentioned all of these throughout our talk today, but I want to end with a couple of highlights in terms of those near-term catalysts. So in orange, you can see our catalysts related to commercialization activities with DARE to PLAY and DARE to RESTORE Flora Sync LF5 this third quarter. And then we got DARE to RECLAIM, which is our menopause product targeted for 2027. And then as I mentioned, we have 2 important clinical events coming up in terms of data readouts next year for both Ovaprene, our contraceptive candidate that's nonhormonal, and DARE-HPV for human papillomavirus infection.

So hopefully, that gave you a great perspective on why Daré and why now. It's definitely a fantastic time to get to know us in terms of really what 10-year evolving has got us to, which is being in a place where we have 2 products commercializing this year, we're in a position for 2 data readouts next year and a third product targeted to commercialize next year. That's on top of the product that we had FDA-approved a few years ago and is already partnered with Organon. So really in an interesting place right now from a commercialization perspective with the pipeline in general.

And then hopefully, you also have a sense that with that development pipeline, particularly with that grant funding that we have there, that nondilutive funding, it really creates a scalable commercial engine of both the commercial infrastructure we have, but also the pipeline to feed it and how we're leveraging that nondilutive funding to achieve that.

So I will stop there and open it up for any questions.

Thank you, Sabrina. Great presentation. [Operator Instructions]

Our first question. For DARE to PLAY, what needs to happen before prescriptions can begin dispensing? And what should investors watch for, for the remainder of 2026?

Yes. Great question. So in terms of before prescriptions can begin dispensing, so as I mentioned upfront, we're working with the 503B outsourcing facility. So what that means is it's a kind of compounding where that facility is actually allowed to make a product like this at large scale, which obviously we want, to meet the demand. And they have to do a few things to be able to do that, both with the FDA and then also at every individual state level.

And so specifically from an FDA perspective, they have to be registered with the FDA. They're subject to FDA inspection, and they have to follow good manufacturing practices. Those are the standards that pharmaceutical products are held to that are not like a pharmacy-compounded product. So that's the standard for pharmaceutical products. And so that does mean that there are certain activities that have to be completed to follow GMP.

And then at the state level, every state into which that 503B outsourcing facility wants to dispense product into, they actually have to register with the board of pharmacies in each of those individual states. And every single state is different.

So in terms of being ready to start dispensing, there are a couple of things that are really important. One, they have to complete all the activities required for GMP manufacturing and manufacturing the product at scale. And then the other thing is we really wanted to see them have a nice critical mass in terms of states in which they're able to start dispensing. We have interest in this product from women across the country and health care providers across the country. So we really wanted to be in a strong place of having them registered and licensed in as many states as possible when prescriptions started going out, so as many women as possible could start accessing them and also for logistics.

So right now, they're in 29 states. So we're getting there in terms of being at that critical point. So that's what we're looking for all of those activities to line up. And the target for that is this third quarter.

And then in terms of what investors should look for, I can tell you what we're looking for from both DARE to PLAY as it starts to commercialize and also Flora Sync. So I'll start with DARE to PLAY first, and then I'll talk a little bit about Flora Sync as well.

So from DARE to PLAY, we really want to see those kind of behaviors that form the foundation for a very successful brand. And what those behaviors are is you want to see providers writing routinely, right? You want to see them writing for multiple patients in their practice. So you want not just breadth, but you want to see that nice depth of providers that are really incorporating this into their practice for their patients. So we'll be looking for those kind of metrics, right, numbers of providers that are writing prescriptions, but also how many repeat prescriptions for different patients, right, are they writing?

And then at the patient level, we want to see how frequently are they filling their orders, right? How frequently do they get a refill so we can start to get a sense because the tube -- did I mention [indiscernible]? The tube is $99, and it comes with 10 doses, 10 uses. So we want to really get a good sense of that frequency also from the women.

And for Flora Sync, what we're going to be looking for? Same thing. We're looking for -- even at the provider level, like, we're looking for providers to actually stock the product in their offices and recommend it to their patients because there really is a dearth of sort of clinically studied vaginal probiotics. So we really want to see that. We'll be looking for that.

And at the consumer level, we're looking for where is she coming from, how did she learn about the product? And then what is her repeat ordering habits. And that's what's really going to help us in the early days of launch, understand what that foundation is and to build on it.

That's great. And you answered 2 other questions around what KPI you're going to be looking for those product launches. So that's great.

And then just to build on that, thanks for hosting these calls for transparent discussion with investors. What are some initiatives you'll be doing to generate buzz and interest around the company and product?

Yes. So hopefully, you're starting to see some of this because some of the podcasts are starting to go live. We've really been leaning into both a podcast strategy that includes influencers and also influencers just on their Instagram and TikTok and other channels. So some of those podcasts are literally starting to go live now. And so check out our Instagram. We're always posting about them. So definitely check out our Instagram. If you're not following us, do, because that's often where we really highlight the podcast and provide the link to those podcasts.

So there are a number of podcasts that are starting to come out this summer, and they're really a mix. Some are with very well-known kind of sexual health influencers. One of those just dropped on, I think, July 29. And then some of them are with organizations that have a real interest in what we're doing and have followers that have a real interest in what we're doing like the Menopause Foundation.

We also do podcasts with health care providers, clinicians that -- we think of them as pro influencers, people that have -- they're professional health care providers, and they have a really strong following from people that look to them for health care information and to learn about products, whether they're health care providers who follow them or women who follow them. And so we record a number of those podcasts as well.

So most of them -- some of them just started coming out in July. So most of that is coming out in July and August. We've also done some stuff with iHeartMedia. And so there's a lot of different platforms that we're looking at to get the word out. But in all of those cases, what we're really trying to do is make sure that we're collaborating with credible spokespeople and influencers that have reach to talk about the products. But first and foremost, that they have a clear understanding of what the clinical benefit that we're delivering is with these products and that they can communicate it.

So those are some of the channels that we're using. And to me, I think those are some of the most interesting channels that we've been able to leverage and then also a lot of peer-to-peer. So we've done some webinars in the past. You'll start seeing more of those where health care providers that have already really incorporated these products into their practices are going to be talking primarily to their peers about what the products are and why and how they use them. So you'll begin to see more of that as well.

That's great. And I have to agree on the podcast, the one from last week; I watched. It was very interesting and a very good discussion. So definitely recommend everyone to check that one out.

Our next question. There are currently no FDA-approved treatments specifically for female sexual arousal disorder. How large do you believe the market is? And how will Daré educate women and doctors about this condition?

Yes. And it really -- the market is significant. When we look at the sort of prevalence rates, the true prevalence rates of female sexual arousal disorder, they're not dissimilar from erectile dysfunction. So very comparable in terms of number of people affected, right? We're talking tens of millions of women and depending on which way you look at the estimates, 20 million, 40 million women, depending on how you look at the data and how you look at those estimates. So it's a significant population. And it's a very motivated population.

When we launched our clinical trial, when we launched our Phase II trial, and we posted some ads about it on -- I think at that time, it was just Facebook. But we posted some ads about it on Facebook, maybe Instagram as well, but definitely Facebook, we had over 10,000 women respond to those ads within the first 16 weeks of putting those ads up about do you have this problem? Are you seeking a solution? And we were only looking for 200 women to participate in the study.

So there's a need. Women are looking for something that is actually evidence-based. There are a lot of products pushed to women purporting, right, to solve their arousal problems, but they haven't been studied. And women are sophisticated consumers, and I think they can see through that. So we're excited to get this out there.

Absolutely. Our next question. Can you explain how the DARE Health Hub telehealth capabilities and provider relationships work together to acquire and retain patients?

Yes. So what's nice about the DARE Health Hub and how it's set up is it's all -- the back end, think of it, is managed by Medvantx, which is a central mail order pharmacy. And so what that means is a health care provider who learns about our product and wants to incorporate it into their practice, they can write a prescription using their normal electronic medical record system that they use. Medvantx is typically in their system as a pharmacy they can select. So it makes it really straightforward for them to write a prescription.

If it's a telehealth practice, like a separate telehealth practice, not the one that we offer on the DARE Health Hub, but a separate one, similarly, it's super easy for them to make sure that Medvantx is in their pharmacy dropdown and for them to write the prescription that way. And it all gets then dispensed through the central pharmacy and all managed through the DARE Health Hub.

And if it's someone who's finding the product, a woman find the product on our website, she heard about -- she listens to LOVERS by Shan, the podcast, and she heard about it and she finds us, on she goes to the website and connects to the DARE Health Hub and she doesn't have a prescription, there, we've integrated a telehealth offering that Medvantx helps support for us that's asynchronous. It's just a 10-minute questionnaire that she has to do.

So it's really set up so that if it's a health care provider that's learning about the product on a webinar or at a conference and is going to be incorporating into their practice, super seamless for them. They're going to the back end of the DARE Health Hub to enter their prescriptions. But then once the prescriptions are in there, we're able to then interact through the DARE Health Hub directly with the patients through the Medvantx pharmacy to send them reminders to do their refills, send them updates on their orders and things like that. So it's really integrated all around.

Great. And it looks like we have time for one more question. Through the relationships you've built with OB/GYNs and women's health specialists through your clinical work, how are you converting those relationships into commercial adoption?

Yes. It really is through -- I mean, it is relationship-building. And then obviously, the products speak for themselves, but we've got to make sure they hear about the products. And so the way we do that is, like I mentioned the webinar, so that's a really important tool that we use. We've done a few of them over the last year. Like I said, you'll be seeing more of those.

We go to conferences. We're at a conference right now where we provide information to health care providers. Often at those conferences, we host like [ learn-ins ] kind of events where we actually give a presentation usually with another -- with a clinician who's already incorporated our product into their treatment practices. We'll give a presentation. So those channels are really important to us for that conversion with our team.

And then the other thing that we do, and this is like super efficient, we're working with a national organization that offers telehealth and specialized services, is we might collaborate with them like listing them on our website, like MyMenopauseRx. The women can access directly from our website, so they can really connect to someone who's truly an expert in that area or we do -- even if we're not collaborating that closely, we do teach-ins with them where we present on our products to their medical leadership for that whole network, which can be also just a really efficient way to make sure that, that whole network learns about our product.

Okay. Well, thank you, Sabrina. That is all the time we have for Q&A. Before we end, do you have any closing remarks?

All right. No, just again -- yeah, just thank you again, everyone, who participated. Really appreciate the time and that you're following us and really excited to keep you updated this year.

Great. Thank you. Well, this does conclude our webinar for Daré Bioscience's Virtual Bus Tour. We look forward to seeing you and everyone at our next stop on August 11. For the full schedule of the bus tour and for more information on Daré Bioscience, please visit darebioscience.com. Thank you, everyone.

Awesome. Thank you.

Bye.

Okay. We are ready to get started. Welcome, everyone, and thank you for joining the Daré Bioscience Virtual Bus Tour. My name is Jenene Thomas. I am CEO of JTC IR, and I will be the moderator for today's event. So today, the company is excited to kick off the virtual bus tour starting with the West Coast stop. And for the format today, Sabrina Martucci Johnson, she is President and Chief Executive Officer of Daré Bioscience, will take you through the Daré story, and then I will open the event up for Q&A to take your questions.

So now it is my pleasure to turn it over to you, Sabrina.

Great. Thank you. Thanks, everyone, for participating today. It's always a pleasure to share more about Daré Bioscience and the work that we do. So the presentation does contain forward-looking statements. So I do encourage you to look at our most recent SEC filings and our most recent 10-K for a full disclosure of the risks and uncertainties associated with an investment in Daré Bioscience.

We are focused solely on advancing health care for women and specifically products for conditions that solely affect women where there's been significant unmet need. And what that means is our portfolio is very purpose-built for these conditions that are large unserved markets across women's health.

I'm going to highlight a few things on today's webinar for you. First, we'll start with talking about really kind of the 4 pillars of what's exciting going on right now. One is commercial launches that are taking place right now. We have revenue commencing this summer, our first product launched earlier in the summer, and we have another coming soon. So we'll talk about that and what that means to the organization.

Across the portfolio, everything we're working on for these conditions affecting women are based on clinical evidence, but we look always for the fastest way to get these products in the hands of women. And so we'll talk about what that means in terms of bringing products to market, sometimes with FDA approvals, sometimes it's what's called 503B compounding for prescription products and sometimes with nonprescriptions. But what they all have in common is that clinical basis and evidence basis.

And that's really what drives us and drives the portfolio is we're looking for programs that are late stage and can come to market and are diversified across health care conditions in women. And we also leverage very strategically nondilutive funding that's available. There are significant grant dollars and foundation dollars available for conditions affecting women. In fact, we brought over $75 million into the portfolio just since 2018 across a variety of programs.

So I mentioned upfront, we work across life stages in women's health, and we're really looking for solutions to fill therapeutic gaps in care. We're really a purpose-driven biotech company, looking to close those gaps where there's promising science and delivering that real-world solution. And again, across the life stage of women. So from contraception to sexual health, to vaginal health to fertility and menopause as well.

So I'm going to highlight a few of the programs across the portfolio. And I'll spend a little more time today on the 2 on the top. So we'll talk about Flora Sync LF5, which is in the DARE to RESTORE family [ competitive ] launch. That's a vaginal probiotic capsule. We're also going to talk a little bit about DARE to PLAY, sildenafil cream. It's a first-of-its-kind sildenafil cream for women, and we are preparing for dispensing to commence later this summer.

I do want to highlight a couple of the other programs, though. So we'll talk a little bit about a product for menopause, the first-of-its-kind once-a-month hormone therapy product for menopause with the hormones that women need together, that we're preparing for commercialization. And then I want to talk about 2 programs that are currently in clinical studies, Ovaprene, a first-of-its-kind non-hormonal once-a-month contraceptive for women. It's in a Phase III trial right now. It's the registration study and also a product to treat human papillomavirus infection, where there is no treatment available for human papillomavirus infection, which is the virus that causes cervical cancer. And we started a completely grant-funded clinical trial earlier this year.

And I want to talk a little bit about pregnancy maintenance and specifically for fertility support and also maintaining pregnancy for women at risk of preterm birth and preparations underway for a Phase I that is NIH grant funded.

So why women's health? And why now? Well, it's definitely a fantastic time to get to know Daré, just given everything we have going on in the portfolio right now, both commercially and also clinically. But why women's health? And what's really interesting about the category is it's such a significant market opportunity. And despite the fact that there's a lot of white space, only about 1% of private health care investment has gone into therapeutic solutions for women's health. Despite that, 27% of the prescription pharmaceutical products that generate over $500 million in annual revenue are for conditions affecting women.

And that is not surprising if you think about the different aspects that women can experience across their lifespan from sexual health to contraception to fighting various infections and also menopause. And all of these typically are affecting tens of millions of women who are seeking solution. And the solutions have really been limited.

And that's one of the reasons that there is so much nondilutive funding that we've been able to leverage. It's really to look at how we can help advance solutions where there are therapeutic gaps. And the grant funding that we brought into the portfolio, it's really important because it, one, validates the approach and the need that exists. And also, it helps to fund that research and advance those programs. And it's the diversity of funding that also matters. So it's quite significant from the Gates Foundation from different government agencies, ARPA-H and NIH and also broadly across the portfolio. So it's not about one specific program. It's about different categories of products for different indications.

And the reason that, that funding is available to us is that we're really a data-driven development. And so we're doing the work. Our portfolio is built on science. It's built on clinical evidence. We take products where it makes sense through the FDA. And we back the products that we bring forward for women with clinical studies and clinical science. And that means also that we're generating proprietary data, and it helps us advance the products through various different pathways.

The products that we're developing, though, often leverage known active pharmaceutical ingredients, so known medicines, but we're developing them for novel areas where there is no product available yet for women that's been clinically studied. A great example of that is our DARE TO PLAY sildenafil cream or we're using them for where there is no FDA-approved treatment whatsoever for that condition like we're doing with our human papillomavirus potential treatment or we're providing them in a very novel way like menopause hormone therapy once a month.

And then as we think about how we commercialize the products, we really want to leverage a platform that can ensure that patients, health care providers have very great access and straightforward without friction to prescriptions where they're needed, product fulfillment and direct patient engagement. And we do that through the DARE Health Hub.

So as I mentioned, it's very much a purpose-built women's health product ecosystem. So I want to spend a minute on the commercial products, and we'll talk about what's coming in development because it's that development pipeline that really feeds that commercial machine.

So the Flora Sync LF5 is in our DARE to RESTORE family, and it is a vaginal probiotic capsule. So it's designed to restore microbiome balance and support lasting comfort. So a lot of us have heard a lot about probiotics and probiotics, we've heard about gut probiotics. The probiotics are also really important in the vaginal environment. A healthy vaginal environment can be very important in terms of maintaining pregnancy, helping prevent other types of infections that can happen. So really important to keep that really healthy microbiome balance.

Most probiotics that are available for women, though, are oral strains. They're developed for gut. They're not developed for the vaginal environment. Flora Sync LF5 is -- so it's available without a prescription. It's a vaginal capsule that was formulated specifically using a strain that was derived from women who have self-reported never gotten used to infection, nice healthy vaginal microbiomes. And then it's been clinically studied. It's backed by over 30 years of probiotic research. And in the clinical study, 96% of women achieved that microbiome balance within just 3 courses and 90% maintained that out to 2 weeks. So it's available now on the DARE Health Hub. We just started making that available.

And the next product that we're looking to have available targeting later this summer on the DARE Health Hub is our DARE TO PLAY sildenafil cream. So sildenafil is the active ingredient in Viagra, which so many of us have heard of, obviously, but it's formulated specifically for women. And so this is the first-of-its-kind arousal cream for women that has specifically been formulated into a cream that has been designed to be used on demand that increases blood flow to those general tissue within 10 to 15 minutes of application and that has been studied using FDA reviewed and clinically validated endpoints and demonstrated to improve arousal sensation in a well-tolerated formulation that, like I said, is used just on demand when she needs it.

It's targeted to be available later this summer. We're making it available as a 503B compounded product while we're continuing the process forward towards an NDA pathway. And what that means is 503B compounding means that the product can be made available imminently. It follows the same quality standards that are required of prescription -- typical prescription pharmaceutical products in terms of quality and consistency. So health care providers and women can be confident they're getting the same thing every single time and then backed by that clinical science to demonstrate what the product does.

And because of the work that we have done in terms of developing our products, running clinical studies and creating those trusted relationships with health care providers around our women's health solutions, it really allows us to turn those clinical relationships into really important commercial momentum. So we can leverage those clinical providers, those thought leaders, those long-standing relationships where they become peers talking about our technologies to other health care providers as well. And so we can really utilize that established network of those thought leaders and their ongoing presence at major conferences along with us. And that really helps us create a commercial advantage where we can leverage that existing provider network.

And then by providing our products both through the DARE Health Hub, which we're going to talk about in a second, but also directly in the clinician offices where that makes sense, it really allows us to have that provider engagement, but also ensure that women have access to the product through a variety of trusted channels. And so as we think about that integrated platform, it's really designed for scalable growth across our portfolio of products. And so we can drive that patient acquisition, the engagement, the portfolio expansion through this unified women's health ecosystem. So it requires those provider relationships, right, that engagement with the health care provider that we have through our clinical programs and now through our clinical products that have been tested and evidence-based.

We want to make sure that women have access regardless of whether they have a brick-and-mortar health care provider or they would prefer asynchronous telehealth, where they can complete a questionnaire within 10 minutes and have access to the product that way. So we also ensure that they have that convenient access with national reach. And that really means that we're leveraging a lot of digital marketing as well, consumer platforms, clinician influencers, which is very targeted and very scalable across the portfolio and across products.

And then the DARE Health Hub really is that centralized fulfillment center that really allows a place where we can be doing both product education, selling directly. It's a cash pay portal. So it is that central commercial platform, but it also allows for prescription fulfillment, both from the health care provider. It's a central place where they can send their prescription in if it's a brick-and-mortar health care provider or a telehealth provider that's not part of our telehealth system or the patient can access telehealth directly there. They can also check on their prescription or check on their Flora Sync LF5, which is nonprescription also available.

And that also means there's an opportunity for cross-selling on the platform. One of the most disruptive things to the vaginal microbiome is actually sexual activity. So it's a great place where they can both have access to DATE TO PLAY sildenafil cream, but also Flora Sync LF5 5.

In terms of the development pipeline, that's really critical because it's that clinical-based development pipeline and evidence-based solutions that feed that commercial machine that we have, which this is really about the products, right? The commercial platform is there to make sure women have access to those products. So in clinical development right now in Phase III, which this is the registration trial for this product is Ovaprene. It's a once-a-month nonhormonal vaginal contraceptive. It's hormone-free. It has a really unique mechanism of activity where it's a physical barrier. It's something a woman inserts herself and removes herself once a month vaginally. So it consistently blocks burn, but then it also releases a spermostatic agent. So it interferes with sperm motility in action.

It's been through 2 positive data safety monitoring board meetings to date in the Phase III trial. In both cases, they had us move forward without any changes to the study. And based on those interim looks at the data, it has an 86% to 91% typical use effectiveness. So to put that in perspective, that's in the same range as the most effective of the like nonhormonal on-demand methods. So that's fantastic. It also has an immediate return to fertility because there are no hormones in the product. And it has the potential to be the first FDA-approved monthly hormone-free contraceptive. To put that in perspective, the first once a month of contraceptive that had hormones, which was NuvaRing was nearly $1 billion brand at peak.

I mentioned upfront human papillomavirus infection. We are very excited to be taking this product into clinical development. So human papillomavirus is a virus that causes cervical cancer. And despite that, there is no treatment for when a woman is tested positive for a high-risk HPV infection. She's told to wait until she develops precancer lesions on the cervix that then have to be surgically removed, which can lead to preterm birth and fertility and often is missed with that watchful waiting approach.

And so this is a treatment option that we are investigating the woman can do at home over a course of treatment with this antiviral agent. The Phase II study is completely funded with a grant from ARPA-H and a contract with ARPA-H, which is a government agency. It's based on a pilot study that's been completed that demonstrated nice proof of concept and it has the potential to become the first FDA-approved pharmacologic treatment for high-risk HPV infection. And we expect to have data on this product next year on the trial. And I go to say Ovaprene, the last product we talked about, we're also expecting data next year on that Phase III trial.

One of the next products for 2027 that we're looking to bring to market for women is something for menopause hormone therapy. So we've been hearing a lot about hormone therapy and the importance of hormone therapy with the black box removal from the FDA, demonstrating that it may be appropriate for more women than was originally envisioned. But nonetheless, there is actually no hormone therapy option available to women right now that actually meets the menopause society guidelines for ideally how women should have hormone therapy. And ideally, if it's a woman with the uterus, she should have something that is nonoral and it has both estradiol for the hormone effect, but also progesterone for safety in one product.

And so this is a vaginal ring that's just a once-a-month product that a woman could use. It's been through clinical studies so far, demonstrated statistically significant improvement in hot flashes and night sweats and other vaginal symptoms as well and quality of life measures. We're looking to bring it forward as a 503B product as well, like we're doing with DARE to PLAY sildenafil cream while we continue the development program towards an NDA pathway.

And then I want to mention just a couple of other things. Some of them cannot take hormone. So think about breast cancer survivors like hormone receptor-positive breast cancer survivors that are on long-term treatment for their breast cancer and where hormone therapy is really not recommended. But one of the most common symptoms often of those therapies that they take for their hormone receptor positive breast cancer is what are called genitourinary syndromes of menopause, even though even if they're young women and they're not a menopause yet, which is basically sexual pain that can be caused from the changes that happen in their tissue because of the treatments that they're on.

And so this is a non-hormonal approach that has been through a Phase I/II study and demonstrated statistically significant improvements in symptoms associated with the genitourinary syndrome of menopause and has potential to be the first intravaginal treatment for that condition, and we have Phase II preparations underway for this product.

And then lastly, I want to talk about our progesterone vaginal ring. So progesterone is commonly used as part of in vitro fertilization, IVF regimens, very painful injections. It's also used sometimes to support pregnancy in women who are at high risk of preterm birth in their pregnancies. This is a vaginal ring form of that. So convenience -- very convenient route of administration as an alternative to those daily injections of vaginal gels. We are preparing for a Phase I study that is funded by the NIH.

A number of other earlier-stage programs, similar to everything else, really first-in-class opportunities where we're filling those therapeutic gaps in care for women. Most of these are grant funded, as you can see. And then I want to highlight a couple of things on the corporate side. Our last financial statements, $18.5 million in cash, about 50 million shares outstanding. In terms of the management team, very highly experienced team in pharmaceutical product development and commercialization and women's health specialization where it's relevant as well.

And as I mentioned right upfront, it's just a really great time to get to know Daré. We have multiple near-term catalysts that really have potential for quite meaningful value drivers across the portfolio, both on the commercial side and importantly, also on the development side. And that's a really rare thing to see in companies that are clinically developing solutions.

So DARE to PLAY sildenafil cream, which is our first-of-a-kind arousal cream is targeted to start having those prescriptions to start dispensing later this summer. We already have prescriptions in the system from health care providers and women who are very excited to get their hands on this product. Flora Sync LF5 5 and the DARE TO RESTORE family is live now. So it is available. It's a nonprescription and available on the DARE Health Hub right now for ordering. Ovaprene and DARE-HPV, both of those in clinical studies right now. We expect data readouts on both of those programs next year. And we're also looking towards -- forward towards that commercial launch that we're targeting for our menopause hormone therapy product in the DARE to PLAY sildenafil cream family next year.

And so I want to close with why Daré, why now? It is such an interesting time as we're transitioning from what was really historically a clinical stage company to now a commercial stage company with 2 revenue-generating products going live this year and purpose-built pipeline for women that is advancing with 2 clinical readouts next year. And we're really set up to scale because with the DARE Health Hub and that telehealth infrastructure, it's really leaning into where women are getting their care today. And we're continuing to leverage that significant nondilutive funding across the portfolio, including programs like Ovaprene and DARE-HPV that are in clinical development, and that really helps advance those programs in a thoughtful way to our shareholders because it does not require shareholder capital.

So with that, I will pause and happy to address any questions.

Perfect. So now I will open up for the Q&A session. [Operator Instructions] All right. So our first question is, thank you for the opportunity to attend this webinar. You mentioned your first commercial launch. When do you expect to see meaningful revenue from Flora Sync?

Yes, great question. So we just went live with that product. So it's definitely in the early days that we just started to -- we announced the July 1, basically. So we're in the very first month of launch. So what we will be doing is we'll continue to give really quarterly updates on our earnings calls as we know when launches like this early days. So the things we're really going to be watching is a few things.

We're going to be watching and giving some guidance on behavior. So reorders, right, frequency of ordering, where we're seeing the orders coming from. We do have a couple of channels at play here. So women -- I talked about the DARE Health Hub, but there are also clinicians that are very interested in offering the product in their offices as well. So as we continue to give updates on that, we're really focused on where we're seeing traction, where we're seeing momentum and some of those important metrics like cost of acquisition of our customers and then also what kind of usage patterns we're seeing. So more to follow on that.

Okay. Our next question is, can you address the NASDAQ delisting notice due to low equity and management's plans?

Yes, definitely. And that's -- obviously, that's a great question. So to give some perspective on that, as we previously discussed, we've requested a hearing with the NASDAQ hearing panel regarding our continued listing. There are certain thresholds that companies have to meet to be listed on NASDAQ. So the hearing is part of the normal NASDAQ process when there's been a deficiency on one of those. And under the strategic guidance of our listing advisers, we're continuing to work cooperatively with NASDAQ throughout this process. Our NASDAQ listing is very important to us. I definitely want to stress that. So we're very committed to taking the appropriate steps to address that listing requirement.

So in the meantime, and simultaneously, our entire team remains focused on executing our strategy, which is so important in earnest. As you know, right now, we're expanding commercial initiatives. We're advancing our product portfolio and clinical development, and we're continuing to work on strengthening our financial position and really creating that long-term value for shareholders. So we will continue to keep shareholders updated on the NASDAQ process. And as I mentioned, the next step is a hearing before the panel.

Our next question is the clinical data for Flora Sync publicly available? And was it tested in women with recurrent BV?

The clinical study is available, and it's -- there's a link available on our website as well. So it's right on the product page for Flora Sync. So if you go to darebioscience.com and you go to the products page and you look at Flora Sync and if you scroll down, there's a link right there to the publication. There's 2 publications link there on the website. One, looking at studies that were done in the laboratory, so in vitro, not in humans that looked at the activity of that probiotic on things in a [indiscernible] and all kinds of types of cultures of things that could exist in the vaginal microbiome.

So not just things like bacteria, like bacteria that can cause bacterial vaginosis, but also looking at things like used in other culprits that can be present. So that's published and that's available. And then the clinical study is also published and available. And it is not conducted in women who have bacterial vaginosis, but it does look specifically at traits in the vaginal microbiome in the women who are studied and then that restoration to a healthy vaginal microbiome using clinical outcomes.

Okay. Can you discuss the Reg A offering? Can you share more about it and what it is and how to participate?

Yes. So a Regulation A offering is a type of offering that can be made available to anyone. So a typical public offering is only available to accredited investors that -- or institutional funds. And we're really a purpose-driven biotech, right? Our sole focus is to close the gap between promising science and real-world solutions for women. And that also means that our customers also may be very interested in having an opportunity to be an owner, right, in the company that is developing products for them very thoughtfully.

And so the Reg A offering is a way for us to do that is to make this available to not just institutions, not just very high net worth accredited investors, but the everyday person who really wants to be an owner in this and who wants to put their hand up and say, women's health matters. And I also believe that not only does it matter, but this is an investment-worthy opportunity to participate in that. And so the way it works is all of the information, there's important disclosures in the offering circular that's on the website.

So if you go again to the darebioscience.com, is the website address. If you go to the website and you -- there's an invest mail button if you click that, it very importantly takes you to the offering circular that has all the details on the offering and how it works. But basically, the offering, it's for a unit and the unit contains 2 shares of stock and 2 warrants to purchase shares at a future time and a future price.

Okay. What are the proactive steps you mentioned for the NASDAQ delisting risk? And I hope you're not leaving it up for luck and putting shareholders under the bus.

Oh my gosh. We don't leave that up for luck.

[indiscernible] question.

Yes. No, no, that's good. So one more thing I meant to say on the Reg A offering is that it was also set where the minimum is $250. So it's really designed, again, for someone who, yes, really is interested in becoming an owner and something they believe in that it's accessible regardless of whether they have $250 they can invest or $250,000 or $2 million.

So in terms of the NASDAQ process, and so just taking a step back for a second. So the NASDAQ listing requirements include a few different parameters for companies, and one of them is obviously, stock price, but then another set of requirements is related to either having a certain market cap, a certain stockholders' equity or certain net profit, which is interesting because we're transitioning to commercialization, but net profit has to be in your year-end 1 year's audited financials.

And so we really have to look at either market capitalization, which is very much based on stock price by market cap, the stock price times shares outstanding, has to be a certain amount or stockholders' equity. So assets equals liability plus stockholders' equity. And so what one does as they go before a panel is really put forward a plan of how they will reach compliance. And things that can affect stockholders' equity are obviously revenue because in part, that's based on net income is part of that calculation. So obviously, that's important. Equity is important in that.

And then also in the case of Daré, we have an interesting situation because we've been so successful with our nondilutive grant funding and the way some of that grant funding comes in. We actually spend the money on the asset side before those dollars come off of the liability side because the liability is tied to the life of the grant sometimes. So it's really going in front of the panel and putting forth our plan and demonstrating how given what the company has going on, given the commercial programs, given the pipeline that we have, given the events, given the strategic opportunities that we have that we are well positioned to maintain compliance.

Our next question, do you anticipate broadening your product offering into other areas of women's health such as mental health?

It's a fantastic question, and we get that question a lot. And where we really like to focus as a company, and I think it's important for our shareholders is where we think there's really good scientific basis. There has to be -- it's kind of a trifecta for us to decide to move into a therapeutic category.

One, first and foremost, there has to be a clear unmet need, right? There has to be a problem that is not being solved adequately with any of the options available today, so first and foremost. Two, though, we also have to have a clear understanding of the science to solve that problem, right? Because we really want to take for solutions where there's really great proof of science, and they just need to be pulled through to the marketplace. And then third is that like the ability to pull through the marketplace. The patients are there, right? It has to be kind of a big enough market size, commercial demand.

So there are definitely a number of gaps, I think, in -- on the mental health side for women, and there are definitely areas where I think we can make improvements. For us, we haven't focused there yet because we have yet to find a solution that we think the science is strong enough to support it as a highly differentiated solution that can fill that need. But we're always looking. And if someone knows of something, please let us know.

Our next question, Daré has been very successful at generating product excitement at conferences. What's Daré's plan to build that excitement among clinicians and patients who weren't there?

Another great question. So we really do want to leverage -- this is a very digital native strategy. So yes, we go to those live conferences. Those are incredibly important, both for us to present, but also thought leaders to present and us to have a presence there. So those have definitely been really great, and we have generated a lot of enthusiasm and excitement there. But obviously, that's just one part of the universe, right, of health care providers and women.

And so online, we're really leveraging social media and specifically working with a lot of -- and you'll start to see this, by the way, coming out because a lot of it is coming out and starting now this summer because we're really -- everything is tied towards the product launches summer and fall. As we're building awareness and building a lot of momentum and excitement. So you'll start to see podcasts. You're going to start to see peer influencers that we're working with. So these are clinicians that have a very great following right on their various platforms, whether it's TikTok or Instagram or whatever that they may be on. So you're going to see us leveraging a lot of that as well.

What isn't as exciting to utilize because it's really not shown to be as cost effective in terms of customer acquisition and sticky customer acquisition is necessarily very undirected ads. Everything we do is going to be very, very targeted to health care providers and users and questions, including things also in Facebook communities and things like that.

Okay. So as your products begin generating revenue, what should investors be watching over for the next year to measure success?

Yes. So specifically, the things we're going to be looking for to measure success is we really want to see a few things. We want to see people who try the products become repeat users. So whether that's for DARE to PLAY sildenafil cream, we want to see them make that part of their sexual health routine and also sexual routine. And also for [indiscernible] DARE to RESTORE Flora Sync LF5 we want to see women make that part of their vaginal healthy vaginal by providing them routine. So we want to see that repeat usage.

For DARE to PLAY sildenafil cream that's a prescription product, we want to see providers that become repeat prescribers. We're already seeing that. We started intaking prescriptions earlier this year because there was so much excitement on the part of health care providers who wanted to start writing the product for their patients. So we have started in taking prescriptions and already see those trends, right, of prescribers becoming repeat prescribers. We've also had women start to go through telehealth. It's a super simple process. It's about 10-minute questionnaire. And so we're also looking at metrics.

The last thing I'll highlight that we're looking at is on the prescription product, what are our ratios of telehealth versus non-telehealth. And on the telehealth platforms, we have our own telehealth platform that we utilize through Medvantx. But then there's other telehealth providers that we're associating with. So we're also going to be looking at just kind of providing prescriber practices across those telehealth platforms as well.

Well, now that looks like the end of the questions. But Sabrina, if you don't mind, we were on the webinar recently together. And one of the questions I thought that you answered excellently was I believe -- so I'm going to paraphrase what the question was. But basically, how do we kind of the value indicator for Daré right now and maybe the peer or the competitive space, like how do we see how the company can really leapfrog from a market cap perspective, from a growth perspective? And like is there a benchmark? How do investors now view this opportunity today and then the opportunity that could exist upon successful achievements?

Yes, absolutely. I mean we are definitely at a moment, right? I mean this is -- I can't stress enough. It's just such an interesting time to get to know us as a company because we're really filling white space. To our knowledge, we're the only publicly traded company working broadly but solely across women's health and filling so many therapeutic gaps. And we're now a story -- we were a pipeline story that is now a commercial story but still with the pipeline behind it. And I think that is -- it's why it's important to get to know us now.

And what we love about what we're doing is it's an opportunity for the medicine to finally catch up with the conversation. There's been a lot of buzz around women's health lately, and we're bringing forward and really filling that white space, frankly, clinically validated solutions, whether it's prescription or nonprescription. So we were that development machine turning into a commercial engine now as well.

Perfect. Excuse me. I have to cough for a second, I'm dealing with the summer cold. So...

Those are [indiscernible]. Yes.

Yes. So I guess any closing remarks?

Yes. Again, just I really appreciate those of you who listened in. And this is a great time for the company in terms of operationally, in terms of what we're doing and really look forward to keeping you guys updated then for what's coming next.

Excellent. Well, I love the commitment to engagement with your shareholders and potential shareholders. So this does conclude the first webinar in the Daré Biosciences Virtual Bus Tour. We look forward to seeing you on our next stop on August 5. And if you are interested in investing in the company's -- offering, visit Daré's website at darebioscience.com and click on the Invest button. And for the full schedule of the bus tour, you can visit the website, Presentations, Events and Webcast page on the company's website under the Investors section.

So with that, I wish everyone a great rest of your day.

Awesome. Thank you. Bye.

Ladies and gentlemen, thank you for standing by. Hello, and welcome to the conference call hosted by Dare Bioscience to review the company's first quarter 2026 financial results and to provide a business update.

This call is being recorded. My name is King, and I will be your operator today.

With us today from Dare are Sabrina Martucci Johnson, President and Chief Executive Officer; and MarDee Haring-Layton, Chief Accounting Officer.

Ms. Haring-Layton, please proceed.

Good afternoon, and welcome to the Dare Bioscience financial results and business update call for the quarter ended March 31, 2026.

Today, we will review our financial results, provide updates on our clinical pipeline and discuss the continued execution of our expanded business strategy. That strategy includes a dual path approach, commercializing proprietary formulations through 503B compounding while pursuing FDA approval, and advancing select solutions as branded consumer health products that do not require a prescription. In all cases, our goal is to bring innovative women's health solutions to market as efficiently and quickly as possible.

I would like to remind you that today's discussion will include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Any statements made during this call that are not statements of historical facts should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties. You should not place undue reliance on forward-looking statements.

Forward-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our quarterly report on Form 10-Q for the quarter ended March 31, 2026, which was filed today, and our annual report on Form 10-K for the year ended December 31, 2025.

Please note that in the context of this call includes time-sensitive information that is current only as of today, May 14, 2026. Dare undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law.

I would also like to point out that when we use the term 503B compounding during this discussion, we are referring to compounding drug products by outsourcing facilities registered under Section 503B of the Federal Food, Drug and Cosmetic Act using both drug substances on the FDA's interim Category 1 list.

I will now turn the call over to Sabrina.

Great. Thank you, MarDee, and good afternoon, everyone, and thank you for joining us.

I am taking the call today from New York in the middle of National Women's Health Week. And this year's theme, which is Prevention, Innovation and Impact, a new era in women's health, couldn't be more relevant to our discussion this afternoon. Dare was built on the conviction that women's health is an investment-grade category, not a niche, not a nice to have, not a pink ribbon in a press release, it's a category worth building, funding and holding accountable for delivering to women the health care options they deserve. And that is exactly what we're doing today and reporting on what we've built and where we're going.

Over 10 years ago, we made a decision to focus exclusively on women's health, as you know, not as a sideline, not as a franchise within a broader portfolio, as our entire reason for existing. Every dollar raised, every clinical trial run, every regulatory submission prepared, every partnership negotiated, all of it for one purpose, building the company with the most comprehensive pipeline comprised exclusively of differentiated products for health issues and conditions that uniquely impact women. From contraception to menopause, sexual health to fertility, vaginal health to human papillomavirus, we're working to close critical gaps in care with science that meets her needs.

And what distinguishes Dare is not just the breadth of the pipeline, but the strategy behind it, that disciplined approach to capital allocation that pairs nondilutive grant funding with focused development so that we can move multiple programs towards the clinic simultaneously.

So it's not a single product bet. It's a portfolio of strategy that's built from the ground up for one of the most chronically underfunded areas in all of medicine despite affecting half the world's population. And we're not a company that's just getting into women's health. What 10 years of commitment looks like is what is coming into view right now.

And I also want to be precise about what kind of company Dare is, because the women's health space is attracting more and more entrants and not all of them are building the same thing. This is a growing category of women's health platform companies that offer services, telehealth subscriptions, care navigation, clinical memberships. That's what's happening. And they make products available as part of the service experience. And we respect those companies and what they're doing.

But that is not what Dare is. Dare is a product company. Our mission is to develop and bring to market clinically studied, differentiated women's health products, products with real data behind them, addressing gaps where, in our view, nothing adequate exists today. The DARE Health Hub and telehealth access we provide, their infrastructure built to put those products in the hands of women efficiently.

Access is essential, but the products are the point. And that distinction matters, especially for clinicians. When a provider writes a prescription for DARE to PLAY, they are prescribing a specific formulation with published clinical data, not some generic compounded product and not a service bundle. We're building relationships with the clinical community that are grounded in the credibility of what's in our tubes or bottles. That's a very different conversation than one built around a subscription platform.

To our knowledge, Dare Bioscience has the most robust development stage pipeline of any company in the world developing products exclusively for conditions that solely affect women. We have not been able to identify a company with a comparable portfolio.

Products are protectable, products can generate recurring product revenue. Products can be partnered, products can be approved by the FDA. Products can be real-world solutions. And a great way to illustrate our product model is to start with DARE to PLAY. Since our last call, one of the most meaningful events we participated in was the American College of Obstetricians and Gynecologists, or ACOG, their annual conference. And I want to share what happened there because I believe it signals something important about where DARE to PLAY is headed.

The reception we received at ACOG for DARE to PLAY was enthusiastic. Health care providers attending, and that includes OB/GYNs, women's health specialists, sexual health clinicians. They were genuinely excited about the product. And I mean, genuinely, we literally had providers who were so enthusiastic about DARE to PLAY that they were writing prescriptions for each other on the spot at the booth.

That's not a marketing anecdote. That's a signal. When experienced clinicians see patients every single day and have long lamented the absence of evidence-based options for women's sexual health, they see DARE to PLAY and immediately want it for themselves and their patients. It tells you something real about the unmet need and the credibility of our product.

We also have clinicians approach us about stocking DARE to PLAY directly in their offices. That level of interest from the provider community is exactly what a new prescription option needs to build sustainable momentum, and we are actively working to support those discussions. Providers are becoming advocates, and that's how sustainable commercial momentum is built, not just relying on advertising, but through clinician conviction.

DARE to PLAY is a first-of-its-kind topical arousal cream for women. To our knowledge, there is no other sildenafil topical cream manufactured under Good Manufacturing Practice requirements with clinical data demonstrating increased genital blood flow in 10 to 15 minutes and improvements in arousal, orgasm, desire as measured by clinically validated and FDA reviewed endpoints.

As we've discussed before, men have had Viagra in their medicine cabinet for over 25 years. Women have not had a sildenafil cream formulation clinically studied and developed specifically for them, until now. An estimated 20 million women in the United States report challenges related to genital arousal. And there's not a single FDA-approved therapy that directly addresses the need, not one. And while there's not yet an FDA-approved therapy, DARE to PLAY was designed to fill the void. And as MarDee mentioned upfront, we are making DARE to PLAY available as a Section 503B compounded product.

I want to reiterate again what we hear from health care providers and women because they continue to tell us the same 3 things about DARE to PLAY that uniquely resonates with them: It works fast; it was genuinely built by biotech; and studied for them. We also hear that following those Good Manufacturing Practices around potency and quality guidelines, so they know exactly what they're getting every single time is important.

And these are not baseless statements, they're what clinical data show and what compliance with GMP requirements validates. The pre-fulfillment prescribing for DARE to PLAY sildenafil cream, as you know, has been live across 50 states since February 2026, and the clinician response we continue to see is encouraging.

Bravado, the 503B registered outsourcing facility for DARE to PLAY, they're targeting dispensing to begin this summer as they continue to complete the necessary state licensing and fulfillment preparations. It's a significant milestone that we have been building toward.

Our 503B commercial model is asset-light and digitally native by design. We drive that consumer awareness through targeted digital marketing. Women can access DARE to PLAY through telehealth without an in-person office visit. It's a discrete, convenient option. Medvantx handles the fulfillment and dispensing through the DARE Health Hub with the quality infrastructure they already have in place.

And so I want to reiterate again about how we think about telehealth in our model. Telehealth is an access infrastructure. It's a critical tool for getting our products to the women who need them, but it's not the business model. We're not a subscription service. We're not a care navigation platform with the burden that those bring. We're a product company. We're using telehealth as one channel among several to deliver clinically studied differentiated solutions efficiently.

That's also why the provider relationship matters so much to us. Health care providers, again, the OB/GYNs, the women's health specialists, the primary care physicians, are not a channel to us, they are our clinical partners. When we say DARE to PLAY was built specifically for women and has been clinically studied in women, that means something to a provider in a way that a generic compounded cream does not.

When a clinician at ACOG asks how to stock our product in her office, she is not asking about a service. She's asking about a product she believes in and she wants to offer her patients directly. That's the kind of relationship we're building, and it's built on the credibility of the product itself. As we prove out what it costs to acquire a patient digitally, and how long they stay on the product and as dispensing commences this summer, we can add channels and scale the spend accordingly. And as our commercial footprint grows, we expect additional strategic collaborations with telehealth provider platforms, right, other ones, platform distributors and clinical networks, all in the service of getting our products to more women faster. So stay tuned.

And here is what makes our approach uniquely powerful. While DARE to PLAY is available for pre-fulfillment today through that 503B compounding pathway, generating real prescribing data, building clinician relationships and creating that patient demand, we are simultaneously working to advance our sildenafil cream towards the 505(b)(2) NDA pathway for FDA approval. Both can happen at the same time, and that's the power of building our products around well-characterized chemical entities, compounds with established safety databases.

We can start building a market for certain of our product candidates. We build that market while we build the regulatory file and the real-world data we generate through the 503B strategy, may ultimately strengthen our NDA submission. So to our knowledge, there is no company our size in women's health that has this kind of strategic flexibility, and it's a result of how deliberately we designed our pipeline.

And I want to take a moment to highlight what I believe is an underappreciated milestone for Dare and one that will mark the second quarter as a milestone for our company. Flora Sync LF5, which is our first DARE to RESTORE vaginal probiotics depository, that we are launching commercially in June of 2026. Seeding campaigns, so these are things designed to build clinician awareness and drive initial consumer trial. Those are beginning now in May ahead of that commercial launch.

We begin to expect recording revenue from Flora Sync LF5 in June. And this will mark the first time that we have recorded direct product revenue as a company. So it is a big milestone for our company and one that we believe changes how investors should think about our story.

The DARE to RESTORE products are probiotics designed to support vaginal microbiome balance. Flora Sync LF5 is a vaginal probiotic depository developed by Probiotical, one of the world's leading probiotic research companies. The formulation is based on scientific research into vaginal microbiome composition and health. It's been studied in a 100-person clinical trial, and the findings have been published in a peer-reviewed journal. Probiotical is the exclusive manufacturer using its proprietary LF5 strain.

We believe that level of clinical evidence distinguishes Flora Sync LF5 from the majority of vaginal probiotic depositories on the market today. And we expect it to be an important differentiator as we build the DARE to RESTORE brand. We intend to distribute DARE to RESTORE products through the DARE Health Hub, where we believe they will be complementary to our 503B prescription offerings. Health care providers may recommend DARE to RESTORE products alongside DARE to PLAY or other Dare products as part of a comprehensive approach to women's vaginal and sexual health.

Intimacy and intercourse can be one of the biggest disruptors of the vaginal microbiome and DARE to RESTORE Flora Sync LF5 is a reset and reconnect solution focused on balance, confidence, comfort and intimacy wellness.

Next, I'll walk you through other program updates and milestones we're targeting for 2026 and 2027. DARE to RECLAIM is our proprietary monthly intravaginal ring designed to deliver bioidentical estradiol and progesterone, targeting the estimated $2.5 billion to $4.5 billion compounded hormone therapy market.

Women are demanding alternatives to synthetic hormones. Bioidentical hormone therapy is a category on the rise, particularly with the removal of the black box warning. And we expect DARE to RECLAIM to be the first monthly intravaginal delivery solution in this space combining bio-identical estradiol and bio-identical progesterone.

We're targeting to have DARE to RECLAIM available for 503B prescription fulfillment in 2027, while simultaneously pursuing activities to support an NDA filing and a pivotal Phase III clinical study utilizing the dual path strategy.

Imagine the first monthly bioidentical hormone therapy IVR, including both estradiol and progesterone together in an estimated $2.5 billion to $4.5 billion market. That's what DARE to RECLAIM is positioned to be. And investors can invest in that potential today.

And Ovaprene. Ovaprene is our monthly, intravaginal, [Technical Difficulty] candidate. And earlier this week, we announced positive interim results from our ongoing Phase III clinical trial, and that's following the second planned interim analysis by the trial's independent Data Safety Monitoring Board, or DSMB.

The DSMB reviewed interim data and recommended the study continue without modification for the second time. This second consecutive positive DSMB review reinforces Ovaprene's potential as a meaningful hormone-free contraceptive alternative as it advances through its Phase III trial. The interim data showed that approximately 9% of women treated in the study had experienced a pregnancy. That rate is consistent with our expectations based on the results of the pre-pivotal postcoital test clinical study, as well as the last DSMB meeting.

There are no new types of adverse events or tolerability concerns identified, neither an increase or decrease in the frequency of adverse events, nor the emergence of new types of adverse events was observed with prolonged Ovaprene use. Approximately 12% of participants discontinued the study due to vaginal odor. That's the most commonly reported product-related adverse event. That rate, though, is a 5% decrease compared to the data reviewed by the DSMB last summer in July of 2025.

No serious adverse events related to the study device were identified and a majority of the participants who completed the study reported that they would be very likely or likely to use Ovaprene if it became available.

The DSMB reviewed data from 340 study subjects contributing nearly 1,800 menstrual cycles of safety data, and that's a meaningful proportion of the study's 2,500 cycle target. The study protocol calls for at least 2,500 cycles of exposure and 250 subjects completing 13 menstrual cycles of use. Based on the current enrollment trends, we would expect to achieve the 2,500 cycles of exposure before 250 subjects complete 13 menstrual cycles of use.

Importantly, the interim safety data suggests that prolonged product use was not associated with the emergence of new types of adverse events or an increased frequency of adverse events. And we believe that may support the sufficiency of fewer than 250 subjects completing 13 cycles to evaluate Ovaprene's safety profile. And we do intend to engage with the FDA regarding these findings.

So that's 2 consecutive positive DSMB reviews on Ovaprene and a pregnancy rate consistent with expectations, tolerability data that improved from the first interim look and a majority of users who say they would use it again. That's a differentiated potential first-in-category asset advancing through its pivotal clinical trial.

There are currently no FDA-approved, hormone-free monthly intravaginal contraceptives. And a growing number of women, particularly younger women, are actively seeking alternatives to hormonal contraceptive. Ovaprene is designed to be the answer. We currently expect to complete enrollment sufficient to achieve at least 2,500 cycles of exposure in 2026. And completing enrollment in 2026 puts the primary endpoint analysis within reach in 2027.

Now a little bit about DARE-HPV. DARE-HPV is perhaps our most underappreciated development program. An estimated 6 million women in the United States alone acquire a high-risk HPV infection every single year. And today, every single one of them is being managed with watchful waiting or surgery. There is no drug therapy. That represents a completely untreated patient population with a clear clinical need and no existing direct competition in the pharmacologic space.

High-risk HPV types are the underlying cause of virtually all cervical cancer cases in the United States, 99% of them. And for decades, women with persistent high-risk HPV infection have been told to watch and wait to monitor and hope that the virus clears on its own. If it doesn't, the only recourse has been surgery once those precancerous changes appear.

As I mentioned, there's not a single FDA-approved pharmacologic treatment for high-risk HPV infection, not one, and we are developing one with ARPA-H funding. So with that ARPA-H funding and FDA clearance of our IND application, which happened in February of this year, we are now preparing to advance DARE-HPV into a Phase II clinical study in May this month. DARE-HPV has the potential to be the first pharmaceutical therapeutic and one of the largest unaddressed infectious disease markets affecting women globally.

Significant addressed market, grant-funded development, advancing into Phase II clinical development, that's exactly the kind of asset that gets rerated when investors discover it, and we believe very few have.

Other potential first-in-category contraceptive candidates that we are currently developing are supported entirely with grant funding. That's DARE-LARC1, Casea S, and DARE-NHC, and they are all continuing to advance. We also have an extended NIH-funded award for DARE-PTB1, which is our bio-identical progesterone intravaginal ring candidate aiming to reduce the risk of preterm birth in at-risk women.

The pipeline was deliberately built to address the most persistent gaps from preterm birth to HPV-associated disease to sexual health and beyond. And every dollar of grant funding we secure, it's a dollar that moves us closer to putting better options in the hands of women without diluting our shareholders.

And I now want to speak directly to every investor on the call, institutional, retail and anyone who's listening to the replay. As I mentioned upfront, I'm joining this call from and during the National Women's Health Week in New York. And as I said upfront, the context matters. Women's health is an investment-grade category, and we believe Dare is the investment-grade vehicle to capture what is still a dramatically underfunded opportunity.

We're not here because it's the right week to say that, we're here because we have spent over 10 years proving it. We built the portfolio with clinical rigor, disciplined capital management and that unwavering commitment to women who have been underserved by the health care system for far, far too long.

And right now, in mid-2026, we're at that moment where all that investment converges into action. The products are coming live, and we expect to record the first direct product revenue this quarter. Demand is building, the data are coming, and we're poised for partnerships.

Women represent half of that global population and approximately 80% of all U.S. health care purchasing decisions are made by women. Conditions that solely affect women, the very conditions for which we are developing treatments, they're attracting less than 1% of private health care investment. Yet women's health drugs represent 27% of all blockbuster pharmaceutical products, and that's not even including GLP-1s. That's not a niche. That's a market failure that created a gap, and that's the gap that Dare was built to address.

And I want to also address a question that we hear as we're approaching commercialization. I get asked, are we an R&D company or are we a commercial company? And I answer, yes. We're in the business of getting first-in-category products into the hands of women who need them. That requires both. We will not stop developing. We have a pipeline that includes potential first-in-category programs across contraception, APV -- HPV, hormone therapy and vaginal health, all advancing, many with nondilutive funding. That R&D engine is running. And starting in June, that engine will be joined by a commercial engine, generating product revenue.

And here is how I want investors to think about that. Product revenue is not a pivot, it's not a change of identity, it's another source of capital, and it's a value driver. Grant funding, equity financings and our product revenue, they are 3 distinct complementary sources of capital that together let us continue building without depending on any one of them alone. And we don't need to choose between R&D and commercial. We're building a company that does both because the women we're working for, they need both, the science and the products. And we intend to deliver on both fronts simultaneously.

And here's what we're targeting to deliver, again, as a recap, DARE to PLAY dispensing. We're targeting commencement nationally this summer via Bravado as our 503B outsourcing facility partner. DARE to RESTORE, Flora Sync LF5 being the first such probiotic. The seeding campaigns are beginning this month in May, the commercial launch and first product revenue is expected in June. Again, I want to reinforce an important first step in building a multiproduct revenue profile for Dare.

Additional DARE to PLAY collaborations, as I said, stay tuned, commercial and telehealth collaborators to be announced as our channel infrastructure matures. DARE to RECLAIM dispensing, we are continuing to target 2027 for another 503B outsourcing facility with IND preparatory activities for what we've often referred to as DARE-HRT1, right, our hormone therapy product, ongoing pursuant to our dual path strategy.

Ovaprene, again, I want to reiterate that second positive DSMB review just happened and was just announced this week. The enrollment expected to complete this year to achieve that 2,500 cycles of exposure. That puts 2027 primary endpoint analysis within reach. And as I mentioned, we do plan on FDA engagement regarding those interim findings and study protocol.

And then DARE-HPV, that Phase II, we're preparing that right now with that ARPA-H funding, we're looking to start this month. So stay tuned on that. And hopefully, what you get with all of that is that we are not a single event binary bet, it's a portfolio with multiple catalysts and multiple pathways to value, multiple ways to win. With every prescription written for DARE to PLAY, we're building a real-world data set. Every Ovaprene patient enrolled in our Phase III moves us closer to data that will attract partners. And every clinician who prescribes one of our products can become an advocate for the next. We're building a platform, not just a single product.

And that year of clinical data on our specific formulations, that's data that a competitor can't replicate overnight. Established and growing relationships with telehealth providers, specialty pharmacies, clinical KOLs in women's sexual health and vaginal health right now, including that clinician community we engage with at ACOG and all the groundwork we're laying for the 505(b)(2) regular pathway that we believe will provide an opportunity to protect our market position after the 503B market matures.

And the brands, DARE to PLAY, DARE to RESTORE, DARE to RECLAIM that we're talking about right now, they're built around a clear resonant identity with women.

We're operating at a moment when the cultural and commercial conversation about women's health has never been louder. The fintech and women's health services sectors are attracting serious capital. Women are demanding that health care take their needs seriously. The rising tide is bringing many entrants, services, platforms, subscription models, there's real investment flowing in the category, and we think that is a good thing for awareness. And we also think it matters enormously what kind of company is doing the building.

Services can be copied, subscriptions can be undercut, but clinical data, that speaks for itself. Products can be real-world solutions. And we're a product company with a pipeline that is not reactive to a trend. We foresaw the trend, and it's exactly what the trend is calling for.

As I said on the last earnings call, the tide is rising in women's health, and Dare has been building its pipeline at low tide. So investors want to be in before the water rises and are looking at our company right now.

And with that, I'll turn it over to MarDee to give a financial review.

Thanks, Sabrina. Good afternoon, everyone.

I'll now walk through our financial results for the quarter ended March 31, 2026, and provide context on our balance sheet and forward financial positioning.

We ended the quarter with approximately $18.5 million in cash and cash equivalents and working capital of approximately $0.5 million. As a reminder, we continue to benefit from meaningful, nondilutive capital sources that help us advance our pipeline. In 2025, we received approximately $13.6 million from the Gates Foundation, $4.5 million under our ARPA-H Award and $1.3 million from NIH grant reimbursements. In February 2026, we received an additional $2 million under our ARPA-H Award. These sources have allowed us to advance multiple programs simultaneously while managing shareholder dilution responsibly.

Selling, general and administrative, or SG&A expenses for the first quarter of 2026 were approximately $2.2 million compared to approximately $2.3 million in the first quarter of 2025. The year-over-year decrease was primarily attributable to decreases in personnel costs, offset by increases in professional services and commercial readiness expenses, including preparations to bring DARE to PLAY and Flora Sync LF5, to market and stock-based compensation expense.

Research and development or R&D expenses were approximately $0.7 million for the first quarter of 2026 compared to approximately $2.3 million in the first quarter of 2025. I want to again highlight an important feature of our R&D expense reporting. We recognize nondilutive funding awards as contra R&D expense, meaning grant funding directly offsets our reported R&D costs. Contra R&D expense related to grant funding was approximately $3.5 million for the first quarter of 2026 compared to approximately $3.1 million for the first quarter of 2025. This means our actual total R&D investment when you add back contra R&D amounts is meaningfully greater than the R&D expense line alone reflects. We believe this is an important dynamic for investors to understand when evaluating the true scale of our R&D investment.

We expect to begin recording product revenue from DARE to PLAY in the third quarter of 2026. Flora Sync LF5 consumer health product revenue is expected to begin in June 2026. We are targeting DARE to RECLAIM revenue to begin in 2027. We are building toward a multiproduct revenue profile that diversifies and grows across 2026 and 2027. The initiation of direct product revenue in June 2026 for the first time in the company's history is a milestone we have worked hard to reach and one that we are proud to be approaching.

I want to offer a perspective on what product revenue means strategically. Dare has funded its development through a combination of equity financings and nondilutive grant funding. Product revenue will add a third leg to that stool, a capital source tied directly to the value we are delivering to patients and clinicians, one that we expect to grow as our commercial footprint grows and that reinforces the development mission rather than competing with it.

We encourage investors to review the more detailed discussion of our financial statements, financial condition, liquidity, capital resources and risk factors in our Form 10-Q for the quarter ended March 31, 2026, filed today.

Operator, please open the line for questions.

[Operator Instructions] We will take our first question from the line of Kemp Dolliver from Brookline Capital Markets.

Great. A couple of questions. First, with regard to the Ovaprene trial and the interplay between enrollment phase and cycles. Sabrina, what kind of impact could this have on the timing of the readout? Just to get a sense as to whether this is a matter of just a couple of months or whether it's potentially something more significant than that?

Yes. No, that's a fantastic question. So if you're just doing the simple math, right, 250 women completing 13 cycles, right, that's a lot more -- not a lot more, but it's more than 2,500 cycles or 250 women completing 12 months, right, might be the easier way to do it, the math clicking your head. And so obviously, it makes a difference.

And the -- What you're looking for with a product like this, I mean, part of the reason, right, in clinical development, we have targets is you don't know what you're going to see from a safety signal, what you might see over time. Ovaprene is very much a first-in-category product. It's the first ever once-a-month vaginal product, non-hormonal vaginal product that women are experiencing.

And so what's exciting about the data that we've seen to date and having the DSMB look at it is that we're not seeing a change in that safety signal over time. We're not seeing any modifications in terms of types of adverse events or when they're happening over the course of the women that have completed the 13 cycles to date.

And so yes, it can make a difference in terms of timing of -- completing the follow-up with the women in terms of timing in 2027, right, when we could be able to target that readout.

At this point, I can't give you more specific insights than that. We do want to engage with the FDA on what we've seen now because we think it's really promising, and we'd love to share it with them and get their perspective.

Okay. That's fair enough.

Switching to DARE to PLAY. The launch has slipped some as we've gone along. It looks like you're now closer to the finish line. What have been the factors that have impacted the timing of getting to the point where you can do nationwide fulfillment?

Yes. We're really trying to work closely with our partner, I refer to them as partner, but the 503B outsourcing facility, Bravado, that really is doing the work, right? They're the ones doing the manufacturing. They're the ones really that have to ensure that they're commercially ready. And that obviously involves GMP, right, Good Manufacturing Practices, having the readiness to supply the product and meet commercial demand, obviously critical.

The other piece of it, though, is state-specific registration activities that a 503B outsourcing facility is required to do. They've been doing a fantastic job with that. Most 503B facilities are not registered across the country. So they have been going through that process. They're up to, I think it's 28 or so registrations at this time. So it's really balancing all of those factors.

And we want to prioritize doing this right, right, and making sure that when the product becomes commercially available via the dispensing, that everything is ready on the Bravado side to ensure that they can have that quality and consistency of supply and that it's meeting the demand. So that's really what it's coming down to and that as many women -- when it becomes commercially available initially, that as many women across the company -- across the country can access it as possible.

There are some states that simply will not allow dispensing in their state until they can review data from other states showing like shipping and quality standards. So there are some states that are going to be a little behind. But it's -- That's all what's behind it.

[Operator Instructions] Our next question comes from the line of Kemp Dolliver from Brookline Capital Markets.

Just quickly, what is -- how are you thinking about the cash runway at this point?

Yes. So as we said in the 10-Q when you get to the details on that, our cash, we have cash that's for grant-funded activities, right, because we have a lot of grant funding that we receive for a number of our programs and then cash that we can use for general operating activities. And without the impact of obviously any of these revenue opportunities that we're talking about, if you just like looked in the vacuum at where we are on cash, we will need to raise. We don't have 12 months of capital from that perspective. And so it's always something that we're looking at.

Obviously, that doesn't take into consideration the revenue inflows that we project for the products, that's just cash in hand today without any of that looking.

And then also the other piece of it is the grant-funded activities, those activities, there's always kind of future disbursements that come with those grants as well. So I know sometimes it's confusing when people are looking at our cash and our grant liability to try to understand where things are. Some of it's the GAAP accounting piece of it that means things don't always line up. But those are the 2 ways we use our capital. It's for the grant-funded activities and then it's for operations like supporting the DARE to PLAY launch, supporting DARE to RESTORE.

So it's fair to say it's at least a couple -- it may not be 12 months, but it's a couple of quarters?

Yes.

That concludes the question-and-answer session. I would like to turn the call back over to Sabrina Martucci Johnson for closing remarks. Please go ahead.

Absolutely. Thank you.

Well, thank you, everyone, for participating today. As we talked a little bit about, women's health has been dismissed, it's been deprioritized, it's been underfunded for generations. And the conditions that we address at Dare, arousal, vaginal health, menopause, contraception, HPV, these affect hundreds of millions of women worldwide. They're not rare diseases. They're common experiences that have been met far too often with inadequate options, clinical dismissal or simply nothing at all.

And we're founded on the belief that women deserve better, and that belief has guided every decision we've made, including the decision to be a product company to do the hard, rigorous work of developing the clinical data and building formulations that providers and patients can trust. That choice was deliberate.

And clinician and patient awareness of DARE to PLAY is growing. As I mentioned, we saw those providers at ACOG who are already writing prescriptions and asking us how to stock the product in their offices. As we just mentioned, dispensing is targeted for this summer. And that -- the Flora Sync LF5, the seeding campaigns are beginning and commercial launch and first product revenues targeted for June.

We talked a lot about that interim data from our Ovaprene Phase III trial that we just received, that second consecutive DSMB review. And Ovaprene is a product that could be the first FDA-approved, hormone-free, monthly contraceptive. And I highlighted a few things about the pipeline behind it, which is deep and differentiated and advancing.

A commercial company and an R&D company, we're entering a phase where both are true for us simultaneously and where product revenue becomes just one more source of capital to fund the science that will produce the next generation of solutions that will, in turn, generate revenue. And that's the model working exactly as we designed it. We built the company to change how women experience health care, and that change is beginning in earnest right now.

And I just thank all of you for your confidence and for being owners. We believe the assets we hold, the catalysts ahead and the window of time we're in, represent a compelling opportunity, and we intend to execute on it.

And June 2026 may be the month investors look back on as the moment that we became that revenue stage company and without ever stopping being a science-driven one.

So thank you for your time today, and I look forward to keeping you updated.

Thank you so much. Ladies and gentlemen, this concludes today's call. Thank you all for joining. You may now disconnect.

Welcome to the conference call hosted by Dare Bioscience to review the company's 2025 financial results and to review -- provide a business update. This call is being recorded.

My name is Desiree, and I will be your operator today. With us today from Dare are Sabrina Martucci Johnson, President and Chief Executive Officer; and MarDee Haring-Layton, Chief Accounting Officer. Ms. Haring-Layton, please proceed.

Good afternoon, and welcome to the Dare Bioscience Financial Results and Business Update Call for the year ended December 31, 2025. Today, we will review our financial results, provide updates on our clinical pipeline and discuss the continued execution of our expanded business strategy. That strategy includes a dual path approach, commercializing proprietary formulations through 503B compounding while pursuing FDA approval and advancing select solutions as branded consumer health products that do not require a prescription.

In all cases, our goal is to bring innovative women's health solutions to market as efficiently and quickly as possible. I would 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 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-K for the year ended December 31, 2025, which was filed today. Please note that the content of this call includes time-sensitive information that is current only as of today, March 26, 2026. Dare undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law.

I would also like to point out that when we use the term 503B compounding during this discussion, we are referring to compounding drug products by outsourcing facilities registered under Section 503B of the Federal Food, Drug and Cosmetic Act using both drug substances on the FDA's interim Category 1 list. I will now turn it over to Sabrina.

Thank you, MarDee. Good afternoon, everyone, and thank you for joining us. 10 years ago, we made a decision to focus exclusively on women's health, not as a sideline, not as a franchise within a broader portfolio as our entire reason for existing. Every dollar raised, every clinical trial run, every regulatory submission prepared, every partnership negotiated, all of it for one purpose. Building the company with the most comprehensive pipeline comprised exclusively of differentiated products for health issues and conditions that uniquely impact women. From contraception to menopause, sexual health to fertility, vaginal health to infectious disease, we're working to close critical gaps in care with science that meets her needs.

What distinguishes Dare is not just the breadth of the pipeline, but the strategy behind it. A disciplined approach to capital allocation, the payers non-dilutive grant funding with focused development, moving multiple programs towards the clinic simultaneously. That's not a single product bet, that's a portfolio of strategy, built from the ground up for one of the most chronically underfunded areas in all of medicine despite affecting half the world's population. We're not a company that's just getting into women's health, we are a women's health company, and 2026 is the year investors get to see what 10 years of that commitment actually looks like.

I want to take the next few minutes to share why we believe the investors who pay attention to the story right now will be glad they did. And the best place to start that story because it's already happening in the market, is DARE to PLAY. Pre-fulfillment prescribing for DARE to PLAY sildenafil cream went live in February 2026 across all 50 states, and we're just getting started. DARE to PLAY is a first of its kind topical arousal cream for women. To our knowledge, there is no other sildenafil topical cream manufactured under GMP requirements with clinical data demonstrated increased general blood flow in just 10 to 15 minutes and improvements in arousal, orgasm and desire measured by clinically validated and FDA reviewed endpoints. Men have had Viagra in their medicine cabinet for over 25 years. Women have had nothing clinically studied and developed specifically for them until now.

An estimated 20 million women in the United States alone report challenges related to genital arousal. There's not a single FDA-approved therapy that directly addresses this need, not one. And while there's not yet an FDA-approved therapy, DARE to PLAY was designed to fill that void, and we're making DARE to PLAY available as a Section 503B compounded product. In December of 2025, prescription intake commenced through the DARE Health Hub, powered by Medvantx Pharmacy, our fulfillment partner, initially in just a handful of states.

That rapidly expanded -- as of February 11, 2026, DARE to PLAY is available for pre-fulfillment prescriptions in all 50 states. Telehealth access launched at the same time so that women in most states can now receive a DARE to PLAY prescription, if it's appropriate for them without ever leaving their home. Prescribers are writing, women are engaging with telehealth. And we expect dispensing to begin in the coming months as the 503B outsourcing facility completes certain state licensing and other fulfillment preparations.

Women are finding their way to the DARE Health Hub, working through the telehealth process and providers are already submitting prescriptions. The market is getting ready before we've even opened the commercial faucet. And you may be wondering why women would want to obtain a prescription for a product that isn't even being dispensed yet when a pharmacy could compound a custom sildenafil cream for them right now.

And that's the question we love because the answer is decisive. Every custom Rx pharmacy compounded prescription sildenafil cream on the market may have been formulated to fill a prescription for women, but not one of them was ever actually studied in women to evaluate whether or how it works in female physiology. They assumed it. DARE to PLAY is the only formulation that's backed by published clinical studies. DARE to PLAY is the only product backed by clinical data in women specifically formulated and demonstrated to increase general blood flow within just 10 minutes of application, studied for female response and manufactured in accordance with FDA's current good manufacturing practice regulations, or GMP, and related product quality standards. That means consistent potency and quality guidelines that custom Rx prescription pharmacy section 503A compounders simply cannot guarantee.

Health care providers and women tell us the same 3 things about DARE to PLAY that uniquely resonate with them. It works fast. It was genuinely built by biotech and studied for them. And following GMP potency and quality guidelines, they like that. So they know exactly what they're getting every single time. And these are not baseless statements. There was the clinical data show and what compliance with GMP requirements validates.

Our 503B commercial model is digitally native by design. We drive consumer awareness through targeted digital marketing. Women can access DARE to PLAY through telehealth without an in-person office visit, a discrete and convenient option. Medvantx handles fulfillment and dispensing through the DARE Health Hub with the quality infrastructure they already have in place. The daretoplaybio.com website is the conversion engine.

The conferences we attend to build health care provider credibility and patient community simultaneously. And as we prove out what it costs us to acquire a patient digitally and how long they stay on the product, and once dispensing commences in all 50 states, we can add channels and scale spend accordingly, layering in platform distribution partnerships from a position of leverage, not dependency and that's the playbook for a capital-efficient, strategically sequenced launch that we believe will maximize value for shareholders. As our commercial footprint grows, we expect additional strategic partnerships with telehealth platforms, platform distributors and clinical networks. So please stay tuned.

And here else is what makes our approach uniquely powerful. While DARE to PLAY is available for pre-fulfillment today through the 503B compounding pathway, generating real prescribing data, building clinician relationships and creating patient demand, we continue to simultaneously work to advance our sildenafil cream towards the 505(b)(2) NDA pathway for FDA approval at the same time, and that's the power of building our products around well-characterized chemical entities, compounds that have established safety databases.

It means we can start building a market for certain of our product candidates and we build that market while we are simultaneously building the regulatory file and the real-world data we generate through our 503B strategy may ultimately strengthen our NDA submission. To our knowledge, there is no company of our size in women's health that has this kind of strategic flexibility. It's a direct result of how deliberately we designed our pipeline. DARE to PLAY is the most immediate new revenue story.

So I wanted to start there because it's happening. But now let me step back and make a broader statement about what we've built because I believe most investors have not yet grasped the full scope of it. To our knowledge, Dare Bioscience has the most robust development stage pipeline of any company in the world developing products exclusively for conditions that solely affect women.

We have not been able to identify another company with a comparable portfolio. So let me walk you through the most advanced programs in that portfolio. In addition to 503B compounding, we're working to bring to market in the United States, a line of consumer health products, branded as the DARE to RESTORE family. DARE to RESTORE products are probiotics designed to support vaginal microbiome balance. Our first DARE to RESTORE product, Flora Sync LF5, a vaginal probiotic suppository developed by Probiotical, one of the world's leading probiotic research companies is expected to become commercially available in the United States in the second quarter of 2026, this year.

The formulation is based on scientific research into the vaginal microbiome composition and health. It's been studied in a 100-person human clinical trial. Findings have been published in a peer-reviewed journal. Probiotical is the exclusive manufacturing using their proprietary LF5 strain. We believe that level of clinical evidence really distinguishes Flora Sync LF5 from the majority of vaginal probiotic depositories on the market today, and we expect it to be an important differentiator. We intend to distribute DARE to RESTORE products through the DARE Health Hub. These vaginal probiotic products are intended to be complementary to our 503B prescription offerings. Health care providers may recommend DARE to RESTORE products alongside DARE to PLAY or other Dare products as part of a comprehensive approach to women's vaginal and sexual health. We also expect to continue exploring opportunities to expand the DARE to RESTORE commercial offering through additional collaborations, including with Probiotical.

DARE to RECLAIM is our proprietary monthly intravaginal ring designed to deliver bioidentical estradiol and progesterone, targeting the estimated $2.5 billion to $4.5 billion compounded hormone therapy market. Women are demanding alternatives to synthetic hormones and bioidentical hormone therapy is a category on the rise. And DARE to RECLAIM is designed to be the first monthly intravaginal delivery solution in this space that includes both bioidentical estradiol and bioidentical progesterone together in 1 product.

We're targeting to have DARE to RECLAIM available for 503B prescription fulfillment in 2027, while simultaneously pursuing activities to support an IND filing for a pivotal Phase III clinical study again, utilizing the dual path strategy of executing on both fronts at once. Imagine being the first monthly bioidentical hormone therapy, intravaginal ring, including both estradiol and progesterone together in that estimated $2.5 billion to $4.5 billion market. That's what DARE to RECLAIM is positioned to be and investors can invest in that potential today.

And now Ovaprene. Ovaprene is our monthly intravaginal hormone-free contraceptive candidate. And it's among the programs that I believe carries some of the most extraordinary long-term value in our portfolio because the contraceptive market is large and it is shifting, a growing number of women, particularly younger women are actively seeking alternatives to hormonal contraception. They're demanding effective, convenient, non-implanted, nonhormonal options. That demand is real and it's growing. And the current market has nothing to offer beyond in-the-moment solutions like condoms or vaginal gels. And Ovaprene is in a Phase III pivotal trial right now. As you may recall, the Data Safety Monitoring Board reviewed interim data in July of 2025, and they recommended that the study continue and that we continue enrollment without modification.

We are now happy to let you know that we currently anticipate enrollment to complete this year and completing enrollment in 2026 puts the 2027 data readout in reach. And with it comes the potential PMA pathway for what could be the first non-implanted nonhormonal monthly contraceptive option on the market. This asset alone in a world actively demanding nonhormonal contraception has partnership and licensing potential that we believe the market has dramatically undervalued.

And speaking of undervalued, I want to turn to DARE-HPV, which is perhaps our most underappreciated program given its potential. Roughly 6 million women in the United States alone acquire a high-risk HPV infection every year. And today, every single one of them is being managed with watchful waiting or surgery. There is no drug therapy and that represents a completely untreated patient population with a clear clinical need and no existing direct competition in the pharmacologic space.

High-risk HPV types are the underlying cause of virtually all cervical cancer cases in the United States, 99% of them. For decades, women with persistent high-risk HPV infection have been told to watch and wait, to monitor and hope that the virus clears on its own. And if it doesn't, the only recourse has been surgery. Once precancerous changes appear, there's not a single FDA-approved pharmacologic treatment for high-risk HPV infection, not one. And we're developing one with ARPA-H funding. With FDA clearance of our IND application just this February of 2026, we are now preparing to advance DARE-HPV into a Phase II clinical study later this year. DARE-HPV has the potential to be the first pharmaceutical therapeutic and one of the largest unaddressed infectious disease markets affecting women globally.

Significant unaddressed market, grant funded development, advancing into Phase II. That's exactly the kind of asset that should get re-rated when investors discover it, and we believe very few have.

And in addition to the portfolio programs that I just highlighted, other potential first-in-category contraceptive candidates currently supported entirely with grant funding, DARE-LARC1, Casea S and activities will aid in the identification and development of a novel nonhormonal intravaginal contraceptive candidate suitable for and acceptable to women in low- and middle-income country settings, who need or would prefer to use such a product to avoid unplanned pregnancy. Those programs continue to advance with that 100% grant funding.

And we also recently announced an extension of an NIH award for DARE-PTB1, which is our bioidentical progesterone intravaginal ring candidate aiming to reduce the risk of preterm birth in at-risk women. Our pipeline is deliberately built to address the most persistent gaps from preterm birth to HPV, associated disease to sexual health and beyond and where we can use strategic non-dilutive funding like the foundation and NIH grants I mentioned and ARPA-H grants to advance that work, we will. Every dollar of grant funding we secure is a dollar that moves us closer to putting better option in women's hands without diluting our shareholders.

And I want to speak directly to every investor on this call, institutional retail and everyone who listens to the replay. We spent 10 years building this, and we did it the right way with clinical rigor, disciplined capital management and with an unwavering commitment to women who have been underserved by the health care system for far too long. And right now, in early 2026, we're at the moment where all of that investment converges into action. Products are coming live, demand is building, data is forthcoming. We're poised for partnership and revenue is on the near-term horizon.

Women represent half the global population yet women's health received just 6% of private health care investments. And conditions that solely affect women, the very conditions we're developing treatments for attract less than 1%. That's not because it's a niche. That's a market failure, and it is exactly the gap that Dare was built to address. And the investors who will look back and say they saw this coming are the ones paying attention right now.

Before the prescriptions become revenue, before the Ovaprene data reads out, before DARE to RECLAIM enters the estimated $2.5 billion to $4.5 billion hormone therapy market and before DARE-HPV data readout, the story is being written today. And this is the catalyst stack that we're targeting to deliver this year. DARE to PLAY dispensing scaling nationally in the coming months, with revenue expected to begin in the second quarter of this year. Additional commercial and telehealth partnerships for DARE to PLAY to be announced as our channel infrastructure matures.

DARE to RESTORE, Flora Sync LF5 advancing towards commercial availability in the U.S. consumer health market in the second quarter of 2026. DARE to RECLAIM targeting 503B commercial availability in 2027 with IND preparatory activities ongoing pursuant to our dual path strategy.

Ovaprene Phase III enrollment expected to complete this year. And as I mentioned, completing enrollment in 2026 puts the 2027 data readout within reach. and DARE-HPV preparing to advance into Phase II this year with our ARPA-H funding. So this is not a single event binary bet, it's a portfolio with multiple catalysts, multiple pathways to value and multiple ways to win.

And here's what I want you to understand about our competitive position. We believe we're positioned for advantages that compound over time with every prescription written for DARE to PLAY, we build the real-world data set that strengthens our NDA submission. Every Ovaprene patient enrolled moves us closer to data that will attract partners. Every clinician who prescribes one of our products becomes an advocate for the next. We're not starting over with each product, we're building a platform on years of clinical data, data that is difficult to replicate, establish relationships with telehealth providers, specialty pharmacies and clinical KOLs and women's sexual health and vaginal health and beyond.

Groundwork laid for the 505(b)(2) regulatory pathway that we believe provides an opportunity to protect and expand our market positions after the 503B market matures and brands DARE to PLAY, DARE to RESTORE, DARE to RECLAIM built around clear resonant identity with women.

We're operating at a moment when the culture and commercial conversation about women's health has never been louder. The femtech and the services sectors are attracting serious capital. Women are demanding that health care take their needs seriously. Payers and providers are beginning to respond and political and media attention on women's health, including contraception, sexual health and menopause is at historic highs.

And Dare Bioscience is not trying to ride that wave, we were building for it for a decade before it arrived. Our pipeline is not reactive to a trend, it foresaw the trend and exactly what the trend is calling for. The tide's rising in women's health, and we have been building our pipeline at low tide, to investors who want to end before the water rises are looking at our company right now. And with that context, I'll turn it back over to MarDee for the financial review.

Thanks, Sabrina. Good afternoon, everyone. I will now walk through our financial results for the full year ended December 31, 2025, and provide context on our balance sheet and forward financial positioning. We ended the year with approximately $24.7 million in cash and cash equivalents and working capital of approximately $3.4 million. During 2025, we received approximately $20.8 million in net proceeds from sales of common stock under our ATM facility and equity line agreement.

Additionally, we received non-dilutive capital that contributed to strengthening our balance sheet in 2025, including approximately $13.6 million received from the Gates Foundation, $4.5 million received under an ARPA-H award and $1.3 million received from NIH grant reimbursements. Together, these sources allowed us to advance multiple programs simultaneously while managing shareholder dilution responsibly. Selling, general and administrative, or SG&A, expenses for the full year were $8.8 million compared to $9.2 million in 2024. The year-over-year change was primarily driven by decreases in stock-based compensation expense, personnel costs and general corporate overhead expenses. Such decreases were partially offset by increased commercial readiness expenses primarily for DARE to PLAY and increased professional services expenses. Research and development, or R&D, expenses were $5.5 million for the full year compared to $14.3 million in 2024.

I want to highlight an important feature of our R&D expense reporting. We recognize non-dilutive funding awards as contra R&D expense, meaning grant funding directly offsets our reported R&D costs on our income statement. In practical terms, this means we are investing more in R&D than our reported R&D expense line suggests. Contra R&D expense, reflecting grant dollars received was $13.9 million in 2025 compared to $7.7 million in 2024. In other words, while reported R&D expenses declined year-over-year are actual total R&D investment when you add back contra R&D amount was much closer between 2025 and 2024 than the R&D expense line alone reflects. We believe this is an important dynamic for investors to understand when evaluating our capital efficiency with the use of grant funding and the true scale of our R&D investment.

We expect to begin recording product revenue from DARE to PLAY in Q2 2026 as dispensing commences nationally. Flora Sync LF5 consumer health revenue is also expected to begin in Q2 2026. We are targeting to begin recording revenue from DARE to RECLAIM in 2027. We are building toward a multiproduct revenue profile that diversifies and grows across 2026 and 2027.

We encourage investors to review the more detailed discussion of our financial statements, financial condition, liquidity, capital resources and risk factors in our Form 10-K for the year ended December 31, 2025, filed today. Operator, please open the line for questions.

[Operator Instructions]

Our first question comes from the line of Catherine Novack with JonesTrading.

This is Leona on for Catherine. When was your last interaction with FDA on sildenafil cream and what are the next steps for clinical development in the 505(b)(2) regulatory path? And I'll ask a follow-up after.

Thanks for the question. So just a reminder of everyone. So we did have interactions with the FDA last year. And really, at this point, what we are looking at with that program is making sure that we're 100% aligned on the endpoints, the primary endpoint for the trial and not so much the arousal part. Our arousal questions are really clear and straightforward. But what else in terms of any kind of interpersonal challenges should constitute part of that co-primary assessment and how specifically that's going to be analyzed for part of the statistical -- like as it pertains to the statistical analysis plan and success.

So we want to make sure that we're very clearly aligned on that and our interactions with the FDA, particularly the last set of interactions in 2025, were really to make sure that we were sharing and providing and discussing together the various assessments that were included not only in the Phase IIb study, but also the work we had done prior to that in the content validity study, which really is a study that helps you ascertain what questions or content valid and fit as patient-reported outcomes to make sure that we're all thinking together at a full picture of what makes sense for this particular indication, which is really focused on improvement of genital sensations of arousal, very analogous couldn't be more analogous to a erectile dysfunction because the clinical definitions are the same.

And so we're working closely with the FDA to make sure that there are endpoint frameworks that are reflective of the similarity between the conditions and the unmet needs. That dialogue is ongoing.

Okay. And then do you need to conduct any additional safety studies? Or will the submission rely on existing data for like systemic sildenafil in women?

Yes. The data we've collected from a safety perspective and what would be planned in the Phase III would certainly be sufficient. I mean one of the things that has been, I would say, fantastic about being able to formulate a product like this into a topical formulation that achieves the blood flow objectives that we want is that it's really been designed to target those tissue and get that very rapid increase in temperature that we've seen quantitatively in the published study within that first 10 to 15 minutes of application without really significant systemic uptick, and in fact, we're 2 orders of magnitude lower than what you would see with a comparable sort of oral dose as seen in the male studies.

And that's really been the objective is to make sure that we keep that systemic exposure very low, so we don't get those off-target effects of headache and flushing. That would not be supportive of the objective of the product in terms of enhancing arousal, but we just get that localized effect.

And so we really did not see any difference in the Phase IIb study and the safety data are all published between the placebo group and the active group in terms of adverse event profile.

Our next question comes from the line of Kemp Dolliver with Brookline Capital Markets.

What are you seeing with the order patterns so far for DARE to PLAY?

Yes. Great question and one we anticipated and they're excited to get to talk about. And what's been exciting about it, I would say, is that we're in this pre-fulfillment phase for the product, while our 503B collaborator continues certain activities. So prescriptions are coming in, but they're not being dispensed yet. And what has been exciting about it is that we're seeing a mix of prescriptions coming in from brick-and-mortar providers, right?

People that we have been engaging with the conferences who have gotten to know the product and are excited to write it for their patients when they see their patients even though it's not dispensing yet, but they want to make sure they get that prescription in for their patient, and they want to make sure that they are letting their patient know, right, that there's a solution like this that is going to be available for them that actually has clinical data, has published peer reviewed findings as well as women engaging with telehealth.

So we're really seeing that both of those channels are active and relevant and so that's been really helpful for us to understand and particularly early in this awareness and education campaign. It's been very nice to be able to have these kind of data to help us see that both channels are important because this is a product that resonates with the health care provider.

It has the data, it has the peer-reviewed publications that they looked like -- they look to and we don't have to solely rely on a consumer channel and to see the breadth of both. So more to follow on that as these convert to orders as they start dispensing and we will, in the coming months, be able to and start to provide more clarity, as I alluded to, in terms of that channel strategy, that approach, acquisition costs.

But right now, the focus has been on that very digital-focused campaign to make sure that consumers are aware of what's available. But also, we've really been attending the conferences and doing the provider to provider education that is very relevant for a product like this that has published clinical data in their most trusted journals for products like this.

And how are you thinking about promoting DARE to RESTORE which really looks -- as you say in the press release, it's a consumer/OTC product?

Great. Another great question. And you really hit something important, which is it does not require a prescription, right? These are products that consumers -- these types of products are something that a consumer is a little more familiar with. I will say it's also in a category of products that a number of consumers do also engage with their health care provider to understand what their health care provider recommends. And so we're going to be able to leverage here some of the same channels that we're leveraging for DARE to PLAY. It will certainly appear on the DARE Health Hub which is where someone who's getting a DARE to PLAY prescription will be going. So it will appear right there as something that can also be purchased at the same time.

We will also be similarly engaging in a very digital native sort of strategy in terms of creating very focused and targeted strategy in the digital channel to create awareness and drive conversion through the DARE Health Hub and through the website. But also, we will be participating in medical conferences and showcasing this product at those conferences because it is very distinct in the fact that there are peer-reviewed published data on both the strain itself and on the final finish formulation.

And we think that's something that health care providers will be very interested in. And there is a whole category of health care providers that are starting to recognize that for some women, they may be interested in obtaining products while they're in that office visit, right, with that health care provider and so those are other channels that we're also looking at, very analogous to the derm space that's very mature, right, in that regard in terms of the kind of products that are sometimes also available in your clinician's office. And so for those clinicians where this becomes a very trusted solution for them, we see those channel opportunities as well.

Our next question comes from the line of Douglas Tsao with H.C. Wainwright.

Sabrina, I guess, on DARE to PLAY, it sounds like you're doing a lot of work in terms of physician education. I know you've also done some work with different online sort of platforms as well. I guess, how do you envision or what you could see as the bigger driver of volume ultimately. Will it be some of the different sort of telehealth and sort of subscription model platforms? Or do you see it being more driven by prescribers?

Yes. It's a fantastic question, and it's something that we have been looking at very closely and monitoring very closely. And as I noted in the comments, one of the things that we want to make sure that we understand very clearly as we look at these various platforms is making sure that we understand in the channels that we have available to us today as well as what those conversations look like, right, with those other telehealth providers and platforms, what the patient acquisition cost -- customer acquisition cost is in those various scenarios paired with their reach, right, kind of their reach in there and the number of touch points that they have.

And what we want to make sure that once dispensing commences in all 50 states, right, that we have all of those -- it's available in all of the states, and we have been collecting all of these data that we're making sure that we're layering in these partnerships with a financial structure that makes sense to extend the reach and the touch points for the product. But in a smart, right? In a smart structure that takes into consideration the various acquisition costs in the channels that we have been in already as well as the reach in those channels. And so it's really coupling all those factors together, right? How many patients, right? How many touch points, how many users do they already have on a particular platform, right? What is that relationship going to look like with them to access those people. Where do the cultures align and this product fit nicely there.

I feel like there's a new telehealth platform stood up every day, practically for women's health right now because it's become a very hot area. And we want to make sure that there is financial stability, there's solid alignment culturally and with the product fit. And then again, there's a financial structured model that makes a lot of sense from a cost of acquisition perspective and reach for this product.

And so those are the things that we've been evaluating. And we do -- we want to make sure that the product is available in all of the channels that make a lot of sense both in terms of reach and demand and to make sure it's available where women are going for their care. So those are the factors that we're looking at.

And I guess, as a follow-up question. And I hear your point earlier in terms of -- you're the only product that's actually been tested. And I guess it's hard and it's like thinking about like sort of the GLP-1 class, right, where they have a lot of compounded products out there as well. How do you necessarily -- but I think with your product, they're arguably more formulation differences that are arguably more important, right, to distinguish your product from other products that are out there, how are you able to -- or how are you thinking about being able to convey that message very broadly to sort of make sure that patients don't try some of the alternative formulations and sort of give up on sort of the topical sildenafil and ultimately, sort of market share coalesces around your product?

Yes, absolutely fantastic question. So -- and you kind of hit the nail on the head in two. So one, on the one hand, the GLP-1 experience that people have had have given people perhaps an impression that you can go anywhere, right, and get the same product. But of course, there are already initiatives underway in that category to educate around that and make sure it's aware. But you also touched on something super important with regard to this formulation, which has been very compelling to people. And it's very easy, both for health care providers, and we found it's very easy messaging with the consumer, to explain that when you're putting something on your skin, the formulation matters, right? We -- women have used a lot of different topical products. We use face creams every day, we use whatever, right? And being able to explain that what is key here is that this is a very important medicine that needs to get into the skin and that you can't just mix something together and do that.

And what it really resonates more than that statement is the fact that we have clinical data demonstrating increase in blood flow, which is basically a surrogate for, right, the arousal sensations that the blood flow is going to cause within 10 minutes. And when a clinician or a consumer looks at any compounded sildenafil cream product that is not DARE to PLAY with our DermaFlux technology inside of it to drive that sildenafil into the tissue.

They all talk about, put it on at least 30 minutes before or longer because they don't have the data. That time factor resonates more than anything. And so with a health care provider, we're able to get into that more complex conversation with them around the clinical work that's been done and the formulation technology and why that matters. That resonates very clearly with them, and they understand it. And with the consumer, it's really about time to effect and that there are -- this has been engineered by biotech specifically for them.

So I guess as a follow-up, though. So in terms of clinicians, I guess that sort of requires sort of traditional sort of sales promotion/detailing? And with consumers, I guess it is some generally kind of mixed through DTC advertising? And are you able to sort of defray some of that cost because DTC can be expensive with some of the different sort of eHealth or partner sort of -- partnerships that you have in place to help with those costs?

Yes, absolutely. And the other way to think about this, again, the world has really changed significantly in terms of -- and I'm going to refer to the influencer space. And I don't mean influencers who have, I don't know, no knowledge of clinical science or medical science, but I'm talking about health care providers who have very significant followings because they have been educators and are sharing knowledge in an area that women are very desperate and hungry to get information around.

So these are the kind of channels. Like when we're talking about enhancing our digital -- our focus around education, these are a lot of the channels that we -- that you'll be seeing more and more, right, as this product starts dispensing, that are getting utilized because these are trusted clinicians, trusted voices that are looking for brands, products solutions that they can get behind.

And I think the other thing to really highlight, and we have seen this at every conference that we've been to, DARE to PLAY is one product, but Dare Bioscience is a brand in and of itself, right? We've run so many clinical trials, so many health care providers have worked with us on one of our studies, right? They are proudly telling their friends, their peers about the products. So we're also very much leveraging, I would call it, provider-to-provider education and provider-to-provider promotion, marketing, for lack of a better word because we have credibility as a builder of solutions for the women that they serve, and many of them have worked with us and that's not something that a compounder, for instance, is going to be able to do. And it really resonates.

That concludes the question-and-answer session. I would like to turn the call back over to Sabrina Martucci Johnson for closing remarks.

Well, thank you. And I definitely want to close to something that I feel deeply and it ties into some of the questions that we just went through, right? So women's health has been dismissed. It's been de-prioritized, it's been underfunded for generations. And the conditions that we address at Dare Bioscience from arousal, vaginal health, menopause, contraception, HPV, these are conditions that affect millions of women worldwide, right? They're not rare. They're common experiences that have been met far too often with inadequate options, clinical dismissal, lack of data or simply nothing at all. And Dare Bioscience is founded on the belief that women deserve better, and that belief has guided every decision we have made.

I started Dare because I believe women's health was both a moral imperative but also a compelling strategic opportunity. And 10 years in, I believe that more than ever, DARE to PLAY is entering the market. And as we just discussed, women are getting prescriptions and clinicians are engaging and telehealth is live and is a great access path and the pipeline behind DARE to PLAY, it's deep, it's differentiated, and we're finding ways to advance it. So we built this company to really change how women experience health care and that change is beginning in earnest now.

And so to our investors, thank you for your confidence and for being owners, we believe the assets we hold, the catalysts that I outlined that are coming up and this window of time that we are in represent a compelling opportunity, and we intend to execute on it. So it's 10 years of building, but the commercial inflection is here and the pipeline is deep and the market is ready. And Dare Bioscience in 2026 is a story that is just beginning to be told. I think the investors who had conviction in the first chapter will be the ones you remember this call. So I thank you all for participating today and look forward to more updates in 2026.

Ladies and gentlemen, that concludes today's call. Thank you all for joining, and you may now disconnect.

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.

Welcome to the conference call hosted by Daré Bioscience to review the company's third quarter 2025 financial results and to provide a business update. This call is being recorded. My name is [Jericho], and I will be your operator today. With us today from Daré are Sabrina Martucci Johnson, President and Chief Executive Officer; and MarDee Haring-Layton, Chief Accounting Officer. Ms. Haring-Layton, please proceed.

Good afternoon, and welcome to the Daré Bioscience Financial Results and Business Update Call for the quarter ended September 30, 2025. Today, we will review our financial results, provide updates on our clinical pipeline and discuss the continued execution of our expanded business strategy. That strategy includes a dual path approach, commercializing proprietary formulations through 503B compounding while pursuing FDA approval and advancing select solutions as branded consumer health products that do not require a prescription.

In all cases, our goal is to bring innovative women's health solutions to market as efficiently and quickly as possible. I would 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 fact 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 September 30, 2025, which was filed today in our Form 10-K for the year ended December 31, 2024. Please note that the content of this call includes time-sensitive information that is current only as of today, November 13, 2025. Daré undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law.

I would also like to point out that when we use the term 503B compounding during this discussion, we are referring to compounding drug products by outsourcing facilities registered under Section 503B of the Federal Food, Drug and Cosmetic Act using both drug substances on the FDA's interim Category 1 list.

I will now turn the call over to Sabrina.

Thank you, MarDee, and thank you, everyone, joining us today. Daré is at an inflection point. The third quarter of 2025 reflects the continued acceleration of our dual path strategy as we focus on closing the gap in women's health between promising science and real-world solutions for women, generating near-term commercial revenue while advancing long-term innovation. We remain on track to support the commercial availability of DARE to PLAY Sildenafil Cream through a 503B outsourcing facility before the end of this year.

This anticipated launch represents a major milestone, not just for Daré, but for the field of women's sexual health, where innovation has historically lagged behind other therapeutic areas. At the same time, we continue to advance our differentiated clinical pipeline, which includes primarily grant-funded programs targeting areas of significant unmet need, including contraception, human papillomavirus infection and preterm birth. We believe this dual path approach enables us to unlock value efficiently by leveraging nondilutive capital and a disciplined investment strategy.

I'll walk you through several highlights from across our portfolio. But before doing so, I want to share reflections on our business model that I shared last week on a panel at the Milken Institute's Women's Health Network event when I was interviewed by former First Lady, Dr. Jill Biden, who chairs the Milken Institute's Women's Health Network Steering Committee on which I serve. Dr. Biden asked me specifically how crossing traditional boundaries and partnering in new ways has helped Daré to stand out and grow. As you know, Daré Bioscience is a purpose-driven health biotech with a sole focus on closing the gap between that promising science and those real-world solutions for women from contraception to menopause, pelvic pain to fertility, sexual health to infectious disease, we're working to close those critical gaps in care using science that serves her needs to specifically design, test and deliver trusted medical-grade solutions for women.

So in response to Dr. Biden's question, I shared that during my decades-long career in life sciences, I've seen a lot of innovation just sitting by the sidelines, right, products with interesting proof of concept or science that we understood, but had not advanced in development. And that's what inspired me to create a company laser-focused on accelerating the process from discovery through development to market. And I want to do this specifically for innovations for health conditions affecting women. So women aren't left waiting for the care they need now. And the way we accelerate it is specifically through collaborations.

Women's health breakthroughs often start in academic labs or single product companies that lack all of the resources to translate ideas into products. So even when the science is solid, there's a disconnect between clinical development, regulatory approval and how women actually access care. And at Daré, we are trying to bridge those gaps by connecting the dots early, by partnering early with the academic innovators and small companies, leveraging public funding sources like NIH, ARPA-H and the Gates Foundation and working directly and in parallel with clinicians and commercialization partners to ensure that solutions reach women quickly.

At Daré, we're turning that rigorous science into real-world solutions delivered with urgency. And this is where I think women's health can lead the broader health care industry, not just follow it by turning on their head the outdated models that separate research, funding, access, so we don't lose time and impact. So connecting the dots thoroughly, designing collaborations around the outcomes we want, which is to move promising science into the hands of women faster and DARE to PLAY Sildenafil Cream is a great example of this. The idea started as a simple question, right? Why should a well-understood drug that helps blood flow in men not be available in a formulation designed for women. We took a well-understood molecule with decades of safety and efficacy data in men, identified and added to our portfolio a topical formulation designed specifically for women and tested it clinically to demonstrate effect.

While we continue pursuing regulatory approval of what would be the first FDA-approved treatment for arousal disorder in women, we are strategically partnering with a 503B outsourcing facility so that our proprietary formula can be accessible via prescription as a compounded drug this year. Women should not have to wait for access to this solution. The channel allows us to accelerate women's access to our proprietary formula while discussions with the FDA continue on defining acceptable endpoints for a future FDA registration path.

The third quarter was a pivotal period for Daré as we advance towards the commercial introduction of DARE to PLAY Sildenafil Cream through the 503B outsourcing facility pathway. And our focus continues to be on execution. We remain on track for our 503B outsourcing facility partner to begin fulfilling prescriptions in select states in December. In addition to the federal requirements overseen by the FDA, 503B outsourcing facilities are also subject to state-specific requirements, and we expect DARE to PLAY Sildenafil Cream prescriptions will be available to be fulfilled in all 50 states in early 2026.

This milestone will mark the first time a topical Sildenafil formulation, designed specifically for women, manufactured in accordance with GMP requirements and supported by clinical data demonstrating increased genital blood flow within 10 to 15 minutes of application and improvements in arousal sensation using clinically validated and FDA reviewed endpoints will be available for women. Our collaboration with the 503B manufacturing partner specializing in topical formulations and Medvantx our pharmacy services and logistics partner positions us to deliver high-quality, compliant and scalable product access beginning this year.

We are supporting the 503B launch through targeted medical education initiatives, patient and clinician resources on www.daretoplaybio.com and engagement programs that emphasize the clinical differentiation and unmet need addressed by this innovation. We believe the product's positioning, science-backed, evidence-driven and female-focused sets a new benchmark for credibility in the female sexual wellness category. Our next webinar titled the DARE to PLAY Difference: The Sildenafil Cream that Raises the Bar will feature renowned experts, Dr. Sheryl Kingsberg and Dr. Jim Simon, both former Presidents of the International Society for the Study of Women's Sexual Health and the Menopause Society.

The discussion will explore DARE to PLAY's formulation science, clinical evidence showing improved genital blood flow and arousal outcomes and critical clinician insights on why DARE to PLAY Sildenafil Cream will set new standards in women's sexual arousal health care. You can find the link to join the webinar at https://cvent.v/KO1obd, also on our website in the Investors section. We believe this is a large under-recognized market where the promise of Sildenafil, the same active ingredient in an oral erectile dysfunction drug is recognized, but the clinical evaluation of topical Sildenafil formulations for women has been lacking.

We, therefore, believe that DARE to PLAY Sildenafil Cream is poised to be the first meaningful prescription innovation in this category, and we are excited about its potential as a near-term revenue driver. Please visit the daretoplaybio.com website for product updates and access alerts so that you can be among the first to know when this only evidence-based Sildenafil Cream formulation for women, DARE to PLAY Sildenafil Cream becomes available. And following DARE to PLAY, we plan to expand our commercial portfolio with the introduction of our DARE to RESTORE product line, proprietary vaginal probiotic products designed to support the vaginal microbiome. These things which will not require a physician's prescription, align with our broader vision to integrate clinically credible evidence-based products into women's health routines, including select consumer health products.

Our goal is simple, to bridge the innovation gap and ensure that women have access to the tools to support their intimate health. To that end, we seek to leverage innovative science-backed vaginal health approaches developed in Europe and are already being used by women in countries where they're available, and we look forward to bringing these differentiated evidence-based products to women in the United States. We're targeting to make 2 DARE to RESTORE vaginal probiotic products available in the U.S. in the first quarter of 2026.

We're also taking action to bring our combination estradiol and progesterone intravaginal ring to market via Section 503B as well. The compounded product will be branded as DARE to RECLAIM and is designed for women experience, perimenopause and menopause. We're targeting to have DARE to RECLAIM available in early 2027. There are no FDA-approved products that provide estradiol and progesterone together in a non-oral monthly form. We are pursuing both a traditional FDA approval path and a 503B compounding opportunity similar to our dual path strategy for Sildenafil Cream. We believe this approach allows us to accelerate patient access while continuing to generate the data necessary, to seek FDA approval and support longer-term value creation.

DATE to RECLAIM will be a one-of-a-kind evidence-based solution in the estimated $4.5 billion compounded hormone therapy market, and we believe it could generate meaningful revenue alongside DARE to PLAY Sildenafil Cream. Our near-term commercial initiatives are designed not only to drive revenue but also to create a self-reinforcing ecosystem for growth. The commercial experience, the brand awareness, the provider engagement generated through these products can position us to efficiently introduce additional pipeline candidates, including potential future FDA-approved products. And by pursuing a balanced strategy that integrates short-term commercial execution with long-term R&D investment, we aim to reduce the reliance on dilutive capital and build a financially sustainable model for innovation in women's health.

And our programs that are supported with grant funding, including work in contraception and HPV, continue to advance with important nondilutive support. Let's start first with Ovaprene. Enrollment is ongoing in our pivotal Phase III multicenter, single-arm, noncomparative clinical study of Ovaprene to evaluate its effectiveness as a contraceptive along with its safety and acceptability. We intend to maintain active recruitment at 5 study sites supported by grant funding we received in November 2024.

We currently anticipate enrollment will be completed in 2026, and we plan and look forward to providing further updates regarding anticipated enrollment and study completion targets next year. We announced in July that the Independent Data Safety Monitoring Board reviewed the interim data from the Phase III study and recommended that the trial continue as planned. There were no new safety or tolerability concerns or serious safety concerns identified and the interim pregnancy rate of women treated in the study was consistent, with our expectations based on our prior postcoidal test study of Ovaprene.

These data support Ovaprene's potential to fill a significant gap in the contraceptive landscape providing women with a non-hormonal user-controlled option without daily interruption. With millions of women in the U.S. seeking effective hormone-free birth control, Ovaprene has the potential to address a significant unmet need and transform the contraceptive landscape. We look forward to the completion of the study and the final analysis of study endpoints, including the primary endpoint of pregnancy rate, which is calculated using the Pearl index. Recall that Daré received the right to obtain exclusive U.S. rights to commercialize the product following completion of this pivotal clinical trial if Daré in, its sole discretion makes a $20 million payment to Daré.

Daré may receive up to $310 million in commercial milestone payments plus double-digit tiered royalties on net sales. The potential $20 million payment and royalty payments are subject to a third party's minority interest under a royalty purchase agreement entered into in April 2024. We're also continuing to advance programs supported entirely by nondilutive funding awards. DARE-HPV is in development as a novel intravaginal therapy for persistent high-risk human papillomavirus infection. That's the virus that causes cervical cancer.

The program is currently funded through an award from ARPA-H and an NIH grant. DARE-LARC1 is a preclinical stage long-acting contraceptive intended to offer multiyear protection with remote pause resume control. A $6 million grant installment was received in July and a $4 million installment was just received last month. And there NHC is a preclinical research program that will aid in the identification and development of a novel nonhormonal intravaginal contraceptive product candidate. The grant funding supports activities to derisk the development of a novel nonhormonal intravaginal contraceptive that can be suitable for and acceptable to women in low and middle-income country settings who need or would prefer to use such a product to avoid an unplanned pregnancy.

A $3.6 million installment under a November 2024 grant agreement is anticipated to be received later this month. Together, these programs demonstrate our ability to leverage strategic collaborations, including with public funders and foundations to advance a portfolio that addresses meaningful gaps in women's health while maintaining disciplined capital allocation.

I'm now going to turn it back over to our Chief Accounting Officer, MarDee, to review the financial results for the recently completed quarter.

Thanks, Sabrina, and thanks, everyone, for joining us today. I would now like to summarize Daré's financial results for the quarter ended September 30, 2025, which I will refer to as the third quarter. We ended the quarter with approximately $23 million in cash and cash equivalents and working capital of approximately $3.8 million. During the third quarter, we received approximately $18.7 million in net proceeds from sales of our common stock and a total of $7.3 million in grant payments. This additional capital strengthened our balance sheet, enhancing our ability to execute on our dual path strategy. G&A expenses were $2.5 million compared to $2 million in Q3 2024. The year-over-year change was primarily due to increases in professional services expense and commercial readiness expenses driven by execution against our expanded business strategy.

R&D expenses were $1.2 million compared to $2.7 million in Q3 2024, a 56% decrease primarily due to an increase in contra R&D expenses or reductions to R&D expenses that we recognized due to nondilutive funding as well as decreases in manufacturing costs related to Ovaprene and in personnel costs, partially offset by increases in costs related to development activities for other clinical and preclinical stage R&D programs, including DARE-HPV and DARE-LARC1, Sildenafil Cream 3.6%, DARE to PLAY Sildenafil Cream and DAR-PTV1. We encourage investors to review the more detailed discussion of our financial statements, our financial condition, liquidity, capital resources and risk factors in our Form 10-Q for the quarter ended September 30, 2025, filed today.

I would now like to turn the call back to Sabrina.

Thank you, MarDee, and I'd actually like to turn the call over to the operator for Q&A.

[Operator Instructions] Our first question comes from Catherine Novack from Jones.

So first one for me is if you can comment on your thoughts on FDA's recent reversal and guidance on hormone replacement therapy and menopause. What feedback have you gotten, if any, since that decision was announced? And what can you do to fill the treatment gap in the near term?

Love that question. Thank you for asking. And we are -- I'll start by saying we are thrilled. We were thrilled to see that change. We, as a company, we're developing, DARE to RECLAIM, which is our hormone menopause hormone therapy, vaginal ring that has estradiol and progesterone together in a single ring, once-a-month product and delivered non-orally, which is what the Menopause Society recommends in both of those hormones together for women without a uterus.

And as such, we've been attending the Menopause Society for years since we started this company and have been working on that program and have watched the presentations year over year over year really that have debunked the scientific research that has debunked some of the outcomes of the 2002 Women's Health initiative that led to the initial black box warning and new data that are citing the potential benefits, right, of hormone therapy, where the recommendations continue to be if you have a uterus, both hormones together, progesterone for endometrial protection, estradiol for the effectiveness, ideally micronized bioidentical non-oral forms, but demonstrating improvements in recent studies that have shown improvements in bone health, in brain health and in cardiovascular health.

So the field, the scientific field has moved forward. The clinicians have moved forward, but sadly, they have not had trusted solutions for menopause hormone therapy and the products that are available have -- that are FDA approved -- there's an oral form approved with the 2 hormones together. And then there are single product patches like estradiol patches or vaginal products and then progesterone that one could take separately. But all those estrogen products have that black box warning that creates fear, frankly, for women in taking those products and in many cases, really unwarranted fear given what the newer data and the newer interpretation of the 2002 findings.

So that's a long way of saying we are so happy. I can tell you I'm at -- I'm currently today at the International Society for the Study of Women's Sexual Health, which is a sexual health focused conference. But health care providers here who know we are working on our hormone therapy, vaginal ring have combined to make sure to see us and tell us how happy they are about the outcome and how hopeful they are in terms of what they think that will mean for our product when it's available and women having access to something like that.

So we are really happy to see the FDA, and we're happy to see FDA Commissioner, really talking about this, right, and elevating this issue and doing something that will make a product available to more women that can benefit from it.

Got it. And is this -- you mentioned it will be available early 2027. Will that also be through a compounder? Or is there a path to make it [FDA approval]?

Both. So we're -- when I talk about 2027, we're talking specifically about that opportunity to pursue a similar strategy like we're doing with DARE to PLAY Sildenafil Cream, where we partner with a third-party 503B outsourcing facility in this case that would have the capabilities to manufacture a product of this nature. We are continuing our process with the FDA. You may recall that we had announced a while ago now that the FDA was aligned that only one Phase III trial would be required to support the registration for this product. But we had not yet filed the IND or continued with that program where we're waiting to work out some additional details on the Phase III design and requirements with the FDA.

So that process is ongoing. And certainly, as we have updates, we will announce those updates. But we do see that there is an opportunity that we can pursue similarly to get this product into the hands of women faster, right, and get that access for this evidence-based product while that FDA process is still ongoing.

Got it. And now just thinking about -- now that you have a decent amount of cash runway, how are you thinking about prioritizing the R&D programs that you are -- that are in clinical development for FDA approval?

Yes, it's a great question. So we're really prioritizing right now, if you think about our activities, it's definitely everything we've been talking about, about DARE to PLAY Sildenafil Cream and getting that out there, some of these opportunities that we've been talking about, just like the DARE to RECLAIM, estradiol progesterone, vaginal ring, the DARE to RESTORE, Vaginal Probiotics, getting those to market. I talked about a number of our grant-funded fully or partially grant-funded programs, those are definitely a priority.

So I'm talking about Ovaprene, which is in Phase III, the DARE-HPV product, which is -- we're working towards filing that IND and getting into Phase II. That's what that ARPA-H and NIH funding supports and as well as DARE-LARC1, which is preclinical and now also getting to do a lot more activities on what we call Daré NHC, that nonhormonal contraceptive technology. So those are definitely a priority. And then as we think about the programs that require additional, right, R&D investment, we're really looking at those one by one, and we're really trying to prioritize those opportunities where we have a very clear path to market. So that means we've got that regulatory roadmap outlined with the FDA, which remember, for us, it is a process. These are all first-in-category products. So they all take discussion with the FDA.

But we will prioritize those opportunities, as you might expect, right, for shareholders, the ones where we have a clear path forward, the market opportunity is clear and robust, and we can clearly execute against that. So more to follow, but I would say right now, big focus on these programs that have grant funding that has really helped propelling them forward and Ovaprene and DARE-HPV are later-stage programs in that regard as well.

Our next question comes from Kemp Dolliver from Brookline Capital Markets.

I have 2 separate and different questions. First, with regard to DARE to PLAY, you have the partnership with Rosy Wellness. And I'm wondering what other similar partnerships you have in mind to essentially increase awareness because I think there are about 250,000 people using Rosy Wellness, at least based on what they've disclosed. And it sounds like you need to have broader partnerships to really tap this market.

Yes. So there are some great question. So there are a few different things that we're looking at as we think about the DARE to PLAY product and as we think about awareness, right? So one pillar of that is around clinician awareness, provider awareness. That has been pretty easy to tap into, quite frankly, just because one is timing, kind of great time of year to be doing this. It's the time of year where the providers that are most relevant to a product like this or having all their meetings, menopause society, sexual health meeting, nurse practitioners and women's health, we're at all of those, plus the webinar and events we're doing with the thought leaders.

So that really helps us get in front of a lot of the providers that are important. One of the other pillars is awareness in terms of really ease of prescribing, right, and having a health portal and an online health portal that makes it very easy for someone who has a prescription to get their prescription as well as people that maybe don't have a prescription yet and need access to telehealth. And we're really doing that through our relationship with Medvantx.

So Medvantx has the ability to take in those prescriptions to manage that prescription inflow, manage the cash pay piece, very straightforward portal that will be available, right, as we start fulfilling prescriptions in December for people to get, but also a connectivity with the telehealth resource for those women that don't have that. And then we're supplementing all of that. Then there will be additional -- like there are additional places, right, where the product is going to be showing up in partnerships. We're really prioritizing those for when we have availability in all 50 states, and we have that full availability across the country. But I would say the other thing that is also really helpful in the near term is using online advertising opportunities, right, I think platforms like Facebook and Instagram and other social media tools like podcasts, appropriate sexual health influencers that have a large community of followers. So you will also start seeing Google Ads where relevant. You'll also start seeing more and more of that as the product becomes available and particularly as we go into the new year.

So those are the kind of things to be looking for. And then once we have that availability across the country, then it's a great opportunity for some of these additional types of relationships, right, where it can be available via their platforms as well. So stay tuned, more to follow. Right now, we've really been prioritizing clinician, right, making sure the health care providers that see these women today are well aware of this product and know exactly how to prescribe it, that they have all the tools that they need and then also making sure that, that patient experience in terms of that online portal through Medvantx is seamless and a wonderful experience.

Great. That's very helpful. The second question is the ATM and whether there's additional capacity left on it?

Yes. So we are -- so Daré is subject to baby shelf. So for those aren't familiar, it has to do with what our market cap is, and that does limit how much is available under a resource like the ATM. And so baby shelf limitations. I think you can kind of do the math with the amount that MarDee talked about that came in during the last quarter. We are limited, therefore, with baby shelf restrictions in terms of being able to actually use an ATM today.

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.

Great. Well, thank you, everyone, for joining us this afternoon. And hopefully, you're coming away with a good understanding that we are executing a multipronged value creation strategy. We're preparing for revenue generation via DARE to PLAY Sildenafil Cream starting in the fourth quarter and advancing a rich clinical pipeline and doing so with a fiscal discipline and access to significant nondilutive capital.

And with 4 commercially available solutions for women on the horizon, one expected to begin generating revenue in this fourth quarter and multiple product candidates advancing in clinical and preclinical development, we believe it's a compelling time for investors to take a fresh look at Daré. Daré is uniquely positioned to cut through the noise. In today's biopharma landscape, companies with relatively low-risk assets, differentiated science and a clear path to near-term revenue are in rare supply, and we believe Daré is one of those rare opportunities.

And women's health is a market that has long been underfunded and underserved. And therefore, that means it is ripe for value creation. With our recently expanded business strategy, we're well positioned to bring multiple products to market efficiently via both prescription and nonprescription channels and generate meaningful return for stakeholders. We believe our nimble model enables us to commercialize through 503B compounding, pursue FDA approvals and launch branded consumer health solutions, all in parallel.

And we believe the coming weeks will represent a historic moment for Daré and for women seeking new options. And we're proud to be leading the science, collaboration and purpose and are excited to begin making DARE to PLAY available through the 503B channel, which is on track for December. We expect initial revenue recognition in the fourth quarter this year and believe our commercial portfolio will serve as a robust foundation, providing a path to profitability. So I thank our team, our partners and our shareholders for all the continued confidence and support. Thank you so much.

This concludes today's conference call. You may now disconnect.