Daré Bioscience, Inc. (NASDAQ:DARE) Q1 2026 Earnings Call Transcript

Daré Bioscience, Inc. (NASDAQ:DARE) Q1 2026 Earnings Call Transcript May 14, 2026

Daré Bioscience, Inc. beats earnings expectations. Reported EPS is $-0.2, expectations were $-0.33.

Operator: Ladies and gentlemen, thank you for standing by. Hello, and welcome to the conference call hosted by Dare Bioscience to review the company’s first quarter 2026 financial results and to provide a business update. This call is being recorded. My name is King, and I will be your operator today. With us today from Dare are Sabrina Martucci Johnson, President and Chief Executive Officer; and MarDee Haring-Layton, Chief Accounting Officer. Ms. Haring-Layton, please proceed.

MarDee Haring-Layton: Good afternoon, and welcome to the Dare Bioscience financial results and business update call for the quarter ended March 31, 2026. Today, we will review our financial results, provide updates on our clinical pipeline and discuss the continued execution of our expanded business strategy. That strategy includes a dual path approach, commercializing proprietary formulations through 503B compounding while pursuing FDA approval, and advancing select solutions as branded consumer health products that do not require a prescription. In all cases, our goal is to bring innovative women’s health solutions to market as efficiently and quickly as possible. I would like to remind you that today’s discussion will include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Any statements made during this call that are not statements of historical facts should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company’s SEC filings, including our quarterly report on Form 10-Q for the quarter ended March 31, 2026, which was filed today, and our annual report on Form 10-K for the year ended December 31, 2025. Please note that in the context of this call includes time-sensitive information that is current only as of today, May 14, 2026.

Dare undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. I would also like to point out that when we use the term 503B compounding during this discussion, we are referring to compounding drug products by outsourcing facilities registered under Section 503B of the Federal Food, Drug and Cosmetic Act using both drug substances on the FDA’s interim Category 1 list. I will now turn the call over to Sabrina.

Sabrina Johnson: Great. Thank you, MarDee, and good afternoon, everyone, and thank you for joining us. I am taking the call today from New York in the middle of National Women’s Health Week. And this year’s theme, which is Prevention, Innovation and Impact, a new era in women’s health, couldn’t be more relevant to our discussion this afternoon. Dare was built on the conviction that women’s health is an investment-grade category, not a niche, not a nice to have, not a pink ribbon in a press release, it’s a category worth building, funding and holding accountable for delivering to women the health care options they deserve. And that is exactly what we’re doing today and reporting on what we’ve built and where we’re going. Over 10 years ago, we made a decision to focus exclusively on women’s health, as you know, not as a sideline, not as a franchise within a broader portfolio, as our entire reason for existing.

Every dollar raised, every clinical trial run, every regulatory submission prepared, every partnership negotiated, all of it for one purpose, building the company with the most comprehensive pipeline comprised exclusively of differentiated products for health issues and conditions that uniquely impact women. From contraception to menopause, sexual health to fertility, vaginal health to human papillomavirus, we’re working to close critical gaps in care with science that meets her needs. And what distinguishes Dare is not just the breadth of the pipeline, but the strategy behind it, that disciplined approach to capital allocation that pairs nondilutive grant funding with focused development so that we can move multiple programs towards the clinic simultaneously.

So it’s not a single product bet. It’s a portfolio of strategy that’s built from the ground up for one of the most chronically underfunded areas in all of medicine despite affecting half the world’s population. And we’re not a company that’s just getting into women’s health. What 10 years of commitment looks like is what is coming into view right now. And I also want to be precise about what kind of company Dare is, because the women’s health space is attracting more and more entrants and not all of them are building the same thing. This is a growing category of women’s health platform companies that offer services, telehealth subscriptions, care navigation, clinical memberships. That’s what’s happening. And they make products available as part of the service experience.

And we respect those companies and what they’re doing. But that is not what Dare is. Dare is a product company. Our mission is to develop and bring to market clinically studied, differentiated women’s health products, products with real data behind them, addressing gaps where, in our view, nothing adequate exists today. The DARE Health Hub and telehealth access we provide, their infrastructure built to put those products in the hands of women efficiently. Access is essential, but the products are the point. And that distinction matters, especially for clinicians. When a provider writes a prescription for DARE to PLAY, they are prescribing a specific formulation with published clinical data, not some generic compounded product and not a service bundle.

We’re building relationships with the clinical community that are grounded in the credibility of what’s in our tubes or bottles. That’s a very different conversation than one built around a subscription platform. To our knowledge, Dare Bioscience has the most robust development stage pipeline of any company in the world developing products exclusively for conditions that solely affect women. We have not been able to identify a company with a comparable portfolio. Products are protectable, products can generate recurring product revenue. Products can be partnered, products can be approved by the FDA. Products can be real-world solutions. And a great way to illustrate our product model is to start with DARE to PLAY. Since our last call, one of the most meaningful events we participated in was the American College of Obstetricians and Gynecologists, or ACOG, their annual conference.

And I want to share what happened there because I believe it signals something important about where DARE to PLAY is headed. The reception we received at ACOG for DARE to PLAY was enthusiastic. Health care providers attending, and that includes OB/GYNs, women’s health specialists, sexual health clinicians. They were genuinely excited about the product. And I mean, genuinely, we literally had providers who were so enthusiastic about DARE to PLAY that they were writing prescriptions for each other on the spot at the booth. That’s not a marketing anecdote. That’s a signal. When experienced clinicians see patients every single day and have long lamented the absence of evidence-based options for women’s sexual health, they see DARE to PLAY and immediately want it for themselves and their patients.

It tells you something real about the unmet need and the credibility of our product. We also have clinicians approach us about stocking DARE to PLAY directly in their offices. That level of interest from the provider community is exactly what a new prescription option needs to build sustainable momentum, and we are actively working to support those discussions. Providers are becoming advocates, and that’s how sustainable commercial momentum is built, not just relying on advertising, but through clinician conviction. DARE to PLAY is a first-of-its-kind topical arousal cream for women. To our knowledge, there is no other sildenafil topical cream manufactured under Good Manufacturing Practice requirements with clinical data demonstrating increased genital blood flow in 10 to 15 minutes and improvements in arousal, orgasm, desire as measured by clinically validated and FDA reviewed endpoints.

As we’ve discussed before, men have had Viagra in their medicine cabinet for over 25 years. Women have not had a sildenafil cream formulation clinically studied and developed specifically for them, until now. An estimated 20 million women in the United States report challenges related to genital arousal. And there’s not a single FDA-approved therapy that directly addresses the need, not one. And while there’s not yet an FDA-approved therapy, DARE to PLAY was designed to fill the void. And as MarDee mentioned upfront, we are making DARE to PLAY available as a Section 503B compounded product. I want to reiterate again what we hear from health care providers and women because they continue to tell us the same 3 things about DARE to PLAY that uniquely resonates with them: It works fast; it was genuinely built by biotech; and studied for them.

We also hear that following those Good Manufacturing Practices around potency and quality guidelines, so they know exactly what they’re getting every single time is important. And these are not baseless statements, they’re what clinical data show and what compliance with GMP requirements validates. The pre-fulfillment prescribing for DARE to PLAY sildenafil cream, as you know, has been live across 50 states since February 2026, and the clinician response we continue to see is encouraging. Bravado, the 503B registered outsourcing facility for DARE to PLAY, they’re targeting dispensing to begin this summer as they continue to complete the necessary state licensing and fulfillment preparations. It’s a significant milestone that we have been building toward.

Our 503B commercial model is asset-light and digitally native by design. We drive that consumer awareness through targeted digital marketing. Women can access DARE to PLAY through telehealth without an in-person office visit. It’s a discrete, convenient option. Medvantx handles the fulfillment and dispensing through the DARE Health Hub with the quality infrastructure they already have in place. And so I want to reiterate again about how we think about telehealth in our model. Telehealth is an access infrastructure. It’s a critical tool for getting our products to the women who need them, but it’s not the business model. We’re not a subscription service. We’re not a care navigation platform with the burden that those bring. We’re a product company.

We’re using telehealth as one channel among several to deliver clinically studied differentiated solutions efficiently. That’s also why the provider relationship matters so much to us. Health care providers, again, the OB/GYNs, the women’s health specialists, the primary care physicians, are not a channel to us, they are our clinical partners. When we say DARE to PLAY was built specifically for women and has been clinically studied in women, that means something to a provider in a way that a generic compounded cream does not. When a clinician at ACOG asks how to stock our product in her office, she is not asking about a service. She’s asking about a product she believes in and she wants to offer her patients directly. That’s the kind of relationship we’re building, and it’s built on the credibility of the product itself.

As we prove out what it costs to acquire a patient digitally, and how long they stay on the product and as dispensing commences this summer, we can add channels and scale the spend accordingly. And as our commercial footprint grows, we expect additional strategic collaborations with telehealth provider platforms, right, other ones, platform distributors and clinical networks, all in the service of getting our products to more women faster. So stay tuned. And here is what makes our approach uniquely powerful. While DARE to PLAY is available for pre-fulfillment today through that 503B compounding pathway, generating real prescribing data, building clinician relationships and creating that patient demand, we are simultaneously working to advance our sildenafil cream towards the 505(b)(2) NDA pathway for FDA approval.

Both can happen at the same time, and that’s the power of building our products around well-characterized chemical entities, compounds with established safety databases. We can start building a market for certain of our product candidates. We build that market while we build the regulatory file and the real-world data we generate through the 503B strategy, may ultimately strengthen our NDA submission. So to our knowledge, there is no company our size in women’s health that has this kind of strategic flexibility, and it’s a result of how deliberately we designed our pipeline. And I want to take a moment to highlight what I believe is an underappreciated milestone for Dare and one that will mark the second quarter as a milestone for our company.

Flora Sync LF5, which is our first DARE to RESTORE vaginal probiotics depository, that we are launching commercially in June of 2026. Seeding campaigns, so these are things designed to build clinician awareness and drive initial consumer trial. Those are beginning now in May ahead of that commercial launch. We begin to expect recording revenue from Flora Sync LF5 in June. And this will mark the first time that we have recorded direct product revenue as a company. So it is a big milestone for our company and one that we believe changes how investors should think about our story. The DARE to RESTORE products are probiotics designed to support vaginal microbiome balance. Flora Sync LF5 is a vaginal probiotic depository developed by Probiotical, one of the world’s leading probiotic research companies.

The formulation is based on scientific research into vaginal microbiome composition and health. It’s been studied in a 100-person clinical trial, and the findings have been published in a peer-reviewed journal. Probiotical is the exclusive manufacturer using its proprietary LF5 strain. We believe that level of clinical evidence distinguishes Flora Sync LF5 from the majority of vaginal probiotic depositories on the market today. And we expect it to be an important differentiator as we build the DARE to RESTORE brand. We intend to distribute DARE to RESTORE products through the DARE Health Hub, where we believe they will be complementary to our 503B prescription offerings. Health care providers may recommend DARE to RESTORE products alongside DARE to PLAY or other Dare products as part of a comprehensive approach to women’s vaginal and sexual health.

Intimacy and intercourse can be one of the biggest disruptors of the vaginal microbiome and DARE to RESTORE Flora Sync LF5 is a reset and reconnect solution focused on balance, confidence, comfort and intimacy wellness. Next, I’ll walk you through other program updates and milestones we’re targeting for 2026 and 2027. DARE to RECLAIM is our proprietary monthly intravaginal ring designed to deliver bioidentical estradiol and progesterone, targeting the estimated $2.5 billion to $4.5 billion compounded hormone therapy market. Women are demanding alternatives to synthetic hormones. Bioidentical hormone therapy is a category on the rise, particularly with the removal of the black box warning. And we expect DARE to RECLAIM to be the first monthly intravaginal delivery solution in this space combining bio-identical estradiol and bio-identical progesterone.

We’re targeting to have DARE to RECLAIM available for 503B prescription fulfillment in 2027, while simultaneously pursuing activities to support an NDA filing and a pivotal Phase III clinical study utilizing the dual path strategy. Imagine the first monthly bioidentical hormone therapy IVR, including both estradiol and progesterone together in an estimated $2.5 billion to $4.5 billion market. That’s what DARE to RECLAIM is positioned to be. And investors can invest in that potential today. And Ovaprene. Ovaprene is our monthly, intravaginal, [Technical Difficulty] candidate. And earlier this week, we announced positive interim results from our ongoing Phase III clinical trial, and that’s following the second planned interim analysis by the trial’s independent Data Safety Monitoring Board, or DSMB.

The DSMB reviewed interim data and recommended the study continue without modification for the second time. This second consecutive positive DSMB review reinforces Ovaprene’s potential as a meaningful hormone-free contraceptive alternative as it advances through its Phase III trial. The interim data showed that approximately 9% of women treated in the study had experienced a pregnancy. That rate is consistent with our expectations based on the results of the pre-pivotal postcoital test clinical study, as well as the last DSMB meeting. There are no new types of adverse events or tolerability concerns identified, neither an increase or decrease in the frequency of adverse events, nor the emergence of new types of adverse events was observed with prolonged Ovaprene use.

Approximately 12% of participants discontinued the study due to vaginal odor. That’s the most commonly reported product-related adverse event. That rate, though, is a 5% decrease compared to the data reviewed by the DSMB last summer in July of 2025. No serious adverse events related to the study device were identified and a majority of the participants who completed the study reported that they would be very likely or likely to use Ovaprene if it became available. The DSMB reviewed data from 340 study subjects contributing nearly 1,800 menstrual cycles of safety data, and that’s a meaningful proportion of the study’s 2,500 cycle target. The study protocol calls for at least 2,500 cycles of exposure and 250 subjects completing 13 menstrual cycles of use.

Based on the current enrollment trends, we would expect to achieve the 2,500 cycles of exposure before 250 subjects complete 13 menstrual cycles of use. Importantly, the interim safety data suggests that prolonged product use was not associated with the emergence of new types of adverse events or an increased frequency of adverse events. And we believe that may support the sufficiency of fewer than 250 subjects completing 13 cycles to evaluate Ovaprene’s safety profile. And we do intend to engage with the FDA regarding these findings. So that’s 2 consecutive positive DSMB reviews on Ovaprene and a pregnancy rate consistent with expectations, tolerability data that improved from the first interim look and a majority of users who say they would use it again.

That’s a differentiated potential first-in-category asset advancing through its pivotal clinical trial. There are currently no FDA-approved, hormone-free monthly intravaginal contraceptives. And a growing number of women, particularly younger women, are actively seeking alternatives to hormonal contraceptive. Ovaprene is designed to be the answer. We currently expect to complete enrollment sufficient to achieve at least 2,500 cycles of exposure in 2026. And completing enrollment in 2026 puts the primary endpoint analysis within reach in 2027. Now a little bit about DARE-HPV. DARE-HPV is perhaps our most underappreciated development program. An estimated 6 million women in the United States alone acquire a high-risk HPV infection every single year.

And today, every single one of them is being managed with watchful waiting or surgery. There is no drug therapy. That represents a completely untreated patient population with a clear clinical need and no existing direct competition in the pharmacologic space. High-risk HPV types are the underlying cause of virtually all cervical cancer cases in the United States, 99% of them. And for decades, women with persistent high-risk HPV infection have been told to watch and wait to monitor and hope that the virus clears on its own. If it doesn’t, the only recourse has been surgery once those precancerous changes appear. As I mentioned, there’s not a single FDA-approved pharmacologic treatment for high-risk HPV infection, not one, and we are developing one with ARPA-H funding.

So with that ARPA-H funding and FDA clearance of our IND application, which happened in February of this year, we are now preparing to advance DARE-HPV into a Phase II clinical study in May this month. DARE-HPV has the potential to be the first pharmaceutical therapeutic and one of the largest unaddressed infectious disease markets affecting women globally. Significant addressed market, grant-funded development, advancing into Phase II clinical development, that’s exactly the kind of asset that gets rerated when investors discover it, and we believe very few have. Other potential first-in-category contraceptive candidates that we are currently developing are supported entirely with grant funding. That’s DARE-LARC1, Casea S, and DARE-NHC, and they are all continuing to advance.

We also have an extended NIH-funded award for DARE-PTB1, which is our bio-identical progesterone intravaginal ring candidate aiming to reduce the risk of preterm birth in at-risk women. The pipeline was deliberately built to address the most persistent gaps from preterm birth to HPV-associated disease to sexual health and beyond. And every dollar of grant funding we secure, it’s a dollar that moves us closer to putting better options in the hands of women without diluting our shareholders. And I now want to speak directly to every investor on the call, institutional, retail and anyone who’s listening to the replay. As I mentioned upfront, I’m joining this call from and during the National Women’s Health Week in New York. And as I said upfront, the context matters.

Women’s health is an investment-grade category, and we believe Dare is the investment-grade vehicle to capture what is still a dramatically underfunded opportunity. We’re not here because it’s the right week to say that, we’re here because we have spent over 10 years proving it. We built the portfolio with clinical rigor, disciplined capital management and that unwavering commitment to women who have been underserved by the health care system for far, far too long. And right now, in mid-2026, we’re at that moment where all that investment converges into action. The products are coming live, and we expect to record the first direct product revenue this quarter. Demand is building, the data are coming, and we’re poised for partnerships. Women represent half of that global population and approximately 80% of all U.S. health care purchasing decisions are made by women.

Conditions that solely affect women, the very conditions for which we are developing treatments, they’re attracting less than 1% of private health care investment. Yet women’s health drugs represent 27% of all blockbuster pharmaceutical products, and that’s not even including GLP-1s. That’s not a niche. That’s a market failure that created a gap, and that’s the gap that Dare was built to address. And I want to also address a question that we hear as we’re approaching commercialization. I get asked, are we an R&D company or are we a commercial company? And I answer, yes. We’re in the business of getting first-in-category products into the hands of women who need them. That requires both. We will not stop developing. We have a pipeline that includes potential first-in-category programs across contraception, APV — HPV, hormone therapy and vaginal health, all advancing, many with nondilutive funding.

That R&D engine is running. And starting in June, that engine will be joined by a commercial engine, generating product revenue. And here is how I want investors to think about that. Product revenue is not a pivot, it’s not a change of identity, it’s another source of capital, and it’s a value driver. Grant funding, equity financings and our product revenue, they are 3 distinct complementary sources of capital that together let us continue building without depending on any one of them alone. And we don’t need to choose between R&D and commercial. We’re building a company that does both because the women we’re working for, they need both, the science and the products. And we intend to deliver on both fronts simultaneously. And here’s what we’re targeting to deliver, again, as a recap, DARE to PLAY dispensing.

We’re targeting commencement nationally this summer via Bravado as our 503B outsourcing facility partner. DARE to RESTORE, Flora Sync LF5 being the first such probiotic. The seeding campaigns are beginning this month in May, the commercial launch and first product revenue is expected in June. Again, I want to reinforce an important first step in building a multiproduct revenue profile for Dare. Additional DARE to PLAY collaborations, as I said, stay tuned, commercial and telehealth collaborators to be announced as our channel infrastructure matures. DARE to RECLAIM dispensing, we are continuing to target 2027 for another 503B outsourcing facility with IND preparatory activities for what we’ve often referred to as DARE-HRT1, right, our hormone therapy product, ongoing pursuant to our dual path strategy.

Ovaprene, again, I want to reiterate that second positive DSMB review just happened and was just announced this week. The enrollment expected to complete this year to achieve that 2,500 cycles of exposure. That puts 2027 primary endpoint analysis within reach. And as I mentioned, we do plan on FDA engagement regarding those interim findings and study protocol. And then DARE-HPV, that Phase II, we’re preparing that right now with that ARPA-H funding, we’re looking to start this month. So stay tuned on that. And hopefully, what you get with all of that is that we are not a single event binary bet, it’s a portfolio with multiple catalysts and multiple pathways to value, multiple ways to win. With every prescription written for DARE to PLAY, we’re building a real-world data set.

Every Ovaprene patient enrolled in our Phase III moves us closer to data that will attract partners. And every clinician who prescribes one of our products can become an advocate for the next. We’re building a platform, not just a single product. And that year of clinical data on our specific formulations, that’s data that a competitor can’t replicate overnight. Established and growing relationships with telehealth providers, specialty pharmacies, clinical KOLs in women’s sexual health and vaginal health right now, including that clinician community we engage with at ACOG and all the groundwork we’re laying for the 505(b)(2) regular pathway that we believe will provide an opportunity to protect our market position after the 503B market matures.

And the brands, DARE to PLAY, DARE to RESTORE, DARE to RECLAIM that we’re talking about right now, they’re built around a clear resonant identity with women. We’re operating at a moment when the cultural and commercial conversation about women’s health has never been louder. The fintech and women’s health services sectors are attracting serious capital. Women are demanding that health care take their needs seriously. The rising tide is bringing many entrants, services, platforms, subscription models, there’s real investment flowing in the category, and we think that is a good thing for awareness. And we also think it matters enormously what kind of company is doing the building. Services can be copied, subscriptions can be undercut, but clinical data, that speaks for itself.

Products can be real-world solutions. And we’re a product company with a pipeline that is not reactive to a trend. We foresaw the trend, and it’s exactly what the trend is calling for. As I said on the last earnings call, the tide is rising in women’s health, and Dare has been building its pipeline at low tide. So investors want to be in before the water rises and are looking at our company right now. And with that, I’ll turn it over to MarDee to give a financial review.

MarDee Haring-Layton: Thanks, Sabrina. Good afternoon, everyone. I’ll now walk through our financial results for the quarter ended March 31, 2026, and provide context on our balance sheet and forward financial positioning. We ended the quarter with approximately $18.5 million in cash and cash equivalents and working capital of approximately $0.5 million. As a reminder, we continue to benefit from meaningful, nondilutive capital sources that help us advance our pipeline. In 2025, we received approximately $13.6 million from the Gates Foundation, $4.5 million under our ARPA-H Award and $1.3 million from NIH grant reimbursements. In February 2026, we received an additional $2 million under our ARPA-H Award. These sources have allowed us to advance multiple programs simultaneously while managing shareholder dilution responsibly.

Selling, general and administrative, or SG&A expenses for the first quarter of 2026 were approximately $2.2 million compared to approximately $2.3 million in the first quarter of 2025. The year-over-year decrease was primarily attributable to decreases in personnel costs, offset by increases in professional services and commercial readiness expenses, including preparations to bring DARE to PLAY and Flora Sync LF5, to market and stock-based compensation expense. Research and development or R&D expenses were approximately $0.7 million for the first quarter of 2026 compared to approximately $2.3 million in the first quarter of 2025. I want to again highlight an important feature of our R&D expense reporting. We recognize nondilutive funding awards as contra R&D expense, meaning grant funding directly offsets our reported R&D costs.

Contra R&D expense related to grant funding was approximately $3.5 million for the first quarter of 2026 compared to approximately $3.1 million for the first quarter of 2025. This means our actual total R&D investment when you add back contra R&D amounts is meaningfully greater than the R&D expense line alone reflects. We believe this is an important dynamic for investors to understand when evaluating the true scale of our R&D investment. We expect to begin recording product revenue from DARE to PLAY in the third quarter of 2026. Flora Sync LF5 consumer health product revenue is expected to begin in June 2026. We are targeting DARE to RECLAIM revenue to begin in 2027. We are building toward a multiproduct revenue profile that diversifies and grows across 2026 and 2027.

The initiation of direct product revenue in June 2026 for the first time in the company’s history is a milestone we have worked hard to reach and one that we are proud to be approaching. I want to offer a perspective on what product revenue means strategically. Dare has funded its development through a combination of equity financings and nondilutive grant funding. Product revenue will add a third leg to that stool, a capital source tied directly to the value we are delivering to patients and clinicians, one that we expect to grow as our commercial footprint grows and that reinforces the development mission rather than competing with it. We encourage investors to review the more detailed discussion of our financial statements, financial condition, liquidity, capital resources and risk factors in our Form 10-Q for the quarter ended March 31, 2026, filed today.

Operator, please open the line for questions.

Q&A Session

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

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

Sabrina Johnson: Yes. No, that’s a fantastic question. So if you’re just doing the simple math, right, 250 women completing 13 cycles, right, that’s a lot more — not a lot more, but it’s more than 2,500 cycles or 250 women completing 12 months, right, might be the easier way to do it, the math clicking your head. And so obviously, it makes a difference. And the — What you’re looking for with a product like this, I mean, part of the reason, right, in clinical development, we have targets is you don’t know what you’re going to see from a safety signal, what you might see over time. Ovaprene is very much a first-in-category product. It’s the first ever once-a-month vaginal product, non-hormonal vaginal product that women are experiencing.

And so what’s exciting about the data that we’ve seen to date and having the DSMB look at it is that we’re not seeing a change in that safety signal over time. We’re not seeing any modifications in terms of types of adverse events or when they’re happening over the course of the women that have completed the 13 cycles to date. And so yes, it can make a difference in terms of timing of — completing the follow-up with the women in terms of timing in 2027, right, when we could be able to target that readout. At this point, I can’t give you more specific insights than that. We do want to engage with the FDA on what we’ve seen now because we think it’s really promising, and we’d love to share it with them and get their perspective.

Brian Kemp Dolliver: Okay. That’s fair enough. Switching to DARE to PLAY. The launch has slipped some as we’ve gone along. It looks like you’re now closer to the finish line. What have been the factors that have impacted the timing of getting to the point where you can do nationwide fulfillment?

Sabrina Johnson: Yes. We’re really trying to work closely with our partner, I refer to them as partner, but the 503B outsourcing facility, Bravado, that really is doing the work, right? They’re the ones doing the manufacturing. They’re the ones really that have to ensure that they’re commercially ready. And that obviously involves GMP, right, Good Manufacturing Practices, having the readiness to supply the product and meet commercial demand, obviously critical. The other piece of it, though, is state-specific registration activities that a 503B outsourcing facility is required to do. They’ve been doing a fantastic job with that. Most 503B facilities are not registered across the country. So they have been going through that process.

They’re up to, I think it’s 28 or so registrations at this time. So it’s really balancing all of those factors. And we want to prioritize doing this right, right, and making sure that when the product becomes commercially available via the dispensing, that everything is ready on the Bravado side to ensure that they can have that quality and consistency of supply and that it’s meeting the demand. So that’s really what it’s coming down to and that as many women — when it becomes commercially available initially, that as many women across the company — across the country can access it as possible. There are some states that simply will not allow dispensing in their state until they can review data from other states showing like shipping and quality standards.

So there are some states that are going to be a little behind. But it’s — That’s all what’s behind it.

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

Brian Kemp Dolliver: Just quickly, what is — how are you thinking about the cash runway at this point?

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

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

Brian Kemp Dolliver: So it’s fair to say it’s at least a couple — it may not be 12 months, but it’s a couple of quarters?

Sabrina Johnson: Yes.

Operator: 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.

Sabrina Johnson: Absolutely. Thank you. Well, thank you, everyone, for participating today. As we talked a little bit about, women’s health has been dismissed, it’s been deprioritized, it’s been underfunded for generations. And the conditions that we address at Dare, arousal, vaginal health, menopause, contraception, HPV, these affect hundreds of millions of women worldwide. They’re not rare diseases. They’re common experiences that have been met far too often with inadequate options, clinical dismissal or simply nothing at all. And we’re founded on the belief that women deserve better, and that belief has guided every decision we’ve made, including the decision to be a product company to do the hard, rigorous work of developing the clinical data and building formulations that providers and patients can trust.

That choice was deliberate. And clinician and patient awareness of DARE to PLAY is growing. As I mentioned, we saw those providers at ACOG who are already writing prescriptions and asking us how to stock the product in their offices. As we just mentioned, dispensing is targeted for this summer. And that — the Flora Sync LF5, the seeding campaigns are beginning and commercial launch and first product revenues targeted for June. We talked a lot about that interim data from our Ovaprene Phase III trial that we just received, that second consecutive DSMB review. And Ovaprene is a product that could be the first FDA-approved, hormone-free, monthly contraceptive. And I highlighted a few things about the pipeline behind it, which is deep and differentiated and advancing.

A commercial company and an R&D company, we’re entering a phase where both are true for us simultaneously and where product revenue becomes just one more source of capital to fund the science that will produce the next generation of solutions that will, in turn, generate revenue. And that’s the model working exactly as we designed it. We built the company to change how women experience health care, and that change is beginning in earnest right now. And I just thank all of you for your confidence and for being owners. We believe the assets we hold, the catalysts ahead and the window of time we’re in, represent a compelling opportunity, and we intend to execute on it. And June 2026 may be the month investors look back on as the moment that we became that revenue stage company and without ever stopping being a science-driven one.

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

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