Dare Bioscience, Inc.

Welcome to the conference call hosted by Daray 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 Daray are Sabrina Martucci-Johnson, President and Chief Executive Officer, and Mardy Herring-Layton, Chief Accounting Officer. Ms. Herring-Layton, please proceed.

Good afternoon and welcome to the DARE Bioscience Financial Results and Business Update Call for the quarter ended September 30th, 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 end of 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. The RA 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 Dari 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 well-being 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-in-category product candidates to improve the health and well-being of women, many of which have already demonstrated proof-of-concept And then 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 well-being 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 and Melinda Gates Foundation to support activities that will aid in the identification, and development of novel non-hormonal intravaginal contraceptive product candidates, and we'll also provide funding to allow DARE to expand the number of clinical sites in the ongoing oviprene pivotal study to accelerate the development timeline. We continue to execute on our mission to accelerate 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 DARI's stakeholders. In addition to the continued commercialization by our collaborator organon of Daciato, clindamycin 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 oviprene at sites across the U.S. and continued constructive interactions with the FDA focused on aligning on the Phase III program for sedentafil 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 three. Additionally, we are conducting activities in preparation for a phase two clinical study of DARE VVA-1 and a phase one study of DARE PTB-1, 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 DARI 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, Marty, to review the third quarter financial results.

Thanks, Sabrina, and thanks, everyone, for joining us today. I would now like to summarize DARE's financial results for the quarter ended September 30, 2024, which I will refer to as the third quarter. As Sabrina mentioned, DARE's business strategy is to assemble in 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 two million, which is a 24% increase compared to Q3, I'm sorry, decrease compared to Q3 2023 due primarily to reduce professional services expenses and reduce 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 13th. 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. But 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 perspective and 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. to 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 oviprene 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 conditions, liquidity, capital resources, and risk factors in our form 10-Q for the quarter ended September 30th, 2024, which we filed this afternoon, as well as our annual form 10-K for the year ended December 31st, 2023, which was filed on March 28th, 2024. I would now like to turn the call back over to Sabrina.

Thanks, Marty. I'm now going to talk through our 2024 accomplishments date and importantly with some perspective on how those frame anticipated milestones. and with a focus, as I mentioned up front, on the late-stage candidates, adenofil cream and oviprene. But first, I do want to provide an update on our on-market asset, Zosciato. So, as a reminder, Zosciato, or clindamycin phosphate 2% vaginal gel, is the first FDA-approved product to emerge from our portfolio. It's indicated, as I mentioned up front, 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, Vasciata 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 Zosciato 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 auth or step edits required, and that provides access to an additional 4.1 million patients. And Organon's Women's Health Field Team remains focused on providing Zasciato'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 sidenafil cream. As I mentioned up front, we have continued our constructive interactions with the FDA on the development program for sidenafil 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 three 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 three 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 three study. As you know, there are currently no FDA-approved treatments for any form of sexual arousal disorder in women, meaning Sidenafil cream has the potential to be the first. And Sidenafil 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 suggests that 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 oviprene, wanted to provide an update on the advancement of the Phase 3 study of oviprene, which is a novel investigational hormone-free monthly intravaginal contraceptive and that commercial rights for the U.S. are under a license agreement with Bayer. So non-hormonal contraception represents a significant commercial market opportunity, and there are currently no monthly hormone-free contraceptives approved by the FDA. So oviprene 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 Oviprene. 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 Oviprene Pivotal Phase III clinical study in December 2023. And as you may recall, women are followed over 13 cycles or 12 months of oviprene 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 study sites that are ongoing in the trial have been the most successful. In translating into study participants, the 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 gonna 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 a single registration study would be required to support a pre-market approval application submission with the FDA. So now onto the DARE HPV program. We mentioned at the start of the call and Marty 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, Dear 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. DARE-HPV is reflective of the type of development program we like to advance at DARE. 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, their 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 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 treatment. 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 receive 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 VBA-1 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 DRVVA1 based on our FDA-cleared IND for that use. And their 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 one clinical study. And that's supported by a $2 million grant from NICHD. That phase one 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 and Melinda Gates Foundation. In addition to the important support for the oviprene clinical trial, the grant will also support activities to de-risk the development of a novel non-hormonal 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 an 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 non-hormonal product development and our proven ability to advance development of differentiated product candidates that fulfill unmet needs in women's health. We'll receive, as Marty 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-month period term of that grant agreement. So similar to the ARPA-H award, which is also a 24-month period term, 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 Zosciato and Bayer for Obaprene, as well as funding agencies 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.

Sabrina, we will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star 1 again. If you are called upon to ask your question and are listening via speakerphone in your device, Please pick up your handset to ensure that your phone is not on mute when asking your question. Again, press star one to join the queue. From the line of Katherine Novak with Jones Trading, your line is open.

Hi, good afternoon. Congrats on all the progress. Congrats especially on, you know, being able to expand or accelerate enrollment in the oviprene study. So I just wanted to touch on the potential interim look by the end of Q25. Is this something we're still expecting? And then what should we be looking for from this interim readout? Is it just safety or how much efficacy can we learn from an interim readout?

Yeah, Catherine, that's a great question. So thanks for asking. And first of all, and 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 you know, go even faster with the program. So we're thrilled about that. In terms of, you know, getting partway through that important enrollment milestone and kind of having that critical, you know, 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 trials. in that everyone in the study, just for ethical reasons, 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, you know, this is a 12-month or 13-cycle program ultimate contraceptive study, and there's a lot of data to indicate that contraceptive rates just get better 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 we will give more updates on that as we get closer.

Great. And then just one more on sildenafil. Can you share a little bit more about what you mean by operational progress towards phase three? And if you can let us know what's still outstanding when it comes to your FDA interactions. Do they need additional information or do they have anything else that they need from you in order to move this along?

Yeah, more great questions. So first of all, what I mean in terms of operational progress is kind of taking a step back and actually going to the second part of your question around discussions with the FDA. Really, our discussions with the FDA have importantly very much been focused on, you know, at end of phase two, they're always focused on big picture, right? What all do we need for the NDA submission? Of course, that's an important part of end of phase two. But in a circumstance like this, when you're pursuing development of a first-in-category product for which the first-in-category fantastic opportunity is because no one's done this before, and so a lot of the focus is really on what should be the appropriate endpoints for a Phase III program, what's important to monitor, what's important to demonstrate. So really that's then a lot of the focus of the conversation and what does that Phase 3 program look like, right? What are the expectations in terms of efficacy and safety from that Phase 3 program? And we've shared before that the expectation is two Phase 3 trials to support registration. But, you know, the detail around what exactly does that entail and what's going to be required. So that's really where the focus has been. And the Phase 2 data... is so rich. It was a learning experience for everyone in terms of the patient population, the endpoints, where they see improvement, where they want to see improvement. And so it's really just going through all that. So frankly, more than anything, it's just time. And these interactions, it's not like you get to just call the FDA every day and have a conversation. So it's very sort of processed in terms of how communication goes back and forth. So it's really just going through that, answering questions, getting feedback, and aligning. But as I said up front, it's been very constructive. We've been very pleased with how constructive the FDA has been in collaborating with us and wanting very much to also get us to the place where where we can be ready to go, but making sure they understand how important it is to us and our shareholders that there's great alignment on the expectations for phase three. So that's what we're really trying to ensure, you know, importantly around expectations for success so that we can clearly communicate those and we all know what we're working towards. In terms of then operational readiness, it's really around making sure that as soon as we reach that alignment, we're ready to go. So ready to go in the things that we can control, such as making sure CRO that we want to work with, making sure we know the sites that we want to work with, making sure that we have drug supply so that we're not waiting to manufacture something. So those are all the things that are completely within our control and that we've been doing to make sure that we are you know, operationally ready such that all we're waiting for is having that phase three protocol that we know everyone's aligned on so that we can then, you know, initiate the process to go. Obviously, we always have to think about, you know, financial considerations, which is also why we've tried to make sure that we're ready for that as well in terms of some of the structures that Marty talked about that we've put in place.

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 Tao with HC Wainwright. Your line is open. Hello. Mr. Douglas Tao, I think your microphone is on mute. All right. Our next question comes from the line of Camp Oliver from Brookline Capital Markets. Your line is open.

Thank you. I'm definitely not on mute. So a couple of questions, if I may. With the overpring trial and this potential interim look, obviously it wouldn't be at a point where you would stop the trial early. So what specific actions might follow from doing that analysis?

Yeah, it's a great question. What the DSM is charged with is really obviously monitoring safety, so that's routine. And it's a great question. That's part of why there's obviously been discussion around it. One can look because it's open label. So one can take a look. Obviously, there's no value in doing that until you're kind of far enough in the study to have enough patience and cycles you know, in order to look at anything, frankly, safety or efficacy perspective. And so there isn't anything, you know, specific beyond that that I can say at this time. It's one of those situations where one can. And the reason that time point is also important is, you know, it is sort of the, you know, partway through, right, the study. And there really isn't any contraceptive product, at least to my knowledge, that's ever been studied for less than that time period, right? You need a certain number of cycles in six months at least looking at these methods. And so that's why that time point, you know, for us has been something, you know, we've thought about and when are we going to be there, right? It's an important sort of milestone. You know, I wish I had a clearer question for you. Like I said up front, there are things that you know, we have to think about in terms of, you know, what we look at then and what we do with that information given what we know very well in the literature about contraceptive studies and how there can be changes in a PERL index between six and 13 months, always getting better, you know, over that time frame. So that does, you know, raise considerations and particularly also for our commercialization partner, Bayer. So... More to follow as we get closer. Importantly, we obviously will be doing our DSM safety assessments, and that's also an important one at that point as well.

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

Yeah, that's a great question. So, and just to be clear too, we have, there's 20 total sites under the clinical trial contraceptive network under the NIH. And, you know, all of those sites have been involved in the study and obviously, you know, would have active patients that are continuing to be followed. We are focusing now recruitment efforts on a little more than half, so a little more than 10 sites. of the sites that, as I mentioned on the August call and kind of reiterated today, have really been quite exceptional in terms of how they translate the interest from the patient from women in the study into study participants. So, you know, we want to be thoughtful with the resources that we have together under our collaborative research agreement with the NIH that really covers those sites in the study and so that's why as we think about forward-looking recruitment, we're really focused on that 10 plus sites through that TCTN group of sites. The additional funding will likely allow us to add a handful of sites to the study, which for a study of this size and just given how many sites we've had and how many have been really our active really efficient enrollers that can have a meaningful impact. So that's why we're super excited about being able to do it, and it allows us to add sites that are outside of the CCTN network. We've been honored and really happy to be working with the CCTN network, the Contraceptive Clinical Trial Network that works so closely with the NIH. But we've also had fantastic experience with community-based sites that have worked with us on all of our other studies. They were in our Zosciato study. They've been in our Sildenafil study. So we're also very excited to get a chance to work with some of them on oviprene as well because they've been very anxious to do so.

Great. And my last question relates to Sildenafil. And, you know, just to think about the potential timeframe, you know, once you get FDA approval, alignment and deal 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?

Yeah, another great question. I mean, really, if you think about operations, like a study startup, we've done as much as we can up front, but there's still operational things that, you know, that take, you know, not days, but weeks and, you know, sometimes several weeks around contracting the sites, things we can't do, even though we know who we want to work with, you can't do until you have the final protocol going through IRB. You know, so those are those things that... we'll go as fast as we can. But there is traditional study startup that some of those things we cannot do until we have the final protocol. So that, to your point, on protocol and funding, then it's just those traditional study startup activities that can often take a couple to a few months, realistically, with site initiations as well.

So a start next year is possible.

Absolutely. Yes, absolutely. Yeah, once we get that final protocol, you know, aligned with the FDA, then, yeah, then it's down to your point. Obviously, you always have to think about the money, importantly, but then it's really just that operational study startup, things like the IRB, the site contracts, and the said initiations.

Great, thank you.

Thanks. Next question from Douglas Tao with HC 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 overview study and the addition of these new sites. How quickly do you anticipate them sort of being able to enroll studies in the trial? And ultimately, you know, sort of do you have a sense of what percentage of the total enrollment might come from these sites? And, you know, will there be sort of, you know, sort of different types of patients that will be added by going outside of the CTN network?

Yeah, more great questions. So, you know, as I kind of alluded to in the last question, you know, from Kemp, these are, you know, sites that we've identified that we would like to add to the study are sites that we've had great experiences with in the past and have a nice track record with. You know, some of them have done both our bacterial vaginosis study as well as the sedentary studies. Some of them just did one. of those studies, but what that translates into is we've contracted with them before, we've worked with them before, so there are going to be efficiencies that would be very different than if we were going out to brand new sites that we don't know. So our expectation is that, again, this is still, it's weeks, right? It's not days, it's weeks to get through this process, but our expectation is we're going to work really quickly to get those sites up and going as quickly as possible, you know, up and going as quickly as possible in the new year, right? We're going to use this time now through the end of the year to work quickly with them and we know who they are that we want to work with. And in terms of your also great question around is going to bring into the study, you know, different types of subjects, you know, we're also always looking at demographics as well. in terms of the women that are enrolling in the study. And we do want to ensure we're hitting some diversity objectives in different parts of the country as well that we're allowing to participate in the study. So it also does give us some additional, I think, kind of opportunity in that regard as well that we want to be very thoughtful about and leveraging. And then in terms of what proportion of the subjects Could they contribute to the study? You know, these are, again, these are sites that have performed very well for us historically in terms of translating, like in the Sedentafil study, translating, again, interest into participants. And that's not trivial, by the way. And, you know, the Clinical Trial Contraceptive Network sites have been great, and just some of them are better than that at others for this particular study. And so that's what it's going to come down to is sort of how the interest is there. And we're selecting sites that have shown us in the past can be very, including in past contraceptive studies that they've run, can be very efficient in translating someone who's interested and meets the eligibility criteria for the study into a study participant. And, you know, if they do that well, they can make a meaningful, you know, We're not so far along in the study that they can't make a meaningful contribution. They can still make a meaningful contribution to the study participants. And we think that would be great in terms of also just overall diversity in the study and diversity of sites.

That's helpful. And Sabrina, you did mention sort of the amount of funding that would be needed to complete this identical screening program. I'm just curious about some thoughts on how much of that you need up front to begin the program.

Yeah, I mean, this is, you know, I would say a particular study, an individual study, we're estimating based on all the conversations we've been, you know, having with the FDA and as well as the CRO, it's about $15 million. you know, of sort of direct external costs related to each of the studies. So that's 30 in total if you add the two together. So, you know, certainly there's not an expectation that we would want to make sure we had 30 million before we started. But, you know, a particular trial is 15 million, and so 15 is an important number for us to think about. Now, having said that, this is not – you know, obviously it's not a life-threatening condition, and it's, you know, the expectation is it's going to be a fairly, you know, it's a shorter study period, you know, for the women who are participating. So, you know, you can be creative around that in terms of how much you literally need up front before you start because it's such a short period of time. You can, you know, keep enrolling and completing, right, people, right? So those are all things we're going to look at at the time, but I think the important thing is to understand that we don't need $30 million, but an individual study is $15 million, and we want to make sure we feel very confident, even if not all of that is there up front, that we feel very confident that we're going to be able to continue the women through the study.

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

Yeah. 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 DARI's stakeholders by identifying and advancing potential new therapies to provide additional choices, enhance outcome, 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 DARI's 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.