We're ready to get started. Welcome, 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. Today, the company completes its virtual bus tour series with the East Coast stop. For the format today, Sabrina Martucci Johnson, President and Chief Executive Officer of Daré Bioscience, will take you through the Daré story, and then I will open it up for a Q&A and take your questions. It is now my pleasure to turn it over to Sabrina Martucci Johnson, and take it away, Sabrina. Great. 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. 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. What does that mean? That means that we're focused exclusively on women's health conditions. As you'll see as I talk about the portfolio, we work very broadly in the space. As you're looking at us now, and some of the things I'm going 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. Also importantly, we're at a time where we're completing some studies that are going to lead to some clinical milestone events next year as well. I really want to highlight what's happening in the development portfolio along those lines as well. 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. 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. As I mentioned upfront, we focus on women's health, and we work broadly. 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. 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. I'm going to focus on a few of the programs in our pipeline. Really, like I said right up front, I'm going to focus on some programs that have commercial relevance right now. We're going to talk about in the Daré 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 vaginal 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-a-month contraceptive, because we got phase III ongoing right now with the top-line data readout expected next year. I'm going to talk about a couple of our other programs that are really relevant, either with the clinical program 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. Before I go deep into the portfolio, a couple 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 typically think of diseases. Why is that important? It's because they're 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, think thinking about whether or not to have a pregnancy and maintaining a pregnancy. Then there's also conditions that are also very hormone-reliant and dependent, like sexual health. Again, most women are going to experience changes and disruptions in that as well. We're going to talk about those markets. 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's 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. We like the space because of the size of the market, certainly not niche. It's also been a highly productive category. Even though only 1%-5% of private healthcare 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 in annual revenue are for women's health conditions. 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 healthcare consumers. The third thing that we think is really impactful about working in this space is the amount of grant funding that is available. That is non-dilutive funding that helps to advance the portfolio, so we do not have to rely on equity dollars to do that. Again, this is in part an artifact of the fact that women's health and women's research was not required until 1993 to be included in clinical research. So there is a lot of foundation money, as well as government funding that is available to really help bridge that gap. We have been quite successful over the last several years in accessing that capital. As you can see across the portfolio, including for our late-stage programs like Ovaprene and DARE-HPV. All right. I mentioned right up front, we are data-driven. What does that mean? First of all, I think it is important to understand, we look at all the paths of getting our products to market. So it is not just about prescription options. Sometimes it is a non-prescription product, and it is not always just about FDA approval. Sometimes we think it is really important to get a product on market for women and fill an important gap that exists, even as a compounded product. 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. That really means that we, one, can have proprietary technologies because there is science behind them and they have 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 healthcare providers. As we talk about our commercial strategy, you will see that it is important to make sure women have access directly, and we will talk about the Daré 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 healthcare provider, regardless of our path to market. Let us talk first about those commercial opportunities that are happening right now. Flora Sync LF5 is our vaginal probiotic. It is a non-hormonal probiotic product that is really designed to restore microbiome balance in the vagina. We talk a lot about gut health. I think we are all familiar with probiotics in the gut health sense. Well, 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-derived strains that are taken orally. So think about that and think about where you want that probiotic to work. That is really where we are addressing it. So Flora Sync LF5 is a vaginally delivered probiotic, so the product is going right where you need it. It is a strain that was developed by isolating it from the vaginal microbiome of women who have never had yeast infection. So that is where the clinical strain came from. It is backed by science, and then importantly, specifically studied in a clinical study to demonstrate that it actually does achieve that vaginal microbiome balance. It is just a three-capsule administration. So it is available now through the Daré Health Hub. It comes in a box of six capsules. It's really something that we are looking to have women incorporate as part of their vaginal wellness routine. It comes with six capsules in the box. That's basically two courses. 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? What I always say is that women know. 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. This is something that women are quite aware of and are seeking a clinically evidence-backed solution. This is available on the Daré Health Hub right now, which we're going to talk about in a second. 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. Daré to PLACE 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. It leverages the same active ingredient that is in Viagra for men. 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. Enhancing that can really help enhance that whole experience. This has been formulated specifically and studied and demonstrated that it increases that genital blood flow within just 10 to 15 minutes after application. Also demonstrated to improve those arousal sensations using clinically validated, FDA-reviewed endpoints. We're making this available as a 503B compounded product. What that means is it's not yet FDA-approved. We are still working on that NDA pathway. What it does mean is it's subject to the same quality manufacturing standards as pharmaceutical products are, manufacturing facility that registers with the FDA and is subject to FDA inspection. 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 U.S. alone who are complaining of symptoms of low or no physical sexual arousal. As you can appreciate, at $99 for the tube, that's about a $2 billion addressable, 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 Daré Health Hub or directly through their healthcare 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. We are looking forward to have dispensing starting later this quarter. I talked about those clinicians already writing the prescriptions and clinicians looking to stock Daré 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, therefore leveraging those trusted relationships around the clinical development we've done to now turn those into commercial relationships. That long-standing relationship that we have with those healthcare providers means that they can now become supporters of our product and actually peer-to-peer educators around our technology. That's really a commercial advantage that we're able to leverage because of the clinical data behind the products. It's also important, though, that we think about an integrated commercial platform and an ecosystem really designed for growth. Those provider relationships are so critical because that's that trusted source, that trusted clinical channel that we have to make sure that we are in. We also recognize that women are seeking and getting their care a lot of different ways. We also want to make sure we have telehealth available to women for our products, whether that's directly through our Daré Health Hub, or they really want it for an asynchronous, quick questionnaire to get a prescription to something that they need, or through a telehealth relationship with a third party that is a really expert telehealth in menopause care or sexual care. 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 healthcare provider, it's online. We're really excited to have really a digital focus with our program. 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. For those healthcare providers, they can talk about our products and be that trusted source of information about products that have been studied. The Daré Health Hub is really that central commercial platform that brings it all together. It is the place where if you're a healthcare provider, you're submitting a prescription on the back end for fulfillment. All of the prescription fulfillment happens through the Daré 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. As you can see from the photo here of 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. I want to spend the last few minutes, before we open it up for questions, just talking about the development pipeline and specifically some of those important clinical readouts we have coming up. 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 two 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. 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. Daré-HPV is our product for human papillomavirus infection. Almost 6 million women every year will be infected with a high-risk strain of human papillomavirus. What does that mean? It means that's a strain that can cause cervical cancer. 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. Then the only intervention is surgery that can lead to preterm birth and infertility. 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 a 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 just briefly up front 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. We may even be talking about the shortage in the patches, which is really unfortunate for women. 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 a uterus, which is both estradiol and progesterone together, ideally in a non-oral form. That's exactly what our once-a-month vaginal ring is designed to do. 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 503B compounded product while the NDA pathway program continues. We are looking forward to that for next year. We also have a phase II clearance from the FDA for a non-hormonal product as something for the sexual symptoms associated with menopause. Really important in women who are breast cancer survivors and where hormone therapy may not be an option. Then we're looking to start up a phase I study, NIH-funded, for our progesterone vaginal ring as an alternative to progesterone injections for IVF, very painful, and also to maintain pregnancy during at-risk pregnancies. I am not going to talk about the earlier stage programs in the interest of time, but as you can see, they are similar first-in-category opportunities and also similar to our later-stage development portfolio, where they are funded with grant funding. We are really not using our equity capital to move those forward. As we think about this year, I said right up front, this year and next year, it is a great time to get to know us. There are multiple meaningful catalysts for the company. On the commercial side right 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. Then I mentioned we got that DARE to RECLAIM menopause hormone therapy that is targeted for 2027 on the commercial side. 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. Hopefully what you are getting from our time today is that we have really been building the commercial momentum with also multiple catalysts coming. We got the commercial catalyst this year and coming next year, and then there are clinical development catalysts that are coming up for next year as well. 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 program. I will pause there and stop there and open it up for any questions on why Daré and why now. Excellent. I will now open up for the Q&A session. Thank you for those who had submitted your questions. If you would like to submit a question, please hit the Q&A button at the bottom of your screen and type it in. Our first question is, can you provide an update on the NASDAQ listing? Absolutely. 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. 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. Then those panel hearings are held about a month after you make that request, so think late August. 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. We present the compliance plan to the panel. It is not just that one event, but also looking over time. Then the panel typically puts out its compliance determination within about 30 days from the hearing. 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. Okay. We'll keep you updated. Great. 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 of capital in 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. That's where things like the equity financing that was recently completed, that's exactly what something like that can do, because equity then does go straight to the stockholders' equity calculation. Okay. Thank you. Our next question is, why is Daré pursuing a phase III program for DARE to PLAY when a compounded formulation will already begin dispensing soon? What's really, I think, strategic for us in thinking about both options is they allow us to do some different things. Obviously, pursuing the 503B 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 healthcare providers to make available to them. Women shouldn't have to wait. Viagra's been on the market for 30 years for men. We're a little bit overdue on having a clinically studied solution for women. 503B means that we can get a quality manufactured product in the hands of women right away. As a 503B compounded product, it is cash pay for women, which, by the way, is not a detriment, frankly, because most people do prefer cash pay when it comes to their sexual health and things they might want to be a little more discreet about. 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 commercial protection. 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? Yeah, 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. 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. Okay. Next question. When do you think we'll see line of sight into the commercialization of Flora Sync LF5? Yeah. We are definitely early days in the launch. Like I said, we just started commercializing it in July, so we are just about a month in, month and plus into that. What I will say is that, obviously, as we start having our earnings calls, we will be giving updates, obviously, on commercial metrics. What we are really looking for in the early days, it is not so much about the dollar amounts. It is really about those fundamental things that set you up for a very successful launch. What we want to see is breadth in terms of where the product is going. We are looking closely at our channel strategy, so right now it is available on the Daré Health Hub. Also clinician offices can make it available through their offices. As we start talking more about what we are seeing, we are going to really be sharing 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 Daré Health Hub, coming from the clinician office channel. We are looking at some other retail channels as well. In these early months of the launch, it is 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 her vaginal wellness routine. That is not a sentence we say all the time, right? As a healthcare consumer, I am looking for stuff for my vaginal wellness routine, but we should, right? Just like we worry about our gut health, we should be worried about that vaginal microbiome because it is really, really important. Those are the kind of things we are going to be talking about and that we will be looking at and watching in the early days. Great. 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? Yay. Yeah. Well, the bus tour has been a lot of. Thank you again to people who 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. 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. 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 two of our programs. 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. Just thanking everyone again and really looking forward to keeping people updated. Excellent. With that, this does conclude the Daré 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 Daré and its mission. Stay tuned for more ways to connect with Daré Bioscience. Thanks, everyone, and wishing everyone a great rest of your day. Awesome. Thank you. Thank you.