Dare Bioscience, Inc. Q3 FY2024 Earnings Call

Welcome to the conference call hosted by Daré Bioscience to review the company's Third Quarter Financial Results and to provide a general business update. This call is being recorded. My name is Desiree and I will be your operator today. With us today from Daré are Sabrina Martucci Johnson, President and Chief Executive Officer and MarDee Haring-Layton, Chief Accounting Officer. Ms. Haring-Layton. Please proceed.

Good afternoon and welcome to the Daré Bioscience financial results and business update call for the quarter ended September 30, 2024. Today we will review our third quarter results and discuss developments and expectations for our pipeline and portfolio. 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 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 cautionary statements in the company's SEC filings, including our Form 10-Q for the quarter ended September 30, 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, November 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. I will now turn it over to Sabrina.

Thank you and thank you for joining the call today. We have a number of updates to cover including regarding the over $20 million in non-dilutive funding that we announced in just the last 30 days. So, we very much look forward to taking you through them. We believe Daré is the only publicly traded company focused solely on women's health pharmaceutical product development broadly across contraception, sexual health, pelvic pain, fertility, infectious disease, and menopause. And we remain dedicated to advancing disruptive products for the health and wellbeing of women through clinical development, regulatory review, and ultimately to market. Our commitment and focus is to improve health outcomes in the lives of women by leveraging the basic science and pharmacology that is understood about certain active pharmaceutical ingredients and marketed products to accelerate innovative treatments that women want and need by boldly addressing existing therapeutic gaps and we believe this is a competitive advantage. We believe we have the broadest portfolio of potentially high impact first and category product candidates to improve the health and wellbeing of women, many of which have already demonstrated proof of concept and that our robust pipeline positions us well for the short, medium, and long-term. Our broad portfolio allows us to integrate clinical and regulatory learnings from across our knowledge base. And this is what has allowed us to conduct eight successful clinical trials to date and hold 25 FDA interactions across six product candidates in 2023 and 2024 alone. We continue to be excited about the increased attention on the health and wellbeing of women, including by the Advanced Research Projects Agency for Health or ARPA-H, as evidenced by their recent announcement related to the awardees of the ARPA-H Sprint for Women's Health and our announcement under that program of the $10 million award we were selected to receive for DARE-HPV, which is an innovative investigational treatment for human papillomavirus or HPV related cervical diseases. Essentially all cervical cancer cases worldwide are caused by HPV infection. And just this week we announced an up to $10.7 million grant from the Bill & Melinda Gates Foundation to support activities that will aid in the identification and development of novel non-hormonal intravaginal contraceptive product candidates. And will also provide funding to allow Daré to expand the number of clinical sites in the ongoing Ovaprene pivotal study to accelerate the development timeline. We continue to execute on our mission to accelerate the development of and bring to market innovative treatments that as I mentioned earlier, women want and need. And we do this by advancing our late-stage candidates, all of which represent a first in category opportunity as we seek to deliver value for all of Daré's stakeholders. In addition to the continued commercialization by our collaborator Organon of XACIATO clindomycin phosphate vaginal gel 2%, which is the first FDA approved product to emerge from our portfolio and which is a treatment for bacterial vaginosis in females age 12 and older that is available by prescription nationwide. We also continued to advance our first in category Phase III development candidates with ongoing enrollment in our Phase III study of Ovaprene at sites across the US and continued constructive interactions with the FDA focused on the lining of the Phase III program for Sildenafil Cream 3.6% in female sexual arousal disorder. As we've discussed before, despite its high prevalence, there are currently no FDA approved treatments for female sexual arousal disorder and we look forward to advancing this program into Phase III. Additionally, we are conducting activities in preparation for a Phase II clinical study of DARE-VVA1 and a Phase I study of DARE-PTB1 which is supported by a $2 million grant from NICHD, all of which I will cover briefly today. The progress across our portfolio, along with the $10.7 million grant announcement yesterday and the $10 million award from ARPA-H announced in October, the $15 million equity line arrangement we established with Lincoln Park Capital Fund LLC or Lincoln Park in October and the $22 million we secured in the non-dilutive strategic royalty financing in the second quarter put Daré on track for meaningful milestones in 2025. We have a number of updates on our development portfolio to that end that I will provide today. But before I do, I'm going to first turn it back over to our Chief Accounting Officer, MarDee, to review the third quarter financial results.

Thanks, Sabrina and thanks everyone for joining us today. I would now like to summarize Daré's financial results for the quarter ended September 30, 2024, which I will refer to as the third 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 third quarter of 2024, our general and administrative expenses were approximately $2 million, which is a 24% increase compared to Q3, which is a decrease compared to Q3 2023 due primarily to reduced professional services expenses and reduced commercial readiness expenses. Our R&D expenses, which vary from period to period based on clinical, preclinical, manufacturing, regulatory, and other activities across our entire portfolio were approximately $2.7 million for the third quarter, which is a 60% decrease compared to Q3 2023. As we guided previously, this year, we continue to anticipate our full year 2024 R&D expenses will be less than our 2023 R&D expenses. Our comprehensive loss for the third quarter was approximately $4.7 million. We ended the third quarter with approximately $11.2 million in cash and cash equivalents and had approximately 8.7 million shares of common stock outstanding as of November 13. In October, we entered into an equity line arrangement with Lincoln Park, pursuant to which we have the right, but not the obligation to sell to Lincoln Park and Lincoln Park is obligated to purchase up to $15 million of our common stock. Such sales of common stock, if any, will be subject to certain limitations and may occur from time to time at our sole discretion over the 24 month period commencing on the date that a registration statement covering the resale by Lincoln Park of shares that have been and may be issued under our Purchase Agreement is declared effective by the SEC and a final prospectus in connection therewith is filed and the other conditions in the Purchase Agreement are satisfied. In October, we also entered into a subaward agreement with a consortium management firm under which we are entitled to receive funding of up to $10 million in milestone-based payments subject to our achievement over an approximately 24 month period of specified research activities and objectives relating to the advancement of our DARE-HPV development program, including commencement of a Phase II clinical study to evaluate the safety and preliminary efficacy of DARE-HPV for the clearance of high-risk HPV infection in women. The subaward agreement was the result of our selection by ARPA-H, an agency within the U.S. Department of Health and Human Services, as an awardee of ARPA-H's Sprint for Women's Health, which was announced by First Lady Jill Biden in February 2024 and as the first major deliverable of the White House Initiative on Women's Health Research. In addition, as Sabrina mentioned and I will share more about later, we announced yesterday that we entered into a grant agreement with the foundation for a grant of up to approximately $10.7 million, approximately $5.4 million of which we expect to receive this year. The fund activities related to the identification and development of a novel non-hormonal intravaginal contraceptive product candidate and to add additional clinical study sites intended to accelerate the ongoing Ovaprene pivotal study. These non-dilutive 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. 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-Q for the quarter ended September 30, 2024, which we filed this afternoon, as well as our annual Form 10-K for the year ended December 31, 2023, which was filed on March 28, 2024. I would now like to turn the call back over to Sabrina.

Thanks, MarDee. I'm now going to talk through our 2024 accomplishments to date and importantly with some perspective on how those frame anticipated milestones and with a focus, as I mentioned upfront on the late-stage candidates Sildenafil Cream and Ovaprene. But first I do want to provide an update on our on-market asset XACIATO. So as a reminder, XACIATO or clindomycin phosphate 2% vaginal gel is the first FDA approved product to emerge from our portfolio. It's indicated, as I mentioned upfront, for the treatment of bacterial vaginosis in females 12 years of age and older. As you may recall, 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. And in the first quarter of this year, of 2024, through our commercialization agreement with Organon, XACIATO became available by prescription across the United States. We've been pleased with Organon's progress in this first year of launch. As of October, the Organon women's health sales team continued to see steady month-over-month increases in total prescriptions of XACIATO, in line with the opportunity for a new branded entrant in the category. And the team continues to work towards novel go-to-market fulfillment options and enhancements to ensure a frictionless experience for both patients and providers. And Organon's access team continues to build on the successful coverage achieved at launch through additional wins. For example, they had a recent addition to the preferred drug list for Texas Medicaid with no prior auths or step edits required. And that provides access to an additional 4.1 million patients. And Organon's women's health sales team remains focused on providing XACIATO's strong clinical value proposition to clinicians who treat bacterial vaginosis and who continue to affirm their belief that unmet needs exist in this therapeutic area. I'll now turn to Sildefanil Cream. As I mentioned upfront, we have continued our constructive interactions with the FDA on the development program for Sildefanil Cream as a treatment for female sexual arousal disorder, including, importantly, with respect to the proposed efficacy endpoints to take forward into Phase III development. As we've mentioned several times, this would be the first-ever Phase III pivotal study of a therapeutic candidate for the treatment of arousal disorder in women. We look forward to providing updates on the FDA's feedback, the Phase III study designs and plans, as well as any relevant updates on our collaboration strategy as they become available. In the meantime, we have been making operational progress towards that planned Phase III study. As you know, there are currently no FDA-approved treatments for any form of sexual arousal disorder in women, meaning Sildefanil Cream has the potential to be the first. And sildefanil 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. And I don't need to remind you, that was undoubtedly one of the most successful prescription products ever launched. And market research suggested approximately 20 million women in the U.S. experience symptoms of low or no sexual arousal. So, we look forward to providing additional updates on the development program as they are available. In terms of Ovaprene, wanted to provide an update on the advancement of the Phase III study of Ovaprene, which is our novel investigational hormone-free monthly intravaginal contraceptive. And the commercial rights for the U.S. are under a license agreement with Bayer. So nonhormonal contraception represents a significant commercial market opportunity. And there are currently no monthly hormone-free contraceptives approved by the FDA. So Ovaprene has the potential to be a disruptive product in the contraceptive category and an important option for women who cannot use hormone-based birth control products or prefer not to do so. Based on market research, approximately 35 million women in the U.S. 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 the patient enrollment in the Ovaprene pivotal Phase III clinical study in December 2023. And as you may recall, women are followed over 13 cycles or 12 months of Ovaprene use. Recruitment is currently proceeding at a little more than 10 sites across the United States, and that's supported by a central advertising campaign for the study that launched in March of this year. As we discussed last quarter, that particular subset of the total substudy sites that are ongoing in the trial have been the most successful and translating into study participants that considerable interest we continue to see from women in response to the central advertising campaign. So based on the current average enrollment rate, we anticipate that approximately half of our target number of participants to complete the study or 125 women will complete approximately six months of product use, which is half of the full 12 months, by the end of the second quarter of 2025. With the grant funds we expect to receive this year under the grant agreement we just announced yesterday, we're going to add additional study sites, and we expect that to accelerate the study. Based on the communications to date with the FDA, if successful, we believe that just the single registration study would be required to support a premarket approval application submission with the FDA. So now on to the DARE-HPV program. We mentioned at the start of the call and MarDee mentioned our announcement of the $10 million award that we were selected to receive for DARE-HPV. As I mentioned, it's an innovative investigational treatment for HPV-related cervical diseases. And I can't stress enough that essentially all cervical cancer cases worldwide are caused by HPV infection. And unfortunately, despite the advancements in HPV screening and vaccination, which are fantastic, in the United States, an estimated 100,000 women are still treated for cervical precancer each year. And even more unsettling, an estimated 4,000 women will die from cervical cancer in 2024. Today, cervical precancers are monitored until they reach the last stage since the most common treatment is surgery, which removes part of the cervix. And that surgery is associated with an increased risk of preterm birth and sexual dysfunction and therefore, is not recommended for patients with fertility concerns. In the U.S., about 10% of women with HPV infection on their cervix will develop long-lasting HPV infection that puts them at risk for cervical cancer. So, DARE-HPV has the potential to be the first FDA-approved pharmaceutical intervention that could treat both late-stage cervical lesions as well as earlier-stage HPV-related cervical infections. And that could really change the paradigm around how HPV-related cervical diseases are clinically managed today. Their HPV is reflective of the type of development program we like to advance at Daré. It's first in category, but it leverages active pharmaceutical ingredients that have been approved to treat other viral infections, so they're well known and understood. Specifically, DARE-HPV is an investigational proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert with the potential, as I mentioned, to be a very first-in-category treatment for HPV-related cervical diseases. We look forward to conducting activities necessary to enable submission of an IND application to the FDA for a Phase II randomized placebo-controlled double-blind clinical study of DARE-HPV for clearance of high-risk HPV infection in women. And all of that will be supported with the funding we received as an ARPA-H Sprint for Women's Health $10 million awardee. We also wanted to provide updates on two of our other first-in-category product opportunities. DARE-VVA1 is our proprietary formulation of tamoxifen for intravaginal administration. And it's being developed as a hormone-free alternative to estrogen-based therapies for the treatment of moderate to severe dyspareunia, which is pain during sexual intercourse. And we're conducting activities in preparation for a Phase II clinical trial of DARE-VVA1 based on our FDA-cleared IND for that use. And DARE-PTB1, as I mentioned up front, that's our intravaginal ring designed to deliver bioidentical progesterone continuously over 14 days for the prevention of preterm birth. We're conducting activities necessary to enable submission of an IND application to the FDA for a Phase I clinical study. And that's supported by a $2 million grant from NICHD. That Phase I study will also serve to support safety and PK for this progesterone intravaginal ring to also be investigated for luteal phase support as part of an IVF regimen. And finally, I did want to share a little bit more about the grant we just announced from the Bill & Melinda Gates Foundation. In addition to the important support for the Ovaprene clinical trial, the grant will also support activities to derisk the development of a novel nonhormonal intravaginal contraceptive that could be suitable for women and acceptable for women in low- and middle-income country settings who need or prefer such a product to avoid unplanned pregnancy. We believe that we're the right organization to move innovations like these programs forward given our extensive experience in the contraceptive space, in particular, with novel nonhormonal product development and our proven ability to advance development of differentiated product candidates that fulfill unmet needs in women's health. So, we'll receive, as MarDee outlined, an initial payment of approximately $5.4 million under the grant agreement in 2024, and then additional payments, as is typical, are contingent upon our achievement of certain development and reporting milestones specified in the grant agreement, during the approximately 24 months period term of that grant agreement. So similar to the ARPA-H award, which is also a 24-month period, for that $10 million disbursement. This $10.7 million disbursement is also over a 24-month period. So in summary, we continue to progress our portfolio of potential first-in-category product candidates and look forward to providing more updates as we work to advance some of the most potentially disruptive candidates for the health and well-being of women in decades, collaborating with leading companies, including Organon for XACIATO and Bayer for Ovaprene, as well as funding agencies, to commercialize and deliver these treatments to as many women as possible. I'd now like to turn the call over to the operator for Q&A.

From the line of Catherine Novack with Jones Trading. Your line is open.

Hi, good afternoon. Congrats on all the progress. Congrats especially on being able to expand or accelerate enrollment in the Ovaprene study. So, I just wanted to touch on the potential interim or the potential interim look by the end of 2Q '25. Is this something we're still expecting? And then what should we be looking for from this interim readout? Just safety? Or how much efficacy can we learn from an interim read?

Yes. Catherine, that's a great question. So, thanks for asking. And first of all, thank you for the congratulations on the non-dilutive funding we got. It's a really nice addition to be able to add some sites, additional sites to the study. And we're really excited to do that. Right now all of the sites are through the NICHD's clinical trial contraceptive network. So, it's going to be really great to be able to add some additional sites to give them experience as well, right, with the product outside of that and the opportunity to go even faster with the program. So, we're thrilled about that. In terms of getting partway through that important enrollment milestone and kind of having that critical halfway mark in terms of subjects and time in this study, it's definitely an important place for us to look at the data. As people may or may not recall, this is open label. That's standard for any contraceptive trial in that everyone in the study, just for ethical reasons, right, they're all getting active product. There's no placebo control. And that does create interesting opportunities like this to continue to look at safety. We do have a data safety monitoring board, as well as other considerations throughout the course of the study, evaluating it. In terms of exactly what information will be reviewed at that time and what may be made publicly available and how that will be handled, that's really something that we are working closely with our commercialization collaborator with Bayer on as well as we think this through as well as, obviously, the data safety monitoring board and charter for the program. And the reason I say that is that this is a 12-month or 13-cycle ultimate contraceptive study, and there's a lot of data to indicate that contraceptive rates just get better, right, over time. So that's one of the things we're going to have to think about in terms of what we look at and how any sort of disclosure would be handled around that. So more to come on that. It's an active and ongoing discussion with our commercialization collaborator, so Bayer. So, we will give more updates on that as we get closer.

Great. Can you provide more details about the operational progress towards Phase III for sildefanil? Additionally, could you tell us what information is still needed regarding your FDA interactions? Do you require more details from them, or is there anything else they need from you to facilitate progress?

Yes, that's a great question. To address your inquiry regarding our operational progress and our discussions with the FDA, these conversations have primarily centered on what we need for the NDA submission at the end of Phase II. Given that we are developing a first-in-category product, much of the focus has been on determining the appropriate endpoints for the Phase III program. We need to consider what is essential to monitor and demonstrate, as well as what the expectations are regarding efficacy and safety from that Phase III program. We previously mentioned that two Phase III trials are anticipated to support registration, but the specifics of what that entails are still being finalized. The Phase II data has provided valuable insights into the patient population, endpoints, and areas for improvement. It's a matter of taking the time to review this information, responding to inquiries, receiving feedback, and ensuring alignment with the FDA. The process of communication is methodical, so it does not involve daily conversations. Overall, it has been a constructive experience, and the FDA is eager to help us reach a stage ready for progress, understanding the importance of alignment between our expectations for Phase III and our shareholders’ interests. Regarding our operational readiness, we are preparing to act as soon as we reach this alignment. This includes taking control of aspects such as selecting the right contract research organization, identifying the sites we will work with, and ensuring drug supply to avoid delays in manufacturing. These are all manageable factors we are actively addressing. Our goal is to be operationally ready so that once we finalize the Phase III protocol, which everyone agrees on, we can promptly begin the necessary processes. Additionally, we are also mindful of financial considerations and have implemented structures to ensure we are well-prepared.

Got it. That makes sense. Definitely looking forward to hearing some of those updates when you're able to share them. Thanks again for taking my questions. Congrats on all the progress.

Thank you. Our next question comes from the line of Douglas Tsao with H.C. Wainwright. Your line is open.

Hi, good afternoon. Can you hear me this time?

Hello?

Mr. Douglas Tsao, I think your microphone is on mute. All right. Our next question comes from the line of Kemp Dolliver from Brookline Capital Markets. Your line is open.

Thank you. I'm definitely not on mute. I have a couple of questions. Regarding the Ovaprene trial and the potential interim look, it seems that the analysis would not lead to stopping the trial early. What specific actions might result from that analysis?

Yes, that's a great question. The DSM is primarily responsible for monitoring safety on a routine basis. This inquiry has sparked considerable discussion. It's an open-label study, and any analysis would only be valuable after accumulating enough patient data and treatment cycles to evaluate safety and efficacy. At this time, I cannot provide specific details beyond that. This phase is critical as it marks a midpoint in the study, and to my knowledge, no contraceptive product has been studied for a shorter duration. A sufficient number of cycles and at least six months of observation are necessary for these methods. Therefore, this milestone is significant for us. While I wish I could give you a firmer answer, we need to consider what to focus on and how to utilize the information based on established literature regarding contraceptive studies, noting that Pro Index changes usually occur between six and thirteen months. This raises important considerations, especially for our commercialization partner, Bayer. More updates will come as we progress. Notably, we will be conducting our DSM safety assessments, which are crucial at that stage.

Okay. That's great. And just stay on that particular trial for the moment. So you have 10 sites now. You're going to have some additional funding available. How many additional sites do you intend to add?

Yes, that's a great question. To clarify, there are a total of 20 sites participating in the clinical trial contraceptive network under the NIH, all of which are engaged in the study and are actively following patients. We are currently focusing our recruitment efforts on just over half of these sites, specifically more than 10, which have shown exceptional success in converting interest from women in the study into actual participants. We aim to use our resources effectively through our collaborative research agreement with the NIH that encompasses these sites. Therefore, as we look ahead to recruitment, our focus will primarily be on those 10-plus sites within the CCTN group. The additional funding will likely enable us to include a few more sites in the study, which is significant given the size of the study and the number of active and efficient enrollers that can make a meaningful impact. We are very excited about this opportunity, which also allows for the addition of sites outside of the CCTN network. We have greatly valued our collaboration with the CCTN, but we have also had excellent experiences with community-based sites that participated in our previous studies like XACIATO and sildefanil. We are eager to work with some of these sites on Ovaprene as they have expressed strong interest in doing so.

Great. And my last question relates to sildefanil and just to think about the potential time frame once you get FDA alignment and with the operational requirements and certainly having funding. So if we just think of funding as being the most gating factor here, if you were to get funding, say, next month, how soon do you think you'd be able to initiate the trial?

Thank you for the question. When it comes to study start-up, we have completed as much as possible on our end, but there are still operations that take not just days, but several weeks, particularly regarding site contracts, which we cannot finalize even though we know our preferred partners. We can only proceed once we have the final protocol approved by the IRB. We will move as quickly as possible, but there are traditional steps in the study start-up process that we cannot begin until the final protocol is in place. So, regarding your question about protocol and funding, those traditional study start-up activities can realistically take a couple of months or more, especially when it comes to site initiations.

So a start next year is possible?

Absolutely. Yes, absolutely. Yes. Once we get that final protocol aligned with the FDA, then yes, then it's down to your point, obviously, always have to think about the money, importantly. But then it's really just that operational study start-up, things like the IRB, site contracts, and the site initiation.

Great, thank you.

Next question from Douglas Tsao with H.C. Wainwright. Your line is now open.

Hi, good afternoon. Can you hear me this time?

Yes, yes. Thank you.

Okay. Sabrina, I'm just curious in terms of the Ovaprene study and the addition of these new sites. How quickly do you anticipate them sort of being able to enroll study in the trial? And ultimately sort of do you have a sense of what percentage of the total enrollment might come from these sites? And will there be sort of different types of patients that will be added by going outside of the CCTN network?

Yes, those are excellent questions. As I mentioned earlier, the sites we've chosen to add to the study are ones we've had positive experiences with in the past and have performed well. Some have participated in both our bacterial vaginosis and sildefanil studies, while others have only been involved in one. This means we have previously contracted with them and collaborated, which should lead to efficiencies compared to working with entirely new sites. Our expectation is that it will take weeks, not days, to progress through this process, but we aim to get these sites up and running as quickly as possible. I plan to move swiftly in the new year, utilizing the time left this year to work closely with these identified sites. Regarding your question about the diversity of subjects in the study, we continually assess demographics, ensuring we meet our diversity objectives in various regions of the country that we want to include. This approach creates additional opportunities that we want to thoughtfully leverage. As for the contribution of these sites to the study, these locations have historically performed well in terms of translating interest into participants, as seen in the sildefanil study. The Clinical Trial Contraceptive Network sites have been exceptional, although some perform better than others for this specific study. Ultimately, we consider the level of interest and select sites that have a track record of efficiently converting interested individuals who meet eligibility criteria into study participants. If they excel in this aspect, they can still make a significant contribution to the study, especially in terms of enhancing diversity among participants and sites.

That's helpful. Sabrina, you mentioned the amount of funding needed to complete the sildefanil program. I'm curious about how much of that funding you need upfront to begin the program.

Yes, we estimate that each individual study will incur around $15 million in direct external costs, leading to a total of $30 million for two studies. However, we do not expect to have the entire $30 million secured before we start. It's important to note that while $15 million is a key figure for us, this is not a life-threatening condition, and the study duration for participants will be relatively short. This allows us some flexibility regarding how much funding is needed upfront, as we can continue enrolling participants even as the study progresses. Ultimately, the crucial point is that we don't require the full $30 million immediately, but we want to ensure we have enough confidence in our ability to support the participants throughout the study.

Okay, great. Thank you so much. That's helpful.

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.

Thanks. Well, thank you all for taking the time this afternoon to hear about our recent updates and our ongoing commitment to drive value for all of Daré's stakeholders by identifying and advancing potential new therapies to provide additional choices and, hence, outcomes and ease of use for women. As you heard today, we continue to make great progress. And with our unique model, including being able to leverage a lot of non-dilutive funding that we just brought in over the last month, and the support of our commercial collaborators, we believe we're well positioned to accelerate innovation for women everywhere, while also driving value for all of Daré stakeholders. So, we look forward to keeping you updated on our progress, and we thank you for listening today.

Ladies and gentlemen, this concludes today's conference call. You may now disconnect.