Q3 2025 Dare Bioscience Inc Earnings Call

Welcome to the conference call hosted by Dare Bioscience to review the company's third quarter 2025 financial results and to provide the business update.

This call is being recorded, my name is Jericho and I'll be your operator. Today with us today. From Daria are Sabrina or 2i Johnson president and chief executive officer and Marty Herring Leon Chief accounting officer. Miss hiring Leon please proceed

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 Health Solutions to Market as afficient 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 uncertainty.

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.

uh,

which was filed today and our Form 10-K for the year ended December 31, 2024.

this call includes time-sensitive information that is currently as of today, November 13th 2025,

Star undertakes, no obligation to update any forward-looking statements, to reflect new information or development 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,

uh, we are referring to compounding drug products by Outsourcing facilities registered under section. 503b of the federal Food, Drug Food, Drug and cosmetic act using bulk drug drug 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, for joining us today.

Dar's 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. So then if feel cream through a 503b 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 teloma virus infection and pre-term birth.

We believe this dual path approach enables us to unlock value efficiently, by leveraging non-dilutive capital, and a disciplined investment strategy.

A 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 milk and institutes Women's Health Network steering committee on which I serve

As you know, Dare Bioscience is a purpose-driven health biotech with a sole focus on closing the gap between promising science and real-world solutions for women—from contraception to menopause, pelvic pain to fertility, sexual health to infectious disease. We are working to close those critical gaps in care. Using science that serves her needs, we 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 and 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, the 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 it dhar. 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 werkley directly and in parallel with clinicians and commercialization partners to ensure that Solutions, reach women quickly

And dare to place. The dfl 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, end points for a future, FDA registration, path.

The third quarter was a pivotal period for Dar as we Advanced towards the commercial introduction of dare to place. And then if feel cream through the 503, be 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 and select States in December.

In addition to the federal requirements ever seen by the FDA 503b. Outsourcing facilities are also subject to State specific requirements and we expect dare to place. Identifying prescriptions will be available to be fulfilled in all 50 states in early 2026.

This Milestone will Mark the first time a topical sapil formulation designed specifically for women manufactured in accordance with GMP requirements and supported by clinical data demonstrating. Increased General blood flow within 10 to 15 minutes of application and improvements in arousal sensation using clinically validated and FDA report reviewed end points will be available for women.

Our collaboration with the 503b manufacturing partner, specializing in topical formulations. And Advantix our Pharmacy services and Logistics, partner positions us to deliver high-quality compliant and scalable product access beginning this year.

We are supporting the 503 launched through targeted medical education initiatives.

Patient and clinician resources on www.dar.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 a difference. This identical cream that raises the bar. We'll 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 place formulation science.

Clinical evidence showing improved. Genital blood flow and arousal outcomes.

And critical clinician insights on why dare to place and NFL cream will set new standards and women sexual arousal. Healthcare

You can find the link to join the webinar at https colon backslash c v e NT me slash ko1 d.

Also on our website in the investor section.

We believe this is a large underrepresented, Phil the same active ingredient in an oral. Erectile dysfunction drug is recognized, but the clinical evaluation of topical sedal formulations for women has been lacking. We therefore believe that dare to place an NFL 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 dare to play bio.com website for product updates and access alerts. So that you can be among the first to know when this only evidence-based identical cream formulation for women dare to play. So then if feel 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.

Probiotic products designed to support the vaginal microbiome.

which will not require a physician's prescription, aligned 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 503 b as well.

The compounded product will be branded as dare to reclaim and is designed for women experience per menopause 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 sapil 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 1 of A Kind evidence-based solution in the estimated 4.5 billion dollar compounded hormone therapy market and we believe it could generate meaningful Revenue alongside dare to play senil 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 overr.

Enrollment is ongoing in our pivotal phase 3 multi-center single arm non-comparative, clinical study of eprine 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 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 postcard test study of ovarin.

These data support overprints potential to fill a significant Gap in the contraceptive landscape.

Providing women with a non hormonal, user controlled option, without daily interruption.

They received 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 parties, minority interest under a royalty. Purchase agreement entered into an April 2024.

We're also continuing to advance program supported entirely by non-dilutive funding Awards.

Dear HPV is in development as a novel intravaginal therapy, for persistent high-risk, human papilloma Virus Infection, that's the virus that causes cervical cancer. The program is currently funded through an award from arpa H and an NIH. Grant

Dear Lark. 1 is a pre-clinical stage long-acting, contraceptive intended to offer multi-year protection. With remote pause resume control.

A million dollar Grant installment was received in July and a 4 million dollar installment was just received last month.

And their NHC is a pre-clinical research program that will Aid in the identification. And development of a novel, non hormonal intervaginal contraceptive product candidate.

The grant funding supports activities to de-risk. The development of a novel non hormonal intervaginal contraceptive. That can be suitable for an 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 allocations

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.

Thanks Sabrina and thanks everyone for joining us today. I would now like to summarize dar's Financial results for the quarter ended. September 30th 2025, which I will refer to as the third quarter, we ended the quarter with a proximately 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 and Grant payments this additional Capital, strengthened our balance sheet and enhancing our ability to execute on our dual pass strategy.

Gina 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 non-dilutive funding, as well as decreases in manufacturing costs related to overreach costs. This was partially offset by increases in costs related to development activities for other clinical and pre-clinical stage R&D programs, including DARE HPV and DARE LARK 1. Additionally, we had costs associated with DARE cream, DARE seleno cream, and DARE PTB1.

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 10q for the quarter ended, September 30th 2025 filed today, I would now like to turn the call back to Sabrina.

Thank you, Marty. And I'd actually like to turn the call over to the operator for Q&A.

Thank you, Sabrina. If you've dialed in and would like to ask a question, please press *1 on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press *1 again.

If you are called upon to ask your question and are listening via speaker phone on your device. Please pick up your handset to ensure that your phone is not on mute when asking your question.

Our first question comes from Katherine, Novak from Jones, please. Go ahead.

Hi um, good afternoon. Thanks for taking our questions.

Uh so first 1 for me is if you can comment on your thoughts on fda's recent reversal on guidance on hormone replacement therapy and met menopause, you know how what?

Decision was announced and what can you do to fill the treatment Gap in the near term?

Love that question. Thank you for for asking and we are I'll start by saying we are thrilled.

We were thrilled to to see that change we as a company. Um, you know, we're we're developing dear to be claimed, which is our hormone menopause hormone therapy vaginal ring. That has estradiol and progesterone together in a single, um, ring once a month product and delivered not orally, which is what the menopause Society recommends, and both of those hormones together for women without a uterus. And I as such, we've been attending the menopause Society for years. Um, since we started this company and I've been working on that program and have watched the presentations year over year over year, uh, really that have debunked, the scientific research that is debunked. Some of the outcomes of the 2002, Women's Health Initiative, that led to the initial blackbox warning and um a new data uh that are citing the potential benefits right of of hormone therapy where the recommendations continue to be. If you have a uterus, both

Four months together, progesterone for endometrial protection, and estradiol for effectiveness. I ideally prefer micronized bioidentical non-oral forms, but demonstrating improvements in recent studies that have shown enhancements in bone health, brain health, and 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 our FDA approved.

There's an oral form approved with the 2 hormones together. And then, there are single product, uh, patches like estradiol patches, or, um, vaginal products, and then progesterone, that 1 could take separately. But all those estrogen products have that black box warning, that creates fear, frankly, for women in taking, um, in taking those products. And in many cases really unwarranted fear, given what the the newer data and the newer interpretation of the 2002 findings say, so that's a long way of saying we are, we are so happy. Um, I can tell you, um, I'm at I'm currently today at the international Society for the study of women's sexual health, which is a sexual health Focus conference. But

Healthcare Providers here, who know we are working on our hormone therapy. Uh, vaginal ring has come by to make sure to see us and and tell us how happy they are about the outcome. And how hopeful they are in terms of what they think, that'll mean for our product when it's available and women, you know, having access to something like that. So we are, we are really happy to see the FDA and we're happy to see, you know, FDA commissioner, uh, you know, really talking about this right? And elevating this issue and and and doing something that will make a product, you know, available at the more women that can benefit from it.

Got it and is this you know you mentioned it will be available early 2027 will that also be um you know through a compounder or is there a path to make this an FBA?

Both. So we're we're when I talk about 2027, we're talking specifically about that opportunity to um, pursue a similar strategy like we're doing with dear to place and then if Oak cream where we partner with a third party, 503b Outsourcing facility. Um, in this case that would have the, you know, the capabilities to to manufacture a product of this nature. We are continuing our process with the FDA. Um, you know, we you may recall that we had announced um, a a while ago now that the FDA was um, aligned that only 1 phase 3 trial would be required to

Support the registration for this product. Um, but we had not yet filed the NDA, uh, the IND or um, continued with that program, where we were waiting to work out some additional details on the phase 3 design and requirements with the FDA. So that process is ongoing and certainly as we have updates, you know, we will, we will announce those updates but we do see that there is an opportunity that we can perceive similarly to get this product into the hands of women.

Faster, right? And get that access for this evidence-based product. Um, while that FDA process is still ongoing

Got it. And now just thinking about now that you have, um,

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.

Now if you think about our our activities, it's definitely everything we've been talking about about dare to play. So then if o cream and getting that out there um some of these opportunities that we've been talking about just like the dare to reclaim estradiol progesterone vaginal ring. The data, restore vaginal probiotics getting this 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 overr which is in Phase 3, the Dare HPV product, which is, you know, we're working towards filing that end and getting into phase 2. That's what that arpa H and MH, uh, funding supports. And, um, as well as dear Lark 1, which is preclinical. And now also getting to do a lot more activities on what we call their um NHC. Um, that non hormonal contraceptive, uh, technology. So those are definitely a priority. And then as we think about, you know, the programs that require um,

Additional right R&D investment. Um, we're really looking those looking at those 1, 1 on 1, by 1, 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 it is a process. These are all first in category products so they all take um 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. Um, and we can clearly execute against that so more to follow. But I would say right now, big focus on these programs that have you know, grant funding that is really help propelling them forward and and you know over Printing and dear HPV are later stage programs in that regard as well.

For taking our questions.

Thank you.

Our next question comes from Chem Dollars from Brooklyn Capital Markets. Please go ahead.

Great, thank you. I have, uh, two separate, and different questions. Um,

You know, first with regard to dare to play, you have the partnership with Rosie Wellness. Uh, and I'm wondering what other similar Partnerships you have in mind too. You know, essentially increase awareness because I think, uh, there are about 250,000 people, uh, using Rosie Wellness, at least based on what they've disclosed and it sounds like you need to have broader Partnerships to really tap this Market.

Yeah, so there are a few other great questions. There are a few different things that we're looking at. As we think about, um, as we think about the dare to play product and as we think about awareness, right? So 1, 1 pillar of that is around clinician awareness, provider awareness, um, that is has been pretty easy to tap into quite frankly just because, um, 1 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, uh, 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, um, a lot of the providers that are important, um 1 of the other pillars is awareness in terms of really um, 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.

Um, as well as um people that maybe don't have a prescription yet and need access to tea health and we're really doing that through our relationship with Advantix. So Advantix has the has the ability to take in those prescriptions to manage that prescription inflow manage the cash pay piece, very straightforward portal. Uh that will be available right as we start. Um fulfilling prescriptions in December for people.

To get but also a connectivity with the telea Health Resource for those women that don't have that. Um and then we're supplementing all of that and there will be additional like we there are additional places right with the products going to be showing up in Partnerships. We're really prioritizing those for when we have availability in all 50 states and we have um that full availability across the country. But I would say the other thing that is also really helpful in the near term is

Um, you know, using online advertising opportunities, right? Think platforms, like, Facebook, and Instagram, and other social media tools. Like podcasts.

Sexual health influencers that have a large community of followers. So, you'll also start seeing Google ads relevant. You’ll also start seeing, you know, more and more of that, um, as the product becomes available and particularly as we go into the new year. Um, so those are the kinds of things, you know, 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 where, right, where it can be available via their platforms as well. So, stay tuned for more to follow. Um, you know, 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 the patient experience in terms of that online portal through an advantage is seamless and a wonderful experience.

Great, that's very helpful. Uh the second question is the ATM and whether there's additional capacity left on it.

Yeah, so we are. Um so Dar is subject to Baby shelf. So if for those aren't familiar, it has to do with what our market cap is and that does limit, um, you know, how much is available under a resource, um, like the ATM and so, you know, baby shelf limitations. I think you can.

Strategy. The math with, with the amount that uh, Marty talked about that came in during the last quarter. Um, we are limited therefore uh, with baby shell friends, you know, baby shell restrictions in terms of being able to actually use an ATM today

Super, thank you.

Thank you, great questions.

That concludes the question and answers session, I would like to turn the call back over to Sabrina Mucci Johnson for any additional or closing remarks.

Great. Well, thank you everyone for joining us. This afternoon and, you know, hopefully you're coming away with a good understanding that. We are executing a multi-pronged value creation strategy. We're preparing for a revenue generation via dare to place an NFL cream. Starting in the fourth quarter, and advancing a rich clinical Pipeline and doing. So, with the fiscal discipline and access to significant non-dilutive capital and with 4 available solutions for women on the horizon, 1 expected to begin generating Revenue in this fourth quarter, uh, and multiple product candidates Advance advancing in clinical and pre-clinical development, we believe it's a compelling time for investors to take a fresh look at dar dar is uniquely positioned to cut through the noise in today's biofarma, landscape companies with relatively low risk assets, differentiated science in a clear path

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 non-prescription 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 Dar and for women seeking new options and we're proud to be leading with science, collaboration and purpose and our excited. To begin. Making dare to play available through the 5033 Channel, which is on track for December.

We expect initial Revenue recognition in the fourth quarter this year and believe our commercial portfolio will serve as a robust Foundation.

Providing a path to profitability.

So I thank our team, our partners, and our shareholders for all the continued confidence and support. Thank you so much.

This concludes today's conference call. You may now disconnect.