DARE

Ladies and gentlemen, thank you for standing by. Hello, and welcome to the conference call hosted by Daré 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 Daré are Sabrina Martucci Johnson, President and Chief Executive Officer, and MarDee Haring-Layton, Chief Accounting Officer. Ms. Haring-Layton, please proceed.

Good afternoon, welcome to the Daré Bioscience financial results and business update call for the quarter ended March 31st, 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 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 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. 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 bulk 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 N.Y. 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. Daré 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 healthcare options they deserve. 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. What distinguishes Daré is not just the breadth of the pipeline, but the strategy behind it. That disciplined approach to capital allocation that pairs non-dilutive grant funding with focused development, so that we can move multiple programs towards the clinic simultaneously.

It's not a single product bet. It's a portfolio of strategies. It'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. 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. I also want to be precise about what kind of company Daré 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. We respect those companies and what they're doing, but that is not what Daré is.

Daré is a product company. Our mission is to develop and bring to market clinically studied, differentiated women's health 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, they're 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, Daré 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. 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. 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.

Healthcare providers attending, and that includes OB/GYNs, women's health specialists, sexual health clinicians, they were genuinely excited about the product. 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 antidote. That's a signal. When experienced clinicians who 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 had 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. 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 U.S. report challenges related to genital arousal, there's not a single FDA-approved therapy that directly addresses the need, not one. While there's not yet an FDA-approved therapy, DARE to PLAY was designed to fill the void. As Marty mentioned up front, we are making DARE to PLAY available as a Section 503B compounded product. I want to reiterate again what we hear from healthcare providers and women because they continue to tell us the same three 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. 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. 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 offce visit. It's a discreet, convenient option. Medvantx handles the fulfillment and dispensing through the DARE Health Hub with the quality infrastructure they already have in place.

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 burdens 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. Healthcare 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 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's 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 to spend accordingly. 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. Stay tuned. Here's 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 505B2 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. 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.

I want to take a moment to highlight what I believe is an underappreciated milestone for Daré, and one that'll mark the second quarter as a milestone for our company. Flora Sync LF5, which is our first DARE to RESTORE vaginal probiotic suppository that we are launching commercially in June 2026. Seeding campaigns, 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. This will mark the first time that we have recorded direct product revenue as a company. 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 suppository 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 suppositories 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. Healthcare providers may recommend DARE to RESTORE products alongside DARE to PLAY or other Daré 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. 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-$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. We expect DARE to RECLAIM to be the first monthly intravaginal delivery solution in this space, combining bioidentical estradiol and bioidentical 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-pass strategy. Imagine the first monthly bioidentical hormone therapy IVR, including both estradiol and progesterone together, in an estimated $2.5 billion-$4.5 billion market. That's what DARE to RECLAIM is positioned to be, and investors can invest in that potential today. Ovaprene. Ovaprene is our monthly intravaginal hormone 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 show 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 nor 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 almost 400, 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. We do intend to engage with the FDA regarding these findings. That's two 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 U.S. 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 U.S., 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. 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. We're developing one with ARPA-H funding. With that ARPA-H funding, 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 in 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 re-rated 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 S3, and DARE-NHC. They all are continuing to advance. We also have an extended NIH-funded award for DARE-PTB1, which is our bioidentical 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. Every $1 of grant funding we secure, it's a $1 that moves us closer to putting better options in the hands of women without diluting our shareholders. 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. As I said up front, the context matters. Women's health is an investment-grade category, and we believe Daré 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 healthcare system for far, far too long. Right now, in mid-2026, we're at that moment where all of 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 1/2 of that global population. Approximately 80% of all U.S. healthcare 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 healthcare investment. 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 Daré was built to address. 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? 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, HPV, hormone therapy, and vaginal health, all advancing, many with non-dilutive funding. That R&D engine's running. Starting in June, that engine will be joined by a commercial engine, generating product revenue. Here's 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 now product revenue. They're three distinct complementary sources of capital that together let us continue building without depending on any one of them alone. 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. We intend to deliver on both fronts simultaneously.

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 family, 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. I want to reinforce an important first step in building a multi-product revenue profile for Daré. 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. As I mentioned, we do plan on FDA engagement regarding those interim findings and study protocol. Then DARE-HPV, that phase II. We're preparing that right now with that ARPA-H funding. We're looking to start this month. Stay tuned on that. 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 the real-world data set.

Every Ovaprene patient enrolled in our phase III moves us closer to data that will attract partners. 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. 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. All the groundwork we're laying for the 505B2 regular pathway that we believe will provide an opportunity to protect our market position after the 503B market matures. 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 femtech and women's health services sectors are attracting serious capital. Women are demanding that healthcare take their needs seriously. The rising tide is bringing many entrants, services, platforms, subscription models. There's real investment flowing in the category. We think that is a good thing for awareness. 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. 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 Daré has been building its pipeline at low tide. Investors want to be in before the water rises are looking at our company right now. With that, I'll turn it over for Marty 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 half a million. As a reminder, we continue to benefit from meaningful non-dilutive 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 non-dilutive 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 multi-product 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 our perspective on what product revenue means strategically. Daré has funded its development through a combination of equity financings and non-dilutive 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 31st, 2026, filed today. Operator, please open the line for questions.

Thank you so much, Marty. Just a quick reminder before we start the Q&A. If you would like to ask a question, please press star one on your telephone keypad to raise your hand and enter the queue. If you would like to withdraw your question, simply press star, one again. We will pause for a brief moment to wait for the questions to come in. Thank you. We will take our first question from the line of Kemp Dolliber from Brookline Capital Markets. Please go ahead.

Great. Thank you. couple questions. first, with regard to the Ovaprene trial and the interplay between enrollment pace and cycles. Sabrina, what kind of impact could this have on the timing of the readout? you know, are we 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? Thank you.

Yeah. No, that's a fantastic question. 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 quick in your head. Obviously, it makes a difference. You know, 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.

You know, 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, you know, 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. Yes, it can make a difference in terms of timing of, you know, 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. You know, we do want to engage with the FDA on what we've seen now because we think it's really promising and, you know, we'd love to share it with them and get their perspective.

Okay, that's fair enough. Thank you. Switching to DARE to PLAY, you know, the launch has slipped some as we've gone along. It looks like you're now closer to the finish line. You know, what have been the factors that have impacted the timing of, you know, getting to the point where you can do nationwide fulfillment?

Yeah. You know, 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. That obviously, you know, involves just GMP, right, good manufacturing practices, you know, 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, they have been going through that process.

They're up to, I think it's 28 or so, you know, registrations at this time. It's really balancing all of those factors and, you know, we want to prioritize doing this right, and making sure that when the product becomes commercially available via the dispensing, that everything's ready on the Bravado side to ensure that they can have that quality and consistency of supply and that it's meeting the demand. That's really what it's, you know, coming down to, and that as many women, you know, when it becomes commercially available initially, that as many women 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, you know, showing like shipping and quality standards. There are some states that are going to be a little behind, but you know, that's all what's behind it.

Okay, great. Thank you. I'll let someone else jump in.

Thanks for the questions.

Thank you so much. Again, if you would like to ask a question, press star, one on your telephone keypad. We will pause for a brief moment to wait for the questions to come in. Thank you. Our next question comes from the line of Kemp Dolliber from Brookline Capital Markets. Please go ahead.

Thanks for taking the follow-up. Just quickly, how are you thinking about the cash runway at this point?

Yeah. As we said in the 10-Q, when you get to the details on that, you know, 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, you know, we can use for general operating activities. Without the impact of obviously any of these revenue opportunities that we're talking about, if you just like looked in a vacuum at where we are on cash, you know, we will need to raise. We don't have 12 months of capital from that perspective. You know, 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. Also, the other piece of it is the grant-funded activities, you know, those activities, there's always a kind of future disbursements that come with those grants as well. I know sometimes it's confusing when people are looking at our cash, you know, and our grant liability to try to understand where things are. Some of it's, you know, it's the GAAP accounting piece of it, that means things don't always line up. Those are the two 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.

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.

Great. Thank you.

Thank you.

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've talked a little bit about, you know, women's health has been dismissed, it's been deprioritized, it's been underfunded for generations. The conditions that we address at Daré, 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. 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. 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, the Flora Sync LF5, the seeding campaigns, they're beginning, commercial launch and first product revenue is 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. You know, Ovaprene's a product that could be the first FDA-approved hormone-free monthly contraceptive. 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. That's the model working exactly as we designed it. You know, we built the company to change how women experience healthcare, and that change is beginning in earnest right now. 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. 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. 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 Daré Bioscience to review the company's 2025 financial results and provide a business update. This call is being recorded. My name is Desiree, 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 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 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-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. 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 bulk drug substances on the FDA's interim Category One 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 Daré is not just the breadth of the pipeline, but the strategy behind it. A disciplined approach to capital allocation that pairs 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 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. 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 demonstrating increased genital 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. 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 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's getting ready before we've even opened the commercial faucet.

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. 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, but 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 genital 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 or Section 503A compounders simply cannot guarantee. Healthcare providers and women tell us the same three things about DARE to PLAY that uniquely resonate with them. It works fast. It was genuinely built by biotech and studied for them. Following GMP potency and quality guidelines, they like that, so they know exactly what they're getting every single time. These are not baseless statements. They're what 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 discreet 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 build healthcare provider credibility and patient community simultaneously. As we prove out what it costs us to acquire a patient digitally and how long they stay on the product, 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. 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. Please stay tuned. Here's what 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. 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. 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 our most immediate new revenue story, so I wanted to start there because it's happening. 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, Daré 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. 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 manufacturer using their proprietary LF5 strain.

We believe that level of clinical evidence really distinguishes Flora Sync LF5 from the majority of vaginal probiotic suppositories 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. Healthcare 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-$4.5 billion compounded hormone therapy market.

Women are demanding alternatives to synthetic hormones, and bioidentical hormone therapy is a category on the rise. 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 one 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-$4.5 billion market. That's what DARE to RECLAIM is positioned to be, and investors can invest in that potential today. 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, non-hormonal options. That demand is real, and it's growing. The current market has nothing to offer beyond in-the-moment solutions like condoms or vaginal gels. Ovaprene is in a phase III pivotal trial right now. As you may recall, the Data Safety Monitoring Board reviewed interim data in July 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.

Completing enrollment in 2026 puts a 2027 data readout in reach. With it comes a potential PMA pathway for what could be the first non-implanted, non-hormonal monthly contraceptive option on the market. This asset alone in a world actively demanding non-hormonal contraception has partnership and licensing potential that we believe the market has dramatically undervalued. 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. 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. 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. We're developing one with ARPA-H funding. With FDA clearance of our IND application just this February 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 in one of the largest unaddressed infectious disease markets affecting women globally. Significant address, 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. 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 non-hormonal 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.

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 options in women's hands without diluting our shareholders. 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 healthcare system for far too long. 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 receives just 6% of private healthcare investment. Conditions that solely affect women, the very conditions we're developing treatments for, attract less than 1%. That's not because it's niche. That's a market failure, and it is exactly the gap that Daré was built to address.

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-$4.5 billion hormone therapy market, and before DARE-HPV data readout, the story is being written today. This is the catalysts, 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 a 2027 data readout within reach. DARE-HPV preparing to advance into phase II this year with our ARPA-H funding. This is not a single event binary bet. It's a portfolio with multiple catalysts, multiple pathways to value, and multiple ways to win. 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 that is difficult to replicate, establish relationships with telehealth providers, specialty pharmacies, and clinical KOLs in 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. 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 healthcare 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. Daré 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 is what the trend is calling for. The tide's rising in women's health, and we have been building our pipeline at low tide. Investors who want in before the water rises are looking at our company right now. 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, our actual total R&D investment when you add back contra-R&D amounts 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 multi-product 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 31st, 2025, filed today. Operator, please open the line for questions.

Thank you, MarDee. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one again. If you are called upon to ask your question and are listening via speakerphone in your device, please pick up your handset to ensure that your phone is not on mute when asking your question. Again, press star one to join the queue. Our first question comes from the line of Catherine Novack with JonesTrading. Your line is open.

Hi, this is Leona on for Catherine. Thank you for taking our questions. When was your last interaction with FDA on Sildenafil Cream? What are the next steps for clinical development in the 505(b)(2) regulatory path? I'll ask a follow-up after.

Thanks. Thanks for the question. Just a reminder to everyone. 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 like, as it pertains to the statistical analysis plan and success. You know, we wanna make sure that we're very clearly aligned on that.

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 II-B 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 are content valid and fit as patient-reported outcomes, to make sure that we're all thinking together about 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 erectile dysfunction because the clinical definitions are the same.

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.

Okay. Got it.

That dialogue is ongoing. Yeah. Thank you.

Okay. Do you need to conduct any additional safety studies, or will the submission rely on existing data for, like, systemic sildenafil in women?

Yeah. 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 objective 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, you know, within that first 10 to 15 minutes of application, without really significant systemic uptake. In fact, we're, you know, two orders of magnitude lower than what you would see with a comparable sort of oral dose as seen in the male studies.

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, you know, not be supportive of the objective of the product in terms of enhancing arousal. But we just get that localized effect. We really did not see any difference in the phase II-B study, and the safety data are all published between the placebo group and the active group in terms of adverse event profile. Okay. Thank you so much. Yeah, thank you.

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

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

Yeah, great question, and one, you know, we anticipated and are excited to get to talk about. You know 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. Prescriptions are coming in, but they're not being dispensed yet. 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 at 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.

They wanna make sure they get that prescription in for their patient, and they wanna 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. We're really seeing that both of those channels are active and relevant. That's been really helpful for us to understand. 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 a healthcare provider.

It has the data, it has the peer-reviewed publications that they look to, and we don't have to solely rely on, you know, a consumer channel and to see the breadth of both. More to follow on that as these convert to orders, as they start dispensing, and we will, you know, in the coming months be able to and start to provide more clarity, as I alluded to, in terms of, you know, that channel strategy, that approach, acquisition costs. Right now the focus has been on that very digital-focused campaign to make sure that consumers are aware of what's available.

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, you know, published clinical data in their most trusted journals for products like this.

How are you thinking about promoting DARE to RESTORE, which really looks like, as you say in the press release?

Yes.

It's a consumer/OTC product.

Great. Another great question. 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 healthcare provider to understand what their healthcare provider recommends. We're gonna be able to leverage here some of the same channels that we're leveraging for DARE to PLAY. It'll certainly appear on the DARE Health Hub, which is where someone who's getting a DARE to PLAY prescription will be going. It'll 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 channels to create awareness and drive conversion through the DARE Health Hub and through the website. 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 finished formulation. We think that's something that healthcare providers will be very interested in. There is a whole category of healthcare providers that are starting to recognize that for some women, you know, they may be interested in obtaining products while they're in that office visit, right, with that healthcare provider.

Those are other channels that we're also looking at, very analogous to, you know, the derm space is very mature, right, in that regard in terms of the kind of products that are sometimes also available in your clinician's office. For those clinicians where this becomes, you know, 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. Your line is open.

Hi. Good afternoon. Thanks for taking the questions. Sabrina, I guess on DARE to PLAY, you know, 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 do you foresee 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, you know, prescribers?

Yeah. It's a fantastic question, and it's something that we have been looking at very closely and monitoring very closely. As I noted in the comments, one of the things that we wanna 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 and the number of touchpoints that they have.

What we wanna make sure that, you know, once dispensing commences in all 50 states, right, that we have all of those, you know, it's available in all of the states, and we've 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 touchpoints 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. It's really coupling all those factors together, right? How many patients, right, how many touchpoints, 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? 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. You know, we wanna make sure that there's financial stability, there's solid alignment culturally and with the product fit, and that again, there's a financially structured model that makes a lot of sense from a cost of acquisition perspective and reach for this product. Those are the things that we've been evaluating. You know, we wanna 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, you know, it's available where women are going for their care. Those are the factors that we're looking at.

I guess as a follow-up question, I hear your point earlier in terms of you're the only product that's actually been tested. I guess it's hard, you know, it's like thinking about like, you know, so the GLP-1 class, right, where there are a lot of compounded products out there as well. You know, how do you necessarily. I think, you know, with your product, there are arguably more formulation differences that are arguably more important, right, to distinguish, you know, your product from other products that are out there.

You know, 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, you know, patients don't try some of the alternative formulations and sort of give up on the, you know, sort of the topical sildenafil, and ultimately any sort of, you know, market share coalesces around your product? Thank you.

Yeah. Absolutely. Fantastic question. You kinda hit the nail on the head in two. One, you know, On the one hand, the GLP-1 experience that people have had given people perhaps an impression that, you know, 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. It's very easy both for healthcare providers, and we've 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, you know, topical products. We use face creams every day, we use whatever, right?

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. 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 the arousal sensations that the blood flow is gonna cause within 10 minutes. When a clinician or a consumer looks at any compounded Sildenafil Cream product that is not DARE to PLAY with our Dermalux 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.

With a healthcare 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. With the consumer, it's really about time to effect and that there are this has been engineered by Biotag specifically for them.

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

Yeah, absolutely. The other way to think about this, again, the world has really changed significantly in terms of. I'm gonna 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 healthcare 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. These are the kind of channels. Like, when we're talking about enhancing our digital, you know, our focus around education, these are a lot of the channels 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. 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 Daré Bioscience is a brand in and of itself, right? We've run so many clinical trials, so many healthcare providers have worked with us on one of our studies, right? They are proudly telling their friends, their peers about the product.

We're also very much leveraging, I would call it provider-to-provider, education and provider-to-provider, you know, promotion, marketing, for lack of a better word. Because we have credibility as a builder of solutions for the women that they serve and, you know, many of them have worked with us. That's not, you know, that's not something that, you know, a compounder, for instance, is going to be able to do. It really resonates.

Okay, great. Thank you very much.

Yeah. Absolutely.

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. I definitely wanna close with something that I feel deeply, and it ties into some of the questions that we just went through, right? Women's health has been dismissed, it's been deprioritized, it's been underfunded for generations. The conditions that we address at Daré 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. Daré Bioscience was founded on the belief that women deserve better, and that belief has guided every decision we have made. I started Daré because I believe women's health was both a moral imperative but also a compelling strategic opportunity. 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. The pipeline behind DARE to PLAY, it's deep, it's differentiated, and we're finding ways to advance it. We built this company to really change how women experience healthcare, and that change is beginning in earnest now. 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. It's 10 years of building, but the commercial inflection is here, and the pipeline is deep, and the market is ready.

Daré 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 who remember this call. 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.

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.