Everyone, thank you so much for joining our 46th Annual Healthcare Conference. I'm Vishwa Shah, one part of the biotech team here at TD Cowen, and I work with Analyst Stacy Koo. Today it is my pleasure to introduce Sabrina Martucci Johnson, the CEO and President of Daré Bioscience. Thank you so much for coming here and for your presentation. Great. Well, thank you guys for being in here today. I really appreciate it. I will start by saying, obviously, we're publicly traded. This will have forward-looking statements, so please do refer to our SEC filings for a full summary of the disclosures. I'm going to start with just giving a little bit of perspective on who we are and what we do, and importantly, why it matters. We are a purpose-driven health biotech. I think that's really the best way to think about us. Our sole focus is really to close the gap between promising science and real-world solutions for women exclusively. What does that mean? From contraception to menopause, sexual health to pelvic pain, fertility, vaginal health, infectious disease, we're looking at areas where we can close gaps in therapeutic options using primarily already known pharmaceutical ingredients. Products that have already been approved as active pharmaceutical ingredients in other products. Why does that matter and why is that important? First of all, there are so many unmet needs in women's health that there are great opportunities to use pharmacology that's already well-known and understood, and just applied in a different way so that we can reduce costs and time to market. It also really opens the door for us to have first-in-category products that can be commercialized through a variety of different pathways that are then open to us, whether that's compounding through 503B, which I'll explain, whether it's FDA approval, and in some cases, whether it's as a consumer health product that actually doesn't require a prescription. That's how we really focus on bringing these first-in-category, evidence-based products to market. We're also really structured where we have a lot of optionality around leveraging strategic partnerships and relationships, as well as grant funding. Those are both ways where we can expand our commercial reach and also lower the cost of the development programs. That's at a high level who we are and what we are doing. Why invest in women's health? There are a lot of mission-oriented reasons to invest in women's health. There are a lot of economic arguments to invest in women's health. McKinsey did a fantastic report about the impact on the GDP. As the founder of Daré, I really looked at it also from a completely financial and economic framework. It's a fascinating category when you think that only 2% of investment that is going into healthcare research are going into conditions that affect women's health. If you look at the other end of the spectrum, when you look at commercial prescription brands, what are generating revenue in the over $500 million, billion-dollar category? 27% of those are in women's health. I look at that math and I see a very productive category where those billion-dollar opportunities are hiding right in plain sight. That's what really excites us about women's health. Also, women are the key healthcare consumers in a household. If you look at just even GLP-1 sales today, it's mostly women. Women are motivated consumers. We're motivated healthcare advocates for ourselves, and we will utilize products that make a lot of sense. I'm realizing the timer's going here. I'll watch here. I'm going to mostly focus on today the products that are really near-term commercialization. If you're just learning about Daré for the first time, it's a great time to get to know us, because we have some super interesting products launching imminently, and then over the next 12 months. I'll talk mostly, first of all, about what we call DARE to PLAY Sildenafil Cream. Men have had Viagra for almost 30 years. There is a condition in women, female sexual arousal disorder, that is just as common as erectile dysfunction. It's similarly mediated by needing increased blood flow. The active in Viagra is a great product, and there's nothing FDA-approved or clinically studied and available for the condition. I'm going to spend a little time on that, because that is now available for prescribing through a really interesting commercialization pathway. Similarly, menopause is definitely having a moment. While it's having a moment of increased awareness and increased understanding and increased call to action for more treatment options, there is yet a single product that is available on the market, FDA-approved or compounded, that is really designed to clinically deliver exactly what The Menopause Society is recommending, whether it's for vaginal symptoms or for hot flashes. I'm going to talk about our hormone therapy vaginal ring and what that's looking like, and that's in the DARE to RECLAIM, which is on the bottom. Then in the middle, there's a lot of movement right now around vaginal health. There's a lot of realization about how important the vaginal microbiome is to not just vaginal infections and things that can be irritating, but also much more serious conditions like UTIs that can lead to sepsis and things like that. There's great evidence around the use of probiotics to maintain a healthy vaginal environment. Nonetheless, there are no available probiotics on the market today that have actually been rigorously clinically studied and demonstrated to achieve the outcomes that they're seeking. We are very excited to be addressing that gap. First, I'm going to talk about DARE to PLAY Sildenafil Cream. As I mentioned, sildenafil is the same active ingredient that is in Viagra for men. Actually, if women can tolerate a very high dose of oral Viagra, it can be effective. The challenge is women have fewer PDE5 receptors in the genital tissue than men, so you need a higher localized dose than what you would deliver to men. That oral dosing tends to come with systemic side effects that are really a non-starter. Sildenafil, though, is actually super difficult to formulate into a topical. It's a highly charged molecule. It's very difficult to formulate it and get it into the skin. While a lot of pharmacy compounders have tried to fill this gap in care by just mixing up, putting some sildenafil into a cream base that they have, those formulations have not been demonstrated to be effective. All of them suggest, if you're going to use one of those products, to apply it 30 minutes or more before sexual activity. It's a product profile that's a non-starter. As we looked at this product and this opportunity in women's health, we said, "Okay, we need something that gets sildenafil into the tissue that is fast-acting." Being able to apply it within 10 minutes before a sexual event and have that increased blood flow effect. Easy to use, on demand, then that's actually clinically demonstrated to improve not only genital sensations of arousal, but also lubrication, orgasm, desire, all those downstream effects. We have done that, and based on the publication of our clinical data from our phase II-B study, we have been overwhelmed with clinician demand of asking us, "Can you make this formulation available?" Initially, as a biotech company, healthcare, pharmaceutical development, we said, "No. We're not just going to license our proprietary formula to a whole bunch of compounding pharmacies around the country to make this available." We discovered, actually, that there's an alternative pathway that sildenafil is eligible for, which is 503B compounding, and that's very different. That's working through one good manufacturing practices facility. They're subject to pharmaceutical GMP. They register with the FDA. They're subject to FDA inspections, and they're able to manufacture at a large quality-controlled scale. Just like any pharmaceutical product. We were really excited to partner with the 503B outsourcing facility so that we could make what we call DARE to PLAY Sildenafil Cream available now. Prescription intake has started. It's cash pay. It's available through an online portal. Meanwhile, we are continuing our discussions with the FDA. We'd love to see an FDA-approved option out there eventually. Those conversations are ongoing. Right now, in 2026, this is a revenue-generating product. Dispensing will start in a couple months or so, that's when you'll start seeing revenue hitting the books. Excited about that, and that we have sort of a dual path strategy. Just to give a little more perspective on some of the key proof points in the clinical data that really resonate with the healthcare providers as well as the consumers that have already gone through telehealth to get this in this pre-fulfillment phase. It's one that you're not getting systemic effects, we showed that in our clinical trials that we established. The pharmacokinetics is very low, and we see that in the clinical studies. We're the only formulation that's actually demonstrated a clinical benefit, as I mentioned, not just in sensations of arousal or lubrication, but kind of all the downstream effects that you would expect, as well as also interpersonal difficulties like guilt, stress about sexual activity as well. Again, think of what a man might go through with erectile dysfunction, very similar kind of endpoints. We also looked at tolerability not just in the woman, but in her partner as well, and exposure. It's great to have the clinical data to establish that for both parties. Great experience. The product's available on daretoplaybio.com, and that's how you can connect to telehealth as well. Right now, telehealth is complimentary during the pre-fulfillment phase, so it's a nice benefit to the healthcare consumer, and we've seen them respond to that positively. I'm going to talk a little bit about Ovaprene. Ovaprene, as I mentioned, our portfolio is broad. From contraception to menopause and kind of everything in between. We really focus on having those first-in-category products. If it's not differentiated, there's not a point in developing it. In the contraceptive space, which in some ways one could argue is a very crowded space. The pill was approved in the '60s. There are a lot of products, a lot of options out there. However, there are no options that are non-hormonal, that are convenient, meaning that they don't require action in the moment, are women-controlled and initiated, and are not implanted, meaning they don't require a clinician to do a procedure like an intrauterine device to implant it. There are big gaps on the non-hormonal side, despite the fact that it's really become even more of a movement lately of women really thinking about hormones and for their contraception, whether they take them. Kind of going back to that, we like to connect promising science with real-world solutions. Ovaprene's a great example of that. We know that in the non-hormonal category that's not implanted, diaphragms work the best. Covering the cervix so sperm cannot get in is your best option. Diaphragms are very inconvenient. They're in the moment. They're actually quite large. It's kind of off-putting. We also know that metal ions interfere with sperm motility, whether it's copper, whether it's iron, in this case. The innovation in Ovaprene is let's put that together, but in something that's small. It's just a little bit bigger than a quarter. That's small, easy to insert. It's a once-a-month product that uses the barrier that a diaphragm provides, but this is a knitted barrier, so you can leave it in place all month. The brown ring is actually iron. That's iron that's released to interfere with sperm motility. We were super excited to announce interim data last summer from this phase III trial, and this is the registration trial that's ongoing right now. Because contraceptive studies are always open label, there's no placebo control, and pregnancies are your endpoint, but they're also an adverse event. When the data safety monitoring board met last summer, they were able to actually look at the pregnancy data. They aren't allowed to actually calculate the primary endpoint, but we were super excited to see that the pregnancy rate at that time was only 9%. That really puts it in a comparable range to things like the diaphragms, which was definitely a target, but also self-administered hormonal contraceptives in terms of their typical use rates. Trial is ongoing and will be ongoing this year. We're hoping to be completing recruitment soon. We'll keep you posted on that. It is a 12-month follow-up period in the study, so it's a 13-cycle study. More to follow on that. I mentioned menopause and that menopause is having its moment. Where society is seeking solutions is actually in both the non-hormonal category and the hormonal category. There have been some new entrants in the menopause space in the non-hormonal category for hot flashes, which definitely is interesting to try to treat those in a different way. However, there have not been any new innovations in the non-hormonal category for vaginal symptoms. Vaginal symptoms in menopause, particularly sexual pain, is super common in a breast cancer population, where they are hormone receptor-positive breast cancer. They're on drugs, like aromatase inhibitors, that put them into menopause regardless of their age in a very abrupt way. Sexual pain is a very common survivor issue in the breast cancer community, and yet they're really contraindicated, or at least cautioned, around the use of vaginal estrogen, which is really our only very effective solution for sexual pain today. We're developing a form of tamoxifen that is a normal, often part of a breast cancer treatment regimen given orally, in a vaginal form, where in our phase I/II data, it's been demonstrated to improve those vaginal symptoms. We're getting ongoing activities to sort of prepare for a phase II start. Timing not planned at this time, but very excited about this opportunity in the non-hormonal category. When it comes to hormones, we've also seen a big shift in understanding the importance and the roles of hormones. Ideally, what The Menopause Society recommends is for women with a uterus to take both hormones. Estradiol is what you're going to take for effectiveness. By the way, that's not just for vaginal symptoms, and that's not just for hot flashes. That's also for brain health, it's also for cardiovascular health, it's also for bone health. All of the new data are really supporting that. You need progesterone to counterbalance it and to have uterine protective properties. Non-oral is really preferred, because with non-oral dosing, you're going to be much more effective with the dosing. Even if you're dosing non-oral to get systemic levels, you're going to be much more efficient in your dosing, and you're going to have a much better side effect profile for some of the consequences that we don't like to see with hormone products. We have developed a vaginal ring. It's a once-a-month vaginal ring with both estradiol and progesterone together. In our phase I/II trial, have demonstrated that it improves vaginal symptoms of menopause as well as vasomotor symptoms of menopause. Importantly, we're getting those estradiol levels that match what women would have normally in their follicular phase. That's really what you're targeting when you're doing hormone replacement, to get her back to that level. We're doing similar like we're doing with our DARE to PLAY Sildenafil Cream. We call this DARE to RECLAIM. Menopause hormone therapy, we're doing a similar path, where we are working on making this available via a 503B outsourcing facility, target early next year, while we continue discussions with the FDA and preparations for a phase III program for this product. Last, in terms of the clinical programs, I want to talk about one that I think could be a very impactful game changer in the area of cervical diseases. If we think about cervical cancer, which I recognize we may not all be thinking about every day, but if you think about cervical cancer and cervical disease, cervical cancer is one of a very small group of cancers we actually know exactly what causes cervical cancer. It's human papillomavirus infection with a high-risk strain. We know what causes it. However, there is no FDA-approved pharmacologic treatment for infection with the virus. What happens today is someone who tests positive for one of these high-risk strains of human papillomavirus, which by the way, is 6 million women every year in the U.S. alone, will test positive for one of these high-risk strains. Her disease progression and course of monitoring right now is really a watch and wait philosophy. We wait, we ask her to come back in for routine screenings to see when and if it progresses to pre-cancerous lesions on the cervix. Once it progresses to those pre-cancerous lesions, her only option is surgery, where part of the cervix is removed. The downstream consequences of that are higher risk of preterm birth and infertility. They're often very hard decisions that women have to make around treating those lesions, particularly if she's planning a family or wants to plan a family. The other component of it is that we lose a lot of women in that watch and wait. That's why there are still deaths from cervical cancer every year in the United States, and hundreds of thousands of deaths globally, because we lose women during that watch and wait period where they're not having symptoms, and so they're not coming in until it's too late. This DARE-HPV is really an interesting combination of two FDA-approved protease inhibitor antiviral agents, lopinavir and ritonavir, in a proprietary fixed-dose combination of the two. Again, the inspiration here came from science that's already happened. There was a proof of concept study in Kenya that was done 10 years ago that showed that even a suboptimal ratio of those two antiviral agents when delivered vaginally, cleared the virus of HPV as well as cervical lesions. We have a $10 million contract with ARPA-H to advance this program through phase II, and we just announced last week, very excited, that the IND has been cleared, and we are cleared to go with our phase II protocol that is planned. The rest of the ARPA-H funding comes in this year through October. We've gotten $6.5 million to date, there's another bit outstanding of that 10 that we'll continue to bring in this year. We're working hard now to get the phase II up and running as quickly as we can. More to follow on that as soon as we have exact timing on getting that study up and going this year. I always love to share a little bit about XACIATO. This is already on market. This is FDA-approved. We took this product from concept in our portfolio, based on a little proof of concept study that had been done with a clinician investigator-initiated study. Based on that study, we were intrigued about the potential here and brought it into our portfolio and got it to an FDA approval within 3 years, and it was launched within 5 years of that proof of concept study. This is a great example of what we try to do. Again, where is there a solution hiding in plain sight? clindamycin is a fantastic antibiotic against the bacteria that cause bacterial vaginosis, but it is a time-course antibiotic. It is a not well-tolerated antibiotic delivered orally. Delivered vaginally, it's very difficult to get it to stay in place in the vaginal environment so it can have effective. The innovation here was we took a formulation technology actually out of veterinary medicine, that was used for dogs to basically keep the antibiotic in their ear. It's a thermosetting gel technology that actually gets more viscous as it heats to body temperature, and it basically coats that mucosal area where it's administered. This FDA-approved product now, we're very proud, it has the best label of any product out there, and it's a one-time vaginal administration of clindamycin. Old antibiotic delivered in a powerful way so that we could get effectiveness in clinical practice that had been not seen before this product. We are partnered with Organon on this, so they are the commercialization partner for this product globally. I highlighted, I think, some of the most near-term programs that are associated with some of the most near-term events. Just to give you a perspective on the pipeline overall, as I mentioned, we're really working broadly in women's health, and really working in areas where similar to everything I've described to you, there's a very clear unmet need and there's a very clear path to a product that can address that. Contraception, sexual health, fertility, pregnancy maintenance, vaginal infections, the gamut. We also have really leveraged non-dilutive funding. I talked about our relationship with Organon on XACIATO. Not only is that relationship provide revenues, we also monetize some of those future proceeds, that was a really great non-dilutive way to bring capital into the company. We also have grant funding from a variety of sources. I mentioned ARPA-H and that $10 million award. We have a number of NIH grants. We have a number of programs with the Gates Foundation around products that are already in our portfolio, as well as innovating new products that are not in our portfolio, and getting to work with them on disease areas that are huge unmet needs like preeclampsia, but where we don't have a great target that we feel good about yet and where we're interested in finding one. To date, we've had over $75 million in grant funding awarded since 2018. All right. In the last sort of minute, what's coming up next? As I mentioned up front, it's great time to be following us. We had that great Ovaprene interim data last summer, and that just really kicked off what is a really momentous sort of next 12-18 months for the company. DARE to PLAY Sildenafil Cream, prescription intake is starting. Dispensing will be starting in the coming months. Telehealth is available, and we've seen just great response to that. The DARE to RESTORE are our vaginal probiotics that are going to be launching later in the spring, and these actually were identified through a grant from the Gates Foundation, where we were tasked to identify what are vaginal probiotics that actually work and are manufactured under GMP. Super exciting to now bring them into our portfolio. We're targeting that hormone therapy product, that vaginal ring, to launch via that 503B pathway next year. Hopefully, that gave some clear perspective as to why Daré and why now and why 2026 is such a fun year for us. Thank you. I'm happy to take questions, I think, for a few minutes, if allowed. If there are any. Awesome. Thank you. Thanks for being in here, you guys.
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