Dare Bioscience, Inc. Common Stock Investor update

We're ready to get started. Welcome, and thank you for joining the Daré Bioscience virtual bus tour. My name is Jenene Thomas. I am CEO of JTCIR, and I will be the moderator for today's event. Today, the company completes its virtual bus tour series with the East Coast stop. For the format today, Sabrina Martucci Johnson, President and Chief Executive Officer of Daré Bioscience, will take you through the Daré story, and then I will open it up for a Q&A and take your questions. It is now my pleasure to turn it over to Sabrina Martucci Johnson, and take it away, Sabrina.

Great. Thank you so much, and thank you, all of you, for tuning in today on the bus tour. Before I start, obviously, the presentation does contain forward-looking statements, so I do encourage you to look at our SEC filings for a full overview of the risks and uncertainties associated with the company. Those of you who know us know we really think of ourselves as a purpose-driven biotech, where our sole focus is to close the gap between promising science and real-world solutions for women. What does that mean? That means that we're focused exclusively on women's health conditions. As you'll see as I talk about the portfolio, we work very broadly in the space.

As you're looking at us now, and some of the things I'm going to highlight in today's presentation, is really where we are in this kind of exciting time for the company and pivotal time for the company in terms of a snapshot. Because 2026 is a time where we're now launching commercial products, and we're going to talk about revenue commencing from product sales for a couple of the products in our portfolio. Also importantly, we're at a time where we're completing some studies that are going to lead to some clinical milestone events next year as well. I really want to highlight what's happening in the development portfolio along those lines as well. What you'll see across the portfolio, what everything has in common, whether it's commercial or development stage, is it's based on clinical evidence.

That's the white space we're filling in women's health, is bringing women options that are truly backed in science and can close those critical gaps in care. I'm also going to talk a little bit about the grant funding that we have in the portfolio and how that helps us move products forward with that non-dilutive funding, which is both obviously a validation of the work we're doing, but importantly also helps us from a funding perspective to move things forward. As I mentioned upfront, we focus on women's health, and we work broadly. From contraception to menopause, sexual health to fertility, vaginal health to infectious disease, we're closing critical gaps in care using science that serves her needs, and really across life stages. We're not a company built around a particular product technology, and we're not a company built around a specific indication.

We're looking at where are those gaps in care that we can fill. I'm going to focus on a few of the programs in our pipeline. Really, like I said right up front, I'm going to focus on some programs that have commercial relevance right now. We're going to talk about in the Daré to RESTORE family, Flora Sync LF5, which is our vaginal probiotic that started commercializing in July of this year. I'm going to talk about our prescription product, DARE to PLACE vaginal cream. That is expected to start commercialization this quarter as well. I'm going to highlight a couple of our development programs, DARE-HPV, in the human papillomavirus treatment therapeutic space in the phase II trial there, and Ovaprene, which is our non-hormonal once-a-month contraceptive, because we got phase III ongoing right now with the top-line data readout expected next year.

I'm going to talk about a couple of our other programs that are really relevant, either with the clinical program starting up, DARE-PTB1 for preterm birth and fertility, or DARE to RECLAIM, which is our menopause product for hormone therapy, where we're looking to start commercializing that next year as well. Before I go deep into the portfolio, a couple highlights that I think are really important to understand upfront to put the opportunity in perspective. First of all, when we think about women's health conditions and therapeutic options, what's important to understand is many of the things that we're looking to address in women's health, they're not diseases the way you typically think of diseases. Why is that important? It's because they're things that a woman is going to experience simply by having that anatomy and biology, and therefore, nearly every woman is going to be affected by thinking about those issues and looking for therapeutic options over the course of her life.

So think menopause, think thinking about whether or not to have a pregnancy and maintaining a pregnancy. Then there's also conditions that are also very hormone-reliant and dependent, like sexual health. Again, most women are going to experience changes and disruptions in that as well. We're going to talk about those markets. Then there are conditions like human papillomavirus infection in women that have been impacted by the fact that it wasn't until 1993 that women were required to be in clinical research. So there's certain conditions in women that are important.

Human papillomavirus is a virus that causes cervical cancer, and we know that, and yet there's no therapeutic option because we're still sort of catching up on those market opportunities. We like the space because of the size of the market, certainly not niche. It's also been a highly productive category. Even though only 1%-5% of private healthcare investment is going into conditions and therapeutic options for conditions affecting women, those products, though, are disproportionately represented. So 27% of the brands that generate over $500 million in annual revenue are for women's health conditions. We like that disproportionality there in terms of how efficient the category is in generating blockbuster products, and that's really because women are such motivated healthcare consumers.

The third thing that we think is really impactful about working in this space is the amount of grant funding that is available. That is non-dilutive funding that helps to advance the portfolio, so we do not have to rely on equity dollars to do that. Again, this is in part an artifact of the fact that women's health and women's research was not required until 1993 to be included in clinical research. So there is a lot of foundation money, as well as government funding that is available to really help bridge that gap. We have been quite successful over the last several years in accessing that capital. As you can see across the portfolio, including for our late-stage programs like Ovaprene and DARE-HPV. All right. I mentioned right up front, we are data-driven. What does that mean? First of all, I think it is important to understand, we look at all the paths of getting our products to market.

So it is not just about prescription options. Sometimes it is a non-prescription product, and it is not always just about FDA approval. Sometimes we think it is really important to get a product on market for women and fill an important gap that exists, even as a compounded product. Regardless of the path we take to market, what all the products have in common is that clinical backing, that clinical development, and that clinical evidence behind them. That really means that we, one, can have proprietary technologies because there is science behind them and they have been studied. Two, it also gives us a lot of optionality in terms of how we think about commercializing our products, because they have the evidence behind them to be credible to healthcare providers.

As we talk about our commercial strategy, you will see that it is important to make sure women have access directly, and we will talk about the Daré Health Hub, and telehealth and what that means, and direct patient engagement. But it also is really an opportunity we can leverage where we can also go straight to the healthcare provider, regardless of our path to market. Let us talk first about those commercial opportunities that are happening right now. Flora Sync LF5 is our vaginal probiotic. It is a non-hormonal probiotic product that is really designed to restore microbiome balance in the vagina. We talk a lot about gut health. I think we are all familiar with probiotics in the gut health sense. Well, the vaginal environment also has its own microbiome, and similarly, probiotics can be very important in restoring that environment.

Unfortunately for women, the vast majority of the probiotics that are available for women today, even for vaginal health, are gut-derived strains that are taken orally. So think about that and think about where you want that probiotic to work. That is really where we are addressing it. So Flora Sync LF5 is a vaginally delivered probiotic, so the product is going right where you need it. It is a strain that was developed by isolating it from the vaginal microbiome of women who have never had yeast infection. So that is where the clinical strain came from. It is backed by science, and then importantly, specifically studied in a clinical study to demonstrate that it actually does achieve that vaginal microbiome balance. It is just a 3-capsule administration. So it is available now through the Daré Health Hub. It comes in a box of 6 capsules.

It's really something that we are looking to have women incorporate as part of their vaginal wellness routine. It comes with six capsules in the box. That's basically two courses. I get this question a lot in terms of, how do women know that they need to do something to restore their vaginal microbiome balance? What I always say is that women know. 65% of women are insecure with their vaginal scent. Odor can often be one of the first signals around a disruption in the vaginal microbiome. This is something that women are quite aware of and are seeking a clinically evidence-backed solution. This is available on the Daré Health Hub right now, which we're going to talk about in a second.

Importantly, there are clinician offices that are looking to make this available to their patients that way directly in the office, which is fantastic for them to have access to a clinically validated solution. Daré to PLACE Sildenafil Cream is our next product looking to be commercialized. We are expecting that prescriptions will start dispensing this quarter in Q3. What's interesting about this product is it's a first-of-a-kind arousal cream for women. It leverages the same active ingredient that is in Viagra for men. Just like men can benefit from having increased blood flow to the genital tissue, so too can women. That blood flow is really what leads to both pleasurable sensations, but also really important in the natural lubrication response in women. It's mediated by that. Enhancing that can really help enhance that whole experience.