Daré Bioscience, Inc.DARENASDAQ
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Operator: 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.
MarDee Haring-Layton: 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.
Sabrina Johnson: 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.
MarDee Haring-Layton: 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.
Sabrina Johnson: Thank you, MarDee, and I'd actually like to turn the call over to the operator for Q&A.
Operator: [Operator Instructions] Our first question comes from Catherine Novack from Jones.
Catherine Novack: 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?
Sabrina Johnson: 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.
Catherine Novack: 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]?
Sabrina Johnson: 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.
Catherine Novack: 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?
Sabrina Johnson: 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.
Operator: Our next question comes from Kemp Dolliver from Brookline Capital Markets.
Brian Kemp Dolliver: 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.
Sabrina Johnson: 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.
Brian Kemp Dolliver: Great. That's very helpful. The second question is the ATM and whether there's additional capacity left on it?
Sabrina Johnson: 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.
Operator: 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.
Sabrina Johnson: 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.
Operator: This concludes today's conference call. You may now disconnect.