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MarDee Haring-Layton

Thanks, Sabrina, and thanks, everyone, for joining us today. I would now like to summarize Dare's financial results for the year ended December 31, 2024, which I will refer to as the year-end results. Put simply, Dare's business strategy is to assemble and advance a portfolio of differentiated product candidates that address meaningful unmet needs we've identified in women's health and then to monetize the value of our portfolio's clinical and regulatory advances over the near and long-term.
The investment required to build and advance our portfolio includes corporate overhead, portfolio acquisition and maintenance costs and ongoing research and development or R&D expenses. During 2024, our general and administrative expenses were approximately $9.2 million, which is a 24% decrease compared to 2023 due primarily to reduced commercial readiness expenses and reduced head count.
We continue to maintain a lean and focused team and are managing overhead costs closely. Our R&D expenses, which vary from period to period based on clinical, preclinical, manufacturing, regulatory and other development program costs, were approximately $14.2 million for 2024, which is a 34% decrease compared to 2023.
We reported a comprehensive loss for 2024 of $4.5 million and ended the year with approximately $15.7 million in cash and cash equivalents and a working capital deficit of approximately $3.2 million. As Sabrina mentioned, in 2024, we entered into two new agreements for nondilutive funding awards, one from a federal agency and the other from the Gates Foundation, totaling up to $20.7 million and closed a royalty monetization transaction in which we received $22 million in gross proceeds.
Together, the royalty financing and nondilutive funding agreements represent our commitment to being creative, collaborative and opportunistic in seeking the capital needed to meet our objectives and to build shareholder value.
As of March 28, 2025, we had approximately 8.9 million shares of our common stock outstanding. We encourage investors to review the more detailed discussion of our financials, our financial condition, liquidity, capital resources and risk factors in our Form 10-K for the year ended December 31, 2024, which we filed this afternoon.
I would now like to turn the call back over to Sabrina.

Sabrina Johnson

Thank you, MarDee. I'm now going to talk through the 2024 accomplishments and the anticipated 2025 milestones, obviously, with a focus on Sildenafil Cream, but also Ovaprene Phase 3 study.
First, I'll provide an update on our on-market asset, XACIATO. So as a reminder, XACIATO or clindamycin phosphate 2% vaginal gel is our first FDA-approved product to emerge from our portfolio. It's indicated for the treatment of bacterial vaginosis in females 12 years of age and older. It's a colorless single-dose vaginal gel that can be applied any time of day, and it's formulated with the goal of limiting leakage and increasing vaginal retention time known as time spent in place.
In the first quarter of 2024 through our commercialization agreement with Organon, XACIATO became available by prescription across the United States, and we have been pleased with Organon's progress in this first year of launch.
In 2024, we entered into a strategic royalty financing with XOMA, wherein we received, as MarDee mentioned, $22 million in gross proceeds at close. As a result of this transaction, I want to remind you that future payments related to XACIATO would come directly from XOMA upon such time that XOMA achieves a prespecified total return on its investment. XOMA would then be required to pay Dare 50% of each successive $22 million that XOMA receives under the transaction agreement. We look forward to keeping you updated.
Now turning back to Sildenafil. As I mentioned upfront, after urging on the part of the healthcare community and hearing the demand from women, we're targeting to make our proprietary Sildenafil Cream formulation available by prescription from a 503B-registered outsourcing facility in the fourth quarter of this year 2025.
As I mentioned already, in the second quarter of this year, we will provide an update on our strategic partnerships to achieve this objective. This is part of our dual path approach I previously discussed because we believe women should not have to wait for needed treatments and solutions.
In terms of our continuing process of pursuing the FDA approval of Sildenafil Cream as a treatment for female sexual arousal disorder, in December of 2024, we announced our plans for Phase 3 development based on the constructive interactions we've been having with the FDA, including with respect to the co-primary and secondary efficacy endpoints for our Phase 3 studies. Our first Phase 3 study of Sildenafil Cream would be the first ever Phase 3 pivotal study of a therapeutic candidate for the treatment of arousal disorder in women.
Pending review of additional forthcoming recommendations from the FDA that impact our statistical analysis plan for the study, we plan to submit the protocol and the statistical analysis plan, reflecting the FDA's recommendations to the FDA in the second quarter of this year. There are currently, as I mentioned, no FDA-approved treatment for any form of sexual arousal disorder in women. So this means that Sildenafil Cream has the potential to be the first. Market research suggests that approximately 33% of women in the US in the ages of 21 to 60 experience symptoms of low or no sexual arousal.
And as a reminder, in 2021, when we ran the targeted ads on Facebook and Instagram for our Sildenafil Cream Phase 2b clinical trial in 45 US cities, we received over 10,000 responses in the first 16 weeks alone. So we look forward to providing additional updates on all of our initiatives around our proprietary Sildenafil Cream formulation in the second quarter this year.
Now turning to Ovaprene. We also want to provide an update on the advancement of the Phase 3 study of Ovaprene, which is our novel investigational hormone-free monthly intravaginal contraceptive whose US commercial rights are under a license agreement with Bayer.
So nonhormonal contraception represents a significant commercial market opportunity. There are currently no monthly hormone-free contraceptive approved by the FDA. Ovaprene has the potential to be a disruptive product in the contraceptive category, an important option for women who cannot use hormone-based birth control products or prefer not to do so. And based on market research, we believe approximately 27 million women in the US alone are potential candidates for Ovaprene.
Working with study collaborators at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, of the National Institute of Health, or NIH, and our commercial collaborator, Bayer, we commenced patient enrollment in the Ovaprene Phase 3 study in December of 2023. 20 clinical research sites from within the NICHD's Contraceptive Clinical Trials Network, or CCTN, were trained on the protocol and were initiated to start screening and enrolling participants in late 2023 and primarily early 2024.
Currently, there are 15 active NICHD CCTN sites following enrolled participants in the study. Enrollment is currently proceeding at five study sites outside of the CCTN that were initiated in 2025, funded by that grant we received in 2024 from the Gates Foundation to accelerate the overall study time line.
We anticipate that approximately 125 women, which is half of our target number of participants to complete the study will complete approximately six months of Ovaprene use by the end of the second quarter of 2025. As you may recall, this is a designated checkpoint for review of interim data by the study's Data Safety Monitoring Board, or DSMB, an independent group of experts, which evaluates the safety and integrity of the study.
I should note at this time that executive orders and other actions taken by the US presidential administration in the first quarter of 2025 have negatively impacted the Phase 3 study and NICHD's ability to carry out its responsibilities under the CRADA. Due to the uncertainty relating to federal contracts and funding for research and development, recruitment at the CCTN sites has been paused to preserve funds that are already under those existing contracts between the CCTN sites and NICHD for the already enrolled subjects.
So at this time, due to the uncertainty with the CCTN sites and because of the five new study sites only recently began participate enrollment, we can't reasonably predict the enrollment rate for the remainder of the Phase 3 study or an estimated time for completion of enrollment.
But we look forward to providing updates as soon as we can this year on that, and we definitely look forward to the review of the interim data by the DSMB this summer, which I will stress the timing of which will not be affected by the current pause in recruitment at the CCTN site since those participants have already been enrolled.
I also want to remind that based on communications to date with the FDA, if successful, we believe that just this single registration study would be required to support a premarket approval application with the FDA. I now want to turn to a couple of other programs in our portfolio very quickly as we wrap up.
First, human papillomavirus. In 2024, we were selected to receive an award of up to $10 million for development of DARE-HPV, which is our innovative investigational treatment for HPV-related cervical diseases. And with the support of that funding, we're advancing DARE-HPV towards a Phase 2 clinical study. Essentially, all cervical cancers worldwide are caused by HPV infection. And despite the advancements in HPV screening as well as vaccination, in the US, an estimated 100,000 women are still treated for cervical precancer each year and an estimated 4,000 women are expected to die from cervical cancer in 2024.
Today, cervical precancers are monitored until they reach a late stage since the most common treatment is a surgery, which essentially just removes part of the cervix. However, the surgery is associated with an increased risk of preterm birth and sexual dysfunction, and therefore, it's not recommended for women with fertility concerns.
In the US, about 10% of women with HPV infection of their cervix will develop long-lasting HPV infections that put them at risk for cervical cancer. So DARE-HPV has the potential to be the first FDA-approved pharmaceutical intervention that could treat both genital HPV infections in women as well as late-stage cervical dysplasia or precancers, which could change the paradigm around how HPV-related cervical diseases are clinically managed today, preventing surgery, stopping the spread and transforming the care for this critical health issue.
DARE-HPV is reflective of the type of development program we like to advance at Dare. It's a first-in-category product, but it leverages active pharmaceutical ingredients that have been approved to treat other viral infections.
Specifically, DARE-HPV is an investigational proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert. So it has the potential to be a first-in-category treatment for HPV infection and HPV-related cervical diseases using two well-known antiviral agents.
We look forward to continuing to conduct activities necessary to enable submission of an IND application to the FDA for a Phase 2 randomized placebo-controlled double-blind clinical study of DARE-HPV for the clearance of high-risk HPV infection in women, all supported with the funding we received under the $10 million award.
I also want to briefly provide updates on a couple of other of our programs, specifically DARE-VVA1, which is our proprietary formulation of tamoxifen for intravaginal administration being developed as a hormone-free alternative to estrogen-based therapies for the treatment of moderate to severe dyspareunia or pain during sexual intercourse. We're conducting activities in preparation for a Phase 2 clinical trial of DARE-VVA1 based on our FDA-cleared IND that happened last year.
This is one of our product candidates intended to really shift the menopause treatment landscape. Gaps in solutions for menopause symptoms have given rise to an explosion of untested supplements and therapies. We believe that developing new FDA-approved therapies to meet the needs of women and their doctors can shift the focus to rigorously studied, safe and effective hormonal and nonhormonal treatment options.
And DARE-PTB1, which is our intravaginal ring designed to deliver bioidentical progesterone continuously for up to 14 days for the prevention of preterm birth, which we are conducting activities necessary to enable an IND and then subsequently a Phase 1 clinical study, which are and will be supported by a $2 million grant from NICHD. The Phase 1 study, I should point out, would also serve to support the safety and pharmacokinetics for this progesterone intravaginal ring to also be investigated for luteal phase support as part of an IVF regimen.
A progesterone intravaginal ring could reduce or eliminate the need for painful daily injections during IVF a potential game changer for women enduring this growing process. So in summary, we continue to accelerate innovation in women's health and seek to bring to market as soon as possible, innovative evidence-based solutions that address persistent unmet needs in areas of women's health that we believe represent compelling and meaningful market opportunities.
We plan to achieve this goal in ways that seek to optimize access to needed treatment solutions in a fiscally responsible manner, as I've mentioned, such as expanding our business strategy to include Section 503B compounding as a dual path approach to bring some of our proprietary formulations to market as soon as practical.
We will continue to seek to advance the product candidates in our portfolio through mid to late-stage clinical development or regulatory approval and to establish and leverage strategic partnerships and other collaborations to complete product development and commercialize the products. And as I mentioned, we also may bring forward -- consumer health products to market that can be obtained without a physician's prescription.
We look forward to providing more updates on the above in the second quarter as we work to advance the commercialization strategies and some of the most -- and to commercialize some of the most potentially disruptive candidates for the health and well-being of women in decades.
I'd now like to turn the call over to the operator for Q&A.

Question and Answer Session

Operator

(Operator Instructions) Catherine Novack, Jones Trading.

Catherine Novack

Congrats on the progress, really exciting stuff happening with Sildenafil Cream. I'm just curious, is there a precedent that we can look at for simultaneous 503B compounding and running an FDA Phase 3 study? And how do you intend to balance the commercial population with the population targeted for Phase 3 enrollment?

Sabrina Johnson

Great question. So we are aware of some precedents. I'm not sure that I'm in a position to kind of mention some of them here just based on things we know. But I will say we like to be novel at Dare and be innovative. And this definitely comes from that.
And also, it's the time for it. I think we are really stepping up to meet the time and finding ways to kind of cut through the noise right now. It's a path that can be taken, right? It kind of solves for three things. It enables women to have access to the formulation and the solution that people want and need.
It obviously creates a nice opportunity to accelerate revenue from this proprietary product, and that's obviously positive. And it meets the demand of the healthcare providers. And to your point, there is an opportunity to do that in a way that does not compromise our ability to importantly seek an FDA approval for the treatment of this indication. And we're very motivated to do that because we think that is also very important to women and the healthcare providers. And so specifically, the way that we can achieve that is a few fold.
One is making sure we're mindful of a pricing strategy. And we'll have more on this as the year progresses and be able to share more about this, but really mindful of a pricing strategy that reflects a continuum of care, right, and allows someone to move very seamlessly from using the product today as a prescription available today via compounding and then transitioning over time to an FDA-approved product that would now be eligible for insurance coverage.
And so one is really being thoughtful about the pricing strategy. Two is being really thoughtful about how we collect real-world evidence to support the process. As I mentioned in my prepared comments, we do believe there's a really interesting opportunity here for a first-in-category product like this where we're blazing the regulatory path to also utilize real-world evidence and real-world experience to support actually the registration process.
And the agency is moving in an interesting direction with some guidance -- draft guidance document around real-world evidence. And then in addition, there are obviously things that we just want to be thoughtful of in terms of the conduct of our clinical trial, right? So why participate in a placebo-controlled trial, you have a risk of getting placebo when you could just be getting the prescription today from your healthcare provider.
But that can also be managed very thoughtfully by ensuring there's an open-label extension, right? So a really nice opportunity for women to both help move the field of science for their indication from which they're suffering, but also have access for sure to the product for free for a period of time.
And so those are our key considerations, right, is making sure we're being really thoughtful on the regulatory side, which we are being very thoughtful in terms of a pricing strategy that ensures that continuum of care. It is very seamless for the healthcare provider and the woman. And then third, just thoughtful around structure of the Phase 3 trial and operations of the study to ensure there's motivation to participate in that when the product is already available.

Catherine Novack

That makes sense. And on the Ovaprene front, obviously, understanding why we're not going to -- that we're not going to be able to see enrollment at the or recruitment at the CCTN site. But Thinking about the interim readout, is this something where -- are we going to be seeing safety primarily or some efficacy? And how is efficacy expected to be different at a six month look versus 12 months?

Sabrina Johnson

Yes. So the DSMB's mandate is really around safety, right? That's really their mandate. And however, obviously, a pregnancy in a contraceptive study is actually technically an adverse event, right? So it is a safety mandate, but obviously, they will -- they're privy to kind of all relevant data as part of their meeting.
But safety is really the mandate of the DSMB is to look at the data from a safety perspective. And I've mentioned this before, and I think it's worth highlighting again, contraceptive studies have demonstrated over the years that whenever there's an opportunity to look at a contraceptive effect at kind of a six-month time point versus a 12-month time point, the effectiveness rates always get better over time.
And that's definitely been an important consideration for us and for our collaborator at Bayer as we think about looking at any interim time point in the study and what that might mean. So in terms of what you should expect is, obviously, we'll give an update that the DSMB has happened, but an efficacy evaluation is not the focus of the DSMB meeting. It's really -- it's a data safety monitoring Board meeting.

Operator

Douglas Tsao, H.C. Wainwright.

Douglas Tsao

I guess, Sabrina, on the compounding strategy, I'm just curious, have you identified the partner that you anticipate working with? Or have you finalized that? Or have you -- are you still going through a process? I think you said you're going to announce it in 2Q, which I guess starts tomorrow. And I'm just curious from a promotion standpoint, how is this different than if you have an FDA-approved product?

Sabrina Johnson

Yes. Two fantastic questions. Thank you, Doug. So first of all, on the first, I hope, as you can expect, we wouldn't be comfortable making this announcement today if we didn't have great strides in place in terms of all of the regulatory guidance, which kind of goes to Catherine's question, obviously, about the dual path approach and really sort of validating that, but also importantly, to your point, on feeling confident that we have a trusted 503B outsourcing facility option. So we felt it was very important to make light of this really announce and put out the open this strategy today given how far along we are in this process.
But you will hear more as we get into the second quarter around the partnerships to support it. But rest assured that obviously, that's something that we have spent time evaluating before we would even make this announcement today in ensuring that we have that trusted partner for supply. And then -- well, in answering that, I already forgot your second half of your question.

Douglas Tsao

Just around promotion.

Sabrina Johnson

Yes, promotion. Yes, what's the different, which is a fantastic question and something that we've spent a lot of time working again with our fantastic regulatory law firm that we utilize to understand, right, the rules and regulations around 503B versus an FDA-approved product. And really, the difference -- I think there's kind of two main differences to think about. One is that 503B products are not any compounded product, 503A or B, and they're different, are not eligible for health insurance, right, coverage. And so women would be paying out of pocket.
They can use their health savings or the FSA plans usually to support that, but they're not eligible for insurance plan coverage. So that's definitely a difference. From the promotion side, it's really around claims, right? We want to pursue the indication for the treatment of female sexual arousal disorder because until you have an indication, that indication is what allows you to make those treatment claims, right.
You're claiming safety and efficacy in a particular population and you have an indication statement that indicates, right, that you're indicated for the treatment of female sexual arousal disorder in premenopausal women, right. And that is what we're very interested in seeking. So there's the validation of that for healthcare providers and their patients, and there's the opportunity for insurance coverage and there's the opportunity to make that treatment claim.
But in terms of otherwise in promotion, obviously, there has been a lot that has been completed importantly with this formulation that we are absolutely allowed under kind of regulatory compliance rules, allowed to make sure that healthcare providers and women are aware of.
So obviously, the fact that toxicology studies have been completed, the fact that pharmacokinetic profile has been established, the fact that pharmacodynamic profile has been established in terms of we've established that it actually improves blood flow through the use of temperature to show that. We can absolutely provide the placebo-controlled clinical study reprints, right.
We can point to its good manufacturing practices. We can talk about who we are as a company, right. We're a pharmaceutical company developing this product. This isn't a marketing brand, right? We're a rigorous scientific-driven company. We can talk about the investment that's been made to date into the product.
And importantly, we can also provide information about disease. We can provide information about the disease state of female sexual arousal disorder and really understanding all of this, Doug, and hearing really since last summer, since our publication came out with the findings, we've just been hearing more and more from the medical community wanting this option and not understanding why we couldn't make it available.
And so I'm really proud of what we've done at Dare to kind of step up and take action to accelerate the availability so that people can have it and have it be available while we're continuing to pursue the FDA approval for treatment.
So hopefully, that helps give a little more context on -- there's a lot of information that can be made available, and we're really happy about that, again, because it's important for people to have options and clear information about what they are and that they're backed by science.

Operator

Kemp Dolliver, Brookline Capital Markets.

Kemp Dolliver

So just to build out on the questions regarding Sildenafil. So based on some of the other models that are out there, and I'm thinking obesity and then also the Sildenafil for men, you would -- so you touched on the reimbursement, but it sounds -- I think the other element to this is that your partner -- you're essentially going to be, to some extent, outsourcing, building awareness, and promotion with your partner because a lot of this is -- since it's out of pocket, it's going to be very advertising or promotion sensitive. And so that's going to be one of the key criteria to identifying or identifying this, what I think would be -- it sounds like it will be an exclusive partnership.

Sabrina Johnson

Yes. So there are a couple of ways to think about it. So we definitely think about it as an exclusive partnership in terms of who are we going to work with to manufacture this proprietary formulation, right, and manufacture it. Compounding is basically it's manufacturing, right? That's what compounding is.
So who will be our 503B partner, outsourcing facility to handle the manufacturing as well as the fulfillment, right, of the prescription, which also has to happen through the 503B. There is, though, nonetheless, an opportunity for us and actually through the KOL community, the healthcare provider community to provide education about the product and support that through education about the disease, about our formulation, some of the things I just outlined in terms of what is known about our formulation, what is unique about our formulation, what's been evidenced to date and scientific resources available about the formulation.
So we will definitely leverage that provider-to-provider opportunity around this product. As I mentioned, because it's the healthcare community that really in large part is what triggered this to happen for us, right, is that interest and that excitement about a product coming from an organization like Dare that is a very trusted pharmaceutical developer as the only, to our knowledge, publicly traded company working broadly in women's health. There are a lot of healthcare providers that we have been working with across multiple programs. So there's a lot of support and interest there.
To your point, as you pointed out with some of these other examples, we're also really interested in meeting women where they are today. Where are people getting their healthcare treatment options today, primarily, a lot of it is online, right, through telehealth and through telehealth providers. And we want to kind of rise to the moment and also leverage that. So more to follow on all the ways that, to your point, we want to make sure women know this is available and all the resources available to us to do that.
I think the important thing to understand and think about it is that we have an opportunity to do this in a way that is definitely kind of fiscally responsible for ourselves and our shareholders in terms of what our investment upfront needing to do this in a way that then we can really focus on the financial impact, the positive financial impact to Dare and then not reinventing the wheel, right? Our idea is to leverage existing platforms and again, telehealth solutions to meet women where they are today and where they're looking today for solutions for this, but to make sure that our Sildenafil Cream is an option for them, and it's not right now, obviously.

Kemp Dolliver

And given that you have data, you would be -- you'd be exclusive to the market, this would not be a generic situation in terms of the competitive -- [environment].

Sabrina Johnson

That's right. It's not an -- yes, that's a really important thing to understand. And obviously, we've had time to kind of really delve in and understand. But a compounded product, it's not the same as a generic product, right. A generic product is when there's already an FDA-approved option that is no longer under regulatory exclusivity or intellectual property patent exclusivity and someone has filed, right, an ANDA to have that generic be available.
A compounded product is really for this circumstance, right, when there is no FDA-approved medication that meets the needs of the healthcare providers and the patients, either not approved at all or not approved in the dosage form. And so that's where this fits very nicely in terms of being a solution.
And we definitely, to our knowledge, as I noted already, are the only Sildenafil Cream that could possibly make the -- have completed all the things that we have done have made the kind of statements that we can make around this formulation.
And I want to stress again, that's why the healthcare provider community has been so interested in us making this available, right, to meet the demand they're having from their patients, but they really want a trusted source that they can count on for a product that is going to be the same every time, right. So manufactured under GMP, where you've got that quality standard that's a requirement in a facility that meets all those FDA standards and that they know they can trust. They know has been studied.

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

Thank you. So I want to thank you all for taking the time this afternoon to hear about the recent updates and our ongoing commitment to drive value for all of our stakeholders by accelerating innovation in women's health. And as I've talked about a few times, utilizing all of the available pathways to bring to market innovative evidence-based solutions designed to provide additional choices and ease of use for women.
And as you heard today, we continue to make great progress. And with our unique model, we believe we're well-positioned to accelerate innovation for women while also driving value for all of our stakeholders. We look forward to keeping you updated on our progress, and thank you for your time today.

Operator

This concludes the meeting. You may now disconnect.