Dare Bioscience, Inc.

financial results and to provide the business update. This call is being recorded. My name is Jericho and I will be your operator today. With us today from DARE are Sabrina Martucci-Johnson, President and Chief Executive Officer, and Mardi Herring-Layton, Chief Accounting Officer. Ms. Herring-Layton, please proceed.

Good afternoon and welcome to the DARE Bioscience Financial Results and Business Update call for the quarter ended September 30th, 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 503 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, 19, sorry, 2025. which was filed today in our Form 10-K for the year ended December 31st, 2024. Please note that the content of this call includes time-sensitive information that is current only as of today, November 13th, 2025. DARAE 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 503 compounding during this discussion, We are referring to compounding drug products by outsourcing facilities registered under Section 503 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.

Thank you, Marty, and thank you everyone joining us today. Dari 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 503 outsourcing facility before the end of this year. This anticipated launch represents a major milestone, not just for DARE, 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 births. We believe this dual path approach enables us to unlock value efficiently by leveraging non-dilutive 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 Noken 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 DARE to stand out and grow. As you know, DARE 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 wanted 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 DARE, 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 DARI, 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 healthcare 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 early, designing collaborations around the outcomes we want, which is to move promising science into the hands of women faster, and Dare to Play Sedanafil 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 503 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 future FDA registration paths The third quarter was a pivotal period for DARE as we advanced towards the commercial introduction of Dare to Play Sydenifil Cream through the 503 outsourcing facility pathway. And our focus continues to be on execution. We remain on track for our 503 outsourcing facility partner to begin fulfilling prescriptions in select states in December. In addition to the federal requirements overseen by the FDA, 503 outsourcing facilities are also subject to state-specific requirements, and we expect Dare to Play Sidenafil cream prescriptions will be available to be fulfilled in all 50 states in early 2026. This milestone will mark the first time a topical Sidenafil 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 503 manufacturing partner specializing in topical formulations and Medvantix, 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.dare2playbio.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 Sedentafil Cream that Raises the Bar, will feature renowned experts Dr. Cheryl 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 Sidenafil cream will set new standards in women's sexual arousal healthcare. You can find the link to join the webinar at https://cvent.me slash K01OBD. Also on our website in the investor 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 dare2playbio.com website for product updates and access alerts so that you can be among the first to know when this only evidence-based Sidenafil cream formulation for women, Dare to Play Sidenafil 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 two 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 503 as well. The compounded product will be branded as Dare to Reclaim and is designed for women experiencing 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 503 compounding opportunity similar to our dual path strategy for Sidenafil 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. Dare 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 Sedentafil 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 non-dilutive support. Let's start first with oviprene. Enrollment is ongoing in our pivotal phase three multi-center single arm non-comparative clinical study of oviprene to evaluate its effectiveness as a contraceptive along with its safety and acceptability. We intend to maintain active recruitment at five 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 3 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 post-coital test study of oviprene. These data support oviprene'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, ibuprene 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 PERL index. Recall that Bayer received the right to obtain exclusive U.S. rights to commercialize the product Following completion of this pivotal clinical trial, IFBEAR in its sole discretion makes a $20 million payment to DARE. DARE 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 non-dilutive 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 multi-year 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 DARE-NHC is a preclinical research program that will aid in the identification and development of a novel non-hormonal intravaginal contraceptive product candidate. The grant funding supports activities to de-risk the development of a novel non-hormonal 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, Marty, to review the financial results for the recently completed quarter.