Dare Bioscience, Inc.

Welcome to the conference call hosted by Dairy Bioscience to review the company's 2025 financial results and to provide a business update. This call is being recorded. My name is Desiree and I will be your operator today. With us today from Dairy are Sabrina Martucci-Johnson, President and Chief Executive Officer, and Marty Haring-Layton, Chief Accounting Officer. Ms. Haring-Layton, please proceed.

Good afternoon and welcome to the DARE 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 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 facts should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by these statements 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 31st, 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. 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 it over to Sabrina.

Thank you, Marty. Good afternoon, everyone, and thank you for joining us. Ten 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 DARE 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. And the best place to start that story, because it's already happening in the market, is Dare to Play. Pre-sophoma 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 silbentafil topical cream manufactured under GMP requirements with clinical data demonstrating increased general 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. And 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 of 2025, prescription intake commenced through the DARE Health Hub, powered by Medvantix 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 503 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. And 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. And 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 503 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. And following GMP potency and quality guidelines, they like that, so they know exactly what they're getting every single time. And 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. Midvanix 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. And as we prove out what it costs us to acquire a patient digitally and how long they stay on the product, and 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. And 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. So please stay tuned. And here 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 Sedentafil cream towards the 505b2 NDA pathway for FDA approval at the same time. And 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. and the real-world data we generate through our 503 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. But 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, 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 another company with a comparable portfolio. So 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, FloraSync 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 manufacturing using their proprietary LF5 strain. We believe that level of clinical evidence really distinguishes FloraSync 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 interaginal ring designed to deliver bioidentical estradiol and progesterone, targeting the estimated $2.5 to $4.5 billion compounded hormone therapy market. Women are demanding alternatives to synthetic hormones, and bioidentical hormone therapy is a category on the rise. And 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 three 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 to 4.5 billion dollar market. That's what Dare to Reclaim is positioned to be. And investors can invest in that potential today. And now oviprene. Oviprene is our monthly intravaginal hormone-free contraceptive candidate. And it's among the programs that I believe carry 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. And the current market has nothing to offer beyond in-the-moment solutions like condoms or vaginal gels. And oviprene is in a phase three pivotal trial right now. As you may recall, the Data Safety Monitoring Board reviewed interim data in July of 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. And completing enrollment in 2026 puts a 2027 data readout in reach. And 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. And 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. And today, every single one of them is being managed with watchful waiting or surgery. There is no drug therapy. And 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. And we're developing one with ARPA-H funding. With FDA clearance of our IMD application just this February of 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 unaddressed market, grant-funded development, Advancing into phase two, that's exactly the kind of asset that should get re-rated when investors discover it, and we believe very few have. And in addition to the portfolio programs that I just highlighted, other potential first and category contraceptive candidates currently supported entirely with grant funding, DERLARC1, CASIA-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 an unplanned pregnancy. Those programs continue to advance with that 100% grant funding. And we also recently announced an extension of an NIH award for DARE PTB-1, which is our bioidentical progesterone intravaginal brain 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-diluted funding like the Foundation and NIH grants I mentioned and ARP-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. And 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. And 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 health care investment. And conditions that solely affect women, the very conditions we're developing treatments for, attract less than 1%. That's not because it's a niche. That's a market failure, and it is exactly the gap that DARI was built to address. And 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 oviprene data reads out, before data reclaim enters the estimated $2.5 to $4.5 billion hormone therapy market, and before DARE HPV data readout. The story is being written today, and this is 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, FloraSync 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 3 enrollment, expected to complete this year. And as I mentioned, completing enrollment in 2026 puts a 2027 data readout within reach. And DARE HPV, preparing to advance into Phase 2 this year with our ARPA-H funding. So this is not a single event binary bet. It's a portfolio with multiple catalysts, multiple pathways to value, and multiple ways to win. And 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 overprint 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, 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 regulatory pathway that we believe provides an opportunity to protect and expand our market positions after the 503 market matures. And 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 fem tech 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. And Dario 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. So investors who want in before the water rises are looking at our company right now. And with that context, I'll turn it back over to Marty for the financial review.