Dare Bioscience, Inc. Q4 FY2024 earnings call

• Target to make proprietary Sildenafil Cream formulation available via 503B-registered outsourcing facility in Q4 2025, part of dual path approach while pursuing FDA approval for female sexual arousal disorder.
• Ovaprene Phase 3 study: Patient enrollment commenced in Dec 2023, but recruitment at CCTN sites paused due to federal contract uncertainty; interim data review by DSMB expected in summer 2025.
• XACIATO: Launched in US via Organon, with a strategic royalty financing with XOMA resulting in $22 million gross proceeds.
• DARE-HPV: Selected for up to $10M award for development of innovative investigational treatment for HPV-related cervical diseases, advancing towards Phase II clinical study.
• Other programs: DARE-VVA1 (tamoxifen intravaginal formulation) in preparation for Phase II trial; DARE-PTB1 (progesterone intravaginal ring) supported by $2M grant from NICHD, with Phase I study to support safety and pharmacokinetics.
• Business strategy elements: Accelerate innovation in women's health, advance clinical development, pursue strategic collaborations, expand portfolio, and seek non-dilutive funding.

Daré's general and administrative expenses for 2024 were approximately $9.2 million, a 24% decrease from 2023, primarily due to reduced commercial readiness expenses and headcount. R&D expenses were approximately $14.2 million, a 34% decrease from 2023. The company reported a comprehensive loss for 2024 of $4.5 million, ended the year with approximately $15.7 million in cash and cash equivalents, and a working capital deficit of approximately $3.2 million. XACIATO, the FDA-approved clindamycin phosphate 2% vaginal gel, was launched in the US in Q1 2024 via a commercialization agreement with Organon, with positive progress noted in its first year of launch.

• Target to have Sildenafil Cream available via 503B-registered outsourcing facility in Q4 2025.
• Expect to provide updates on strategic partnerships for Sildenafil Cream in Q2 2025.
• Ovaprene Phase 3 study: Anticipate review of interim data by DSMB in summer 2025, with enrollment progress uncertain due to federal contract issues.
• Updates on other programs, including DARE-HPV, DARE-VVA1, and DARE-PTB1, expected in Q2 2025.

• Executive orders and actions in Q1 2025 negatively impacted Ovaprene Phase III study, pausing recruitment at CCTN sites to preserve funds for enrolled subjects; uncertainty around enrollment rate and completion of Phase III study.
• Uncertainty regarding federal contracts and funding for research and development affecting Ovaprene Phase III study recruitment at CCTN sites.

Q: Hi. Good afternoon. 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 III study? And how do you intend to balance the commercial population, with the population targeted for Phase III enrollment?

A: 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 III trial and operations of the study to ensure there's motivation to participate in that when the product is already available.

Q: Hi, good afternoon. Thanks for taking the question. 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?

A: 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. Yes, 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.

Q: Hi, thank you. 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.

A: 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 its 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.