Welcome to the conference call hosted by Daré Bioscience to review the company's first quarter financial results and to provide the general business update. This call is being recorded. My name is Alex, and I will be your operator for today. With us today from Daré are Sabrina Martucci Johnson, President and Chief Executive Officer; and MarDee Haring-Layton, Chief Accounting Officer. Ms. Johnson, please proceed.

Thank you. Good afternoon, and welcome to the Daré Bioscience Financial Results and Business Update Call for the quarter ended March 31, 2024. Today, we'll review our first quarter results and discuss developments and expectations from our pipeline and portfolio. I would like to remind you that today's discussion will include forward-looking statements within the meaning of the 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 due 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-Q for the quarter ended March 31, 2024, which was filed today. I would also like to point out that the content of this call includes time-sensitive information that is current only as of today, May 14, 2024. Daré undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. Before we begin today's update, I'd like to take a minute to remind those of you who may be newer to the Daré story of our purpose and mission. We believe Daré is the only publicly traded company focused solely on women's health, pharmaceutical product development broadly, and we remain dedicated to advancing disruptive products for the health and well-being of women through clinical development, regulatory review and ultimately to market. Our commitment and focus is to improve health outcomes and the lives of women by leveraging the basic science and…

Thanks, Sabrina, and thanks, everyone, for joining us today. I would now like to summarize Daré's financial results for the quarter ended March 31, 2024, which I will refer to as the first quarter. As Sabrina mentioned, Daré'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 a portfolio includes corporate overhead portfolio acquisition and maintenance costs and ongoing research and development or R&D expenses. During the first quarter of 2024, our general and administrative expenses were approximately $2.7 million. Our R&D expenses, which vary from period to period based on clinical, preclinical, manufacturing, regulatory and other R&D activities across our entire portfolio were approximately $3.3 million for the first quarter, which is a 34% decrease compared to Q1 2023. Closeout costs related to the Phase IIb RESPOND clinical study of Sildenafil Cream and other clinical studies conducted in 2023 and contributed significantly to our first quarter R&D expenses, which will not be the case in future quarters. Until we commence a Sildenafil Cream Phase III clinical study, we expect R&D expenses for future quarters to be lower than the first quarter R&D expenses. Our comprehensive loss for the quarter was approximately $6.8 million. We ended the first quarter with approximately $3.6 million in cash and cash equivalents and had approximately 101 million shares of common stock outstanding as of May 13. We recently announced a royalty monetization transaction with XOMA in which Daré received $22 million in gross proceeds and following a prespecified total return to XOMA, XOMA will make upside sharing milestone payments to Daré equal to 50%…

Thank you, MarDee. I'm now going to talk through our first quarter 2024 accomplishments and some anticipated 2024 milestones with a focus on our Phase III assets, Sildenafil Cream and Ovaprene. The first, I'll provide an update on our on-market assets, XACIATO clindamycin phosphate vaginal gel 2%, or just XACIATO. As a reminder, XACIATO is 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 at 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. The Organon Women's Health sales team continues to see strong acceptance from clinicians who have tried with their patients multiple uses of XACIATO in their practice. This progressive ramp-up of trial from key health care provider targets continues to build momentum as we move through the first full year of launch. I'll now talk about Sildenafil Cream, 3.6%. During the first quarter, we also announced the successful completion of an end of Phase II meeting with the FDA on the development of Sildenafil Cream as a treatment for female sexual arousal disorder. In terms of market and revenue potential, there are currently no FDA-approved treatments for any form of sexual arousal disorder in women, meaning Sildenafil Cream has the potential to be the first. Sildenafil is the active ingredient in tablet form for oral administration currently marketed under the brand name Viagra for the treatment of erectile dysfunction in men, which was undoubtedly one of the most successful prescription products ever launched. Market research suggests that approximately 20 million women in the United States…

[Operator Instructions] And your first question comes from the line of Douglas Tsao with H.C. Wainwright.

I guess, Sabrina, you're looking now for some additional feedback from FDA on Sildenafil Cream. I mean can you just maybe help us walk through some of the steps that would be needed to initiate that Phase III?

Yes, Doug, thanks. Great question. So yes, so as I mentioned, we're waiting for some feedback so that we can make sure we're lined on the final Phase III design and the endpoints for that. And important things like endpoint hierarchy and all of that. But to your question, what we're trying to do is make sure that all of the other activities that are required to start up a clinical trial that we're doing everything we can to make sure that we are ready. So those activities include things such as selecting your CRO, right, and having your study budget and materials in place, making sure we have a clear line of sight into these sites that we want to use. Now obviously, we had the experience of the Phase IIb study, so that's helpful in terms of selecting sites because we know the Phase III used in that study and who we want to continue, but just making sure we're ready from that regard, making sure that we're ready with clinical supplies, materials, right, the investigational product and placebo to test in the trial. So those are the activities that are underway and that we really started earlier this year, quite frankly, and that are well underway to make sure that as soon as we get the feedback from the FDA that we are ready to move as quickly as reasonable to proceed, and there isn't some other -- right, some other gating activity that we had not yet completed.

Okay. Great. That's helpful. And then just maybe on Ovaprene, maybe just help us understand when we should sort of start to think about sort of getting initial data or just a final readout from a timing standpoint?

Yes. Great question. So the trial, for those who may not be familiar to the trial, is a 12-month study, meaning the subjects in the study, our goal is to follow them to have them use Ovaprene over the course of 12 months. And we'd like to have around 200, 250 women complete 12 months of use with the product. And so we started -- as I mentioned, we started enrolling the subjects at the end of last year. And the advertising campaign, which is important in studies like this, it went live in March. And as I mentioned in my comments, we are definitely very happy with how much responsiveness we saw to the advertisement campaign, which really leverages like, as you can imagine, social media platforms to make sure people are aware of the study and can reach out to express their interest and then matches them to sites. So with the ad campaign just going live in March, it's a little bit early for us to give very specific guidance, which we do want to do and give some perspective on time lines and when we expect all that. But having said that, we are very happy with how the advertising campaign has been going and the responsiveness that we're seeing to the advertising campaign. And the reason all of that is important and going to your question about the time lines, they're important is because this is an open-label study, meaning everyone is single arm, everyone is on Ovaprene. And so obviously, having a line of sight into how enrollment is going gives us an opportunity to understand if there's an opportunity to look at interim data and when that will happen and when the final data will come. So at this point, what I can say definitively, given that we didn't start recruiting until the end of last year is that we certainly we don't anticipate to have final data this year. That wouldn't really be feasible given the time line of the study. But we definitely hope to have some meaningful updates that we can share this year. And then as we get a little bit further with the live enrollment with the ad campaign, we'll be able to give better guidance as to exactly when we expect -- when we would anticipate last patient out.

Your next question comes from the line of Kemp Dolliver with Brookline Capital Markets.

I want to ask a couple of questions regarding the your balancing act now between your current funding and your plans because there's some language in the 10-Q that's pretty sober regarding the cash runway. But at the same time, your current spending levels in theory, could get you past 12 months and possibly to the Ovaprene readout based on the step down, we'll likely see an R&D expense and the fact that you really don't have much -- you have a small remaining obligation for the Ovaprene trial. So how should we think about the spending? And where you're able to get with the readouts with the -- particularly with the XOMA financing in place?

Yes. Thank you. Great question. And so as MarDee mentioned in her comments and you noted, R&D spending until we start the Sildenafil trial because of the nature of our arrangement on Ovaprene and the funds we had already remitted to the NIH under a collaborative research agreement, as you noted, there's not a lot left that we've already committed to spend on that. There's another $500,000 payment on that. But otherwise, right, the R&D spend, as MarDee noted, is significantly reduced compared to last year until we start a Sildenafil Phase III study. And as I was mentioning in the response to Doug's question, we want to be prepared to move on that as quickly as we can and a single Phase III study, our expectations at this point, at least based on what we know today, it's around $15 million. So when you look at just our baseline burn, which we, in our last call, had provided some guidance that our expected G&A this year was about $10 million for the year, right? When you start just taking all of that into consideration with MarDee, $22 million is absolutely impactful. And to your point, really gets us to some very important milestones n terms of Ovaprene, progressing opportunities potentially to look at some of that interim data timing and even to your point, depending on how enrollment goes even further than that, but we want to be very clear, right, in our communication that a single Sildenafil trial is $15 million. In the scheme of things, is that a lot when you think about the potential of like what Viagra is in the marketplace, no, but we do want to make sure we're being clear in our communication given that dollar amount in relation to the $22 million.

That's very helpful. And to be clear, does that $15 million include the activities you're engaged in now prior to initiation?

It does because the $15 million does include things like manufacturing, right, the cost of manufacturing the product for the clinical trials certain startup right site startup activities, it's what we expect the all-in number to be.

Okay. And assuming the feedback from FDA is not surprising and there are only minor hiccups along the way with preparation, when do you -- when is a reasonable expectation or initiating the trial? Because it looks like that early 2025 is reasonable, but maybe you can start early in 2024?

Yes, that's definitely our hope. That's a great way to look at it, right? Like we're trying to just make sure that we've checked all the boxes that we can check and have that final protocol and then being able to move as quickly as we can once we have the protocol but there's start-up activities, right? You got to contract with all the sites. There's things we can't do until we have a final protocol. So our intent is to move as fast as we possibly can. That's our objective. That's our goal. And so we love to be in a position to do that this year. But it definitely, to your point, is predicated on timing of getting the comments back from the FDA. And hopefully, they're clear. as you noted, so that we can move very quickly. But like I said up front, we're trying to make sure that we have ticked off every other activity so that we're ready to sprint.

Okay. And you have the flexibility to delay initiating the trial until you have, say, more certainty around your runway?

Absolutely. It's all within our control, right? So the things that we're doing now are not significant in terms of expenses, but they're important activities so that we are ready to go at our choice, right, at timing completely 100% in our discretion.

Your next question comes from the line of Catherine Novack with Jones Research.

Good afternoon. Just another one on the Sildenafil trial, the potential Phase III trial. Can you remind us what you are still waiting on with regard to feedback. We know that you were aligned previously on indication and study population. So what endpoints are you proposing? And then the timing, is this a 12-week study? Or are you -- would it potentially be longer or shorter? What's the duration?

Yes. Great question and great reminder to sort of refresh everyone on where we feel we already have great clarity from the FDA based on our December meeting and where really, given that this is the first Phase III study of its kind, where reasonably the FDA needs a little more time to go through all of the information we provided. So to your question. So first of all, importantly, the patient population and the indication statement and the duration of the efficacy period, have all been agreed with the FDA. So the indication statement is treatment of female sexual arousal disorder, very straightforward. The patient population are women with female sexual arousal disorder, including women who may as a result, right, as their arousal disorder have a decrease in desire. That's very common. It's not only common in female sexual arousal disorder. It's the same thing that happens in a rectal dysfunction. So very common for an erasable dysfunction to lead to a decrease in desire. So that's the patient population. And then in terms of the duration of the efficacy assessment, the FDA guidance document for conditions of this nature, it actually includes a few different sexual dysfunctions but arousal disorder is in there suggest that 24-week studies may be necessary for Phase III. But based on our end of Phase II meeting with the FDA and frankly, just a number of sexual events that women had in our study and our ability to show how much data you can capture in a 12-week period in terms of experiences with the product FDA was comfortable that an adequately powered 12-week efficacy study would be sufficient. So those are places where we've got good clarity. And that does, by the way, give us a lot in terms of --…

Yes. No. That's helpful. Looking forward to FDA feedback, hopefully later this quarter. And then just one more question on the DARE-LARC1. That's a really interesting technology. And I'm just curious, what is the clinical program like that looks for like that? Is it comparable to, let's say, what IMPLANON or NEXPLANON looked at? Are you also trying to test the pause and resuming dose?

Yes, that's a great question. So we've started to obviously do work on what the ultimate clinical program looks like and started to map out kind of that engagement with the FDA around that. But to the first part of your question, the contraceptive effectiveness part is, yes, it's going to look very much like what an NEXPLANON, right, any sort of implant hormone releasing implant product looks like where you're able to establish through Phase I, what your relevant doses of those hormones are and then typically move straight into a contraceptive effectiveness study because you've demonstrated that you have the hormones at the right level, and then you continue to -- you do have to study. So similar to like what those products do is you tend to like get your approval in increments, right? So you might first go after a 1-year, 2-year, 3-year, right duration and then you keep following the women to keep extending your years of effectiveness. So very analogous to what the hormone releasing products have done and like with NEXPLANON as well, going for their 5 years. So that's -- so from that piece, the piece that -- and then nonclinically, we've already demonstrated like the pause open on-demand component of the pause-resume, but that will be a piece that will definitely be part of the conversation with the FDA in terms of what demonstration of that in vivo, right, is this -- will it be sufficient to show that in Phase I, right? Or would that be -- need to be part of any Phase III regimen as well?

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.

Thank you. Well, I really appreciate the great questions, and I do have some closing comments. First of all, thanks, everyone, for taking the time. to hear about the recent updates and our ongoing commitment to drive value for all of our Daré stakeholders by identifying and advancing potential new therapies to provide additional choices enhanced outcomes and use of use for women. And building on the momentum of 2023, there's no doubt that it's an incredible time to be working in women's health, quite frankly. We continue to be excited about the increased attention on the space through the various White House initiatives and our active participation in them including the ARPA Ideation event that we attended in February of this year, the executive order signing at the White House in March, and additionally, we're thrilled to see the recent unveiling of a bipartisan Senate bill that would authorize $275 million to boost research, training and public awareness around menopause, specifically and mid-life women's health issues, an area that is often stigmatized and overlooked and underfunded and that is particularly relevant to us given our work on DARE-HRT1 which, while it was not the focus of today's call is a program that we are also preparing for Phase III. It's a potential first vaginal monthly therapy for the vasomotor symptoms and menopause, as well as our Phase II-ready DARE-VVA1, our hormone-free vaginal candidate for sexual pain related to menopause. So we're looking forward to seeing continued progress in the menopause space and the potential progress of this new bill. Earlier this month, we were also selected as a member spoke of the Investor Catalyst Hub, which is the regional hub of arpa/inet.h, the nationwide health innovation network launched by ARPA-H. Through our participation, we get access to potential funding…

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect